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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05654428
Other study ID # 337
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date September 22, 2022
Est. completion date February 1, 2023

Study information

Verified date February 2023
Source Neuro Counsel Hospital, Pakistan
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Lumbosacral radiculopathy (LR) is among most common disorder caused due to irritation or compression of nerve pathway leading to symptoms of pain, numbness and tingling sensations along the nerve root. Lumbosacral radiculopathy consists at any lumbar region including L1-S1. Occurrence rate of Lumbosacral radiculopathy is 3-5% distributed equally in men and women affecting more men than women. It commonly occurs in late 40s in men and late 50s-60s in females. Men are more prone to develop lumbosacral radiculopathy due to mechanical disturbance during routine work.


Description:

- William flexion exercises: Exercises for strengthening of gluteal and abdominal muscles which help to reduce pressure on the nerve root by promoting flexion at lumber spine such as knee to chest, double knee to chest, bridging(Gluets bridge), and straight leg raise (SLR). - Mckenzie extension exercises: The exercises used to create space between under lying structures of lumber spine which help centralization of pain and can be performed in prone lying such as prone press ups, prone on elbow, and head lift in prone A randomized controlled trial. Group 1 Group 2 55 patients 55 patients Standard treatment: TENS (4-pole) + Hot pack for 15 minutes Standard treatment: TENS (4-pole) + Hot pack for 15 minutes New Intervention: Mckenzie Extension - Prone press-ups - Head life in prone - Prone on elbow - Prone on hands - Prone on pillow New Intervention: William Flexion - Single knee to chest - Double knee to chest - Straight Leg Raise - Bridging - Pelvic tilt Each exercise will be repeated 5 minutes with 10 seconds hold and 5 sec rest. The duration of intervention will be four weeks, 3 sessions a week on alternate days and total of 12 sessions will be given. Data will be collected in three phases Pre-Treatment at end of second week and at the completion of treatment time i.e end of 4th week.


Recruitment information / eligibility

Status Completed
Enrollment 110
Est. completion date February 1, 2023
Est. primary completion date January 21, 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 40 Years to 60 Years
Eligibility Inclusion Criteria: - • Males and females with age between 40-60 years - Patients referred from neuro and orthopedic departments with diagnosed lumbosacral radiculopathy. - Complaint of low back pain on walk, bending and after long sitting with positive slump test. - Complaint of low back pain, and numbness and tingling in leg with positive SLR test Exclusion Criteria: - • Lumbar Trauma - Any other orthopedic and neurological conditions of hip and lumbosacral spine. - Hip Fracture - Malignancy

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Mckenzie Extension Exercises
The exercises used to create space between under lying structures of lumber spine which help centralization of pain and can be performed in prone lying such as prone press ups, prone on elbow, and head lift in prone.
William Flexion Exercises
Exercises for strengthening of gluteal and abdominal muscles which help to reduce pressure on the nerve root by promoting flexion at lumber spine such as knee to chest, double knee to chest, bridging(Gluets bridge), and straight leg raise (SLR).

Locations

Country Name City State
Pakistan Isra niversity Islamabad Federal

Sponsors (2)

Lead Sponsor Collaborator
Neuro Counsel Hospital, Pakistan National Institute of Rehabilitation Medicine, Islamabad, Pakistan

Country where clinical trial is conducted

Pakistan, 

Outcome

Type Measure Description Time frame Safety issue
Primary Numeric Pain Rating Scale 0 means no pain and 10 means worst pain ever felt 4 weeks
Primary Flexi curve ruler to measure the lumber cure 4 weeks
Primary Bubble inclinometer Measure the cure 4 weeks
Primary King Health Questionnaire quality of life lesser score means low quality of life and higher score means better quality of life 4 weeks
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