Low Back PainNCT05544890
Effects of Core Exercise in Low Back Pain
A study testing Exercise, Manual Therapy and Kinesiotape in people with Low Back Pain, run by Universitat Jaume I at 1 site in Spain.
Trial summary
Non-specific low back pain in one of the main causes of disability for health care worldwide. The effectiveness of therapeutic exercise, of kinesio tape and of manual therapy in the treatment of low back pain is evaluated, but not a comparison of these techniques. Moreover, can these techniques be combined? Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Low Back Pain
- What is being tested?
- Exercise, Manual Therapy and Kinesiotape
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteSpain
- Study dates
- 20 Sep 2022to 23 Dec 2022
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Medical diagnosis of CLBP confirmed by an orthopaedic specialist Classification at Stage 2 by ODI Not receiving pharmacological treatment such as anti-inflammatories or corticosteroids.
Who cannot join
- Previous or scheduled surgeries in the low back and abdominal area
- Presence of severe fractures or pathologies.
- Diagnosis of radiculopathy or neuropathy (with or without spinal canal stenosis).
- Structural deformity in the spinal column.
- Neurological or psychiatric disorder.
- Presence or suspicion of pregnancy.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Core Stability (Therapeutic) Exercise Alone or in Combination With Manual Therapy or Kinesio Tape in Patients With Chronic Low Back Pain: Randomized Control Trial.
Non-specific low back pain in one of the main causes of disability for health care worldwide. The effectiveness of therapeutic exercise, of kinesio tape and of manual therapy in the treatment of low back pain is evaluated, but not a comparison of these techniques. Moreover, can these techniques be combined?
Read the detailed description
Non-specific low back pain is one of the main causes of disability for health care worldwide. Nowadays, the mostly used technique to research low back muscular activity in electromyography.
Among the published studies, the effectiveness of therapeutic exercise, of kinesio tape and of manual therapy in the treatment of low back pain is evaluated, but not a comparison of these techniques.
Therefore, the purpose of this study was to investigate the effects of core stability exercise alone or in combination with manual therapy or kinesiotape on pain, dysfunction, psychosocial factors and pressure pain threshold (PPTs) in patients with low back pain in ODI stage 2. The investigators hypothesized that exercise combined with manual therapy would provide greater changes and benefits than exercise alone.
This study's population will be composed by at least 15 individuals per group, both the male and female, with ages among 20 and 60.
Participants will be randomly and blindly divided in three groups of intervention. The three groups will be: Exercise group or ET (realize therapeutic exercise alone), manual therapy group o ETmanualtherapy (realize manual therapy prior therapeutic exercise), and kinesiotape group or ETkinesiotape (realize therapeutic exercise plus kinesiotape).
- Conditions
- Low Back Pain
- Being tested
- Exercise, Manual Therapy, Kinesiotape
- Keywords
- Chronic pain, Muskuloskeletal manipulation, Complementary therapies, Catastrophization, Kinesiophobia
- Medical subject headings
- Low Back Pain, Chronic Pain, Kinesiophobia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ExerciseProcedure or surgery
All patients will start learning how to activate the transversus abdominal muscle in the first training session. The exercises will be made in 1 to 3 series of among 8 and 15 repetitions and the isometric contractions for 5 to 10 seconds. The rest between series will be of 30 seconds, and between exercise of 2-3 minutes.
Other Names:
- Therapeutic exercise
Manual TherapyProcedure or surgery
All patients will start learning how to activate the transversus abdominal muscle in the first training session. The exercises will be made in 1 to 3 series of among 8 and 15 repetitions and the isometric contractions for 5 to 10 seconds. The rest between series will be of 30 seconds, and between exercise of 2-3 minutes.
Other Names:
- Manipulation
KinesiotapeProcedure or surgery
All patients will start learning how to activate the transversus abdominal muscle in the first training session. The exercises will be made in 1 to 3 series of among 8 and 15 repetitions and the isometric contractions for 5 to 10 seconds. The rest between series will be of 30 seconds, and between exercise of 2-3 minutes.
Other Names:
- Kinesiotaping
| Study group | Role | What they receive |
|---|---|---|
| Therapeutic exercise Group (ET) | Active comparator | The ET group is going to follow a program of core stabilization through specific therapeutic exercise. Two weekly sessions will be programmed for 12 weeks, making a total of 24 sessions. Each session will have a duration of 60 minutes. All patients will start learning how to activate the transversus abdominal muscle in the first training session. The exercises will be made in 1 to 3 series of among 8 and 15 repetitions and the isometric contractions for 5 to 10 seconds. The rest between series will be of 30 seconds, and between exercise of 2-3 minutes. Receives: Procedure: Exercise |
| Manual Therapy group (ETmanualtherapy) | Active comparator | Prior the core exercise previously exposed in group ET, group ETmanualtherapy will lay on the stretcher, where the physiotherapist will work on a manual therapy thrust. The participant will receive a high velocity and low range impulse technique in lateral position on both sides. Receives: Procedure: Exercise; Procedure: Manual Therapy |
| Kinesiotape Group (ETkinesiotape) | Active comparator | The ETkinesiotape will go previously through physiotherapy, where a kinesiotape band will be applied (Kinesiotape "Nondolens" 5cmx5cm black color), in Y technique, by applying the kinesiotape base in neutral position of the lumbar spine without any tension on the tape. The participants realize the same exercise program than the other groups plus the kinesiotape applied. Receives: Procedure: Exercise; Procedure: Kinesiotape |
What is being measured
The primary outcome is the main question the study is designed to answer.
Oswestry Disability Index.
The Oswestry Disability Index (ODI) test will be made to all participants at three months. Divided into 10 sections (each is scored from zero to five, with higher scores meaning higher disability), it is self-administered to assess the limitations of different activities of daily living. That is why, it has been established that all participants in Stage 2 of the test are subsidiaries to make all the treatment modes of the study (manual therapy, kinesiotape and exercise). This way, we are able to rise the homogeneity that imposes a diagnostic label such as the chronic low back pain.
Measured: 12 weeks
Secondary outcomes (6)
Catastrophism (PCS)
To quantify the degree of catastrophism in the present study, the validated spanish version will be used as the pain catastrophism scale (PCS). The PCS is a 13-item self-report scale of 13 items, that presents same factor structure composed of the factors of rumination, despair and magnification. For each of these factors, it is given a value of 0 (without agreement) to 4 (always), so that at the end the examiner obtains a score between 0 and 52. Low scores indicate a low level of catastrophism and high values show high levels of catastrophism.
Measured: 12 weeks
Kinesiophobia (TKS)
The mostly used questionnaire to evaluate kinesiophobia is the TKS (Tampa Kinesiophobia Scale) questionnaire, which we will use to measure which is the fear to movement of patients of low back pain. This scale includes work related lesions, lesions due to repetitive effort, relapses and the avoidance-fear. The questionnaire is composed of 17 items in which there is a differentiation between the negative and positive elements.
This questionnaire will be filled in based on a Likert sale which ranges between 0 and 5, being 0 never and 5 always. The total punctuation ranges between 17 and 68, the higher the rate, the higher the degree of kinesiophobia.
Measured: 12 weeks
Visual analog scale (VAS)
The VAS from 0 to 100, the scale considered to be the most representative, with the VAS being the best option due to its easy understanding and handling. This scale constitutes an effective tool to subjectively quantify this range, more discriminating than the scale that establishes its values from 0 to 10. This way, 0 will be considered as non-existent pain reflected by the individual and 10 as the worst pain imaginable by the patient.
Measured: 12 weeks
Self-efficacy:questionnaire
To assess self-efficacy, it will be used the Chronic Pain Self-Efficacy Questionnaire, which assesses a person's belief in their ability to perform a specific behavior. It consists of 19 items, a Likert-type scale, and a response range of 0 to 10, where 0 is equivalent to feeling totally incapable, 5 moderately incapable and 10 fully capable. The result determines that the higher the score, the greater the degree of self-efficacy.
Measured: 12 weeks
Pressure pain threshold
Pressure pain threshold (PPTs) is considered a useful method to calculate the degree of sensitization of deep tissues. It will be carried out using an algometer, which in this study will consist of a manometer attached to a cylindrical rubber tip. The manometer measures the pressure applied through the rubber and the patient should signal when this pressure starts being painful). Algometry is a widely studied and validated technique to quantify sensitivity in the diagnosis of symptomatic points and myofascial trigger points. The reliability of pressure pain threshold is relatively high, presenting coefficients of 0.9 and 0.95.
Measured: 12 weeks
Electromyography
To obtain an objective measure of the muscle activation, surface electromyography will be used to evaluate the main core muscles - basically the rectus abdominis and multifidus.
The electromyograph to be used will be the FREEEMG model of the brand BTS Bioengineering. It is a wireless electromyograph with probes attached to the prefilled electrodes, which collect the information. No additional hardware is required, as the same software processes the information taken. The data resolution is 16 bit and the frequency of 1 kHz.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2022
- Study start20 Sep 2022
- Primary completion20 Dec 2022
- Study completion23 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitat Jaume I
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Paula Blanco, PDI, Principal investigator, Doctoral School. Catholic University of Valencia San Vicente Mártir
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05544890
- Sponsor's protocol ID
- UCV/2019-2020/138
- Status last verified
- Jan 2023
- First submitted
- 8 Sep 2022
- Last updated
- 19 Jan 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Hoy D, March L, Brooks P, Blyth F, Woolf A, Bain C, Williams G, Smith E, Vos T, Barendregt J, Murray C, Burstein R, Buchbinder R. The global burden of low back pain: estimates from the Global Burden of Disease 2010 study. Ann Rheum Dis. 2014 Jun;73(6):968-74. doi: 10.1136/annrheumdis-2013-204428. Epub 2014 Mar 24.
PubMed 24665116Finucane LM, Downie A, Mercer C, Greenhalgh SM, Boissonnault WG, Pool-Goudzwaard AL, Beneciuk JM, Leech RL, Selfe J. International Framework for Red Flags for Potential Serious Spinal Pathologies. J Orthop Sports Phys Ther. 2020 Jul;50(7):350-372. doi: 10.2519/jospt.2020.9971. Epub 2020 May 21.
PubMed 32438853Pitcher MH, Von Korff M, Bushnell MC, Porter L. Prevalence and Profile of High-Impact Chronic Pain in the United States. J Pain. 2019 Feb;20(2):146-160. doi: 10.1016/j.jpain.2018.07.006. Epub 2018 Aug 7.
PubMed 30096445Ketenci A, Zure M. Pharmacological and non-pharmacological treatment approaches to chronic lumbar back pain. Turk J Phys Med Rehabil. 2021 Mar 4;67(1):1-10. doi: 10.5606/tftrd.2021.8216. eCollection 2021 Mar.
PubMed 33948537Kreiner DS, Matz P, Bono CM, Cho CH, Easa JE, Ghiselli G, Ghogawala Z, Reitman CA, Resnick DK, Watters WC 3rd, Annaswamy TM, Baisden J, Bartynski WS, Bess S, Brewer RP, Cassidy RC, Cheng DS, Christie SD, Chutkan NB, Cohen BA, Dagenais S, Enix DE, Dougherty P, Golish SR, Gulur P, Hwang SW, Kilincer C, King JA, Lipson AC, Lisi AJ, Meagher RJ, O'Toole JE, Park P, Pekmezci M, Perry DR, Prasad R, Provenzano DA, Radcliff KE, Rahmathulla G, Reinsel TE, Rich RL Jr, Robbins DS, Rosolowski KA, Sembrano JN, Sharma AK, Stout AA, Taleghani CK, Tauzell RA, Trammell T, Vorobeychik Y, Yahiro AM. Guideline summary review: an evidence-based clinical guideline for the diagnosis and treatment of low back pain. Spine J. 2020 Jul;20(7):998-1024. doi: 10.1016/j.spinee.2020.04.006. Epub 2020 Apr 22.
PubMed 32333996Toomey D, Reid D, White S. How manual therapy provided a gateway to a biopsychosocial management approach in an adult with chronic post-surgical low back pain: a case report. J Man Manip Ther. 2021 Apr;29(2):107-132. doi: 10.1080/10669817.2020.1813472. Epub 2020 Sep 15.
PubMed 32930642Hayden JA, Ellis J, Ogilvie R, Stewart SA, Bagg MK, Stanojevic S, Yamato TP, Saragiotto BT. Some types of exercise are more effective than others in people with chronic low back pain: a network meta-analysis. J Physiother. 2021 Oct;67(4):252-262. doi: 10.1016/j.jphys.2021.09.004. Epub 2021 Sep 16.
PubMed 34538747Vicente-Mampel J, Blanco-Gimenez P, Barrios C. Influence of patient-reported outcomes on the effect of exercise therapy, manual therapy, and kinesiotaping in chronic low back pain: secondary statistical analysis. Sci Rep. 2025 Nov 3;15(1):38400. doi: 10.1038/s41598-025-22260-3.
PubMed 41184444Blanco-Gimenez P, Vicente-Mampel J, Gargallo P, Baraja-Vegas L, Bautista IJ, Ros-Bernal F, Barrios C. Clinical relevance of combined treatment with exercise in patients with chronic low back pain: a randomized controlled trial. Sci Rep. 2024 Jul 24;14(1):17042. doi: 10.1038/s41598-024-68192-2.
PubMed 39048701
Study at a glance
From the registry record, last updated by the sponsor on 19 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Core Stability (Therapeutic) Exercise Alone or in Combination With Manual Therapy or Kinesio Tape in Patients With Chronic Low Back Pain: Randomized Control Trial.
- ClinicalTrials.gov ID
- NCT05544890
- Acronym / sponsor ID
- UCV/2019-2020/138
- Conditions
- Low Back Pain
- Keywords
- Chronic pain, Muskuloskeletal manipulation, Complementary therapies, Catastrophization, Kinesiophobia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Universitat Jaume IUniversity, hospital or other
- Study start
- 20 Sep 2022 (actual)
- Primary completion
- 20 Dec 2022 (actual)
- Study completion
- 23 Dec 2022 (actual)
- First posted
- 19 Sep 2022 (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.
Non-specific low back pain in one of the main causes of disability for health care worldwide. The effectiveness of therapeutic exercise, of kinesio tape and of manual therapy in the treatment of low back pain is evaluated, but not a comparison of these techniques. Moreover, can these techniques be combined?
Detailed description
Non-specific low back pain is one of the main causes of disability for health care worldwide. Nowadays, the mostly used technique to research low back muscular activity in electromyography.
Among the published studies, the effectiveness of therapeutic exercise, of kinesio tape and of manual therapy in the treatment of low back pain is evaluated, but not a comparison of these techniques.
Therefore, the purpose of this study was to investigate the effects of core stability exercise alone or in combination with manual therapy or kinesiotape on pain, dysfunction, psychosocial factors and pressure pain threshold (PPTs) in patients with low back pain in ODI stage 2. The investigators hypothesized that exercise combined with manual therapy would provide greater changes and benefits than exercise alone.
This study's population will be composed by at least 15 individuals per group, both the male and female, with ages among 20 and 60.
Participants will be randomly and blindly divided in three groups of intervention. The three groups will be: Exercise group or ET (realize therapeutic exercise alone), manual therapy group o ETmanualtherapy (realize manual therapy prior therapeutic exercise), and kinesiotape group or ETkinesiotape (realize therapeutic exercise plus kinesiotape).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Therapeutic exercise Group (ET) | Active comparator | Procedure: ExerciseThe ET group is going to follow a program of core stabilization through specific therapeutic exercise. Two weekly sessions will be programmed for 12 weeks, making a total of 24 sessions. Each session will have a duration of 60 minutes. All patients will start learning how to activate the transversus abdominal muscle in the first training session. The exercises will be made in 1 to 3 series of among 8 and 15 repetitions and the isometric contractions for 5 to 10 seconds. The rest between series will be of 30 seconds, and between exercise of 2-3 minutes. |
| Manual Therapy group (ETmanualtherapy) | Active comparator | Procedure: Exercise, Procedure: Manual TherapyPrior the core exercise previously exposed in group ET, group ETmanualtherapy will lay on the stretcher, where the physiotherapist will work on a manual therapy thrust. The participant will receive a high velocity and low range impulse technique in lateral position on both sides. |
| Kinesiotape Group (ETkinesiotape) | Active comparator | Procedure: Exercise, Procedure: KinesiotapeThe ETkinesiotape will go previously through physiotherapy, where a kinesiotape band will be applied (Kinesiotape "Nondolens" 5cmx5cm black color), in Y technique, by applying the kinesiotape base in neutral position of the lumbar spine without any tension on the tape. The participants realize the same exercise program than the other groups plus the kinesiotape applied. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Medical diagnosis of CLBP confirmed by an orthopaedic specialist Classification at Stage 2 by ODI Not receiving pharmacological treatment such as anti-inflammatories or corticosteroids.
Key exclusion criteria (6 listed)
- Previous or scheduled surgeries in the low back and abdominal area
- Presence of severe fractures or pathologies.
- Diagnosis of radiculopathy or neuropathy (with or without spinal canal stenosis).
- Structural deformity in the spinal column.
- Neurological or psychiatric disorder.
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 |
|---|---|---|
| ExerciseAll patients will start learning how to activate the transversus abdominal muscle in the first training session. The exercises will be made in 1 to 3 series of among 8 and 15 repetitions and the isometric contractions for 5 to 10 seconds. The rest between series will be of 30 seconds, and between exercise of 2-3 minutes. Other Names: - Therapeutic exercise | Procedure or surgery | Kinesiotape Group (ETkinesiotape), Manual Therapy group (ETmanualtherapy), Therapeutic exercise Group (ET) |
| Manual TherapyAll patients will start learning how to activate the transversus abdominal muscle in the first training session. The exercises will be made in 1 to 3 series of among 8 and 15 repetitions and the isometric contractions for 5 to 10 seconds. The rest between series will be of 30 seconds, and between exercise of 2-3 minutes. Other Names: - Manipulation | Procedure or surgery | Manual Therapy group (ETmanualtherapy) |
| KinesiotapeAll patients will start learning how to activate the transversus abdominal muscle in the first training session. The exercises will be made in 1 to 3 series of among 8 and 15 repetitions and the isometric contractions for 5 to 10 seconds. The rest between series will be of 30 seconds, and between exercise of 2-3 minutes. Other Names: - Kinesiotaping | Procedure or surgery | Kinesiotape Group (ETkinesiotape) |
Primary outcome
Oswestry Disability Index.
Time frame: 12 weeks
The Oswestry Disability Index (ODI) test will be made to all participants at three months. Divided into 10 sections (each is scored from zero to five, with higher scores meaning higher disability), it is self-administered to assess the limitations of different activities of daily living. That is why, it has been established that all participants in Stage 2 of the test are subsidiaries to make all the treatment modes of the study (manual therapy, kinesiotape and exercise). This way, we are able to rise the homogeneity that imposes a diagnostic label such as the chronic low back pain.
6 secondary outcomes
Catastrophism (PCS)
Time frame: 12 weeks
Kinesiophobia (TKS)
Time frame: 12 weeks
Visual analog scale (VAS)
Time frame: 12 weeks
Self-efficacy:questionnaire
Time frame: 12 weeks
Pressure pain threshold
Time frame: 12 weeks
Electromyography
Time frame: 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jan 2023.
- Background: PubMed 24665116Hoy D, March L, Brooks P, Blyth F, Woolf A, Bain C, Williams G, Smith E, Vos T, Barendregt J, Murray C, Burstein R, Buchbinder R. The global burden of low back pain: estimates from the Global Burden of Disease 2010 study. Ann Rheum Dis. 2014 Jun;73(6):968-74. doi: 10.1136/annrheumdis-2013-204428. Epub 2014 Mar 24.
- Background: PubMed 32438853Finucane LM, Downie A, Mercer C, Greenhalgh SM, Boissonnault WG, Pool-Goudzwaard AL, Beneciuk JM, Leech RL, Selfe J. International Framework for Red Flags for Potential Serious Spinal Pathologies. J Orthop Sports Phys Ther. 2020 Jul;50(7):350-372. doi: 10.2519/jospt.2020.9971. Epub 2020 May 21.
- Background: PubMed 30096445Pitcher MH, Von Korff M, Bushnell MC, Porter L. Prevalence and Profile of High-Impact Chronic Pain in the United States. J Pain. 2019 Feb;20(2):146-160. doi: 10.1016/j.jpain.2018.07.006. Epub 2018 Aug 7.
- Background: PubMed 33948537Ketenci A, Zure M. Pharmacological and non-pharmacological treatment approaches to chronic lumbar back pain. Turk J Phys Med Rehabil. 2021 Mar 4;67(1):1-10. doi: 10.5606/tftrd.2021.8216. eCollection 2021 Mar.
- Background: PubMed 32333996Kreiner DS, Matz P, Bono CM, Cho CH, Easa JE, Ghiselli G, Ghogawala Z, Reitman CA, Resnick DK, Watters WC 3rd, Annaswamy TM, Baisden J, Bartynski WS, Bess S, Brewer RP, Cassidy RC, Cheng DS, Christie SD, Chutkan NB, Cohen BA, Dagenais S, Enix DE, Dougherty P, Golish SR, Gulur P, Hwang SW, Kilincer C, King JA, Lipson AC, Lisi AJ, Meagher RJ, O'Toole JE, Park P, Pekmezci M, Perry DR, Prasad R, Provenzano DA, Radcliff KE, Rahmathulla G, Reinsel TE, Rich RL Jr, Robbins DS, Rosolowski KA, Sembrano JN, Sharma AK, Stout AA, Taleghani CK, Tauzell RA, Trammell T, Vorobeychik Y, Yahiro AM. Guideline summary review: an evidence-based clinical guideline for the diagnosis and treatment of low back pain. Spine J. 2020 Jul;20(7):998-1024. doi: 10.1016/j.spinee.2020.04.006. Epub 2020 Apr 22.
- Background: PubMed 32930642Toomey D, Reid D, White S. How manual therapy provided a gateway to a biopsychosocial management approach in an adult with chronic post-surgical low back pain: a case report. J Man Manip Ther. 2021 Apr;29(2):107-132. doi: 10.1080/10669817.2020.1813472. Epub 2020 Sep 15.
- Background: PubMed 34538747Hayden JA, Ellis J, Ogilvie R, Stewart SA, Bagg MK, Stanojevic S, Yamato TP, Saragiotto BT. Some types of exercise are more effective than others in people with chronic low back pain: a network meta-analysis. J Physiother. 2021 Oct;67(4):252-262. doi: 10.1016/j.jphys.2021.09.004. Epub 2021 Sep 16.
- Derived from this study: PubMed 41184444Vicente-Mampel J, Blanco-Gimenez P, Barrios C. Influence of patient-reported outcomes on the effect of exercise therapy, manual therapy, and kinesiotaping in chronic low back pain: secondary statistical analysis. Sci Rep. 2025 Nov 3;15(1):38400. doi: 10.1038/s41598-025-22260-3.
- Derived from this study: PubMed 39048701Blanco-Gimenez P, Vicente-Mampel J, Gargallo P, Baraja-Vegas L, Bautista IJ, Ros-Bernal F, Barrios C. Clinical relevance of combined treatment with exercise in patients with chronic low back pain: a randomized controlled trial. Sci Rep. 2024 Jul 24;14(1):17042. doi: 10.1038/s41598-024-68192-2.
- Individual participant dataSharing planned: No
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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.
Paula Blanco, PDI principal investigator
Doctoral School. Catholic University of Valencia San Vicente Mártir
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise, Manual Therapy and Kinesiotape in people with Low Back Pain, run by Universitat Jaume I at 1 site in Spain.
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 1 inclusion and 6 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: finished, as of the sponsor's last update on 19 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Oswestry Disability Index. (time frame: 12 weeks). 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 NCT05544890, which also lists 9 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 Jan 2023.