Myofascial Release and Joint Mobilization Therapy in Non-Specific Low Back Pain

Low Back Pain Clinical Trial

Official title:

Effects of Myofascial Release and Joint Mobilization Therapy on Pain, Muscle Thickness, Range of Motion and Functional Disability in Non-Specific Low Back Pain

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04860726
• Other study ID #: Rec/Lhr/1104
• Status: Recruiting
• Phase: N/A
• Start date: April 25, 2021
• Est. completion date: November 30, 2022

Study information

• Verified date: May 2022
• Source: Riphah International University
• Contact: Muhammad Salman Bashir, PhD
• Phone: 00923334497959
• Email: salman.bashir[@]riphah.edu.pk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Low back pain is a common condition affecting many individuals at some point in their lives.The prevalence of Non-specific low back pain (LBP) is between 4.2% and 19.6%, which is responsible for high treatment costs, sick leave, and individual suffering, in addition to being one of the main reasons for people to seek health care services. LBP prevalence increases linearly from the third decade of life on, until the 60 years of age, being more prevalent in women.This trial will be a prospective, parallel, double blinded, randomized, interventional clinical trial (comparing Myofascial Release and Joint Mobilization therapy). The patients will be screened by researcher and randomly allocated into either experimental groups. After recruitment, the person will be contacted for allocation so that randomization will be secured and concealed. The participants and therapist providing treatment will not be blinded but the assessor and the biostatistician will be blinded. The outcome measure tools for data quantification will be used i.e. Diagnostic Ultrasound Scanner to measure lumbar multifidis and transversus abdominis muscle thickness, pain pressure algometer to measure pain pressure sensitivity and Halo-digital inclinometer to measure range of motion of the lumbar region.Sample size of 45 will be calculated using G. power software with 12% attrition rate. Patientswill be randomly allocated in 3 groups (Group A, Joint mobilization: Group B, Myofascial Release: Group C, both joint mobilization and myofascial release: Common treatment, Heating for 15 minutes). Each group will receive 4 sessions of treatment in 2 weeks' period on Day 1st day 4th, day 8th and day 12th.Data will be collected on Day 1st; Pre and post-treatment, Day 4th, Day 8th,Day 12th; post treatment and after 1 month. Data will be analyzed with SPSS version.21. Study will be conducted in Al-Razi Healthcare, Shalamar Hospital and Riphah Rehabilitation Centre, Lahore, Pakistan. The duration of study will be 18 months after the approval of synopsis.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 45
• Est. completion date: November 30, 2022
• Est. primary completion date: October 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 50 Years

Eligibility

Inclusion Criteria:

• 1. Patients between the ages of 20 to 50 years for non-specific low back pain diagnosed by researcher according to the non-specific low back pain criteria comprising of history and physical examination. Physical examination should be done in different positions as follows
• Inspect the back for deformities e.g. stooping forward
• Palpate for muscle guarding, trigger points
• Lumbar excursion and range of motion
• Gait
• Heel and Toe Walking (Inability to walk on heels alone or toes alone signifies significant muscle weakness) • Hip joint range of motion
• FABER test (Flexion, Abduction and External Rotation)
• Straight Leg Raising Test (SLR)
• Cross SLR
• Neurological examination • Palpate for muscle guarding, trigger points
• Femoral Extension Test • Straight Leg Raising Test (SLR)
• Both male and female patients will be recruited.
• Patient diagnosis based on clinical assessment and duration of pain.
• People who have not received physical therapy application or exercise regimen for the past 3 months
• Patients suffering with low back pain for less than 3 months. Severity of Pain should be 3 to 7 on NPRS will be included in the study.
• Patients not received analgesics and Non-steroidal anti-inflammatory drugs for previous 1 week.

Exclusion Criteria:

• Patients already diagnosed with any systemic or musculoskeletal pathology e.g. vasculogenic, viscerogenic, neurogenic Low back pain or any history of any recent trauma etc.
• Patients having as severe to extreme findings of low back pain reflecting the patient irritable.
• Any previous surgery or epidural injection treatment or nerve block in the lumbosacral region.
• Females who are pregnant or any recent pregnancy in past 6 months
• Any sensory or motor deficit in the lower extremities.
• Any signs of reg flags; i.e. tumors, constitutional symptoms, integumentary issues, cauda equina syndromes etc. will be excluded.

Related Conditions & MeSH terms

• Back Pain
• Low Back Pain

Intervention

Other:
• Joint mobilization
Maitland Mobilization GIII and GIV i. PA Central and unilateral vertebral pressure ii.Transverse vertebral pressure iii. heating pad for 15 minutes
• Myofascial Release
Myofascial release is a hands-on soft tissue technique that facilitates a stretch into the restricted fascia. A sustained pressure is applied into the restricted tissue barrier; after 90-120 seconds the tissue will undergo histological length changes allowing the first release to be felt. The therapist will follow the release into a new tissue barrier and holds. After a few releases the tissue will become softer and more pliable. The middle point of the Lateral raphae of the Thoracolumbarfascia between the posterior musculofascial junction of the Transversus Abdominis will be identified by ultrasonography. Vertical manual pressure will be applied on the middle point of the thoracolumbarfascia for 1 min ii. heating pad for 15 minutes
• Joint mobilization & Myofascial Release
Maitland Mobilization GIII and GIV i. PA Central and unilateral vertebral pressure ii.Transverse vertebral pressure iii. heating pad for 15 minutes iv. Myofascial release is a hands-on soft tissue technique that facilitates a stretch into the restricted fascia. A sustained pressure is applied into the restricted tissue barrier; after 90-120 seconds the tissue will undergo histological length changes allowing the first release to be felt. The therapist will follow the release into a new tissue barrier and holds. After a few releases the tissue will become softer and more pliable. The middle point of the Lateral raphae of the Thoracolumbarfascia between the posterior musculofascial junction of the Transversus Abdominis will be identified by ultrasonography. Vertical manual pressure will be applied on the middle point of the thoracolumbarfascia for 1 min

Locations

Country	Name	City	State
Pakistan	Al-Razi Healthcare	Lahore	Punjab
Pakistan	Riphah Rehabilitation Centre	Lahore	Punjab
Pakistan	Shalamar Hospital	Lahore	Punjab

Sponsors (1)

Lead Sponsor	Collaborator
Riphah International University

Country where clinical trial is conducted

Pakistan, 

References & Publications (7)

Freburger JK, Holmes GM, Agans RP, Jackman AM, Darter JD, Wallace AS, Castel LD, Kalsbeek WD, Carey TS. The rising prevalence of chronic low back pain. Arch Intern Med. 2009 Feb 9;169(3):251-8. doi: 10.1001/archinternmed.2008.543. — View Citation

Heneweer H, Staes F, Aufdemkampe G, van Rijn M, Vanhees L. Physical activity and low back pain: a systematic review of recent literature. Eur Spine J. 2011 Jun;20(6):826-45. doi: 10.1007/s00586-010-1680-7. Epub 2011 Jan 9. Review. — View Citation

Johannes CB, Le TK, Zhou X, Johnston JA, Dworkin RH. The prevalence of chronic pain in United States adults: results of an Internet-based survey. J Pain. 2010 Nov;11(11):1230-9. doi: 10.1016/j.jpain.2010.07.002. Epub 2010 Aug 25. — View Citation

Liao ZT, Pan YF, Huang JL, Huang F, Chi WJ, Zhang KX, Lin ZM, Wu YQ, He WZ, Wu J, Xie XJ, Huang JX, Wei QJ, Li TW, Wu Z, Yu BY, Gu JR. An epidemiological survey of low back pain and axial spondyloarthritis in a Chinese Han population. Scand J Rheumatol. 2009 Nov-Dec;38(6):455-9. doi: 10.3109/03009740902978085. — View Citation

Meucci RD, Fassa AG, Faria NM. Prevalence of chronic low back pain: systematic review. Rev Saude Publica. 2015;49. pii: S0034-89102015000100408. doi: 10.1590/S0034-8910.2015049005874. Epub 2015 Oct 20. Review. — View Citation

Meucci RD, Fassa AG, Paniz VM, Silva MC, Wegman DH. Increase of chronic low back pain prevalence in a medium-sized city of southern Brazil. BMC Musculoskelet Disord. 2013 May 1;14:155. doi: 10.1186/1471-2474-14-155. — View Citation

Olafsson G, Jonsson E, Fritzell P, Hägg O, Borgström F. Cost of low back pain: results from a national register study in Sweden. Eur Spine J. 2018 Nov;27(11):2875-2881. doi: 10.1007/s00586-018-5742-6. Epub 2018 Aug 28. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Ultrasonography for Muscle thickness	Interpretation will be done according to the images received after ultrasonography. Readings will be done 1st day, 4th,8th,12th,and after one month.	1 month
Primary	Pain Pressure Algometer	Pai threshold will be measured by applying pain pressure algometer and readings will be measured.Readings will be done 1st day, 4th,8th,12th,and after one month.	1 month
Primary	Digital Inclinometer for Range of motion	Instrument used for Range of motion.Readings will be done 1st day, 4th,8th,12th,and after one month.; Normal Ranges: FLEXION : 0-60, EXTENSION: 0-25, LATERAL FLEXION: 0-25, ROTATION :0-18	1 month
Secondary	Numeric pain rating scale	0= no pain 10 = worse pain Readings will be done 1st day, 4th,8th,12th,and after one month.	1 month
Secondary	Sit and Reach test	Excellent: >34-26 cm Good= 34-26 cm Above average: 32-23 Average: 29-20 Below average: 26-17 cm Poor: 23-14 cm V poor: < 21- <12 cm Readings will be done 1st day, 4th,8th,12th,and after one month.	1 month