Effects of Lumbar Traction on the Straight Leg Raise Test and Pain

Effects of One-fifth, One-third, and One-half of the Bodyweight Lumbar Traction on the Straight Leg Raise Test and Pain in Prolapsed Intervertebral Disc Patients

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.

Study Overview

• Status: Completed
• Conditions: Prolapsed Intervertebral Disc
• Intervention / Treatment: Procedure: Mechanical Traction

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 45
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Saudi Arabia
  • Riyadh, Saudi Arabia, 11433
    • King Saud University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 40 years (ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: Group A; One-fifth of body weight traction force will be given	Procedure: Mechanical Traction; Mechanical Traction will be applied to the lumbar region using a traction unit.
ACTIVE_COMPARATOR: Group B; One-third of body weight traction force will be given	Procedure: Mechanical Traction; Mechanical Traction will be applied to the lumbar region using a traction unit.
ACTIVE_COMPARATOR: Group C; One-half of body weight traction force will be given	Procedure: Mechanical Traction; Mechanical Traction will be applied to the lumbar region using a traction unit.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Straight Leg Raise test	Straight leg raise test is used in supine position to test neurological signs	upto 1 month
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

Collaborators and Investigators

• Sponsor: King Saud University

Study record dates

Study Major Dates

• Study Start (ACTUAL): January 25, 2021
• Primary Completion (ACTUAL): March 24, 2021
• Study Completion (ACTUAL): March 24, 2021

Study Registration Dates

• First Submitted: January 24, 2021
• First Submitted That Met QC Criteria: January 27, 2021
• First Posted (ACTUAL): January 28, 2021

Study Record Updates

• Last Update Posted (ACTUAL): August 31, 2021
• Last Update Submitted That Met QC Criteria: August 30, 2021
• Last Verified: August 1, 2021

More Information

Terms related to this study

• Keywords: pain; Mechanical Traction; Prolapsed intervertebral disc; straight leg raise test
• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Pathological Conditions, Anatomical; Spinal Diseases; Bone Diseases; Hernia; Intervertebral Disc Displacement
• Other Study ID Numbers: RRC-2019-29

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No