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

NCT04728685 | Completed

• 1 other identifier: RRC-2019-29
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Prolapsed Intervertebral Disc

Keywords

Mechanical Traction; Prolapsed intervertebral disc; straight leg raise test; pain

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (3)

Group A

ACTIVE COMPARATOR

One-fifth of body weight traction force will be given

Procedure: Mechanical Traction

Group B

ACTIVE COMPARATOR

One-third of body weight traction force will be given

Procedure: Mechanical Traction

Group C

ACTIVE COMPARATOR

One-half of body weight traction force will be given

Procedure: Mechanical Traction

Interventions

Mechanical Traction PROCEDURE

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

Group A; Group B; Group C

Eligibility Criteria

• Age: 20 Years - 40 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• King Saud University: lead

Study Sites (1)

King Saud University

Riyadh, 11433, Saudi Arabia

Location

MeSH Terms

Conditions

Intervertebral Disc Displacement; Pain

Condition Hierarchy (Ancestors)

Spinal Diseases; Bone Diseases; Musculoskeletal Diseases; Hernia; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Neurologic Manifestations; Signs and Symptoms

Study Officials

• Masood Khan, MPTh

  King Saud University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Three-arm parallel groups

Study Record Dates

• First Submitted: January 24, 2021
• First Posted: January 28, 2021
• Study Start: January 25, 2021
• Primary Completion: March 24, 2021
• Study Completion: March 24, 2021
• Last Updated: August 31, 2021

Record last verified: 2021-08

Data Sharing

• IPD Sharing: Will not share

Locations

SA (1)