Low Back PainNCT06599645
Impact of Combined CST, BFR, and Tai Chi on Muscle Physiology and Functional Characteristics Among Adults With LBP
A study testing CST+BFR+Tai Chi+Education, CST+BFR+Education and Tai Chi +BFR+Education in people with Low Back Pain, run by Universiti Teknologi Mara.
Trial summary
Background: Low back pain (LBP) is highly prevalent globally, affecting people of all ages(Wu et al., 2020). In China, LBP is a leading cause of disease burden(Wu et al., 2019). Exercise therapy such as core stability training(CST), Tai Chi(TC) and education are commonly recommended treatments, but research on optimal… Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Low Back Pain
- What is being tested?
- CST+BFR+Tai Chi+Education, CST+BFR+Education and Tai Chi +BFR+Education
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- No sites listed yet
- Study dates
- 8 Oct 2024to 31 Jul 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- All participants had stable vital signs, were cognizant, and had no cognitive impairment.
- Aged 18-60 years old, able to understand Mandarin Chinese, and willing to cooperate.
- LBP duration ≥ 3 months.
- Be diagnosed as NLBP.
- VAS score ≤ 5 points.
Who cannot join
- Patients with severe heart disease, liver disease, renal disease, pulmonary insufficiency, tumors, and postoperative dysfunction.
- Patients who are unconscious and unable to cooperate.
- Spinal fractures, severe arthritis, bony spinal stenosis, ankylosing spondylitis, open fractures, or unhealed traumatic wounds.
- Patients who have not been diagnosed with NLBP.
- Unable to communicate and read in Chinese.
- Age <18 \& >60 years old.
Show all 9Show fewer
- LBP duration < 3 months.
- Patients with high blood pressure and abnormal heartbeat.
- VAS score > 5 points.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Impact of Combined Core Stability Training, Blood Flow Restriction, and Tai Chi on Muscle Physiology and Functional Characteristics Among Adults With Low Back Pain
Background:
Low back pain (LBP) is highly prevalent globally, affecting people of all ages(Wu et al., 2020). In China, LBP is a leading cause of disease burden(Wu et al., 2019). Exercise therapy such as core stability training(CST), Tai Chi(TC) and education are commonly recommended treatments, but research on optimal protocols has been limited. Blood flow restriction(BFR) is beneficial for inducing muscle hypertrophy and promoting muscle strength (Hughes et al., 2019). Combined approaches using multiple modalities may provide added benefits but are understudied.
Read more
Research objectives:
- To determine the effects of combined CST, BFR and Tai Chi on muscle physiology (muscle activation, muscle fatigue, back extensor strength, and transverses abdominus control) among working adults with LBP.
- To determine the effects of combined CST+ BFR+Tai Chi on functional performance (gait speed, balance, proprioception, and postural sway) among working adults with LBP.
- To determine the effects of combined CST+BFR+Tai Chi on pain intensity among working adults with LBP.
- To determine the effects of combined CST+BFR+Tai Chi on fear among working adults with LBP.
Location of research:
Qianxinan Wutong Orthopedic Hospital, Guizhou Province, China
Instrumentations:
- Demographic Data
- Surface Electromyography (S-EMG)
- Pressure Biofeedback Unit (PBU)
- Back Extensor Strength Test (BEST)
- Joint Repositioning Error(JRE)
- APECS app
- Y-Balance Test(YBT)
8.10-Meter Walk Test(10MWT)
9.Visual Analogue Scale (VAS)
10.Chinese version of the Fear-Avoidance Beliefs Questionnaire(FABQ-CHI)
Interventions:
Group A: CST+BFR+Tai Chi+Education;
Group B: CST+BFR+Education;
Group C: Tai Chi +BFR+Education;
Group D: CST+Education.
Sample size:
Considering 30% drop out. 52 participants. 13 participants in each group
Statistical analysis:
Data were processed using SPSS version 25.0 and Microsoft Excel 2010 software.
- Demographic data = descriptive analytics.
- All objectives = repeated measure ANCOVA (within-between interactions) for all variables.
- The significant level is P < 0.05.
Read the detailed description
Research objectives:
- To determine the effects of combined CST, BFR and Tai Chi on muscle physiology (muscle activation, muscle fatigue, back extensor strength, and transverses abdominus control) among working adults with LBP.
- To determine the effects of combined CST+ BFR+Tai Chi on functional performance (gait speed, balance, proprioception, and postural sway) among working adults with LBP.
- To determine the effects of combined CST+BFR+Tai Chi on pain intensity among working adults with LBP.
- To determine the effects of combined CST+BFR+Tai Chi on fear among working adults with LBP.
Test methods for each indicator:
- The RMS and MF value test by S-EMG For each muscle, double electrode sheets are put to the belly. The electrode placement site is as follows: ①Erecter spinae: Open 2cm lateral to the midline of the trunk, between the spinous process of the twelfth thoracic vertebra and the first lumbar vertebra. ②Multifidus: 2cm next to the L4-5 interspinous. ③Rectus abdominis: On both sides of the midline of the abdomen, 3cm away from the navel. ④Transversus abdominis: Approximately 2 cm medial to the intersection of the vertical line traversing the anterior superior iliac spine and the lower border of the costal arch. Test action: Back Bridge, Side Bridge, Abdominal Bridge. Each action lasts 10 seconds, and there is a 2-minute break between two adjacent actions to ensure that muscle weariness from the previous measurement does not interfere with the following measurement. S-EMG analysis: It is the recording of electrical activity in muscles utilizing the BioForce surface electromyography tester model JE-TB1610 and the accompanying wireless data collection equipment. The sampling frequency was 2000Hz, the above three exercise groups lasted 10 seconds each, and the original EMG signal was recorded for 10 seconds. Use the InstallShield Wizard operating software to execute 10-500Hz noise processing on the original muscle electrical data(Perchthaler et al., 2015). Then, from the 3rd to the 7th second, extract the data, remove the baseline, demodulate and smooth the original signal, take the absolute value of the signal during the demodulation process, and acquire the average value of the EMG data from the 3rd to the 7th second (RMS value, MF value).
- Transverses abdominus control test In the case of muscle control, which is quantified by PBU. In the prone position, the transversus abdominis will be tested. The inflated cuff will be placed beneath the abdomen at the anterior superior iliac spine level. The patient will be asked to draw in the lower abdomen without moving the upper stomach, back, or pelvis once the PBU has been inflated to 70 mm Hg. Readings will be taken at the end of a 10-second contraction. Two submaximal force tests will be performed to familiarise participants with each test position, followed by two repeats of maximum isometric contraction. For analysis, the average of the two greatest contractions will be used(Cairns et al., 2000).
- Back extensor strength test The participant will be seated on the treatment table with their head in the midline, trunk straight, arms along their body, palms facing upwards, and feet over the table's edge. The dynamometer will be placed at the inferior angle of the scapulae, in the center of the back between the shoulder blades. The therapist will be above and to the side of the patient. The test will be executed by the guidelines of Yang et al. (2020). After obtaining the proper starting posture, the participant will be asked to relax their arms, lift their head and chest, and push back against the dynamometer for 5 seconds with maximal force (N) .
- Lumbar proprioception test The procedure utilized for the proprioception test was reported by Puntumetakul(2018). "The participant was seated (90° hips and knees) with feet on the ground and hands on thighs, and the examiner guided the participant into the neutral lumbar spine position." The center of the 10-centimeter tape measure was placed on sacral segment 1 (S1) as the measurement's starting point. The start point was marked by a laser pointer with a stable foundation. The examiner advised the participant to "remember the target position, then perform the maximum anterior and posterior pelvic tilt twice, holding each position for five seconds," before returning to the neutral target position. As a combined repositioning error, deviation from the starting location was assessed in centimeters. The participant received no feedback regarding any errors. The participants practiced the relocation test twice before the evaluation. This examination process was repeated three times with one-minute rest intervals in between. For analysis, the mean values will be employed.
- Trunk postural sway test According to Trovato et al.(2020), APECS will record the participants in a standing stance for the 30s, and participants will be asked to wear little clothes to reduce biases associated with incorrect landmark positioning during the postural analysis; for the same reason, trained clinicians will place markers on the participants' bodies in correlation to the app's specified landmarks. One video will be taken for the sagittal plane (left). Participants will be told to keep their feet the same width as their shoulders. Finally, the videos that meet the regulations will be imported into the video analysis system in APECS for analysis. The maximum angle of the torso wobbles will be recorded and used for analysis.
- Standing dynamic balance test While standing on one leg (barefoot) in a central location on the Y-Balance Test instrument, with hands on the wing of the ilium, the subjects will be asked to move the pointer as far as possible in three directions - anterior, posteromedial, and posterolateral. All Y-Balance Test efforts will be made in the same order: first in the anterior direction, then in the posterolateral direction, and finally in the posteromedial direction. Participants moved the pointer with their dominant leg first. The following is the measuring protocol (Linek et al., 2017): 1. A training effort consists of four replications of the right and left lower limbs in each of three directions: anterior, posteromedial, and posterolateral. 2. Execution of the proper test, which consisted of three attempts in each direction, measuring the distance between the pointer's closest location and the central plate. Only when the individual tested was able to return to the starting location while fully controlling the movement was the result of each attempt saved. During the performance of an attempt, the following will be considered irregularities: support using the movement-performing limb on the surface of the pointer to maintain balance, pushing the pointer to achieve a better result, changing the starting position (taking the upper limbs off the iliac wing). In such a case, the participant repeated the attempt until three properly accomplished repetitions were obtained (Linek et al., 2017). For the analysis, the maximum reach distance in each direction and the composite score are employed (Picot et al., 2021)
- Gait speed test For gait speed, a 10-meter walk test was used, which required the participant to walk for 10 meters in a straight line at their normal speed, with a 1-meter start-up before starting timing and a 1-meter stop-time timing. It is permissible to employ an assistance walking device. For the walking test, each participant completed three consecutive trials. The participants are told to "walk at your normal, comfortable pace" until they reach the end of the indicated course. The duration is recorded using a stopwatch, which is started when the participant's lead leg (or assistive device) crosses the first marker and stopped when the participant's lead leg (or assistive device) crosses the second marker. By dividing the distance of 8 m by the time recorded, the recorded time is translated into walking speed (m/s).
- Fear avoidance belief test The subject will next be allowed 3-5 minutes to respond to the FABQ-CHI. Those who are unable to read will receive assistance.
- Pain test
Finally, the subject will be allowed 2-3 minutes to respond to the VAS. The following is the specific evaluation method: Choose a 10 cm ruler and face the experimenter with it marked with a complete digital scale from 0 to 10. The patient only sees scales at both ends of the ruler, and the 0 end is blank. "No pain" implies no pain at all, "14" means mild pain, "56" means moderate discomfort, "7" or more means severe pain, and "10" signifies agonizing pain(Langley \& Sheppard, 1985). When the low back pain arises on the 0 scale, the patient begins to picture his pain state, and the experimenter notes the ultimate number, which can be immediately recorded as the patient's pain intensity score(Wewers \& Lowe, 1990).
Rest for 30-60 seconds between tests to remove the confounding impact of weariness.
Procedure
This study will screen subjects according to inclusion and exclusion criteria. Before the evaluation and examination, the physiotherapist will tell the participants the purpose and methods, and the participants need to sign the consent form. The demographic data, which includes biographical information, short questions concerning the occurrence of LBP, and past medical history, will then be recorded. The subjects must then complete the anthropometric data, such as weight, height, and BMI. All patients require blood pressure and heart rate measurements before and after treatment.
For all subjects, the measurement indicators will be measured before the intervention, six weeks after the treatment, and 12 weeks after the treatment. In addition, all the subjects need to perform a warm-up before each exercise intervention and a cooldown after the exercise intervention. Warm up includes walking (5 min) and dynamic stretching (5 mins). Cooldown includes static stretching (5 min).
For group A, subjects will receive education from a qualified physiotherapist before the first treatment. Subsequent treatment begins with a warm-up. After the warm up, the physical therapist will install the BFR device for the subject as required. Then, the patients will receive CST for 15 minutes. Then, they will receive Tai Chi practice for 15 minutes. Finally, complete a 5-minute cooldown. The above treatments are performed 3 times a week for 12 weeks(Zou, Zhang, Liu, et al., 2019).
For group B, subjects will receive education from a qualified physiotherapist before the first treatment. Subsequent treatment begins with a warm-up. After the warm up, the physical therapist will install the BFR device for the subject as required. Then, the patients will receive CST for 30 minutes. Finally, complete a 5-minute cooldown. The above treatments are performed 3 times a week for 12 weeks(Nipa et al., 2022).
For group C, subjects will receive education from a qualified physiotherapist before the first treatment. Subsequent treatment begins with a warm-up. After the warm up, the physical therapist will install the BFR device for the subject as required. Then, the patients will receive Tai Chi for 30 minutes. Finally, complete a 5-minute cooldown. The above treatments are performed 3 times a week for 12 weeks(Qin et al., 2019).
For group D, subjects will receive education from a qualified physiotherapist before the first treatment. Subsequent treatment begins with a warm-up. Then, the patients will receive CST for 30 minutes. Finally, complete a 5-minute cooldown. The above treatments are performed 3 times a week for 12 weeks(Nipa et al., 2022).
Statistical analysis:
Data were processed using SPSS version 25.0 and Microsoft Excel 2010 software.
- Demographic data = descriptive analytics.
- All objectives = repeated measure ANCOVA (within-between interactions) for all variables.
- The significant level is P < 0.05.
- Conditions
- Low Back Pain
- Being tested
- CST+BFR+Tai Chi+Education, CST+BFR+Education, Tai Chi +BFR+Education, CST+Education
- Keywords
- Tai Ji; Core stability; Low back pain
- Medical subject headings
- Low Back Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CST+BFR+Tai Chi+EducationOther
- Core Stability Training: It includes core activation exercises (feed-forward control)(Libenson,2006). Each set will consist of 10 repetitions of this exercise with a 10-second hold. There will be a 30-second rest between repetitions and a 60-second rest after each set.
- Tai Chi: The first 10 Tai Chi movements from the 24-simplified Tai Chi form. Three qualified teachers will lead the training sessions.
- Blood Flow Restriction: The professional physical therapist puts on the cuff pneumatic tourniquet system(Kaastu Master) on the proximal end of the left lower limb of the subjects and gives a certain pressure through the Kaastu Master. The pressure needs to ensure that the venous return of the particapants is restricted to perfect ground, while the artery still has some blood flow.
- Education: After enrollment, patients will receive face-to-face education sessions at baseline, 30-45 min each time. Guided education by the same experienced professional physiotherapist.
CST+BFR+EducationOther
- Core Stability Training: It includes core activation exercises (feed-forward control)(Libenson,2006). Each set will consist of 10 repetitions of this exercise with a 10-second hold. There will be a 30-second rest between repetitions and a 60-second rest after each set.
- Blood Flow Restriction: The professional physical therapist puts on the cuff pneumatic tourniquet system(Kaastu Master) on the proximal end of the left lower limb of the subjects and gives a certain pressure through the Kaastu Master. The pressure needs to ensure that the venous return of the particapants is restricted to perfect ground, while the artery still has some blood flow.
- Education: After enrollment, patients will receive face-to-face education sessions at baseline, 30-45 min each time. Guided education by the same experienced professional physiotherapist.
Tai Chi +BFR+EducationOther
- Tai Chi: The first 10 Tai Chi movements from the 24-simplified Tai Chi form. Three qualified teachers will lead the training sessions.
- Blood Flow Restriction: The professional physical therapist puts on the cuff pneumatic tourniquet system(Kaastu Master) on the proximal end of the left lower limb of the subjects and gives a certain pressure through the Kaastu Master. The pressure needs to ensure that the venous return of the particapants is restricted to perfect ground, while the artery still has some blood flow.
- Education: After enrollment, patients will receive face-to-face education sessions at baseline, 30-45 min each time. Guided education by the same experienced professional physiotherapist.
CST+EducationOther
- Core Stability Training: It includes core activation exercises (feed-forward control)(Libenson,2006). Each set will consist of 10 repetitions of this exercise with a 10-second hold. There will be a 30-second rest between repetitions and a 60-second rest after each set.
- Education: After enrollment, patients will receive face-to-face education sessions at baseline, 30-45 min each time. Guided education by the same experienced professional physiotherapist.
| Study group | Role | What they receive |
|---|---|---|
| Group A | Experimental | CST+BFR+Tai Chi+Education Receives: Other: CST+BFR+Tai Chi+Education |
| Group B | Experimental | CST+BFR+Education Receives: Other: CST+BFR+Education |
| Group C | Experimental | Tai Chi +BFR+Education Receives: Other: Tai Chi +BFR+Education |
| Group D | Other | CST+Education Receives: Other: CST+Education |
What is being measured
The primary outcome is the main question the study is designed to answer.
Core muscle activation by root mean square(RMS)
Root Mean Square (RMS) is a vector used to analyze the properties of electrical signal fluctuations, and the size of the RMS value represents the level of activity of a certain muscle(Abdelouahad et al., 2018). Absolute RMS demonstrated the highest overall dependability (ICC: 0.66-0.98) across activities (ICC: 0.66-0.98)(Van Helden et al., 2022).
Measured: Baseline (1st week), 6th week, and 12th week
Core muscle fatigue by mean frequency (MF)
Mean Frequency (MF) is a frequency-domain index that represents the midpoint of muscle fiber discharge frequency during skeletal muscle contraction. It is widely assumed that it is connected to the proportion of fast and slow fibers in muscle tissue. The multifidus muscle demonstrated good to outstanding reproducibility of initial MF and MF fatigue changes during Trunk Holding Tests (ICCwithindays =82%; ICCbetweendays =78%) (Ng \& Richardson, 1996).
Measured: Baseline (1st week), 6th week, and 12th week
Abdominal drawing-in maneuver by the pressure biofeedback unit (PBU)
The Pressure Biofeedback Unit (PBU) device consists of a pressure transducer with three airbags, a catheter, and a sphygmomanometer (with a range of 0 to 200 mmHg). It will be applied to evaluate abdominal drawing-in movements objectively (Grooms et al., 2013b). It is a trustworthy clinical instrument for assessing deep abdominal muscle function, with moderate to good (ICC = 0.47-0.82) and acceptable construct validity (ICC = 0.48-0.90) (P. O. D. P. Lima et al., 2011).
Measured: Baseline (1st week), 6th week, and 12th week
Back Extensor Strength by a push-pull dynamometer
A push-pull dynamometer will be applied to assess back extensor strength in the prone position. Because of its acceptable reliability (ICC=0.93), validity (r=0.54), and measurement errors, maximal isometric back extensor strength assessment in a prone posture can be applied to individuals with varying levels of back strength and may be the most useful for ranking back extensor strength in clinical and epidemiological studies (Yang et al., 2020).
Measured: Baseline (1st week), 6th week, and 12th week
Postural sway by the mobile app APECS
The application of a mobile app could represent a quick, safe, and accurate method for researchers and clinicians to evaluate general posture quantitatively. Adopting a movable and affordable tool for postural assessment could benefit the primary prevention of musculoskeletal disorders of the spine. The mobile app APECS-AI Posture Evaluation and Correction System® (New Body Technologies SAS, Grenoble, France) (APECS app) will be applied to evaluate the subject's postural sway in this study. The evaluation index is the maximum angle of the torso wobbles. According to a recommendation from a study, clinicians should consider APECS's worth as an auxiliary posture evaluation tool with (ICC > 0.60) (Trovato et al., 2022).
Measured: Baseline (1st week), 6th week, and 12th week
Balance by Y-Balance Test
The Y-Balance Test Kit will be applied to measure balance in this study. The device includes a single central plastic plate and three attached tubes positioned anteriorly, posteromedially, and posterolaterally. A measurement with a 0.5 cm spacing is placed on each of the tubes. A study found that the Y-Balance Test has high inter-rater reliability and validity for assessing dynamic balance in the CLBP group (Alshehre et al., 2021).
Measured: Baseline (1st week), 6th week, and 12th week
Lumbar proprioception by joint repositioning error(JRE)
The primary result of proprioception was a joint repositioning error(JRE). The absolute error, constant error, and variable error can all be used to describe repositioning errors. We picked absolute error since it affects accuracy(Strimpakos et al., 2006), reflects the magnitude of the inaccuracy (Sheeran et al., 2012), and is the most widely used measurement (Tong et al., 2017). The proprioception test had great inter-rater reliability(ICC=0.61-0.76)(Petersen \& Rundquist, 2009).
Measured: Baseline (1st week), 6th week, and 12th week
Gait speed by the 10-meter walk test.
The gait speed is measured using the 10-Meter Walk Test. The gait speed test is the most commonly used outcome measure to assess functional limitations of the lower limbs (Muñoz-Mendoza et al., n.d.). With ICC values ranging from 0.96 to 0.98, 10m gait speed measurement shows outstanding test-retest reliability(Peters et al., 2013).
Measured: Baseline (1st week), 6th week, and 12th week
Fear avoidance belief by the Chinese version of the Fear-avoidance Beliefs. Questionnaire (FABQ-CHI)
The Chinese version of the Fear-avoidance Beliefs Questionnaire (FABQ-CHI) is a relatively basic, easy-to-understand, easy-to-use, low-cost, and comprehensive LBP evaluation tool. The FABQ-CHI was shown to have adequate factor structure, internal consistency, test-retest reliability, and construct validity. (Pei et al., 2010). The maximum possible score for each question is 6, the lowest possible score is 0, and the total score is 96. The higher the score, the greater the severity of the perceived fear-avoidance belief.
Measured: Baseline (1st week), 6th week, and 12th week
Pain by visual analogue scale (VAS)
Visual Analogue Scale (VAS) is a 10 cm horizontal strip with numbers ranging from 0 to 10 (the most severe pain possible). This is one of the most dependable quantitative scales that is commonly utilized in research (Scrimshaw \& Maher, 2001). VAS has proven to be trustworthy and valid (ICC=0.49-0.83) (Crossley et al., 2004).
Measured: Baseline (1st week), 6th week, and 12th week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2024
- Study start8 Oct 2024 (estimated)
- Primary completion8 May 2025 (estimated)
- Study completion31 Jul 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (18)Papers the sponsor has linked to this study.
- Other trials for Low Back PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 52 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universiti Teknologi Mara
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lin Pipeng, Universiti Teknologi Mara
- Investigators
- Zarina Zahari, Doctor, Study director, Centre of Physiotherapy, Faculty of Health Sciences, Universiti Teknologi MARA, Malaysia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06599645
- Sponsor's protocol ID
- LPipeng
- Status last verified
- Sep 2024
- First submitted
- 13 Sep 2024
- Last updated
- 19 Sep 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Abdelraouf OR, Abdel-Aziem AA. THE RELATIONSHIP BETWEEN CORE ENDURANCE AND BACK DYSFUNCTION IN COLLEGIATE MALE ATHLETES WITH AND WITHOUT NONSPECIFIC LOW BACK PAIN. Int J Sports Phys Ther. 2016 Jun;11(3):337-44.
PubMed 27274419Abe T, Kearns CF, Sato Y. Muscle size and strength are increased following walk training with restricted venous blood flow from the leg muscle, Kaatsu-walk training. J Appl Physiol (1985). 2006 May;100(5):1460-6. doi: 10.1152/japplphysiol.01267.2005. Epub 2005 Dec 8.
PubMed 16339340Ainpradub K, Sitthipornvorakul E, Janwantanakul P, van der Beek AJ. Effect of education on non-specific neck and low back pain: A meta-analysis of randomized controlled trials. Man Ther. 2016 Apr;22:31-41. doi: 10.1016/j.math.2015.10.012. Epub 2015 Nov 2.
PubMed 26585295Dos Santos LP, Santo RCDE, Ramis TR, Portes JKS, Chakr RMDS, Xavier RM. The effects of resistance training with blood flow restriction on muscle strength, muscle hypertrophy and functionality in patients with osteoarthritis and rheumatoid arthritis: A systematic review with meta-analysis. PLoS One. 2021 Nov 10;16(11):e0259574. doi: 10.1371/journal.pone.0259574. eCollection 2021.
PubMed 34758045Foster NE, Anema JR, Cherkin D, Chou R, Cohen SP, Gross DP, Ferreira PH, Fritz JM, Koes BW, Peul W, Turner JA, Maher CG; Lancet Low Back Pain Series Working Group. Prevention and treatment of low back pain: evidence, challenges, and promising directions. Lancet. 2018 Jun 9;391(10137):2368-2383. doi: 10.1016/S0140-6736(18)30489-6. Epub 2018 Mar 21.
PubMed 29573872Hughes L, Rosenblatt B, Haddad F, Gissane C, McCarthy D, Clarke T, Ferris G, Dawes J, Paton B, Patterson SD. Comparing the Effectiveness of Blood Flow Restriction and Traditional Heavy Load Resistance Training in the Post-Surgery Rehabilitation of Anterior Cruciate Ligament Reconstruction Patients: A UK National Health Service Randomised Controlled Trial. Sports Med. 2019 Nov;49(11):1787-1805. doi: 10.1007/s40279-019-01137-2.
PubMed 31301034Korakakis V, Whiteley R, Epameinontidis K. Blood Flow Restriction induces hypoalgesia in recreationally active adult male anterior knee pain patients allowing therapeutic exercise loading. Phys Ther Sport. 2018 Jul;32:235-243. doi: 10.1016/j.ptsp.2018.05.021. Epub 2018 May 31.
PubMed 29879638Paungmali A, Henry LJ, Sitilertpisan P, Pirunsan U, Uthaikhup S. Improvements in tissue blood flow and lumbopelvic stability after lumbopelvic core stabilization training in patients with chronic non-specific low back pain. J Phys Ther Sci. 2016 Jan;28(2):635-40. doi: 10.1589/jpts.28.635. Epub 2016 Feb 29.
PubMed 27064327Qaseem A, Wilt TJ, McLean RM, Forciea MA; Clinical Guidelines Committee of the American College of Physicians; Denberg TD, Barry MJ, Boyd C, Chow RD, Fitterman N, Harris RP, Humphrey LL, Vijan S. Noninvasive Treatments for Acute, Subacute, and Chronic Low Back Pain: A Clinical Practice Guideline From the American College of Physicians. Ann Intern Med. 2017 Apr 4;166(7):514-530. doi: 10.7326/M16-2367. Epub 2017 Feb 14.
PubMed 28192789Qin J, Zhang Y, Wu L, He Z, Huang J, Tao J, Chen L. Effect of Tai Chi alone or as additional therapy on low back pain: Systematic review and meta-analysis of randomized controlled trials. Medicine (Baltimore). 2019 Sep;98(37):e17099. doi: 10.1097/MD.0000000000017099.
PubMed 31517838Semeru GM, Halim MS. Acceptance versus catastrophizing in predicting quality of life in patients with chronic low back pain. Korean J Pain. 2019 Jan;32(1):22-29. doi: 10.3344/kjp.2019.32.1.22. Epub 2019 Jan 2.
PubMed 30671200Smith BE, Littlewood C, May S. An update of stabilisation exercises for low back pain: a systematic review with meta-analysis. BMC Musculoskelet Disord. 2014 Dec 9;15:416. doi: 10.1186/1471-2474-15-416.
PubMed 25488399Vlaeyen JWS, Maher CG, Wiech K, Van Zundert J, Meloto CB, Diatchenko L, Battie MC, Goossens M, Koes B, Linton SJ. Low back pain. Nat Rev Dis Primers. 2018 Dec 13;4(1):52. doi: 10.1038/s41572-018-0052-1.
PubMed 30546064Wang R, Zhu D, Wang L, Liu J, Zou J, Sun Y, Jiang Y, Hu HY, Deng ZW, Weng LM, Zheng KY, Kiartivich S, Wang XQ. Tai Chi Quan Versus Physical Therapy on Pain and Cognitive Performance for Elderly People With Chronic Low Back Pain: Study Protocol for a Randomized Controlled Trial. Front Aging Neurosci. 2022 Jun 16;14:900430. doi: 10.3389/fnagi.2022.900430. eCollection 2022.
PubMed 35783144Wang XQ, Xiong HY, Du SH, Yang QH, Hu L. The effect and mechanism of traditional Chinese exercise for chronic low back pain in middle-aged and elderly patients: A systematic review. Front Aging Neurosci. 2022 Oct 10;14:935925. doi: 10.3389/fnagi.2022.935925. eCollection 2022.
PubMed 36299610
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Combined Core Stability Training, Blood Flow Restriction, and Tai Chi on Muscle Physiology and Functional Characteristics Among Adults With Low Back Pain
- ClinicalTrials.gov ID
- NCT06599645
- Acronym / sponsor ID
- LPipeng
- Conditions
- Low Back Pain
- Keywords
- Tai Ji; Core stability; Low back pain
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 52 participants (estimated)
- Lead sponsor
- Universiti Teknologi MaraUniversity, hospital or other
- Study start
- 8 Oct 2024 (estimated)
- Primary completion
- 8 May 2025 (estimated)
- Study completion
- 31 Jul 2025 (estimated)
- First posted
- 19 Sep 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Background:
Low back pain (LBP) is highly prevalent globally, affecting people of all ages(Wu et al., 2020). In China, LBP is a leading cause of disease burden(Wu et al., 2019). Exercise therapy such as core stability training(CST), Tai Chi(TC) and education are commonly recommended treatments, but research on optimal protocols has been limited. Blood flow restriction(BFR) is beneficial for inducing muscle hypertrophy and promoting muscle strength (Hughes et al., 2019). Combined approaches using multiple modalities may provide added benefits but are understudied.
Research objectives:
- To determine the effects of combined CST, BFR and Tai Chi on muscle physiology (muscle activation, muscle fatigue, back extensor strength, and transverses abdominus control) among working adults with LBP.
- To determine the effects of combined CST+ BFR+Tai Chi on functional performance (gait speed, balance, proprioception, and postural sway) among working adults with LBP.
- To determine the effects of combined CST+BFR+Tai Chi on pain intensity among working adults with LBP.
- To determine the effects of combined CST+BFR+Tai Chi on fear among working adults with LBP.
Location of research:
Qianxinan Wutong Orthopedic Hospital, Guizhou Province, China
Instrumentations:
- Demographic Data
- Surface Electromyography (S-EMG)
- Pressure Biofeedback Unit (PBU)
- Back Extensor Strength Test (BEST)
- Joint Repositioning Error(JRE)
- APECS app
- Y-Balance Test(YBT)
8.10-Meter Walk Test(10MWT)
9.Visual Analogue Scale (VAS)
10.Chinese version of the Fear-Avoidance Beliefs Questionnaire(FABQ-CHI)
Interventions:
Group A: CST+BFR+Tai Chi+Education;
Group B: CST+BFR+Education;
Group C: Tai Chi +BFR+Education;
Group D: CST+Education.
Sample size:
Considering 30% drop out. 52 participants. 13 participants in each group
Statistical analysis:
Data were processed using SPSS version 25.0 and Microsoft Excel 2010 software.
- Demographic data = descriptive analytics.
- All objectives = repeated measure ANCOVA (within-between interactions) for all variables.
- The significant level is P < 0.05.
Detailed description
Research objectives:
- To determine the effects of combined CST, BFR and Tai Chi on muscle physiology (muscle activation, muscle fatigue, back extensor strength, and transverses abdominus control) among working adults with LBP.
- To determine the effects of combined CST+ BFR+Tai Chi on functional performance (gait speed, balance, proprioception, and postural sway) among working adults with LBP.
- To determine the effects of combined CST+BFR+Tai Chi on pain intensity among working adults with LBP.
- To determine the effects of combined CST+BFR+Tai Chi on fear among working adults with LBP.
Test methods for each indicator:
- The RMS and MF value test by S-EMG For each muscle, double electrode sheets are put to the belly. The electrode placement site is as follows: ①Erecter spinae: Open 2cm lateral to the midline of the trunk, between the spinous process of the twelfth thoracic vertebra and the first lumbar vertebra. ②Multifidus: 2cm next to the L4-5 interspinous. ③Rectus abdominis: On both sides of the midline of the abdomen, 3cm away from the navel. ④Transversus abdominis: Approximately 2 cm medial to the intersection of the vertical line traversing the anterior superior iliac spine and the lower border of the costal arch. Test action: Back Bridge, Side Bridge, Abdominal Bridge. Each action lasts 10 seconds, and there is a 2-minute break between two adjacent actions to ensure that muscle weariness from the previous measurement does not interfere with the following measurement. S-EMG analysis: It is the recording of electrical activity in muscles utilizing the BioForce surface electromyography tester model JE-TB1610 and the accompanying wireless data collection equipment. The sampling frequency was 2000Hz, the above three exercise groups lasted 10 seconds each, and the original EMG signal was recorded for 10 seconds. Use the InstallShield Wizard operating software to execute 10-500Hz noise processing on the original muscle electrical data(Perchthaler et al., 2015). Then, from the 3rd to the 7th second, extract the data, remove the baseline, demodulate and smooth the original signal, take the absolute value of the signal during the demodulation process, and acquire the average value of the EMG data from the 3rd to the 7th second (RMS value, MF value).
- Transverses abdominus control test In the case of muscle control, which is quantified by PBU. In the prone position, the transversus abdominis will be tested. The inflated cuff will be placed beneath the abdomen at the anterior superior iliac spine level. The patient will be asked to draw in the lower abdomen without moving the upper stomach, back, or pelvis once the PBU has been inflated to 70 mm Hg. Readings will be taken at the end of a 10-second contraction. Two submaximal force tests will be performed to familiarise participants with each test position, followed by two repeats of maximum isometric contraction. For analysis, the average of the two greatest contractions will be used(Cairns et al., 2000).
- Back extensor strength test The participant will be seated on the treatment table with their head in the midline, trunk straight, arms along their body, palms facing upwards, and feet over the table's edge. The dynamometer will be placed at the inferior angle of the scapulae, in the center of the back between the shoulder blades. The therapist will be above and to the side of the patient. The test will be executed by the guidelines of Yang et al. (2020). After obtaining the proper starting posture, the participant will be asked to relax their arms, lift their head and chest, and push back against the dynamometer for 5 seconds with maximal force (N) .
- Lumbar proprioception test The procedure utilized for the proprioception test was reported by Puntumetakul(2018). "The participant was seated (90° hips and knees) with feet on the ground and hands on thighs, and the examiner guided the participant into the neutral lumbar spine position." The center of the 10-centimeter tape measure was placed on sacral segment 1 (S1) as the measurement's starting point. The start point was marked by a laser pointer with a stable foundation. The examiner advised the participant to "remember the target position, then perform the maximum anterior and posterior pelvic tilt twice, holding each position for five seconds," before returning to the neutral target position. As a combined repositioning error, deviation from the starting location was assessed in centimeters. The participant received no feedback regarding any errors. The participants practiced the relocation test twice before the evaluation. This examination process was repeated three times with one-minute rest intervals in between. For analysis, the mean values will be employed.
- Trunk postural sway test According to Trovato et al.(2020), APECS will record the participants in a standing stance for the 30s, and participants will be asked to wear little clothes to reduce biases associated with incorrect landmark positioning during the postural analysis; for the same reason, trained clinicians will place markers on the participants' bodies in correlation to the app's specified landmarks. One video will be taken for the sagittal plane (left). Participants will be told to keep their feet the same width as their shoulders. Finally, the videos that meet the regulations will be imported into the video analysis system in APECS for analysis. The maximum angle of the torso wobbles will be recorded and used for analysis.
- Standing dynamic balance test While standing on one leg (barefoot) in a central location on the Y-Balance Test instrument, with hands on the wing of the ilium, the subjects will be asked to move the pointer as far as possible in three directions - anterior, posteromedial, and posterolateral. All Y-Balance Test efforts will be made in the same order: first in the anterior direction, then in the posterolateral direction, and finally in the posteromedial direction. Participants moved the pointer with their dominant leg first. The following is the measuring protocol (Linek et al., 2017): 1. A training effort consists of four replications of the right and left lower limbs in each of three directions: anterior, posteromedial, and posterolateral. 2. Execution of the proper test, which consisted of three attempts in each direction, measuring the distance between the pointer's closest location and the central plate. Only when the individual tested was able to return to the starting location while fully controlling the movement was the result of each attempt saved. During the performance of an attempt, the following will be considered irregularities: support using the movement-performing limb on the surface of the pointer to maintain balance, pushing the pointer to achieve a better result, changing the starting position (taking the upper limbs off the iliac wing). In such a case, the participant repeated the attempt until three properly accomplished repetitions were obtained (Linek et al., 2017). For the analysis, the maximum reach distance in each direction and the composite score are employed (Picot et al., 2021)
- Gait speed test For gait speed, a 10-meter walk test was used, which required the participant to walk for 10 meters in a straight line at their normal speed, with a 1-meter start-up before starting timing and a 1-meter stop-time timing. It is permissible to employ an assistance walking device. For the walking test, each participant completed three consecutive trials. The participants are told to "walk at your normal, comfortable pace" until they reach the end of the indicated course. The duration is recorded using a stopwatch, which is started when the participant's lead leg (or assistive device) crosses the first marker and stopped when the participant's lead leg (or assistive device) crosses the second marker. By dividing the distance of 8 m by the time recorded, the recorded time is translated into walking speed (m/s).
- Fear avoidance belief test The subject will next be allowed 3-5 minutes to respond to the FABQ-CHI. Those who are unable to read will receive assistance.
- Pain test
Finally, the subject will be allowed 2-3 minutes to respond to the VAS. The following is the specific evaluation method: Choose a 10 cm ruler and face the experimenter with it marked with a complete digital scale from 0 to 10. The patient only sees scales at both ends of the ruler, and the 0 end is blank. "No pain" implies no pain at all, "14" means mild pain, "56" means moderate discomfort, "7" or more means severe pain, and "10" signifies agonizing pain(Langley \& Sheppard, 1985). When the low back pain arises on the 0 scale, the patient begins to picture his pain state, and the experimenter notes the ultimate number, which can be immediately recorded as the patient's pain intensity score(Wewers \& Lowe, 1990).
Rest for 30-60 seconds between tests to remove the confounding impact of weariness.
Procedure
This study will screen subjects according to inclusion and exclusion criteria. Before the evaluation and examination, the physiotherapist will tell the participants the purpose and methods, and the participants need to sign the consent form. The demographic data, which includes biographical information, short questions concerning the occurrence of LBP, and past medical history, will then be recorded. The subjects must then complete the anthropometric data, such as weight, height, and BMI. All patients require blood pressure and heart rate measurements before and after treatment.
For all subjects, the measurement indicators will be measured before the intervention, six weeks after the treatment, and 12 weeks after the treatment. In addition, all the subjects need to perform a warm-up before each exercise intervention and a cooldown after the exercise intervention. Warm up includes walking (5 min) and dynamic stretching (5 mins). Cooldown includes static stretching (5 min).
For group A, subjects will receive education from a qualified physiotherapist before the first treatment. Subsequent treatment begins with a warm-up. After the warm up, the physical therapist will install the BFR device for the subject as required. Then, the patients will receive CST for 15 minutes. Then, they will receive Tai Chi practice for 15 minutes. Finally, complete a 5-minute cooldown. The above treatments are performed 3 times a week for 12 weeks(Zou, Zhang, Liu, et al., 2019).
For group B, subjects will receive education from a qualified physiotherapist before the first treatment. Subsequent treatment begins with a warm-up. After the warm up, the physical therapist will install the BFR device for the subject as required. Then, the patients will receive CST for 30 minutes. Finally, complete a 5-minute cooldown. The above treatments are performed 3 times a week for 12 weeks(Nipa et al., 2022).
For group C, subjects will receive education from a qualified physiotherapist before the first treatment. Subsequent treatment begins with a warm-up. After the warm up, the physical therapist will install the BFR device for the subject as required. Then, the patients will receive Tai Chi for 30 minutes. Finally, complete a 5-minute cooldown. The above treatments are performed 3 times a week for 12 weeks(Qin et al., 2019).
For group D, subjects will receive education from a qualified physiotherapist before the first treatment. Subsequent treatment begins with a warm-up. Then, the patients will receive CST for 30 minutes. Finally, complete a 5-minute cooldown. The above treatments are performed 3 times a week for 12 weeks(Nipa et al., 2022).
Statistical analysis:
Data were processed using SPSS version 25.0 and Microsoft Excel 2010 software.
- Demographic data = descriptive analytics.
- All objectives = repeated measure ANCOVA (within-between interactions) for all variables.
- The significant level is P < 0.05.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Group A | Experimental | Other: CST+BFR+Tai Chi+EducationCST+BFR+Tai Chi+Education |
| Group B | Experimental | Other: CST+BFR+EducationCST+BFR+Education |
| Group C | Experimental | Other: Tai Chi +BFR+EducationTai Chi +BFR+Education |
| Group D | Other | Other: CST+EducationCST+Education |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- All participants had stable vital signs, were cognizant, and had no cognitive impairment.
- Aged 18-60 years old, able to understand Mandarin Chinese, and willing to cooperate.
- LBP duration ≥ 3 months.
- Be diagnosed as NLBP.
- VAS score ≤ 5 points.
Key exclusion criteria (9 listed)
- Patients with severe heart disease, liver disease, renal disease, pulmonary insufficiency, tumors, and postoperative dysfunction.
- Patients who are unconscious and unable to cooperate.
- Spinal fractures, severe arthritis, bony spinal stenosis, ankylosing spondylitis, open fractures, or unhealed traumatic wounds.
- Patients who have not been diagnosed with NLBP.
- Unable to communicate and read in Chinese.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CST+BFR+Tai Chi+Education1. Core Stability Training: It includes core activation exercises (feed-forward control)(Libenson,2006). Each set will consist of 10 repetitions of this exercise with a 10-second hold. There will be a 30-second rest between repetitions and a 60-second rest after each set. 2. Tai Chi: The first 10 Tai Chi movements from the 24-simplified Tai Chi form. Three qualified teachers will lead the training sessions. 3. Blood Flow Restriction: The professional physical therapist puts on the cuff pneumatic tourniquet system(Kaastu Master) on the proximal end of the left lower limb of the subjects and gives a certain pressure through the Kaastu Master. The pressure needs to ensure that the venous return of the particapants is restricted to perfect ground, while the artery still has some blood flow. 4. Education: After enrollment, patients will receive face-to-face education sessions at baseline, 30-45 min each time. Guided education by the same experienced professional physiotherapist. | Other | Group A |
| CST+BFR+Education1. Core Stability Training: It includes core activation exercises (feed-forward control)(Libenson,2006). Each set will consist of 10 repetitions of this exercise with a 10-second hold. There will be a 30-second rest between repetitions and a 60-second rest after each set. 2. Blood Flow Restriction: The professional physical therapist puts on the cuff pneumatic tourniquet system(Kaastu Master) on the proximal end of the left lower limb of the subjects and gives a certain pressure through the Kaastu Master. The pressure needs to ensure that the venous return of the particapants is restricted to perfect ground, while the artery still has some blood flow. 3. Education: After enrollment, patients will receive face-to-face education sessions at baseline, 30-45 min each time. Guided education by the same experienced professional physiotherapist. | Other | Group B |
| Tai Chi +BFR+Education1. Tai Chi: The first 10 Tai Chi movements from the 24-simplified Tai Chi form. Three qualified teachers will lead the training sessions. 2. Blood Flow Restriction: The professional physical therapist puts on the cuff pneumatic tourniquet system(Kaastu Master) on the proximal end of the left lower limb of the subjects and gives a certain pressure through the Kaastu Master. The pressure needs to ensure that the venous return of the particapants is restricted to perfect ground, while the artery still has some blood flow. 3. Education: After enrollment, patients will receive face-to-face education sessions at baseline, 30-45 min each time. Guided education by the same experienced professional physiotherapist. | Other | Group C |
| CST+Education1. Core Stability Training: It includes core activation exercises (feed-forward control)(Libenson,2006). Each set will consist of 10 repetitions of this exercise with a 10-second hold. There will be a 30-second rest between repetitions and a 60-second rest after each set. 2. Education: After enrollment, patients will receive face-to-face education sessions at baseline, 30-45 min each time. Guided education by the same experienced professional physiotherapist. | Other | Group D |
Primary outcome
Core muscle activation by root mean square(RMS)
Time frame: Baseline (1st week), 6th week, and 12th week
Root Mean Square (RMS) is a vector used to analyze the properties of electrical signal fluctuations, and the size of the RMS value represents the level of activity of a certain muscle(Abdelouahad et al., 2018). Absolute RMS demonstrated the highest overall dependability (ICC: 0.66-0.98) across activities (ICC: 0.66-0.98)(Van Helden et al., 2022).
Core muscle fatigue by mean frequency (MF)
Time frame: Baseline (1st week), 6th week, and 12th week
Mean Frequency (MF) is a frequency-domain index that represents the midpoint of muscle fiber discharge frequency during skeletal muscle contraction. It is widely assumed that it is connected to the proportion of fast and slow fibers in muscle tissue. The multifidus muscle demonstrated good to outstanding reproducibility of initial MF and MF fatigue changes during Trunk Holding Tests (ICCwithindays =82%; ICCbetweendays =78%) (Ng \& Richardson, 1996).
Abdominal drawing-in maneuver by the pressure biofeedback unit (PBU)
Time frame: Baseline (1st week), 6th week, and 12th week
The Pressure Biofeedback Unit (PBU) device consists of a pressure transducer with three airbags, a catheter, and a sphygmomanometer (with a range of 0 to 200 mmHg). It will be applied to evaluate abdominal drawing-in movements objectively (Grooms et al., 2013b). It is a trustworthy clinical instrument for assessing deep abdominal muscle function, with moderate to good (ICC = 0.47-0.82) and acceptable construct validity (ICC = 0.48-0.90) (P. O. D. P. Lima et al., 2011).
Back Extensor Strength by a push-pull dynamometer
Time frame: Baseline (1st week), 6th week, and 12th week
A push-pull dynamometer will be applied to assess back extensor strength in the prone position. Because of its acceptable reliability (ICC=0.93), validity (r=0.54), and measurement errors, maximal isometric back extensor strength assessment in a prone posture can be applied to individuals with varying levels of back strength and may be the most useful for ranking back extensor strength in clinical and epidemiological studies (Yang et al., 2020).
Postural sway by the mobile app APECS
Time frame: Baseline (1st week), 6th week, and 12th week
The application of a mobile app could represent a quick, safe, and accurate method for researchers and clinicians to evaluate general posture quantitatively. Adopting a movable and affordable tool for postural assessment could benefit the primary prevention of musculoskeletal disorders of the spine. The mobile app APECS-AI Posture Evaluation and Correction System® (New Body Technologies SAS, Grenoble, France) (APECS app) will be applied to evaluate the subject's postural sway in this study. The evaluation index is the maximum angle of the torso wobbles. According to a recommendation from a study, clinicians should consider APECS's worth as an auxiliary posture evaluation tool with (ICC > 0.60) (Trovato et al., 2022).
Balance by Y-Balance Test
Time frame: Baseline (1st week), 6th week, and 12th week
The Y-Balance Test Kit will be applied to measure balance in this study. The device includes a single central plastic plate and three attached tubes positioned anteriorly, posteromedially, and posterolaterally. A measurement with a 0.5 cm spacing is placed on each of the tubes. A study found that the Y-Balance Test has high inter-rater reliability and validity for assessing dynamic balance in the CLBP group (Alshehre et al., 2021).
Lumbar proprioception by joint repositioning error(JRE)
Time frame: Baseline (1st week), 6th week, and 12th week
The primary result of proprioception was a joint repositioning error(JRE). The absolute error, constant error, and variable error can all be used to describe repositioning errors. We picked absolute error since it affects accuracy(Strimpakos et al., 2006), reflects the magnitude of the inaccuracy (Sheeran et al., 2012), and is the most widely used measurement (Tong et al., 2017). The proprioception test had great inter-rater reliability(ICC=0.61-0.76)(Petersen \& Rundquist, 2009).
Gait speed by the 10-meter walk test.
Time frame: Baseline (1st week), 6th week, and 12th week
The gait speed is measured using the 10-Meter Walk Test. The gait speed test is the most commonly used outcome measure to assess functional limitations of the lower limbs (Muñoz-Mendoza et al., n.d.). With ICC values ranging from 0.96 to 0.98, 10m gait speed measurement shows outstanding test-retest reliability(Peters et al., 2013).
Fear avoidance belief by the Chinese version of the Fear-avoidance Beliefs. Questionnaire (FABQ-CHI)
Time frame: Baseline (1st week), 6th week, and 12th week
The Chinese version of the Fear-avoidance Beliefs Questionnaire (FABQ-CHI) is a relatively basic, easy-to-understand, easy-to-use, low-cost, and comprehensive LBP evaluation tool. The FABQ-CHI was shown to have adequate factor structure, internal consistency, test-retest reliability, and construct validity. (Pei et al., 2010). The maximum possible score for each question is 6, the lowest possible score is 0, and the total score is 96. The higher the score, the greater the severity of the perceived fear-avoidance belief.
Pain by visual analogue scale (VAS)
Time frame: Baseline (1st week), 6th week, and 12th week
Visual Analogue Scale (VAS) is a 10 cm horizontal strip with numbers ranging from 0 to 10 (the most severe pain possible). This is one of the most dependable quantitative scales that is commonly utilized in research (Scrimshaw \& Maher, 2001). VAS has proven to be trustworthy and valid (ICC=0.49-0.83) (Crossley et al., 2004).
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2024.
- Background: PubMed 27274419Abdelraouf OR, Abdel-Aziem AA. THE RELATIONSHIP BETWEEN CORE ENDURANCE AND BACK DYSFUNCTION IN COLLEGIATE MALE ATHLETES WITH AND WITHOUT NONSPECIFIC LOW BACK PAIN. Int J Sports Phys Ther. 2016 Jun;11(3):337-44.
- Background: PubMed 16339340Abe T, Kearns CF, Sato Y. Muscle size and strength are increased following walk training with restricted venous blood flow from the leg muscle, Kaatsu-walk training. J Appl Physiol (1985). 2006 May;100(5):1460-6. doi: 10.1152/japplphysiol.01267.2005. Epub 2005 Dec 8.
- Background: PubMed 26585295Ainpradub K, Sitthipornvorakul E, Janwantanakul P, van der Beek AJ. Effect of education on non-specific neck and low back pain: A meta-analysis of randomized controlled trials. Man Ther. 2016 Apr;22:31-41. doi: 10.1016/j.math.2015.10.012. Epub 2015 Nov 2.
- Background: PubMed 34758045Dos Santos LP, Santo RCDE, Ramis TR, Portes JKS, Chakr RMDS, Xavier RM. The effects of resistance training with blood flow restriction on muscle strength, muscle hypertrophy and functionality in patients with osteoarthritis and rheumatoid arthritis: A systematic review with meta-analysis. PLoS One. 2021 Nov 10;16(11):e0259574. doi: 10.1371/journal.pone.0259574. eCollection 2021.
- Background: PubMed 29573872Foster NE, Anema JR, Cherkin D, Chou R, Cohen SP, Gross DP, Ferreira PH, Fritz JM, Koes BW, Peul W, Turner JA, Maher CG; Lancet Low Back Pain Series Working Group. Prevention and treatment of low back pain: evidence, challenges, and promising directions. Lancet. 2018 Jun 9;391(10137):2368-2383. doi: 10.1016/S0140-6736(18)30489-6. Epub 2018 Mar 21.
- Background: PubMed 31301034Hughes L, Rosenblatt B, Haddad F, Gissane C, McCarthy D, Clarke T, Ferris G, Dawes J, Paton B, Patterson SD. Comparing the Effectiveness of Blood Flow Restriction and Traditional Heavy Load Resistance Training in the Post-Surgery Rehabilitation of Anterior Cruciate Ligament Reconstruction Patients: A UK National Health Service Randomised Controlled Trial. Sports Med. 2019 Nov;49(11):1787-1805. doi: 10.1007/s40279-019-01137-2.
- Background: PubMed 29879638Korakakis V, Whiteley R, Epameinontidis K. Blood Flow Restriction induces hypoalgesia in recreationally active adult male anterior knee pain patients allowing therapeutic exercise loading. Phys Ther Sport. 2018 Jul;32:235-243. doi: 10.1016/j.ptsp.2018.05.021. Epub 2018 May 31.
- Background: PubMed 27064327Paungmali A, Henry LJ, Sitilertpisan P, Pirunsan U, Uthaikhup S. Improvements in tissue blood flow and lumbopelvic stability after lumbopelvic core stabilization training in patients with chronic non-specific low back pain. J Phys Ther Sci. 2016 Jan;28(2):635-40. doi: 10.1589/jpts.28.635. Epub 2016 Feb 29.
- Background: PubMed 28192789Qaseem A, Wilt TJ, McLean RM, Forciea MA; Clinical Guidelines Committee of the American College of Physicians; Denberg TD, Barry MJ, Boyd C, Chow RD, Fitterman N, Harris RP, Humphrey LL, Vijan S. Noninvasive Treatments for Acute, Subacute, and Chronic Low Back Pain: A Clinical Practice Guideline From the American College of Physicians. Ann Intern Med. 2017 Apr 4;166(7):514-530. doi: 10.7326/M16-2367. Epub 2017 Feb 14.
- Background: PubMed 31517838Qin J, Zhang Y, Wu L, He Z, Huang J, Tao J, Chen L. Effect of Tai Chi alone or as additional therapy on low back pain: Systematic review and meta-analysis of randomized controlled trials. Medicine (Baltimore). 2019 Sep;98(37):e17099. doi: 10.1097/MD.0000000000017099.
- Background: PubMed 30671200Semeru GM, Halim MS. Acceptance versus catastrophizing in predicting quality of life in patients with chronic low back pain. Korean J Pain. 2019 Jan;32(1):22-29. doi: 10.3344/kjp.2019.32.1.22. Epub 2019 Jan 2.
- Background: PubMed 25488399Smith BE, Littlewood C, May S. An update of stabilisation exercises for low back pain: a systematic review with meta-analysis. BMC Musculoskelet Disord. 2014 Dec 9;15:416. doi: 10.1186/1471-2474-15-416.
- Individual participant dataSharing planned: No
Related trials for Low Back Pain
Not yet recruiting
Effects of Hip Hinge Exercises on Pain, Range of Motion and Functional Disability in Non-specific Low Back Pain.
Low Back Pain
Not yet recruiting
Effect of Lumbar Stabilization Exercises With and Without YTWL (Scapular Stabilization Exercises) on Reducing Chronic Low Back Pain and Related Disability. A Randomized Clinical Trial,
Chronic Non Specific Mechanical Low Back Pain
Not yet recruiting
Comparing Non-Medicine Strategies for Improving Low Back Pain
Chronic Low-back Pain (cLBP), High-Impact Chronic Pain (HICP)
Not yet recruiting
Effects of Whole-Body Vibration and Cervical Stabilization With Core Stabilization in Young Adults With Non-Specific Low Back Pain
Nonspecific Low Back Pain
Not yet recruiting
Spinery Basivertebral Nerve Ablation for Vertebrogenic Chronic Low Back Pain
Low Back Pain, Chronic Low Back Pain (CLBP)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Zarina Zahari, Doctor study director
Centre of Physiotherapy, Faculty of Health Sciences, Universiti Teknologi MARA, Malaysia
Questions about this trial
What is this clinical trial studying?
A study testing CST+BFR+Tai Chi+Education, CST+BFR+Education and Tai Chi +BFR+Education in people with Low Back Pain, run by Universiti Teknologi Mara.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 19 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Lin Pipeng, Master (86-15513697108, 137793134@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Core muscle activation by root mean square(RMS) (time frame: Baseline (1st week), 6th week, and 12th week). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06599645, which also lists 18 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Sep 2024.