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

Low Back Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05167435
• Other study ID #: Swaniya
• Status: Completed
• Phase: N/A
• Start date: September 15, 2021
• Est. completion date: December 30, 2021

Study information

• Verified date: February 2022
• Source: Dow University of Health Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: December 30, 2021
• Est. primary completion date: December 30, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 45 Years

Eligibility

Inclusion Criteria:

Nonspecific low back pain > 3 months

8 and 45 years of age

IPMR and civil musculoskeletal outpatient department patients

Without referred leg pain

Exclusion Criteria:

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

Related Conditions & MeSH terms

• Back Pain
• Low Back Pain

Intervention

Other:
• Myofascial Release Experimental
Myofascial release is a gentle sustained pressure that elongates fascial adhesions so that tissue can return to proper realignment.
• Posterior-Anterior Glide
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).

Locations

Country	Name	City	State
Pakistan	Dow University of Health Sciences	Karachi	Sindh
Pakistan	Dr. Ruth.K.M.Pfau Civil Hospital	Karachi	Sindh
Pakistan	Sindh Institute o Physical Medicine and Rehabilitation	Karachi	Sindh

Sponsors (1)

Lead Sponsor	Collaborator
Dow University of Health Sciences

Country where clinical trial is conducted

Pakistan, 

References & Publications (23)

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. Review. — View Citation

Anderson RU, Wise D, Sawyer T, Glowe P, Orenberg EK. 6-day intensive treatment protocol for refractory chronic prostatitis/chronic pelvic pain syndrome using myofascial release and paradoxical relaxation training. J Urol. 2011 Apr;185(4):1294-9. doi: 10.1016/j.juro.2010.11.076. Epub 2011 Feb 22. — View Citation

Arguisuelas MD, Lisón JF, Sánchez-Zuriaga D, Martínez-Hurtado I, Doménech-Fernández 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. — View Citation

Bae HI, Kim DY, Sung YH. Effects of a static stretch using a load on low back pain patients with shortened tensor fascia lata. J Exerc Rehabil. 2017 Apr 30;13(2):227-231. doi: 10.12965/jer.1734910.455. eCollection 2017 Apr. — View Citation

Baig AAM, Ahmed SI, Ali SS, Rahmani A, Siddiqui F. Role of posterior-anterior vertebral mobilization versus thermotherapy in non specific lower back pain. Pak J Med Sci. 2018 Mar-Apr;34(2):435-439. doi: 10.12669/pjms.342.12402. — View Citation

Bernstein IA, Malik Q, Carville S, Ward S. Low back pain and sciatica: summary of NICE guidance. BMJ. 2017 Jan 6;356:i6748. doi: 10.1136/bmj.i6748. Erratum in: BMJ. 2021 Jul 14;374:n1627. — View Citation

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. Review. — View Citation

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. Review. — View Citation

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. Review. — View Citation

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. — View Citation

Ehrlich GE. Low back pain. Bull World Health Organ. 2003;81(9):671-6. Epub 2003 Nov 14. — View Citation

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. — View Citation

Goubert D, Oosterwijck JV, Meeus M, Danneels L. Structural Changes of Lumbar Muscles in Non-specific Low Back Pain: A Systematic Review. Pain Physician. 2016 Sep-Oct;19(7):E985-E1000. Review. — View Citation

Hodges PW, Danneels L. Changes in Structure and Function of the Back Muscles in Low Back Pain: Different Time Points, Observations, and Mechanisms. J Orthop Sports Phys Ther. 2019 Jun;49(6):464-476. doi: 10.2519/jospt.2019.8827. — View Citation

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. Review. — View Citation

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. — View Citation

Laimi K, Mäkilä A, Bärlund 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. Review. — View Citation

Nadler SF, Weingand K, Kruse RJ. The physiologic basis and clinical applications of cryotherapy and thermotherapy for the pain practitioner. Pain Physician. 2004 Jul;7(3):395-9. — View Citation

Qaseem A, Wilt TJ, McLean RM, Forciea MA; Clinical Guidelines Committee of the American College of Physicians, Denberg TD, Barry MJ, Boyd C, Chow RD, Fitterman N, Harris RP, Humphrey LL, Vijan S. Noninvasive Treatments for Acute, Subacute, and Chronic Low Back Pain: A Clinical Practice Guideline From the American College of Physicians. Ann Intern Med. 2017 Apr 4;166(7):514-530. doi: 10.7326/M16-2367. Epub 2017 Feb 14. — View Citation

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. Review. Erratum in: Spine 2001 Apr 1;26(7):847. — View Citation

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. — View Citation

Walker J. Back pain: pathogenesis, diagnosis and management. Nurs Stand. 2012 Dec 5-11;27(14):49-56; quiz 58. — View Citation

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. Epub 2016 Oct 28. — View Citation

* Note: There are 23 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Baseline and Post Intervention
Primary	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.	Baseline and 12 weeks follow-up
Primary	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.	Post Intervention and 12 weeks follow-up
Primary	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.	Baseline and Post Intervention
Primary	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.	Baseline and 12 weeks follow-up
Primary	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.	Post Intervention and 12 weeks follow-up
Primary	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.	Baseline and Post Intervention
Primary	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.	Baseline and 12 weeks follow-up
Primary	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.	Post Intervention and 12 weeks follow-up

External Links

•   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.
•   Doherty M, Ralston S.H. Musculoskeletal disease. Davidson's Principles and Practice of Medicine, 21st Edition. Churchill Livingstone, Elsevier. 2010.
•   Duncan R. myofascial release hands-on guides for therapists. 1st ed. Florida, United States of America: Hum Kinet Inc 2014.
•   Hengeveld E, Banks K.(ed) Maitland's Peripheral Manipulation. 4th ed. Elsevier: London.(2005)
•   Mora´n Esquerdo O, Arechabala I. Stretching Exercises Encyclopedia. Maidenhead: Meyer & Meyer Sport; 2013.
•   Ohtsuki K et al. Comparison of the immediate changes in subjects with chronic lower back pain effected by lower back pain exercises and direct stretching of the tensor fasciae latae, the hamstring and the adductor magnus. J Phys Ther:2012;24(1):97-100..
•   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.
•   Sauer S, Biancalana M. Trigger point therapy for low back pain. New Harbinger Publications; 2010.
•   Thomas Scioscia M. Back Muscles and Low Back Pain. Spine-health. 2021.