Non-specific Chronic Low Back PainNCT05393336
V-sitting Posture Stabilization Versus Modified Clamshell in Patients With Non-specific Chronic Low Back Pain.
A study testing V-sitting posture stabilization and Modified clamshell exercises in people with Non-specific Chronic Low Back Pain, run by Riphah International University at 1 site in Pakistan.
Trial summary
The aim of this study is to compare the v-siting posture stabilization and clamshell exercises on pain and disability in patients with non-specific chronic low back pain. Read more about this study
- Who is it for?
- Ages 20 to 50 years
- Conditions the study is for
- Non-specific Chronic Low Back Pain
- What is being tested?
- V-sitting posture stabilization and Modified clamshell exercises
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 sitePakistan
- Study dates
- 1 Jun 2022to 1 Jan 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
- Patients with non-specific low back pain for more than 3 months
- Subjects being able to sustain 5 seconds of isometric hip abduction in the side-lying position
- Negative Crossed Straight leg raise test
- Negative Straight leg raise test
Who cannot join
- Metabolic Bone disease (Osteoporosis)
- Any History of Hip pathology
- History of trauma
- History of systemic disease (Rheumatologic disorders, spondylitis, spinal cord disease)
- Radiculopathy
Trial locations and contacts
1 site in 1 country.
Pakistan1 site
Riphah Rehabilitation Clinic
Lahore, Punjab Province, 54000
Muhammad Salman Bashir, PhD, +923334497959, salman.bashir@riphah.edu.pk
Muhammad Ahmed Saleemi
About this study
Official title: Comparison of V-sitting Posture Stabilization and Modified Clamshell Exercises on Pain and Disability in Patients With Non-specific Chronic Low Back Pain.
The aim of this study is to compare the v-siting posture stabilization and clamshell exercises on pain and disability in patients with non-specific chronic low back pain.
Read the detailed description
Chronic low back pain (LBP) is a common musculoskeletal pain disorder that affects most adults and has the highest prevalence among other chronic musculoskeletal pain disorders. Non-traumatic lower back pain can have different etiologies: intervertebral disc related, vertebral body related, and facet joint related and sacroiliac joint related. Non-specific low back pain affects people of all ages and is a leading contributor to disease burden worldwide. Non-specific low back pain does not have a known pathoanatomical cause. Treatment of non-specific chronic low back pain includes manual therapy, exercise therapy, massage, acupuncture, yoga, cognitive behavioral therapy, and intensive interdisciplinary treatment.
Previous studies have compared the effects of different exercise therapies, other treatment modalities, osteopathic techniques, manual therapies, and yoga and eurhythmy therapy for the management of low back pain. There is very little literature found to evaluate the effects of single movement technique V-sitting exercises and modified clamshell exercises in the management of non-specific chronic low back pain. Previous literature showed less treatment sessions and follow up periods as they are barrier to see the exact picture of effects of treatment protocol followed. In contrast longer duration of treatment regime allow deep insight of the effects of the main treatment body. This study will fulfill these literature gaps. This study will find the comparative effects of V-sitting posture stabilization and Modified Clamshell exercises in the treatment of non-specific chronic low back pain with more treatment sessions in both genders.
- Conditions
- Non-specific Chronic Low Back Pain
- Being tested
- V-sitting posture stabilization, Modified clamshell exercises
- Keywords
- low back pain, disability, pain intensity, chronic pain
- Medical subject headings
- Low Back Pain, Pain, Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
V-sitting posture stabilizationOther
15 patients will be given a hot pack with TENS for 15 minutes. Followed by static stretching of the gluteus, hamstrings, and Iliopsoas muscles for 10 to 30 seconds hold and 2 to 4 repetitions. Then the patient will perform the V-sitting exercise for 10 seconds starting with 5 repetitions and progressing to 15 overtime. Each patient will receive treatment for 6 days per week and 6 weeks.
Modified clamshell exercisesOther
15 patients will be given a hot pack with TENS for 15 minutes. Followed by static stretching of the gluteus, hamstrings, and Iliopsoas muscles for 10 to 30 seconds hold and 2 to 4 repetitions. Then the patient will perform the modified clamshell exercise for 10 seconds starting with 5 repetitions and progressing to 15 overtime. Each patient will receive treatment for 6 days per week and 6 weeks.
| Study group | Role | What they receive |
|---|---|---|
| V-sitting posture stabilization | Experimental | V sitting exercises will be administered where patients will be asked to lift the torso and legs while engaging the core and abdominal muscles. Receives: Other: V-sitting posture stabilization |
| modified clamshell exercises | Experimental | Participants will perform modified clamshell exercises monitored visually and using a stabilizer pressure biofeedback unit. Receives: Other: Modified clamshell exercises |
What is being measured
The primary outcome is the main question the study is designed to answer.
NPRS for pain
The Numerical Pain Rating Scale (NPRS) is a subjective measure in which individuals rate their pain on an eleven-point numerical scale. The scale is composed of 0 (no pain at all) to 10 (worst imaginable pain).
Measured: 6th week
RMQ for pain and disability
The Roland-Morris Questionnaire (RMQ) is a self-administered disability measure in which greater levels of disability are reflected by higher numbers on a 24-point scale. For example, at the beginning of treatment, a patient's score was 12 and, at the conclusion of treatment, their score was 2 (10 points of improvement), we would calculate an 83% (10/12 x 100) improvement.
Measured: 6th week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 May 2022
- Study start1 Jun 2022 (estimated)
- Primary completion1 Jan 2023 (estimated)
- Study completion1 Jan 2023 (estimated)
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 Non-specific Chronic 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
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Muhammad Salman Bashir, PhD, Principal investigator, Riphah International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05393336
- Sponsor's protocol ID
- REC/RCR & AHS/22/0104
- Status last verified
- May 2022
- First submitted
- 23 May 2022
- Last updated
- 26 May 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Kwok BC, Lim JXL, Kong PW. The Theoretical Framework of the Clinical Pilates Exercise Method in Managing Non-Specific Chronic Low Back Pain: A Narrative Review. Biology (Basel). 2021 Oct 25;10(11):1096. doi: 10.3390/biology10111096.
PubMed 34827088Cho JH, Lee KH, Lim ST. Aged Lumbar Extension Strength of Chronic Low Back Pain in Korean Population of 10-80 Years. Iran J Public Health. 2020 Oct;49(10):1894-1901. doi: 10.18502/ijph.v49i10.4692.
PubMed 33346210Popescu A, Lee H. Neck Pain and Lower Back Pain. Med Clin North Am. 2020 Mar;104(2):279-292. doi: 10.1016/j.mcna.2019.11.003. Epub 2019 Dec 20.
PubMed 32035569Clark JR, Nijs J, Smart K, Holmes P, Yeowell G, Goodwin PC. Prevalence of Extreme Trait Sensory Profiles and Personality Types in Nonspecific Chronic Low Back Pain with Predominant Central Sensitization: Secondary Analysis of an International Observational Study. Pain Physician. 2019 May;22(3):E181-E190.
PubMed 31151341Tanabe H, Akai M, Doi T, Arai S, Fujino K, Hayashi K; for Low back-pain Traction Therapy (LTT) Study. Immediate effect of mechanical lumbar traction in patients with chronic low back pain: A crossover, repeated measures, randomized controlled trial. J Orthop Sci. 2021 Nov;26(6):953-961. doi: 10.1016/j.jos.2020.09.018. Epub 2021 Mar 27.
PubMed 33785233van Dillen LR, Lanier VM, Steger-May K, Wallendorf M, Norton BJ, Civello JM, Czuppon SL, Francois SJ, Roles K, Lang CE. Effect of Motor Skill Training in Functional Activities vs Strength and Flexibility Exercise on Function in People With Chronic Low Back Pain: A Randomized Clinical Trial. JAMA Neurol. 2021 Apr 1;78(4):385-395. doi: 10.1001/jamaneurol.2020.4821.
PubMed 33369625Krause F, Niederer D, Banzer W, Vogt L. Medical exercise and physiotherapy modes and frequency as predictors for a recurrence of chronic non-specific low back pain. J Back Musculoskelet Rehabil. 2021;34(4):665-670. doi: 10.3233/BMR-200149.
PubMed 33749637Dal Farra F, Risio RG, Vismara L, Bergna A. Effectiveness of osteopathic interventions in chronic non-specific low back pain: A systematic review and meta-analysis. Complement Ther Med. 2021 Jan;56:102616. doi: 10.1016/j.ctim.2020.102616. Epub 2020 Nov 13.
PubMed 33197571Sanchis-Sanchez E, Lluch-Girbes E, Guillart-Castells P, Georgieva S, Garcia-Molina P, Blasco JM. Effectiveness of mechanical diagnosis and therapy in patients with non-specific chronic low back pain: a literature review with meta-analysis. Braz J Phys Ther. 2021 Mar-Apr;25(2):117-134. doi: 10.1016/j.bjpt.2020.07.007. Epub 2020 Aug 4.
PubMed 32773288
Study at a glance
From the registry record, last updated by the sponsor on 26 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of V-sitting Posture Stabilization and Modified Clamshell Exercises on Pain and Disability in Patients With Non-specific Chronic Low Back Pain.
- ClinicalTrials.gov ID
- NCT05393336
- Acronym / sponsor ID
- REC/RCR & AHS/22/0104
- Conditions
- Non-specific Chronic Low Back Pain
- Keywords
- low back pain, disability, pain intensity, chronic pain
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 1 Jun 2022 (estimated)
- Primary completion
- 1 Jan 2023 (estimated)
- Study completion
- 1 Jan 2023 (estimated)
- First posted
- 26 May 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.
The aim of this study is to compare the v-siting posture stabilization and clamshell exercises on pain and disability in patients with non-specific chronic low back pain.
Detailed description
Chronic low back pain (LBP) is a common musculoskeletal pain disorder that affects most adults and has the highest prevalence among other chronic musculoskeletal pain disorders. Non-traumatic lower back pain can have different etiologies: intervertebral disc related, vertebral body related, and facet joint related and sacroiliac joint related. Non-specific low back pain affects people of all ages and is a leading contributor to disease burden worldwide. Non-specific low back pain does not have a known pathoanatomical cause. Treatment of non-specific chronic low back pain includes manual therapy, exercise therapy, massage, acupuncture, yoga, cognitive behavioral therapy, and intensive interdisciplinary treatment.
Previous studies have compared the effects of different exercise therapies, other treatment modalities, osteopathic techniques, manual therapies, and yoga and eurhythmy therapy for the management of low back pain. There is very little literature found to evaluate the effects of single movement technique V-sitting exercises and modified clamshell exercises in the management of non-specific chronic low back pain. Previous literature showed less treatment sessions and follow up periods as they are barrier to see the exact picture of effects of treatment protocol followed. In contrast longer duration of treatment regime allow deep insight of the effects of the main treatment body. This study will fulfill these literature gaps. This study will find the comparative effects of V-sitting posture stabilization and Modified Clamshell exercises in the treatment of non-specific chronic low back pain with more treatment sessions in both genders.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| V-sitting posture stabilization | Experimental | Other: V-sitting posture stabilizationV sitting exercises will be administered where patients will be asked to lift the torso and legs while engaging the core and abdominal muscles. |
| modified clamshell exercises | Experimental | Other: Modified clamshell exercisesParticipants will perform modified clamshell exercises monitored visually and using a stabilizer pressure biofeedback unit. |
Who may qualify
- Ages
- 20 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Patients with non-specific low back pain for more than 3 months
- Subjects being able to sustain 5 seconds of isometric hip abduction in the side-lying position
- Negative Crossed Straight leg raise test
- Negative Straight leg raise test
Key exclusion criteria (5 listed)
- Metabolic Bone disease (Osteoporosis)
- Any History of Hip pathology
- History of trauma
- History of systemic disease (Rheumatologic disorders, spondylitis, spinal cord disease)
- Radiculopathy
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 |
|---|---|---|
| V-sitting posture stabilization15 patients will be given a hot pack with TENS for 15 minutes. Followed by static stretching of the gluteus, hamstrings, and Iliopsoas muscles for 10 to 30 seconds hold and 2 to 4 repetitions. Then the patient will perform the V-sitting exercise for 10 seconds starting with 5 repetitions and progressing to 15 overtime. Each patient will receive treatment for 6 days per week and 6 weeks. | Other | V-sitting posture stabilization |
| Modified clamshell exercises15 patients will be given a hot pack with TENS for 15 minutes. Followed by static stretching of the gluteus, hamstrings, and Iliopsoas muscles for 10 to 30 seconds hold and 2 to 4 repetitions. Then the patient will perform the modified clamshell exercise for 10 seconds starting with 5 repetitions and progressing to 15 overtime. Each patient will receive treatment for 6 days per week and 6 weeks. | Other | modified clamshell exercises |
Primary outcome
NPRS for pain
Time frame: 6th week
The Numerical Pain Rating Scale (NPRS) is a subjective measure in which individuals rate their pain on an eleven-point numerical scale. The scale is composed of 0 (no pain at all) to 10 (worst imaginable pain).
RMQ for pain and disability
Time frame: 6th week
The Roland-Morris Questionnaire (RMQ) is a self-administered disability measure in which greater levels of disability are reflected by higher numbers on a 24-point scale. For example, at the beginning of treatment, a patient's score was 12 and, at the conclusion of treatment, their score was 2 (10 points of improvement), we would calculate an 83% (10/12 x 100) improvement.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 May 2022.
- Background: PubMed 34827088Kwok BC, Lim JXL, Kong PW. The Theoretical Framework of the Clinical Pilates Exercise Method in Managing Non-Specific Chronic Low Back Pain: A Narrative Review. Biology (Basel). 2021 Oct 25;10(11):1096. doi: 10.3390/biology10111096.
- Background: PubMed 33346210Cho JH, Lee KH, Lim ST. Aged Lumbar Extension Strength of Chronic Low Back Pain in Korean Population of 10-80 Years. Iran J Public Health. 2020 Oct;49(10):1894-1901. doi: 10.18502/ijph.v49i10.4692.
- Background: PubMed 32035569Popescu A, Lee H. Neck Pain and Lower Back Pain. Med Clin North Am. 2020 Mar;104(2):279-292. doi: 10.1016/j.mcna.2019.11.003. Epub 2019 Dec 20.
- Background: PubMed 31151341Clark JR, Nijs J, Smart K, Holmes P, Yeowell G, Goodwin PC. Prevalence of Extreme Trait Sensory Profiles and Personality Types in Nonspecific Chronic Low Back Pain with Predominant Central Sensitization: Secondary Analysis of an International Observational Study. Pain Physician. 2019 May;22(3):E181-E190.
- Background: PubMed 33785233Tanabe H, Akai M, Doi T, Arai S, Fujino K, Hayashi K; for Low back-pain Traction Therapy (LTT) Study. Immediate effect of mechanical lumbar traction in patients with chronic low back pain: A crossover, repeated measures, randomized controlled trial. J Orthop Sci. 2021 Nov;26(6):953-961. doi: 10.1016/j.jos.2020.09.018. Epub 2021 Mar 27.
- Background: PubMed 33369625van Dillen LR, Lanier VM, Steger-May K, Wallendorf M, Norton BJ, Civello JM, Czuppon SL, Francois SJ, Roles K, Lang CE. Effect of Motor Skill Training in Functional Activities vs Strength and Flexibility Exercise on Function in People With Chronic Low Back Pain: A Randomized Clinical Trial. JAMA Neurol. 2021 Apr 1;78(4):385-395. doi: 10.1001/jamaneurol.2020.4821.
- Background: PubMed 33749637Krause F, Niederer D, Banzer W, Vogt L. Medical exercise and physiotherapy modes and frequency as predictors for a recurrence of chronic non-specific low back pain. J Back Musculoskelet Rehabil. 2021;34(4):665-670. doi: 10.3233/BMR-200149.
- Background: PubMed 33197571Dal Farra F, Risio RG, Vismara L, Bergna A. Effectiveness of osteopathic interventions in chronic non-specific low back pain: A systematic review and meta-analysis. Complement Ther Med. 2021 Jan;56:102616. doi: 10.1016/j.ctim.2020.102616. Epub 2020 Nov 13.
- Background: PubMed 32773288Sanchis-Sanchez E, Lluch-Girbes E, Guillart-Castells P, Georgieva S, Garcia-Molina P, Blasco JM. Effectiveness of mechanical diagnosis and therapy in patients with non-specific chronic low back pain: a literature review with meta-analysis. Braz J Phys Ther. 2021 Mar-Apr;25(2):117-134. doi: 10.1016/j.bjpt.2020.07.007. Epub 2020 Aug 4.
- 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.
Muhammad Salman Bashir, PhD 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 V-sitting posture stabilization and Modified clamshell exercises in people with Non-specific Chronic 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 4 inclusion and 5 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 26 May 2022. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Imran Amjad, PhD (03324390125, imran.amjad@riphah.edu.pk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
NPRS for pain (time frame: 6th week). The study lists 2 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 NCT05393336, 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 26 May 2022.