Dose Response of Neural Mobilization on Hamstring Flexibility in Low Back Pain
1 other identifier
interventional
34
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Nov 2021
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 19, 2021
CompletedFirst Posted
Study publicly available on registry
November 1, 2021
CompletedStudy Start
First participant enrolled
November 1, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 30, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
May 30, 2022
CompletedDecember 15, 2022
December 1, 2022
7 months
October 19, 2021
December 13, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (4)
Numeric Pain Rating Scale (NPRS)
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)
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).
4 Weeks
Active Knee Extension test for hamstring flexibility
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
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
Study Arms (2)
High Dose Neural Mobilization Technique
EXPERIMENTALPatients in this Group will receive High Dose Neural Mobilization Technique
Low Dose Neural Mobilization Technique
EXPERIMENTALPatients in this Group will receive Low Dose Neural Mobilization Technique
Interventions
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.
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.
Eligibility Criteria
You may qualify if:
- Low back pain \> 3 months
- No exercises for last 6 months
- Non-specific LBP in its sub-acute \& chronic phase
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
National orthopedic and specialist hospital
Rawalpindi, Punjab Province, 44000, Pakistan
Study Officials
- PRINCIPAL INVESTIGATOR
Waqar Ahmed Awan, Ms-OMPT
Riphah International University
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 19, 2021
First Posted
November 1, 2021
Study Start
November 1, 2021
Primary Completion
May 30, 2022
Study Completion
May 30, 2022
Last Updated
December 15, 2022
Record last verified: 2022-12
Data Sharing
- IPD Sharing
- Will not share