Low Back PainNCT05905562
Core Muscle Activation Exercise Training Program Effects in Patients With Chronic Low Back Pain
A study testing core stabilization exercises and Spinal mobilization techniques in people with Low Back Pain, run by Riphah International University at 1 site in Pakistan.
Trial summary
The study will be a Randomized clinical trial to check the effects of a core muscle activation exercise training program on pain, range of motion, and function in patients with chronic low back pain so that we can devise a treatment protocol for patients with chronic low back pain. Read more about this study
- Who is it for?
- Ages 20 to 50 years
- Conditions the study is for
- Low Back Pain
- What is being tested?
- core stabilization exercises and Spinal mobilization techniques
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 1 sitePakistan
- Study dates
- 15 Apr 2023to 15 Sep 2023
- 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 20 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- • Both Gender
- Age range from 20-50 years.
- Chronicity of low back pain for at least 3 months.
Who cannot join
- Patients with any signs of spinal cord involvement
- Pregnant female patients
- History of spinal trauma or spinal or abdominal surgery
- History of systemic disease (e.g., systemic scleroderma or muscular dystrophy), spinal deformity (e.g., scoliosis and kyphosis), or abdominal wall hernia
- History of participation in core stability exercise or any physical therapy treatment in the past 6 months
- Any bony or soft tissue systemic disease
Trial locations and contacts
1 site in 1 country.
Pakistan1 site
Orthopedics Medical Complex Hospital
Lahore, Punjab Province, 54700
About this study
Official title: Effects of Core Muscle Activation Exercise Training Program on Pain, Range of Motion, and Function in Patients With Chronic Low Back Pain
The study will be a Randomized clinical trial to check the effects of a core muscle activation exercise training program on pain, range of motion, and function in patients with chronic low back pain so that we can devise a treatment protocol for patients with chronic low back pain. The study duration was 10 months, convenient sampling technique was used subject following eligibility criteria from the Orthopaedic medical center, Lahore. were randomly allocated in two groups via lottery method, a baseline assessment was done, and Group A received Mobilization and Electrotherapy Modalities including Ultrasound, TENS, and Core muscles activation exercises. Group B received Mobilization and Electrotherapy Modalities including Ultrasound and TENS for a total training program duration of 12 weeks with 3 sessions per week. Outcome measures were NPRS for assessment of pain, Modified Oswestry Disability index for functional disability, PBU for assessment and training of core stability, and baseline bubble inclinometer and were assessed and documented at 0 week, 4 weeks, 8 weeks, and 12 weeks of the treatment session
Read the detailed description
Low back pain is one of the most common musculoskeletal disorders in both males and females, with a prevalence rate of 80% of the world population. However, in some cases, acute low back pain persists for more than 3 months and becomes chronic low back pain. During low back pain, significant complaints of patients other than pain are decreased mobility and functional limitations in their workplace and at home In recent years, multiple studies have explored the evidence for treating chronic low back pain; options include soft tissue mobilization, spinal manipulation therapy, spinal joint mobilization therapy, behavioral therapy, exercise therapy, transcutaneous electrical nerve stimulation, interferential currents, low-level laser therapy, and yoga. Other treatments include massage, acupuncture, and superficial heat therapy thermal heat wraps, hot water bottles, heated packs filled with grain, hot towels, and electric heating pads). Manual modalities such as physiotherapy, massage, chiropractic, occupational, and osteopathic therapies, including spinal manipulation and mobilization, are often used together and alone to treat chronic non-specific low back pain Exercises are a way to induce strength, endurance, functional mobility, and neuromuscular control in back muscles. A variety of Exercises like Motor control stabilization exercises, back stabilization exercises, core muscle activation exercises, and endurance exercises are used to reduce the effect of low back pain. These particular exercises are for lumber and core Stabilization and strengthening but there is very limited research on the superiority of each exercise over the other.
Earlier work suggested that there is little or no evidence that spinal manipulative therapy was superior to other standard treatments for chronic low back pain. however, recent systematic reviews suggest that spinal manipulation and mobilization are "viable" options for pain treatment
- Conditions
- Low Back Pain
- Being tested
- core stabilization exercises, Spinal mobilization techniques
- 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.
core stabilization exercisesOther
Core muscles activation exercises will be performed on patients to target the abdominals.
Spinal mobilization techniquesOther
lumbar spine joint mobilization techniques will be performed to patient in prone lying.
| Study group | Role | What they receive |
|---|---|---|
| Spinal mobilization and core stabilization exercises group: | Experimental | will have core muscle activation exercises along with lumber spine joint mobilization along with TENS and Ultrasound for 12 weeks and 3 sessions per week Receives: Other: core stabilization exercises; Other: Spinal mobilization techniques |
| Spinal mobilization techniques group | Active comparator | will have lumber spine joint mobilization along with TENS and Ultrasound duration of 12 weeks with 3 sessions per week. Receives: Other: Spinal mobilization techniques |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bubble base inclinometer for Range of Motion
It will be used to measure lumbar Range of motion. It will be placed near the joint to be measured; turn the dial until the scale reads zero; take the joint through its range and range of motion will be recorded (in degrees) directly from the dial.
Measured: up to 12 weeks
Pressure biofeedback unit for Muscle strength
Pressure Biofeedback Unit will be use to assess core stability muscle strength contraction. pressure biofeedback unit will be placed under the lumbar spine at the height of L3 and inflate the cuff to 40mmHg.The patient is then instructed to perform core contraction and increase the pressure in steps of 2-4mmHg. So from 40 to 42or44mmHg and so on. The contraction should be held whilst being able to keep breathing calmly. Ideally, the patient is able to hold this contraction for 15 seconds. Time will be noted.
Measured: up to 12 weeks
Numeric Pain Rating Scale
The NPRS is a segmented numeric scale in which the respondent selects a whole number (0-10 integers) that best reflects the intensity of his/her pain. The common format is a horizontal bar or line. NPRS is anchored by terms describing pain severity extremes
Measured: up to 12 weeks
Modified Oswestry Disability Index
The Oswestry Disability Index (also known as the Oswestry Low Back Pain Disability Questionnaire) is an extremely important tool that researchers and disability evaluators use to measure a patient's permanent functional disability. The test is considered the 'gold standard' of low back functional outcome tools. It has 10 different sections. For each section the total possible score is 5. If all 10 sections are completed the score is calculated and interpreted in percentage measures.
Measured: up to 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2023
- Study start15 Apr 2023
- Primary completion1 Sep 2023
- Study completion15 Sep 2023
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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sana Gohar, MS*, Principal investigator, Riphah International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05905562
- Sponsor's protocol ID
- REC/RCR & AHS/23/0114
- Status last verified
- Mar 2024
- First submitted
- 18 Apr 2023
- Last updated
- 5 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Coulter ID, Crawford C, Hurwitz EL, Vernon H, Khorsan R, Suttorp Booth M, Herman PM. Manipulation and mobilization for treating chronic low back pain: a systematic review and meta-analysis. Spine J. 2018 May;18(5):866-879. doi: 10.1016/j.spinee.2018.01.013. Epub 2018 Jan 31.
PubMed 29371112Waseem M, Karimi H, Gilani SA, Hassan D. Treatment of disability associated with chronic non-specific low back pain using core stabilization exercises in Pakistani population. J Back Musculoskelet Rehabil. 2019;32(1):149-154. doi: 10.3233/BMR-171114.
PubMed 30248035Areeudomwong P, Buttagat V. Comparison of Core Stabilisation Exercise and Proprioceptive Neuromuscular Facilitation Training on Pain-related and Neuromuscular Response Outcomes for Chronic Low Back Pain: A Randomised Controlled Trial. Malays J Med Sci. 2019 Nov;26(6):77-89. doi: 10.21315/mjms2019.26.6.8. Epub 2019 Dec 30.
PubMed 31908589Ozsoy G, Ilcin N, Ozsoy I, Gurpinar B, Buyukturan O, Buyukturan B, Kararti C, Sas S. The Effects Of Myofascial Release Technique Combined With Core Stabilization Exercise In Elderly With Non-Specific Low Back Pain: A Randomized Controlled, Single-Blind Study. Clin Interv Aging. 2019 Oct 9;14:1729-1740. doi: 10.2147/CIA.S223905. eCollection 2019.
PubMed 31631992Mueller J, Niederer D. Dose-response-relationship of stabilisation exercises in patients with chronic non-specific low back pain: a systematic review with meta-regression. Sci Rep. 2020 Oct 9;10(1):16921. doi: 10.1038/s41598-020-73954-9.
PubMed 33037280Frizziero A, Pellizzon G, Vittadini F, Bigliardi D, Costantino C. Efficacy of Core Stability in Non-Specific Chronic Low Back Pain. J Funct Morphol Kinesiol. 2021 Apr 22;6(2):37. doi: 10.3390/jfmk6020037.
PubMed 33922389Hlaing SS, Puntumetakul R, Khine EE, Boucaut R. Effects of core stabilization exercise and strengthening exercise on proprioception, balance, muscle thickness and pain related outcomes in patients with subacute nonspecific low back pain: a randomized controlled trial. BMC Musculoskelet Disord. 2021 Nov 30;22(1):998. doi: 10.1186/s12891-021-04858-6.
PubMed 34847915Kumar T, Kumar S, Nezamuddin M, Sharma VP. Efficacy of core muscle strengthening exercise in chronic low back pain patients. J Back Musculoskelet Rehabil. 2015;28(4):699-707. doi: 10.3233/BMR-140572.
PubMed 25467999Sanchez Romero EA, Fernandez Carnero J, Villafane JH, Calvo-Lobo C, Ochoa Saez V, Burgos Caballero V, Laguarta Val S, Pedersini P, Pecos Martin D. Prevalence of Myofascial Trigger Points in Patients with Mild to Moderate Painful Knee Osteoarthritis: A Secondary Analysis. J Clin Med. 2020 Aug 7;9(8):2561. doi: 10.3390/jcm9082561.
PubMed 32784592
Study at a glance
From the registry record, last updated by the sponsor on 5 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Core Muscle Activation Exercise Training Program on Pain, Range of Motion, and Function in Patients With Chronic Low Back Pain
- ClinicalTrials.gov ID
- NCT05905562
- Acronym / sponsor ID
- REC/RCR & AHS/23/0114
- Conditions
- Low Back Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 15 Apr 2023 (actual)
- Primary completion
- 1 Sep 2023 (actual)
- Study completion
- 15 Sep 2023 (actual)
- First posted
- 15 Jun 2023 (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.
The study will be a Randomized clinical trial to check the effects of a core muscle activation exercise training program on pain, range of motion, and function in patients with chronic low back pain so that we can devise a treatment protocol for patients with chronic low back pain. The study duration was 10 months, convenient sampling technique was used subject following eligibility criteria from the Orthopaedic medical center, Lahore. were randomly allocated in two groups via lottery method, a baseline assessment was done, and Group A received Mobilization and Electrotherapy Modalities including Ultrasound, TENS, and Core muscles activation exercises. Group B received Mobilization and Electrotherapy Modalities including Ultrasound and TENS for a total training program duration of 12 weeks with 3 sessions per week. Outcome measures were NPRS for assessment of pain, Modified Oswestry Disability index for functional disability, PBU for assessment and training of core stability, and baseline bubble inclinometer and were assessed and documented at 0 week, 4 weeks, 8 weeks, and 12 weeks of the treatment session
Detailed description
Low back pain is one of the most common musculoskeletal disorders in both males and females, with a prevalence rate of 80% of the world population. However, in some cases, acute low back pain persists for more than 3 months and becomes chronic low back pain. During low back pain, significant complaints of patients other than pain are decreased mobility and functional limitations in their workplace and at home In recent years, multiple studies have explored the evidence for treating chronic low back pain; options include soft tissue mobilization, spinal manipulation therapy, spinal joint mobilization therapy, behavioral therapy, exercise therapy, transcutaneous electrical nerve stimulation, interferential currents, low-level laser therapy, and yoga. Other treatments include massage, acupuncture, and superficial heat therapy thermal heat wraps, hot water bottles, heated packs filled with grain, hot towels, and electric heating pads). Manual modalities such as physiotherapy, massage, chiropractic, occupational, and osteopathic therapies, including spinal manipulation and mobilization, are often used together and alone to treat chronic non-specific low back pain Exercises are a way to induce strength, endurance, functional mobility, and neuromuscular control in back muscles. A variety of Exercises like Motor control stabilization exercises, back stabilization exercises, core muscle activation exercises, and endurance exercises are used to reduce the effect of low back pain. These particular exercises are for lumber and core Stabilization and strengthening but there is very limited research on the superiority of each exercise over the other.
Earlier work suggested that there is little or no evidence that spinal manipulative therapy was superior to other standard treatments for chronic low back pain. however, recent systematic reviews suggest that spinal manipulation and mobilization are "viable" options for pain treatment
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Spinal mobilization and core stabilization exercises group: | Experimental | Other: core stabilization exercises, Other: Spinal mobilization techniqueswill have core muscle activation exercises along with lumber spine joint mobilization along with TENS and Ultrasound for 12 weeks and 3 sessions per week |
| Spinal mobilization techniques group | Active comparator | Other: Spinal mobilization techniqueswill have lumber spine joint mobilization along with TENS and Ultrasound duration of 12 weeks with 3 sessions per week. |
Who may qualify
- Ages
- 20 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- • Both Gender
Key exclusion criteria (6 listed)
- Patients with any signs of spinal cord involvement
- Pregnant female patients
- History of spinal trauma or spinal or abdominal surgery
- History of systemic disease (e.g., systemic scleroderma or muscular dystrophy), spinal deformity (e.g., scoliosis and kyphosis), or abdominal wall hernia
- History of participation in core stability exercise or any physical therapy treatment in the past 6 months
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 |
|---|---|---|
| core stabilization exercisesCore muscles activation exercises will be performed on patients to target the abdominals. | Other | Spinal mobilization and core stabilization exercises group: |
| Spinal mobilization techniqueslumbar spine joint mobilization techniques will be performed to patient in prone lying. | Other | Spinal mobilization and core stabilization exercises group:, Spinal mobilization techniques group |
Primary outcome
Bubble base inclinometer for Range of Motion
Time frame: up to 12 weeks
It will be used to measure lumbar Range of motion. It will be placed near the joint to be measured; turn the dial until the scale reads zero; take the joint through its range and range of motion will be recorded (in degrees) directly from the dial.
Pressure biofeedback unit for Muscle strength
Time frame: up to 12 weeks
Pressure Biofeedback Unit will be use to assess core stability muscle strength contraction. pressure biofeedback unit will be placed under the lumbar spine at the height of L3 and inflate the cuff to 40mmHg.The patient is then instructed to perform core contraction and increase the pressure in steps of 2-4mmHg. So from 40 to 42or44mmHg and so on. The contraction should be held whilst being able to keep breathing calmly. Ideally, the patient is able to hold this contraction for 15 seconds. Time will be noted.
Numeric Pain Rating Scale
Time frame: up to 12 weeks
The NPRS is a segmented numeric scale in which the respondent selects a whole number (0-10 integers) that best reflects the intensity of his/her pain. The common format is a horizontal bar or line. NPRS is anchored by terms describing pain severity extremes
Modified Oswestry Disability Index
Time frame: up to 12 weeks
The Oswestry Disability Index (also known as the Oswestry Low Back Pain Disability Questionnaire) is an extremely important tool that researchers and disability evaluators use to measure a patient's permanent functional disability. The test is considered the 'gold standard' of low back functional outcome tools. It has 10 different sections. For each section the total possible score is 5. If all 10 sections are completed the score is calculated and interpreted in percentage measures.
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 5 Mar 2024.
- Background: PubMed 29371112Coulter ID, Crawford C, Hurwitz EL, Vernon H, Khorsan R, Suttorp Booth M, Herman PM. Manipulation and mobilization for treating chronic low back pain: a systematic review and meta-analysis. Spine J. 2018 May;18(5):866-879. doi: 10.1016/j.spinee.2018.01.013. Epub 2018 Jan 31.
- Background: PubMed 30248035Waseem M, Karimi H, Gilani SA, Hassan D. Treatment of disability associated with chronic non-specific low back pain using core stabilization exercises in Pakistani population. J Back Musculoskelet Rehabil. 2019;32(1):149-154. doi: 10.3233/BMR-171114.
- Background: PubMed 31908589Areeudomwong P, Buttagat V. Comparison of Core Stabilisation Exercise and Proprioceptive Neuromuscular Facilitation Training on Pain-related and Neuromuscular Response Outcomes for Chronic Low Back Pain: A Randomised Controlled Trial. Malays J Med Sci. 2019 Nov;26(6):77-89. doi: 10.21315/mjms2019.26.6.8. Epub 2019 Dec 30.
- Background: PubMed 31631992Ozsoy G, Ilcin N, Ozsoy I, Gurpinar B, Buyukturan O, Buyukturan B, Kararti C, Sas S. The Effects Of Myofascial Release Technique Combined With Core Stabilization Exercise In Elderly With Non-Specific Low Back Pain: A Randomized Controlled, Single-Blind Study. Clin Interv Aging. 2019 Oct 9;14:1729-1740. doi: 10.2147/CIA.S223905. eCollection 2019.
- Background: PubMed 33037280Mueller J, Niederer D. Dose-response-relationship of stabilisation exercises in patients with chronic non-specific low back pain: a systematic review with meta-regression. Sci Rep. 2020 Oct 9;10(1):16921. doi: 10.1038/s41598-020-73954-9.
- Background: PubMed 33922389Frizziero A, Pellizzon G, Vittadini F, Bigliardi D, Costantino C. Efficacy of Core Stability in Non-Specific Chronic Low Back Pain. J Funct Morphol Kinesiol. 2021 Apr 22;6(2):37. doi: 10.3390/jfmk6020037.
- Background: PubMed 34847915Hlaing SS, Puntumetakul R, Khine EE, Boucaut R. Effects of core stabilization exercise and strengthening exercise on proprioception, balance, muscle thickness and pain related outcomes in patients with subacute nonspecific low back pain: a randomized controlled trial. BMC Musculoskelet Disord. 2021 Nov 30;22(1):998. doi: 10.1186/s12891-021-04858-6.
- Background: PubMed 25467999Kumar T, Kumar S, Nezamuddin M, Sharma VP. Efficacy of core muscle strengthening exercise in chronic low back pain patients. J Back Musculoskelet Rehabil. 2015;28(4):699-707. doi: 10.3233/BMR-140572.
- Background: PubMed 32784592Sanchez Romero EA, Fernandez Carnero J, Villafane JH, Calvo-Lobo C, Ochoa Saez V, Burgos Caballero V, Laguarta Val S, Pedersini P, Pecos Martin D. Prevalence of Myofascial Trigger Points in Patients with Mild to Moderate Painful Knee Osteoarthritis: A Secondary Analysis. J Clin Med. 2020 Aug 7;9(8):2561. doi: 10.3390/jcm9082561.
- 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.
Sana Gohar, MS* principal investigator
Riphah International University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing core stabilization exercises and Spinal mobilization techniques in people with Low Back Pain, run by Riphah International University at 1 site in Pakistan.
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 3 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 5 Mar 2024. 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 Pakistan. 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?
Bubble base inclinometer for Range of Motion (time frame: up to 12 weeks). The study lists 4 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 NCT05905562, 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 5 Mar 2024.