Dose Response of Neural Mobilization on Hamstring Flexibility in Low Back Pain
Primary Purpose
Non-specific Low Back Pain
Status
Completed
Phase
Not Applicable
Locations
Pakistan
Study Type
Interventional
Intervention
High Dose Neural Mobilization Technique
Low Dose Neural Mobilization Technique
Sponsored by

About this trial
This is an interventional treatment trial for Non-specific Low Back Pain focused on measuring Neural Mobilization Technique, Oswestry Disability Index, Active Knee Extension Test, Numeric Pain Rating Scale, Lumbar flexion by Schober method
Eligibility Criteria
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
Sites / Locations
- National orthopedic and specialist hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
High Dose Neural Mobilization Technique
Low Dose Neural Mobilization Technique
Arm Description
Patients in this Group will receive High Dose Neural Mobilization Technique
Patients in this Group will receive Low Dose Neural Mobilization Technique
Outcomes
Primary Outcome Measures
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.
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).
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.
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT05101200
First Posted
October 19, 2021
Last Updated
December 13, 2022
Sponsor
Riphah International University
1. Study Identification
Unique Protocol Identification Number
NCT05101200
Brief Title
Dose Response of Neural Mobilization on Hamstring Flexibility in Low Back Pain
Official Title
Dose Response of Neural Mobilization on Hamstring Flexibility in Patients With Non-specific Low Back Pain
Study Type
Interventional
2. Study Status
Record Verification Date
December 2022
Overall Recruitment Status
Completed
Study Start Date
November 1, 2021 (Actual)
Primary Completion Date
May 30, 2022 (Actual)
Study Completion Date
May 30, 2022 (Actual)
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
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non-specific Low Back Pain
Keywords
Neural Mobilization Technique, Oswestry Disability Index, Active Knee Extension Test, Numeric Pain Rating Scale, Lumbar flexion by Schober method
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
34 (Actual)
8. Arms, Groups, and Interventions
Arm Title
High Dose Neural Mobilization Technique
Arm Type
Experimental
Arm Description
Patients in this Group will receive High Dose Neural Mobilization Technique
Arm Title
Low Dose Neural Mobilization Technique
Arm Type
Experimental
Arm Description
Patients in this Group will receive Low Dose Neural Mobilization Technique
Intervention Type
Other
Intervention Name(s)
High Dose Neural Mobilization Technique
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Low Dose Neural Mobilization Technique
Intervention Description
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.
Primary Outcome Measure Information:
Title
Numeric Pain Rating Scale (NPRS)
Description
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.
Time Frame
4 Weeks
Title
Oswestry Disability Index (ODI)
Description
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).
Time Frame
4 Weeks
Title
Active Knee Extension test for hamstring flexibility
Description
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.
Time Frame
4 Weeks
Title
Lumbar flexion by Schober method
Description
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.
Time Frame
4 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Waqar Ahmed Awan, Ms-OMPT
Organizational Affiliation
Riphah International University
Official's Role
Principal Investigator
Facility Information:
Facility Name
National orthopedic and specialist hospital
City
Rawalpindi
State/Province
Punjab
ZIP/Postal Code
44000
Country
Pakistan
12. IPD Sharing Statement
Plan to Share IPD
No
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Dose Response of Neural Mobilization on Hamstring Flexibility in Low Back Pain
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