Back to resultsEffects of Lumbar Traction on the Straight Leg Raise Test and Pain
Primary Purpose
Prolapsed Intervertebral Disc
Status
Completed
Phase
Not Applicable
Locations
Saudi Arabia
Study Type
Interventional
Intervention
Mechanical Traction
Sponsored by
About this trial
This is an interventional treatment trial for Prolapsed Intervertebral Disc focused on measuring Mechanical Traction, Prolapsed intervertebral disc, straight leg raise test, pain
Eligibility Criteria
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.
Sites / Locations
- King Saud University
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Active Comparator
Active Comparator
Arm Label
Group A
Group B
Group C
Arm Description
One-fifth of body weight traction force will be given
One-third of body weight traction force will be given
One-half of body weight traction force will be given
Outcomes
Primary Outcome Measures
Straight Leg Raise test
Straight leg raise test is used in supine position to test neurological signs
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.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04728685
Brief Title
Effects of Lumbar Traction on the Straight Leg Raise Test and Pain
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
August 2021
Overall Recruitment Status
Completed
Study Start Date
January 25, 2021 (Actual)
Primary Completion Date
March 24, 2021 (Actual)
Study Completion Date
March 24, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
King Saud University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prolapsed Intervertebral Disc
Keywords
Mechanical Traction, Prolapsed intervertebral disc, straight leg raise test, pain
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Three-arm parallel groups
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
45 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Group A
Arm Type
Active Comparator
Arm Description
One-fifth of body weight traction force will be given
Arm Title
Group B
Arm Type
Active Comparator
Arm Description
One-third of body weight traction force will be given
Arm Title
Group C
Arm Type
Active Comparator
Arm Description
One-half of body weight traction force will be given
Intervention Type
Procedure
Intervention Name(s)
Mechanical Traction
Intervention Description
Mechanical Traction will be applied to the lumbar region using a traction unit.
Primary Outcome Measure Information:
Title
Straight Leg Raise test
Description
Straight leg raise test is used in supine position to test neurological signs
Time Frame
upto 1 month
Title
Visual analog scale
Description
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.
Time Frame
upto 1 month
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Masood Khan, MPTh
Organizational Affiliation
King Saud University
Official's Role
Principal Investigator
Facility Information:
Facility Name
King Saud University
City
Riyadh
ZIP/Postal Code
11433
Country
Saudi Arabia
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Effects of Lumbar Traction on the Straight Leg Raise Test and Pain
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