- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05935163
Immediate Effects of Bowen Technique Versus Dynamic Soft Tissue Mobilization on Hamstrings Tightness in Chronic Non-specific Low Back Pain.
July 4, 2023 updated by: Foundation University Islamabad
Low back pain (LBP) is leading cause of disability and its burden is growing worldwide with an increasing and ageing of population.
Poor flexibility or tightness of hamstring muscle has been associated with low back pain.
It is a prominent cause of activity limitations and work absenteeism throughout world.
Hence this study was designed to find out superior form of effective technique on active knee extension and experience of pain and disability in chronic nonspecific low back pain.
Study Overview
Status
Recruiting
Conditions
Detailed Description
Low back pain (LBP) is leading cause of disability and it is most leading cause of work absenteeism throughout world.
Poor flexibility or tightness of hamstring muscle has been associated with low back pain.
Hence this study was designed to find out superior form of effective technique on hamstrings tightness and experience of pain and disability in chronic nonspecific low back pain.
This study will also assist to set the foundation for further more studies designing magnificent protocols of treatment for affected population.
Study Type
Interventional
Enrollment (Estimated)
42
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Maryam Tariq, MS MSKPT
- Phone Number: +923165360826
- Email: marytareq2097@gmail.com
Study Contact Backup
- Name: Saba Murad
- Phone Number: +923478669827
- Email: saba.murad@fui.edu.pk
Study Locations
-
-
Punjab
-
Rawalpindi, Punjab, Pakistan, 46000
- Recruiting
- Fauji Foundation Hospital Department of Rehabilitation
-
Contact:
- Dr Naureen Tassadaq, MBBS, FCPS
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- The patients aged 18-45 years will be included in the study.
- Patients with chronic low back pain (more than 3 months) will be included.
- Both genders.
- 20 to 40 degrees active knee extension loss with hip in 90 degree flexion
- Pain Intensity (moderate to severe) NPRS (4-6 intensity)
Exclusion Criteria:
- Individuals who were receiving treatment for their pain with another(medical treatment) at the same time
- Patients who had undergone vertebral column surgery (less than three months before the time of this study).
- Patients with the infection, neoplasms, metastasis, rheumatoid arthritis, fractures or inflammatory processes were excluded.
- Dislocations of lower limb
- Hypermobility of lower limb joint
- Hamstrings injuries
- Nerve lesions of lower limb
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Group A (Coventional treatment with Bowen Therapy)
Group A will be treated with Bowen Technique in addition to conventional treatment.
One session, 45 minutes for technique along with conventional treatment will be given.
Technique will be performed for 10 minutes on each limb.
The data will be collected at baseline and at 4th week.
Follow up will be performed for 4 weeks and 3 sessions will be given each week.
|
Conventional Physical therapy will include TENS , hot pack , Hamstring self stretch , Calf self stretching , bridging exercise , piriformis stretch , prone on hands and prone on elbows.
Bowen Technique:
|
|
Active Comparator: Group B (Conventional treatment with DSTM)
Group B will be treated with Dynamic Soft Tissue Mobilizations (DSTM) in addition to conventional treatment.
One session, 45 minutes for technique along with conventional treatment will be given.
Technique will be performed for 10 minutes on each limb.
The data will be collected at baseline and at 4th week.
Follow up will be performed for 4 weeks and 3 sessions will be given each week.
|
Conventional Physical therapy will include TENS , hot pack , Hamstring self stretch , Calf self stretching , bridging exercise , piriformis stretch , prone on hands and prone on elbows.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Active knee extension test
Time Frame: 4 weeks
|
active knee extension test, the participant will be in supine-lying position on the treatment bed.
Then, participant will flex the hip to 90° while keeping the contralateral hip and knee extended on plinth.
The goniometer's fulcrum will be placed on the lateral condyle of the femur at knee joint.
The proximal arm of goniometer placed along with the long axis of femur, while moveable arm aligned in line with lateral malleolus.
The subject will then extend the knee actively without any pain and tilting of pelvis.
|
4 weeks
|
|
Active straight leg raise (aSLR)
Time Frame: 4 weeks
|
The active straight leg raise will be conducted bilaterally three times, and best out of 3 attempts will be recorded.
The classic straight leg raise is a complete active test.
Each leg is tested individually.
When performing the aSLR test, the patient is positioned in supine without a pillow under his/her head.
The starting position is described with a distance of 20cm between feet.
The patient must rise the leg 20cm from the starting position maintaining the knee in complete extension.
The participant will be then asked to rate the difficulty of the task using a 6- point Likert scale.
6-point Likert scale (0= not difficult at all, 1 = minimally difficult, 2 = somewhat difficult, 3= fairly difficult, 4= very difficult, and 5= unable to perform).
The test is considered positive when the subjective feeling of fatigue is >3.
|
4 weeks
|
|
The sit-and-reach (SR) tests
Time Frame: 4 weeks
|
The subjects sat on the flat surface with their head, back, and hips against a wall, knees straight, legs together, and soles of the feet positioned flat against Sit and Reach box.
In keeping this position, the subject will be requested to extend the arms with palms down and lightly touch the index fingers together.
The finger-to-box distance will be measured as the distance between the fingertips and the point at which the feet contacted to the box.
Then, the subjects will be asked to bend forward slowly and reached as far forward as possible while keeping the knees extended and sliding their hands along a measuring scale placed on the box.
Throughout the test, examiner will check to ensure that the heels remained at the box and that the knees are fully extended.
The 0 cm mark of the measuring scale represent the position of the feet against the box, with larger values for better performance having higher flexibility.
|
4 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Pain intensity
Time Frame: 4 Weeks
|
Pain status of patients will be assessed using NPRS.
|
4 Weeks
|
|
Disability
Time Frame: 4 Weeks
|
Disability will be assessed using RMDQ.
|
4 Weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 1, 2023
Primary Completion (Estimated)
July 15, 2023
Study Completion (Estimated)
August 1, 2023
Study Registration Dates
First Submitted
May 22, 2023
First Submitted That Met QC Criteria
July 4, 2023
First Posted (Actual)
July 7, 2023
Study Record Updates
Last Update Posted (Actual)
July 7, 2023
Last Update Submitted That Met QC Criteria
July 4, 2023
Last Verified
July 1, 2023
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- FUI/CTR/2023/10
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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