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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05101200
Other study ID # Rabia Liaquat
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date November 1, 2021
Est. completion date May 30, 2022

Study information

Verified date December 2022
Source Riphah International University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 34
Est. completion date May 30, 2022
Est. primary completion date May 30, 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years to 40 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Other:
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.
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.

Locations

Country Name City State
Pakistan National orthopedic and specialist hospital Rawalpindi Punjab

Sponsors (1)

Lead Sponsor Collaborator
Riphah International University

Country where clinical trial is conducted

Pakistan, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Primary 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
Primary 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
Primary 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
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