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

Primary Purpose

Low Back Pain

Status
Recruiting
Phase
Not Applicable
Locations
Pakistan
Study Type
Interventional
Intervention
Joint mobilization
Myofascial Release
Joint mobilization & Myofascial Release
Sponsored by
Riphah International University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Low Back Pain focused on measuring Fascia, Range of motion, Ultrasonography, Low back pain

Eligibility Criteria

20 Years - 50 Years (Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Al-Razi HealthcareRecruiting
  • Riphah Rehabilitation CentreRecruiting
  • Shalamar HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

GROUP A

GROUP B

GROUP C

Arm Description

Joint mobilization

Myofascial release

Joint Mobilization & Myofascial release

Outcomes

Primary Outcome Measures

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.
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.
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

Secondary Outcome Measures

Numeric pain rating scale
0= no pain 10 = worse pain Readings will be done 1st day, 4th,8th,12th,and after one month.
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.

Full Information

First Posted
April 22, 2021
Last Updated
May 31, 2022
Sponsor
Riphah International University
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1. Study Identification

Unique Protocol Identification Number
NCT04860726
Brief Title
Myofascial Release and Joint Mobilization Therapy in Non-Specific Low Back Pain
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
Study Type
Interventional

2. Study Status

Record Verification Date
May 2022
Overall Recruitment Status
Recruiting
Study Start Date
April 25, 2021 (Actual)
Primary Completion Date
October 30, 2022 (Anticipated)
Study Completion Date
November 30, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Riphah International University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Low Back Pain
Keywords
Fascia, Range of motion, Ultrasonography, Low back pain

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
45 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
GROUP A
Arm Type
Experimental
Arm Description
Joint mobilization
Arm Title
GROUP B
Arm Type
Experimental
Arm Description
Myofascial release
Arm Title
GROUP C
Arm Type
Experimental
Arm Description
Joint Mobilization & Myofascial release
Intervention Type
Other
Intervention Name(s)
Joint mobilization
Intervention Description
Maitland Mobilization GIII and GIV i. PA Central and unilateral vertebral pressure ii.Transverse vertebral pressure iii. heating pad for 15 minutes
Intervention Type
Other
Intervention Name(s)
Myofascial Release
Intervention Description
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
Intervention Type
Other
Intervention Name(s)
Joint mobilization & Myofascial Release
Intervention Description
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
Primary Outcome Measure Information:
Title
Ultrasonography for Muscle thickness
Description
Interpretation will be done according to the images received after ultrasonography. Readings will be done 1st day, 4th,8th,12th,and after one month.
Time Frame
1 month
Title
Pain Pressure Algometer
Description
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.
Time Frame
1 month
Title
Digital Inclinometer for Range of motion
Description
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
Time Frame
1 month
Secondary Outcome Measure Information:
Title
Numeric pain rating scale
Description
0= no pain 10 = worse pain Readings will be done 1st day, 4th,8th,12th,and after one month.
Time Frame
1 month
Title
Sit and Reach test
Description
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.
Time Frame
1 month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Muhammad Salman Bashir, PhD
Phone
00923334497959
Email
salman.bashir@riphah.edu.pk
First Name & Middle Initial & Last Name or Official Title & Degree
Hafiz Muhammad Waseem Javaid, Phd*
Phone
03005047143
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Muhammad Salman Bashir, PhD
Organizational Affiliation
Riphah International University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Al-Razi Healthcare
City
Lahore
State/Province
Punjab
ZIP/Postal Code
54000
Country
Pakistan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Muhammad Salman Bashir, PhD
Phone
00923334497959
Email
salman.bashir@riphah.edu.pk
First Name & Middle Initial & Last Name & Degree
Wasim Javaid, PhD*
Facility Name
Riphah Rehabilitation Centre
City
Lahore
State/Province
Punjab
Country
Pakistan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Salman Bashir, PhD
First Name & Middle Initial & Last Name & Degree
Wasim Javaid, PhD
Facility Name
Shalamar Hospital
City
Lahore
State/Province
Punjab
Country
Pakistan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Salman Bashir, PhD
First Name & Middle Initial & Last Name & Degree
Waseem Javaid, PhD*

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
26487293
Citation
Meucci RD, Fassa AG, Faria NM. Prevalence of chronic low back pain: systematic review. Rev Saude Publica. 2015;49:1. doi: 10.1590/S0034-8910.2015049005874. Epub 2015 Oct 20.
Results Reference
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PubMed Identifier
19922021
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.
Results Reference
background
PubMed Identifier
30155730
Citation
Olafsson G, Jonsson E, Fritzell P, Hagg O, Borgstrom 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.
Results Reference
background
PubMed Identifier
20797916
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.
Results Reference
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PubMed Identifier
23634830
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.
Results Reference
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PubMed Identifier
19204216
Citation
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.
Results Reference
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PubMed Identifier
21221663
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.
Results Reference
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Myofascial Release and Joint Mobilization Therapy in Non-Specific Low Back Pain

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