- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05101200
Dose Response of Neural Mobilization on Hamstring Flexibility in Low Back Pain
December 13, 2022 updated by: Riphah International University
Dose Response of Neural Mobilization on Hamstring Flexibility in Patients With Non-specific Low Back Pain
This study will be a randomized control trial and will be conducted in Riphah International Hospital, National orthopedic and specialist hospital, Riphah international hospital and Chambeli institute of physiotherapy.
A sample of 34 participants will be taken.
Participants will be randomized into Group A and Group B through lottery method.
Group A will receive High Dose Neural Mobilization Technique, Hot pack for 15 minutes, strengthening exercises with 10rep/8sets , strengthening exercises for quadriceps and static stretching exercise for hamstring with 10 rep/8sets, While Group B will receive Low Dose Neural Mobilization Technique with minimal intensity, hot pack: 15 minutes, strengthening exercises with 10rep/4sets.
Both groups will be given session of 40 min/day, 2 days/week for 4 weeks, assessment will be done at baseline, at the end of 1st week, 2nd week, 3rd week & at the end of 4th week.
The outcome measure will be Numeric Pain Rating Scale (NPRS), Oswestry Disability Index (ODI), Active Knee Extension test (AKE) and Lumbar flexion by Schober method.
Data will be analyzed be SPSS 22.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
34
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 Locations
-
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Punjab
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Rawalpindi, Punjab, Pakistan, 44000
- National orthopedic and specialist hospital
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-
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
16 years to 38 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Low back pain > 3 months
- No exercises for last 6 months
- Non-specific LBP in its sub-acute & chronic phase
Exclusion Criteria:
- Specific causes of LBP (disc herniation, lumbar stenosis, spinal deformity, fracture, spondylolisthesis),
- Central or peripheral neurologic signs
- Systemic illness (tumor and rheumatologic diseases),
- Psychiatric and mental deficits.
- Patients who had undergone operations within 6 months
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: High Dose Neural Mobilization Technique
Patients in this Group will receive High Dose Neural Mobilization Technique
|
Patients in This Group will receive the high dose neural mobilization along with hot pack, strengthening exercises, Neural mobilization technique (slump, sciatic).
Participants in the NMG will be asked to actively perform knee extension, ankle dorsiflexion, and head extension in a slumped posture (body and neck semi flexion) followed by simultaneous ankle plantar flexion together with knee and head flexion, Hot pack for 15 minutes, Strengthening exercises of muscles with 10 /8sets.
Strengthening exercises of quadriceps with10 rep/8sets, Static stretching exercise for hamstring muscle with 10 rep/8sets, Group A will be given session of 40 min/day, 2 days/week for 4 weeks.
|
Experimental: Low Dose Neural Mobilization Technique
Patients in this Group will receive Low Dose Neural Mobilization Technique
|
Patients in this Group will receive the same treatment as group A but with less intensity and low dosage.
Hot pack: 15 minutes, Strengthening exercises of muscles with 10 rep/4sets, Static stretching exercise for hamstring muscle with 10 rep/4sets.
Group B will be given session of 40min/day, 2 days/week for 4weeks.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Numeric Pain Rating Scale (NPRS)
Time Frame: 4 Weeks
|
The Numeric Pain Rating Scale that is a uni-dimensional measure of pain intensity in adults.
The 11-point numeric scale ranges from '0' representing one pain extreme (no pain) to '10' representing the other pain extreme (or "worst pain imaginable").
The intrarater reliability with ICC = 0.67.
|
4 Weeks
|
Oswestry Disability Index (ODI)
Time Frame: 4 Weeks
|
Oswestry Low Back Pain Disability Index(ODI) is a questionnaire reported by the patient itself for low back pain.
The questionnaire into ten sections is divided and used to assess daily living activities limitations.
Scored on scales of 0- 5 for each section, greatest disability is represented by 5. To calculate index summed scores is divided by the total score, then by 100 multiplied and as percentage it is expressed.
With degree of disability associated are the scores indicating minimal to bed bound disability.
0% to 20% scores shows minimal disability, moderate disability indicated by scores from 20% to 40%, severe disability indicated by from 40% to 60% scores, 60% to 80% indicates crippled; and bedbound or exaggerating indicated by scores from 80% to 100%.
Test-retest has high reliability (r = 0.83 to 0.99).
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4 Weeks
|
Active Knee Extension test for hamstring flexibility
Time Frame: 4 Weeks
|
AKE test as known as active knee extension test is used to assess the flexibility and available Range of motion of hamstring muscle.The range of active knee extension in the position of hip flexion is easily assessed.
M. Shamsi, Meriam et.al discussed the reliability and validity of this test and proved it as a valid tool for measurement of shortness in hamstring muscle.
|
4 Weeks
|
Lumbar flexion by Schober method
Time Frame: 4 weeks
|
For the measurement of OST, the participant stood erect while the lumbosacral junction was marked as indicated by the dimples of Venus.
A second mark was placed 10 cm above the junction.
The participant was then asked to bend forward as far as possible, and the stretched distance was indicated as the OST in cm.
|
4 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Waqar Ahmed Awan, Ms-OMPT, Riphah International University
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)
November 1, 2021
Primary Completion (Actual)
May 30, 2022
Study Completion (Actual)
May 30, 2022
Study Registration Dates
First Submitted
October 19, 2021
First Submitted That Met QC Criteria
October 19, 2021
First Posted (Actual)
November 1, 2021
Study Record Updates
Last Update Posted (Estimate)
December 15, 2022
Last Update Submitted That Met QC Criteria
December 13, 2022
Last Verified
December 1, 2022
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- Rabia Liaquat
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
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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