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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06241027
Other study ID # REC/RCR & AHS/23/0234
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date July 17, 2023
Est. completion date February 12, 2024

Study information

Verified date January 2024
Source Riphah International University
Contact Muhammad Aqeel, MSPT(NM)
Phone 03037862835
Email ilyassaqeel@gmail.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Radiculopathy is a clinical condition which involves one or more nerves resulting in impaired function. The site of injury in radiculopathy is at the level of the spinal nerve root. The result is pain known as radicular pain, weakness in limb, numbness, paresthesia and difficulty in controlling specific muscles. The objective of the study will be to see the effects of myofacsial release and nerve flossing technique on pain and disability in patients with lumbar radiculopathy.


Description:

This study will be randomized controlled trail. Participants having age in between 20-45 with low back pain radiating to the lower leg from last 2 months will be included in the study while the participants with lumbar spinal fracture, lumbar spinal tumor, peripheral vascular disease and systemic disease will be excluded from the study. Total 36 number of participants will be included in the study by non probability convenient sampling that will be randomly allocated into two groups by lottery method. Group A will receive nerve flossing technique and myofascial release along with conventional treatment while group B will receive nerve flossing technique along with conventional treatment. Nerve flossing technique will be given to patients 3 times per week for 15 minutes per session. Myofascial release technique will be given to the patients 3 times a week for 10 minutes with a total 4 weeks of treatment plan. All the participants will undergo a pre and post treatment test via numeric pain rating scale which will be used for rating pain, SLR, oswestry disability index which will be used for rating the level of disability. The importance of the study is to investigate the effects of these techniques in a controlled research setting will help determine their potential role in personalized treatment plans for patients with lumbar radiculopathy. The data will be analyzed via SPSS version 23.


Recruitment information / eligibility

Status Recruiting
Enrollment 36
Est. completion date February 12, 2024
Est. primary completion date February 12, 2024
Accepts healthy volunteers No
Gender All
Age group 20 Years to 45 Years
Eligibility Inclusion Criteria: The age of patients in between 20-45 years old, Patients with low back pain radiating to the lower leg from the last 2 month, patients with positive straight leg raise test. - Exclusion Criteria: Patients with lumbar spinal fracture, patients having spinal tumor, patients with unhealed wound on the lumbosacral area, patients having peripheral vascular disease, patients who diagnosed with systemic disease such as diabetes mellitus and rheumatoid arthritis. -

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Nerve flossing technique
The nerve flossing technique will be perform actively with the participant sitting on the chair. The participant flexed the knee of the target lower extremity backward beside the chair as far back as possible and flexed the neck at the same time, holding both the flexed knee and neck in thisposition for 5 seconds. The participant in turn extended the neck and knee of the target lower extremity, abducted and flexed the hip until pain will feel and did not push beyond that point. This extended position will be hold for 5 seconds.
Myofascial release
Myofascial release therapy involved the application of a low load, long duration stretch along the line of maximal fascial restriction. Pressure will be applied directly on the skin toward the direction of restriction until resistance of the tissue barrier will felt, Once found , the collagenous barrier will engaged for 90-120 seconds without sliding over the skin or forcing the tissues until the fascia complex started to yield and a sensation of softening will achieved.This stage will be repeated up to 5 times for new barrier until the sensation of tissue restriction during stretching became weaker.

Locations

Country Name City State
Pakistan Ripha international university Lahore Punjab

Sponsors (1)

Lead Sponsor Collaborator
Riphah International University

Country where clinical trial is conducted

Pakistan, 

Outcome

Type Measure Description Time frame Safety issue
Other Oswestry disability index questionnaire This questionnaire provides information as to how your back pain has affected your ability to manage everyday life and check the level of disability. 4 weeks
Primary Numeric pain rating scale This scale rates the level of pain. The 11-point numeric scale ranges from '0' representing one pain extreme (e.g. "no pain") to '10' representing the other pain extreme. 4 weeks
Secondary Straight leg raise test The Straight Leg Raise (SLR) test is to identify disc pathology or nerve root irritation, as it mechanically stresses lumbosacral nerve roots. 4 weeks
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