Low Back PainNCT05167435

Myofascial Release Technique vs Posterior-anterior Glide on Non-specific Low Back Pain

A study testing Myofascial Release Experimental and Posterior-Anterior Glide in people with Low Back Pain, run by Dow University of Health Sciences at 3 sites in Pakistan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

Who is it for?: Ages 18 to 45 years
Conditions the study is for: Low Back Pain
What is being tested?: Myofascial Release Experimental and Posterior-Anterior Glide
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 80 participants
Where: 3 sitesPakistan
Study dates: 15 Sep 2021to 30 Dec 2021
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 45 years
All sexes
No healthy volunteers
Adult

Who may be able to join

Nonspecific low back pain > 3 months
8 and 45 years of age
IPMR and civil musculoskeletal outpatient department patients
Without referred leg pain

Who cannot join

Any trauma, spinal infection or tumor, spinal fracture, previous spinal surgery, systemic disease, fibromyalgia, cauda equine syndrome, serious chronic disease, specific neurological disease (stroke, MS, and Parkinson's disease)
Uncontrolled diabetes or hypertension
Pregnant females
Spondylolisthesis, spinal stenosis, spondylolysis, ankylosing spondylitis, structural deformity, congenital deformation, disc disease, sacroiliitis, severe structural deformity, scoliosis, active structural deficit, and severe postural abnormality
Acute coronary disease
Asthmatic patients
Any contraindication prescribed for myofascial treatment

Trial locations and contacts

3 sites in 1 country.

Pakistan3 sites

Dow University of Health Sciences
Karachi, Sindh, 74200
Dr. Ruth.K.M.Pfau Civil Hospital
Karachi, Sindh, 75950
Sindh Institute o Physical Medicine and Rehabilitation
Karachi, Sindh, 75950

Other trials in Pakistan

About this study

Official title: Myofascial Release Technique vs Posterior-anterior Glide on Non-specific Low Back Pain: a Randomized Controlled Trial

The objective of this randomized control trial is to determine the effectiveness of myofascial release in patients with nonspecific low back pain to improve Pain, Disability, and Quality of life This study is being conducted at the Outpatient Physiotherapy department of Sindh Institute of Physical Medicine and Rehabilitation, Karachi (former institute of Dow University of Health Sciences) and Musculoskeletal outpatient department of Dr. Ruth K. M. Pfau, Civil Hospital Karachi among 72 patients with nonspecific back pain on the basis of non-probability purposive sample technique with screening for study criteria through a consultant physician (blinded). After taking informed consent, all participants will be randomly allocated into two groups through a second researcher who is not involved in screening, baseline assessment, and providing intervention. Group 1 will receive myofascial release with generalized low back stretching and thermotherapy and Group 2 will receive Posterior-anterior glide with generalized low back stretching and thermotherapy. A total of 18 sessions will be provided. Outcomes will be assessed at baseline, at the last session, and after 12 weeks of follow-up.

Conditions: Low Back Pain
Being tested: Myofascial Release Experimental, Posterior-Anterior Glide
Keywords: Chronic Pain, Disabled Persons, Myofascial Release, Low back pain, Back pain, Exercise Therapy, Quality of life
Medical subject headings: Low Back Pain, Chronic Pain, Back Pain

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Myofascial Release ExperimentalOther
Myofascial release is a gentle sustained pressure that elongates fascial adhesions so that tissue can return to proper realignment.
Posterior-Anterior GlideOther
Posterior-anterior mobilization is a standard assessment and treatment technique for most clinicians. It is a mobilization technique that involves passive oscillatory movements applied to a vertebral segment in a posteroanterior direction (Back to front).

Study groups in NCT05167435
Study group	Role	What they receive
Group A (Intervention)	Experimental	Myofascial release (Following Cross-hand release techniques of myofascial release in a manner of 2 minutes approach: Cross-Hand Release of Back [For Thoracolumbar Fascia] Cross-Hand Release of the Lumbosacral Junction [L5-S1] Cross-Hand Release of Lateral low back area [for quadratus lumborum]) will be provided with conventional therapy including stretching exercises (Stretching of Latissimus Dorsi [10 seconds hold, 10 reps, 2 sets], Quadratus Lumborum Stretching [10 seconds hold, 3 reps, 1 set bilaterally], Lower Back Stretching [10 seconds hold, 10 reps, 2 sets], Hamstring Stretching [10 seconds hold, 10 reps, 2 sets bilaterally], Tensor Fasciae Latae Stretching [10 sec hold, 10 reps, 2 sets bilaterally] with duration rest will be of thirty seconds after five minutes) and Thermotherapy will be given for 20 minutes Receives: Other: Myofascial Release Experimental
Group B (Control)	Active comparator	Posterior-anterior glide: Grade 1-4 [depending on tolerance] (120 oscillations per minute x 3 sets, Duration of rest between each set: 30 seconds) will be provided with the same conventional therapy as in Group A (Intervention) Receives: Other: Posterior-Anterior Glide

What is being measured

The primary outcome is the main question the study is designed to answer.

Change from baseline in pain on Short Form McGill Questionnaire 2 (SFMPQ-2) at 6 weeks (post intervention).
The patient will be asked to mark the Quality and Intensity of pain on a scale of 0-10 that measures the level of pain. The 0 refers no pain and 10 refers worse possible pain and perceived as maximum.
Measured: Baseline and Post Intervention
Change from baseline in pain on Short Form McGill Questionnaire 2 (SFMPQ-2) at 12 weeks follow-up.
The patient will be asked to mark the Quality and Intensity of pain on a scale of 0-10 that measures the level of pain. The 0 refers no pain and 10 refers worse possible pain and perceived as maximum.
Measured: Baseline and 12 weeks follow-up
Change from 6 weeks (post intervention) in pain on Short Form McGill Questionnaire 2 (SFMPQ-2) at 12 weeks follow-up.
The patient will be asked to mark the Quality and Intensity of pain on a scale of 0-10 that measures the level of pain. The 0 refers no pain and 10 refers worse possible pain and perceived as maximum.
Measured: Post Intervention and 12 weeks follow-up
Change from baseline in disability on the Roland Morris Disability Questionnaire at 6 weeks (post intervention)..
A list of 24 sentences will be provided that are found to be difficult to be done by back pain patients. The patient will be asked to mark the sentence. The higher the number of sentences represents the greater intensity of disability means extreme disability. On the other hand the lower the number of sentences marked means the lower the score on the scale for example like 0 (zero) shows no disability.
Measured: Baseline and Post Intervention
Change from baseline in disability on the Roland Morris Disability Questionnaire at 12 weeks follow-up.
A list of 24 sentences will be provided that are found to be difficult to be done by back pain patients. The patient will be asked to mark the sentence. The higher the number of sentences represents the greater intensity of disability means extreme disability. On the other hand the lower the number of sentences marked means the lower the score on the scale for example like 0 (zero) shows no disability.
Measured: Baseline and 12 weeks follow-up
Change from 6 weeks (post intervention) in disability on the Roland Morris Disability Questionnaire at 12 weeks follow-up.
A list of 24 sentences will be provided that are found to be difficult to be done by back pain patients. The patient will be asked to mark the sentence. The higher the number of sentences represents the greater intensity of disability means extreme disability. On the other hand the lower the number of sentences marked means the lower the score on the scale for example like 0 (zero) shows no disability.
Measured: Post Intervention and 12 weeks follow-up
Change from baseline in Quality of life on the WHOQOL BREF at 6 weeks (post intervention).
This questionnaire assess the quality of life within the context of an individual's physical health, psychological, social relationships and environment. Other than these 4 domains 2 questions are asked separately to evaluate an individuals overall perception of quality of life and about an individuals overall perception of their health. The higher the score denote the higher the quality of life and lower score denotes lower quality of life. All 26 assessment questions in the questionnaire has a range of 1-5. 3 of the questions are negatively phrased and so are reversed scored when calculating the domain scores - a score of 5 becomes a 1 and vice versa, a score of 4 becomes a two and vice versa etc. This is performed on questions 3, 4, and 26. You do this before calculating any domain scores. The domain scores are than added to get the final score.
Measured: Baseline and Post Intervention
Change from baseline in Quality of life on the WHOQOL BREF at 12 weeks follow-up.
This questionnaire assess the quality of life within the context of an individual's physical health, psychological, social relationships and environment. Other than these 4 domains 2 questions are asked separately to evaluate an individuals overall perception of quality of life and about an individuals overall perception of their health. The higher the score denote the higher the quality of life and lower score denotes lower quality of life. All 26 assessment questions in the questionnaire has a range of 1-5. 3 of the questions are negatively phrased and so are reversed scored when calculating the domain scores - a score of 5 becomes a 1 and vice versa, a score of 4 becomes a two and vice versa etc. This is performed on questions 3, 4, and 26. You do this before calculating any domain scores. The domain scores are than added to get the final score.
Measured: Baseline and 12 weeks follow-up
Change from 6 weeks (post intervention) in Quality of life on the WHOQOL BREF at 12 weeks follow-up.
This questionnaire assess the quality of life within the context of an individual's physical health, psychological, social relationships and environment. Other than these 4 domains 2 questions are asked separately to evaluate an individuals overall perception of quality of life and about an individuals overall perception of their health. The higher the score denote the higher the quality of life and lower score denotes lower quality of life. All 26 assessment questions in the questionnaire has a range of 1-5. 3 of the questions are negatively phrased and so are reversed scored when calculating the domain scores - a score of 5 becomes a 1 and vice versa, a score of 4 becomes a two and vice versa etc. This is performed on questions 3, 4, and 26. You do this before calculating any domain scores. The domain scores are than added to get the final score.
Measured: Post Intervention and 12 weeks follow-up

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

15 Sep 202130 Dec 2021

First posted22 Dec 2021
Study start15 Sep 2021
Primary completion30 Dec 2021
Study completion30 Dec 2021

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (23)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
Model description: It is a randomized controlled trial. Total 80 patients will be recruited, 40 in each group that includes 4 patients as a dropout in both groups. There will be one interventional group and one control group. Treatment will be allocated using a random number sheet generated by SPSS software version 21. Participants are assigned to one of two groups in parallel for the duration of the study.
Masking: Single blind
Who is masked: Outcomes assessor
Enrolment: 80 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05167435
Sponsor's protocol ID: Swaniya
Status last verified: Feb 2022
First submitted: 25 Nov 2021
Last updated: 8 Mar 2022
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No

Publications

Blyth FM, Noguchi N. Chronic musculoskeletal pain and its impact on older people. Best Pract Res Clin Rheumatol. 2017 Apr;31(2):160-168. doi: 10.1016/j.berh.2017.10.004. Epub 2017 Nov 4.
PubMed 29224694
Chenot JF, Greitemann B, Kladny B, Petzke F, Pfingsten M, Schorr SG. Non-Specific Low Back Pain. Dtsch Arztebl Int. 2017 Dec 25;114(51-52):883-890. doi: 10.3238/arztebl.2017.0883.
PubMed 29321099
Ehrlich GE. Low back pain. Bull World Health Organ. 2003;81(9):671-6. Epub 2003 Nov 14.
PubMed 14710509
Savigny P, Watson P, Underwood M; Guideline Development Group. Early management of persistent non-specific low back pain: summary of NICE guidance. BMJ. 2009 Jun 4;338:b1805. doi: 10.1136/bmj.b1805. No abstract available.
PubMed 19502217
Walker J. Back pain: pathogenesis, diagnosis and management. Nurs Stand. 2012 Dec 5-11;27(14):49-56; quiz 58. doi: 10.7748/ns2012.12.27.14.49.c9478.
PubMed 23488026
Hoy D, Brooks P, Blyth F, Buchbinder R. The Epidemiology of low back pain. Best Pract Res Clin Rheumatol. 2010 Dec;24(6):769-81. doi: 10.1016/j.berh.2010.10.002.
PubMed 21665125
Arguisuelas MD, Lison JF, Sanchez-Zuriaga D, Martinez-Hurtado I, Domenech-Fernandez J. Effects of Myofascial Release in Nonspecific Chronic Low Back Pain: A Randomized Clinical Trial. Spine (Phila Pa 1976). 2017 May 1;42(9):627-634. doi: 10.1097/BRS.0000000000001897.
PubMed 28441294
Laimi K, Makila A, Barlund E, Katajapuu N, Oksanen A, Seikkula V, Karppinen J, Saltychev M. Effectiveness of myofascial release in treatment of chronic musculoskeletal pain: a systematic review. Clin Rehabil. 2018 Apr;32(4):440-450. doi: 10.1177/0269215517732820. Epub 2017 Sep 28.
PubMed 28956477
Husky MM, Ferdous Farin F, Compagnone P, Fermanian C, Kovess-Masfety V. Chronic back pain and its association with quality of life in a large French population survey. Health Qual Life Outcomes. 2018 Sep 26;16(1):195. doi: 10.1186/s12955-018-1018-4.
PubMed 30257670
Ajimsha MS, Al-Mudahka NR, Al-Madzhar JA. Effectiveness of myofascial release: systematic review of randomized controlled trials. J Bodyw Mov Ther. 2015 Jan;19(1):102-12. doi: 10.1016/j.jbmt.2014.06.001. Epub 2014 Jun 13.
PubMed 25603749
Yu SH, Sim YH, Kim MH, Bang JH, Son KH, Kim JW, Kim HJ. The effect of abdominal drawing-in exercise and myofascial release on pain, flexibility, and balance of elderly females. J Phys Ther Sci. 2016 Oct;28(10):2812-2815. doi: 10.1589/jpts.28.2812. Epub 2016 Oct 28.
PubMed 27821941
Buchbinder R, Blyth FM, March LM, Brooks P, Woolf AD, Hoy DG. Placing the global burden of low back pain in context. Best Pract Res Clin Rheumatol. 2013 Oct;27(5):575-89. doi: 10.1016/j.berh.2013.10.007. Epub 2013 Oct 12.
PubMed 24315140
Fouquet N, Bodin J, Descatha A, Petit A, Ramond A, Ha C, Roquelaure Y. Prevalence of thoracic spine pain in a surveillance network. Occup Med (Lond). 2015 Mar;65(2):122-5. doi: 10.1093/occmed/kqu151. Epub 2014 Oct 24.
PubMed 25344959
Roland M, Fairbank J. The Roland-Morris Disability Questionnaire and the Oswestry Disability Questionnaire. Spine (Phila Pa 1976). 2000 Dec 15;25(24):3115-24. doi: 10.1097/00007632-200012150-00006. No abstract available.
PubMed 11124727
Dworkin RH, Turk DC, Trudeau JJ, Benson C, Biondi DM, Katz NP, Kim M. Validation of the Short-form McGill Pain Questionnaire-2 (SF-MPQ-2) in acute low back pain. J Pain. 2015 Apr;16(4):357-66. doi: 10.1016/j.jpain.2015.01.012. Epub 2015 Jan 29.
PubMed 25640290

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 8 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Myofascial Release Technique vs Posterior-anterior Glide on Non-specific Low Back Pain: a Randomized Controlled Trial
ClinicalTrials.gov ID: NCT05167435
Acronym / sponsor ID: Swaniya
Conditions: Low Back Pain
Keywords: Chronic Pain, Disabled Persons, Myofascial Release, Low back pain, Back pain, Exercise Therapy, Quality of life
Study type: Interventional
Recruitment status: Completed
Enrolment: 80 participants (actual)
Lead sponsor: Dow University of Health SciencesUniversity, hospital or other
Study start: 15 Sep 2021 (actual)
Primary completion: 30 Dec 2021 (actual)
Study completion: 30 Dec 2021 (actual)
First posted: 22 Dec 2021 (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.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (outcomes assessor)
Number of arms: 2
Model description: It is a randomized controlled trial. Total 80 patients will be recruited, 40 in each group that includes 4 patients as a dropout in both groups. There will be one interventional group and one control group. Treatment will be allocated using a random number sheet generated by SPSS software version 21. Participants are assigned to one of two groups in parallel for the duration of the study.

Arm	Type	Receives
Group A (Intervention)	Experimental	Other: Myofascial Release ExperimentalMyofascial release (Following Cross-hand release techniques of myofascial release in a manner of 2 minutes approach: Cross-Hand Release of Back [For Thoracolumbar Fascia] Cross-Hand Release of the Lumbosacral Junction [L5-S1] Cross-Hand Release of Lateral low back area [for quadratus lumborum]) will be provided with conventional therapy including stretching exercises (Stretching of Latissimus Dorsi [10 seconds hold, 10 reps, 2 sets], Quadratus Lumborum Stretching [10 seconds hold, 3 reps, 1 set bilaterally], Lower Back Stretching [10 seconds hold, 10 reps, 2 sets], Hamstring Stretching [10 seconds hold, 10 reps, 2 sets bilaterally], Tensor Fasciae Latae Stretching [10 sec hold, 10 reps, 2 sets bilaterally] with duration rest will be of thirty seconds after five minutes) and Thermotherapy will be given for 20 minutes
Group B (Control)	Active comparator	Other: Posterior-Anterior GlidePosterior-anterior glide: Grade 1-4 [depending on tolerance] (120 oscillations per minute x 3 sets, Duration of rest between each set: 30 seconds) will be provided with the same conventional therapy as in Group A (Intervention)

Who may qualify

Ages: 18 to 45 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult

Key inclusion criteria (4 listed)

Nonspecific low back pain > 3 months
8 and 45 years of age
IPMR and civil musculoskeletal outpatient department patients
Without referred leg pain

Key exclusion criteria (7 listed)

Any trauma, spinal infection or tumor, spinal fracture, previous spinal surgery, systemic disease, fibromyalgia, cauda equine syndrome, serious chronic disease, specific neurological disease (stroke, MS, and Parkinson's disease)
Uncontrolled diabetes or hypertension
Pregnant females
Spondylolisthesis, spinal stenosis, spondylolysis, ankylosing spondylitis, structural deformity, congenital deformation, disc disease, sacroiliitis, severe structural deformity, scoliosis, active structural deficit, and severe postural abnormality
Acute coronary disease

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
Myofascial Release ExperimentalMyofascial release is a gentle sustained pressure that elongates fascial adhesions so that tissue can return to proper realignment.	Other	Group A (Intervention)
Posterior-Anterior GlidePosterior-anterior mobilization is a standard assessment and treatment technique for most clinicians. It is a mobilization technique that involves passive oscillatory movements applied to a vertebral segment in a posteroanterior direction (Back to front).	Other	Group B (Control)

Primary outcome

Change from baseline in pain on Short Form McGill Questionnaire 2 (SFMPQ-2) at 6 weeks (post intervention).
Time frame: Baseline and Post Intervention
The patient will be asked to mark the Quality and Intensity of pain on a scale of 0-10 that measures the level of pain. The 0 refers no pain and 10 refers worse possible pain and perceived as maximum.
Change from baseline in pain on Short Form McGill Questionnaire 2 (SFMPQ-2) at 12 weeks follow-up.
Time frame: Baseline and 12 weeks follow-up
The patient will be asked to mark the Quality and Intensity of pain on a scale of 0-10 that measures the level of pain. The 0 refers no pain and 10 refers worse possible pain and perceived as maximum.
Change from 6 weeks (post intervention) in pain on Short Form McGill Questionnaire 2 (SFMPQ-2) at 12 weeks follow-up.
Time frame: Post Intervention and 12 weeks follow-up
The patient will be asked to mark the Quality and Intensity of pain on a scale of 0-10 that measures the level of pain. The 0 refers no pain and 10 refers worse possible pain and perceived as maximum.
Change from baseline in disability on the Roland Morris Disability Questionnaire at 6 weeks (post intervention)..
Time frame: Baseline and Post Intervention
A list of 24 sentences will be provided that are found to be difficult to be done by back pain patients. The patient will be asked to mark the sentence. The higher the number of sentences represents the greater intensity of disability means extreme disability. On the other hand the lower the number of sentences marked means the lower the score on the scale for example like 0 (zero) shows no disability.
Change from baseline in disability on the Roland Morris Disability Questionnaire at 12 weeks follow-up.
Time frame: Baseline and 12 weeks follow-up
A list of 24 sentences will be provided that are found to be difficult to be done by back pain patients. The patient will be asked to mark the sentence. The higher the number of sentences represents the greater intensity of disability means extreme disability. On the other hand the lower the number of sentences marked means the lower the score on the scale for example like 0 (zero) shows no disability.
Change from 6 weeks (post intervention) in disability on the Roland Morris Disability Questionnaire at 12 weeks follow-up.
Time frame: Post Intervention and 12 weeks follow-up
A list of 24 sentences will be provided that are found to be difficult to be done by back pain patients. The patient will be asked to mark the sentence. The higher the number of sentences represents the greater intensity of disability means extreme disability. On the other hand the lower the number of sentences marked means the lower the score on the scale for example like 0 (zero) shows no disability.
Change from baseline in Quality of life on the WHOQOL BREF at 6 weeks (post intervention).
Time frame: Baseline and Post Intervention
This questionnaire assess the quality of life within the context of an individual's physical health, psychological, social relationships and environment. Other than these 4 domains 2 questions are asked separately to evaluate an individuals overall perception of quality of life and about an individuals overall perception of their health. The higher the score denote the higher the quality of life and lower score denotes lower quality of life. All 26 assessment questions in the questionnaire has a range of 1-5. 3 of the questions are negatively phrased and so are reversed scored when calculating the domain scores - a score of 5 becomes a 1 and vice versa, a score of 4 becomes a two and vice versa etc. This is performed on questions 3, 4, and 26. You do this before calculating any domain scores. The domain scores are than added to get the final score.
Change from baseline in Quality of life on the WHOQOL BREF at 12 weeks follow-up.
Time frame: Baseline and 12 weeks follow-up
This questionnaire assess the quality of life within the context of an individual's physical health, psychological, social relationships and environment. Other than these 4 domains 2 questions are asked separately to evaluate an individuals overall perception of quality of life and about an individuals overall perception of their health. The higher the score denote the higher the quality of life and lower score denotes lower quality of life. All 26 assessment questions in the questionnaire has a range of 1-5. 3 of the questions are negatively phrased and so are reversed scored when calculating the domain scores - a score of 5 becomes a 1 and vice versa, a score of 4 becomes a two and vice versa etc. This is performed on questions 3, 4, and 26. You do this before calculating any domain scores. The domain scores are than added to get the final score.
Change from 6 weeks (post intervention) in Quality of life on the WHOQOL BREF at 12 weeks follow-up.
Time frame: Post Intervention and 12 weeks follow-up
This questionnaire assess the quality of life within the context of an individual's physical health, psychological, social relationships and environment. Other than these 4 domains 2 questions are asked separately to evaluate an individuals overall perception of quality of life and about an individuals overall perception of their health. The higher the score denote the higher the quality of life and lower score denotes lower quality of life. All 26 assessment questions in the questionnaire has a range of 1-5. 3 of the questions are negatively phrased and so are reversed scored when calculating the domain scores - a score of 5 becomes a 1 and vice versa, a score of 4 becomes a two and vice versa etc. This is performed on questions 3, 4, and 26. You do this before calculating any domain scores. The domain scores are than added to get the final score.

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 8 Mar 2022.
Background: PubMed 29224694Blyth FM, Noguchi N. Chronic musculoskeletal pain and its impact on older people. Best Pract Res Clin Rheumatol. 2017 Apr;31(2):160-168. doi: 10.1016/j.berh.2017.10.004. Epub 2017 Nov 4.
Background: PubMed 29321099Chenot JF, Greitemann B, Kladny B, Petzke F, Pfingsten M, Schorr SG. Non-Specific Low Back Pain. Dtsch Arztebl Int. 2017 Dec 25;114(51-52):883-890. doi: 10.3238/arztebl.2017.0883.
Background: PubMed 14710509Ehrlich GE. Low back pain. Bull World Health Organ. 2003;81(9):671-6. Epub 2003 Nov 14.
Background: PubMed 19502217Savigny P, Watson P, Underwood M; Guideline Development Group. Early management of persistent non-specific low back pain: summary of NICE guidance. BMJ. 2009 Jun 4;338:b1805. doi: 10.1136/bmj.b1805. No abstract available.
Background: PubMed 23488026Walker J. Back pain: pathogenesis, diagnosis and management. Nurs Stand. 2012 Dec 5-11;27(14):49-56; quiz 58. doi: 10.7748/ns2012.12.27.14.49.c9478.
Background: PubMed 21665125Hoy D, Brooks P, Blyth F, Buchbinder R. The Epidemiology of low back pain. Best Pract Res Clin Rheumatol. 2010 Dec;24(6):769-81. doi: 10.1016/j.berh.2010.10.002.
Background: PubMed 28441294Arguisuelas MD, Lison JF, Sanchez-Zuriaga D, Martinez-Hurtado I, Domenech-Fernandez J. Effects of Myofascial Release in Nonspecific Chronic Low Back Pain: A Randomized Clinical Trial. Spine (Phila Pa 1976). 2017 May 1;42(9):627-634. doi: 10.1097/BRS.0000000000001897.
Background: PubMed 28956477Laimi K, Makila A, Barlund E, Katajapuu N, Oksanen A, Seikkula V, Karppinen J, Saltychev M. Effectiveness of myofascial release in treatment of chronic musculoskeletal pain: a systematic review. Clin Rehabil. 2018 Apr;32(4):440-450. doi: 10.1177/0269215517732820. Epub 2017 Sep 28.
Background: PubMed 30257670Husky MM, Ferdous Farin F, Compagnone P, Fermanian C, Kovess-Masfety V. Chronic back pain and its association with quality of life in a large French population survey. Health Qual Life Outcomes. 2018 Sep 26;16(1):195. doi: 10.1186/s12955-018-1018-4.
Background: PubMed 25603749Ajimsha MS, Al-Mudahka NR, Al-Madzhar JA. Effectiveness of myofascial release: systematic review of randomized controlled trials. J Bodyw Mov Ther. 2015 Jan;19(1):102-12. doi: 10.1016/j.jbmt.2014.06.001. Epub 2014 Jun 13.
Background: PubMed 27821941Yu SH, Sim YH, Kim MH, Bang JH, Son KH, Kim JW, Kim HJ. The effect of abdominal drawing-in exercise and myofascial release on pain, flexibility, and balance of elderly females. J Phys Ther Sci. 2016 Oct;28(10):2812-2815. doi: 10.1589/jpts.28.2812. Epub 2016 Oct 28.
Background: PubMed 24315140Buchbinder R, Blyth FM, March LM, Brooks P, Woolf AD, Hoy DG. Placing the global burden of low back pain in context. Best Pract Res Clin Rheumatol. 2013 Oct;27(5):575-89. doi: 10.1016/j.berh.2013.10.007. Epub 2013 Oct 12.
Doherty M, Ralston S.H. Musculoskeletal disease. Davidson's Principles and Practice of Medicine, 21st Edition. Churchill Livingstone, Elsevier. 2010.Link provided by the sponsor.
Arun B. Effects of myofascial release therapy on pain related disability, quality of sleep and depression in older adults with chronic low back pain. Int J Physiother Res 2014;2(1):318-23.Link provided by the sponsor.
Duncan R. myofascial release hands-on guides for therapists. 1st ed. Florida, United States of America: Hum Kinet Inc 2014.Link provided by the sponsor.
Thomas Scioscia M. Back Muscles and Low Back Pain. Spine-health. 2021.Link provided by the sponsor.
Morán Esquerdo O, Arechabala I. Stretching Exercises Encyclopedia. Maidenhead: Meyer \& Meyer Sport; 2013.Link provided by the sponsor.
Raza S, Awan WA, Ghauri MW, Mahmood T, Abbas S. Effectiveness of spinal stabilization exercises with and without stretching of Latissimus dorsi Muscle in chronic mechanical low back pain. RMJ. 2020; 45(4): 857-862.Link provided by the sponsor.

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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.

The record lists no contact. Use the official record to reach the sponsor.

3 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Myofascial Release Experimental and Posterior-Anterior Glide in people with Low Back Pain, run by Dow University of Health Sciences at 3 sites 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 7 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 8 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites 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?

Change from baseline in pain on Short Form McGill Questionnaire 2 (SFMPQ-2) at 6 weeks (post intervention). (time frame: Baseline and Post Intervention). The study lists 9 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 NCT05167435, which also lists 23 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 8 Mar 2022.