Low Back PainNCT04860726
Myofascial Release and Joint Mobilization Therapy in Non-Specific Low Back Pain
A study testing Joint mobilization, Myofascial Release and Joint mobilization & Myofascial Release in people with Low Back Pain, run by Riphah International University at 2 sites in Pakistan.
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… Read more about this study
- Who is it for?
- Ages 20 to 50 years
- Conditions the study is for
- Low Back Pain
- What is being tested?
- Joint mobilization, Myofascial Release and Joint mobilization & Myofascial Release
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 84 participants
- Where
- 2 sitesPakistan
- Study dates
- 25 Apr 2021to 1 Apr 2024
- 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 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
Show all 16Show fewer
- 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.
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country.
Pakistan2 sites
Al-Razi Healthcare
Lahore, Punjab Province, 54000
Riphah Rehabilitation Centre
Lahore, Punjab Province
About this study
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
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 outcome measure tools for data quantification will be used i.e. Diagnostic Ultrasound Scanner to measure lumbar multifidus 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. A pilot study was done on a sample of 30 with 10 participants in each group. A sample of 84 participants (28 participants in each group) with an attrition rate of 12%, level of significance 5%, margin of error 20% was the output. Patients will 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.26.
Study will be conducted in Al-Razi Healthcare and Riphah Rehabilitation Centre, Lahore, Pakistan. The duration of study will be 18 months after the approval of synopsis.
- Conditions
- Low Back Pain
- Being tested
- Joint mobilization, Myofascial Release, Joint mobilization & Myofascial Release
- Keywords
- Fascia, Range of motion, Ultrasonography, Low back pain
- Medical subject headings
- Low Back Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Joint mobilizationOther
Maitland Mobilization GIII and GIV i. PA Central and unilateral vertebral pressure ii.Transverse vertebral pressure iii. heating pad for 15 minutes
Myofascial ReleaseOther
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 ReleaseOther
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
| Study group | Role | What they receive |
|---|---|---|
| GROUP A | Experimental | Joint mobilization Receives: Other: Joint mobilization |
| GROUP B | Experimental | Myofascial release Receives: Other: Myofascial Release |
| GROUP C | Experimental | Joint Mobilization \& Myofascial release Receives: Other: Joint mobilization & Myofascial Release |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 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.
Measured: 1 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
Measured: 1 month
Secondary outcomes (2)
Numeric pain rating scale
0= no pain 10 = worse pain Readings will be done 1st day, 4th,8th,12th,and after one month.
Measured: 1 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.
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2021
- Study start25 Apr 2021
- Primary completion1 Mar 2024
- Study completion1 Apr 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Low Back PainStudies of the same condition, open and under way.
- More trials run by Riphah International UniversityThe sponsor's other registered studies.
- 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
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 84 participants (actual)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Syed Shakil ur Rehman, PhD, Principal investigator, Riphah International UniversityHafiz Muhammad Waseem Javaid, PhD*, Principal investigator, Riphah International UniversityMuhammad Kashif, PhD, Principal investigator, Riphah International UniversityMuhammad Salman Bashir, PhD, Principal investigator, Riphah International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04860726
- Sponsor's protocol ID
- Rec/Lhr/1104 Waseem
- Status last verified
- Feb 2025
- First submitted
- 22 Apr 2021
- Last updated
- 12 Feb 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04860726
- Acronym / sponsor ID
- Rec/Lhr/1104 Waseem
- Conditions
- Low Back Pain
- Keywords
- Fascia, Range of motion, Ultrasonography, Low back pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 84 participants (actual)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 25 Apr 2021 (actual)
- Primary completion
- 1 Mar 2024 (actual)
- Study completion
- 1 Apr 2024 (actual)
- First posted
- 27 Apr 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.
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 outcome measure tools for data quantification will be used i.e. Diagnostic Ultrasound Scanner to measure lumbar multifidus 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. A pilot study was done on a sample of 30 with 10 participants in each group. A sample of 84 participants (28 participants in each group) with an attrition rate of 12%, level of significance 5%, margin of error 20% was the output. Patients will 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.26.
Study will be conducted in Al-Razi Healthcare and Riphah Rehabilitation Centre, Lahore, Pakistan. The duration of study will be 18 months after the approval of synopsis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| GROUP A | Experimental | Other: Joint mobilizationJoint mobilization |
| GROUP B | Experimental | Other: Myofascial ReleaseMyofascial release |
| GROUP C | Experimental | Other: Joint mobilization & Myofascial ReleaseJoint Mobilization \& Myofascial release |
Who may qualify
- Ages
- 20 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (16 listed)
- 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
- 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.
Key exclusion criteria (6 listed)
- 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.
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 |
|---|---|---|
| Joint mobilizationMaitland Mobilization GIII and GIV i. PA Central and unilateral vertebral pressure ii.Transverse vertebral pressure iii. heating pad for 15 minutes | Other | GROUP A |
| Myofascial ReleaseMyofascial 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 | Other | GROUP B |
| Joint mobilization & Myofascial ReleaseMaitland 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 | Other | GROUP C |
Primary outcome
Ultrasonography for Muscle thickness
Time frame: 1 month
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
Time frame: 1 month
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
Time frame: 1 month
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
2 secondary outcomes
Numeric pain rating scale
Time frame: 1 month
Sit and Reach test
Time frame: 1 month
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 12 Feb 2025.
- 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.
Syed Shakil ur Rehman, PhD principal investigator
Riphah International University
Hafiz Muhammad Waseem Javaid, PhD* principal investigator
Riphah International University
Muhammad Kashif, PhD principal investigator
Riphah International University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Joint mobilization, Myofascial Release and Joint mobilization & Myofascial Release in people with Low Back Pain, run by Riphah International University at 2 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 16 inclusion and 6 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 12 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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?
Ultrasonography for Muscle thickness (time frame: 1 month). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 12 Feb 2025.