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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04728685
Other study ID # RRC-2019-29
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date January 25, 2021
Est. completion date March 24, 2021

Study information

Verified date August 2021
Source King Saud University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Disc prolapse causes impairment of function by nerve root compression compelling the patient to seek medical advice for low backache. Traction is one of the physical modalities frequently used for the treatment of lumbar disc herniations. So the purpose of the study is to determine the effect of one-fifth, one-half, and one-third of body weight traction on the straight leg raise test and pain.


Description:

A total of 45 patients suffering from lumbar PIVD and having neurological symptoms will be selected for the study. Lumbar PIVD will be confirmed from MRI. Participants will be divided into three groups with 15 participants in each group. group A. for one-fifth of body weight traction, group b for one-third of body weight traction, and group C for one-half of body weight traction. SLR and pain will be measured before traction and after traction. A goniometer will be used to measure SLR and VAS will be used to measure pain.


Recruitment information / eligibility

Status Completed
Enrollment 45
Est. completion date March 24, 2021
Est. primary completion date March 24, 2021
Accepts healthy volunteers No
Gender All
Age group 20 Years to 40 Years
Eligibility Inclusion Criteria: - Back pain for less than 3 months - Positive unilateral Straight Leg Raise test which includes reports of back and leg pain or paraesthesia below 45-degree hip flexion - At least one additional neurological sign should be present including- (a) Diminished Achillis/Hamstring tendon reflex, tested in the supine position or (b) Hyposthesia in any of the L4-S2 dermatome, or (c) Muscle weakness in any of the L4-S2 myotome. - MRI evidence of L-4-L5 or L5-S1 disc prolapse or both. Exclusion Criteria: - Malignancy, Tuberculosis, Osteoporosis, Osteomyelitis of the vertebral column - Cord compression, Pregnancy, Hypertension, Cardiovascular disease, Joint hyper mobility - Subjects who could not tolerate the traction force secondary to being in an acute stage of back pain. - Subjects who have taken previous physiotherapy treatment in the last three months for back pain.

Study Design


Related Conditions & MeSH terms


Intervention

Procedure:
Mechanical Traction
Mechanical Traction will be applied to the lumbar region using a traction unit.

Locations

Country Name City State
Saudi Arabia King Saud University Riyadh

Sponsors (1)

Lead Sponsor Collaborator
King Saud University

Country where clinical trial is conducted

Saudi Arabia, 

Outcome

Type Measure Description Time frame Safety issue
Primary Straight Leg Raise test Straight leg raise test is used in supine position to test neurological signs upto 1 month
Primary Visual analog scale Visual analog scale is used to measure pain. This scale has 0 to 10 points, 0 being no pain and 10 means maximum pain someone has felt. Higher the score worse is the condition. upto 1 month
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