Positional Distraction and Stabilization Exercises in Adults With Lumbar Radiculopathy.
Primary Purpose
Lumbar Radiculopathy
Status
Completed
Phase
Not Applicable
Locations
Pakistan
Study Type
Interventional
Intervention
physical therapy treatment
Sponsored by
About this trial
This is an interventional prevention trial for Lumbar Radiculopathy
Eligibility Criteria
Inclusion Criteria:
- Clinical diagnosis of lumbar radiculopathy
- Age limit 30-50 years
- Both males and females
- Pain history more than 12 weeks but less than one year
- Patient having lumbar disc bulge at maximum two adjacent levels
Exclusion Criteria:
- Any type of tumor and infection in the spine
- Spondylolisthesis at L4- L5, L5-S1
- Fracture of the lumbar spine
- Sciatica other than lumbar region (piriformis syndrome)
- Acute cardiopulmonary conditions
- Morbid obesity (BMI > 30)
Sites / Locations
- Dow University of Health Sciences
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Positional Distraction plus Stabilization Exercise group
Stabilization Exercise group
Arm Description
The treatment group will receive positional distraction with stabilization exercises
control group will be treated with stabilization exercises only.
Outcomes
Primary Outcome Measures
Change from baseline Pain intensity at 8 weeks
The pain intensity measured on self reported Visual Analogue Scale. (0 means no pain and 10 is the high intensity of pain).
Change from baseline Disability at 8 weeks
The disability were assessed on Roland Morris Disability Questionnaire. where 0 means no disability and 24 is the high disability.
Secondary Outcome Measures
Full Information
NCT ID
NCT04427423
First Posted
April 27, 2020
Last Updated
February 21, 2021
Sponsor
Dow University of Health Sciences
1. Study Identification
Unique Protocol Identification Number
NCT04427423
Brief Title
Positional Distraction and Stabilization Exercises in Adults With Lumbar Radiculopathy.
Official Title
Experimental-controlled, Randomized, Single Blind Trial of Effectiveness of Positional Distraction With Stabilization Exercises Versus Stabilization Exercises Alone in the Management of Lumbar Radiculopathy.
Study Type
Interventional
2. Study Status
Record Verification Date
February 2021
Overall Recruitment Status
Completed
Study Start Date
April 10, 2020 (Actual)
Primary Completion Date
December 12, 2020 (Actual)
Study Completion Date
January 25, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Dow University of Health Sciences
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
This study evaluate the addition of positional distraction to stabilization exercises in the treatment of lumbar radiculopathy in adults. Half of the patients will recieve positional distraction and stabilization exercises in combination, while the other half will recieve stabilization exercises only.
Detailed Description
In positioanl distraction making use of the body position to produce traction at an isolated spinal level to maximally open the affected neuroforamen. It is an alternative to lumbar mechanical traction.
The spinal level of vertebral level requiring traction is palpated and a soft roll is placed and the patient side lies on the unaffected side. For further distraction both hips are flexed until movement is noted at the spinal level needing traction.
Further, distraction applied by rotating upper trunk to opposite side of pain.
Stabilization exercises are mainly used for the stability of joints and for improving muscle strength.
The first step of lumbar stabilization exercises are to maintain functional back positions during all activities. The second step is to improve strength and endurance of the core muscles.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lumbar Radiculopathy
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
All the patients will be randomly allocated into treatment and control groups 50 in experimental and 50 in control group. The treatment group will receive positional with stabilization exercises while the control group will be treated with stabilization exercises only.
Masking
Participant
Masking Description
The patients were blinded from the treatment groups that either he/she are in experimental or control group.
Allocation
Randomized
Enrollment
96 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Positional Distraction plus Stabilization Exercise group
Arm Type
Experimental
Arm Description
The treatment group will receive positional distraction with stabilization exercises
Arm Title
Stabilization Exercise group
Arm Type
Active Comparator
Arm Description
control group will be treated with stabilization exercises only.
Intervention Type
Other
Intervention Name(s)
physical therapy treatment
Intervention Description
the experimental group received positional distraction plus stabilization exercises and the control group received stabilization exercises only.
Primary Outcome Measure Information:
Title
Change from baseline Pain intensity at 8 weeks
Description
The pain intensity measured on self reported Visual Analogue Scale. (0 means no pain and 10 is the high intensity of pain).
Time Frame
All the subjects were assessed before and after 8 weeks of treatment.
Title
Change from baseline Disability at 8 weeks
Description
The disability were assessed on Roland Morris Disability Questionnaire. where 0 means no disability and 24 is the high disability.
Time Frame
All the subjects were assessed before and after 8 weeks of treatment.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Clinical diagnosis of lumbar radiculopathy
Age limit 30-50 years
Both males and females
Pain history more than 12 weeks but less than one year
Patient having lumbar disc bulge at maximum two adjacent levels
Exclusion Criteria:
Any type of tumor and infection in the spine
Spondylolisthesis at L4- L5, L5-S1
Fracture of the lumbar spine
Sciatica other than lumbar region (piriformis syndrome)
Acute cardiopulmonary conditions
Morbid obesity (BMI > 30)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
IPMR DUHS
Organizational Affiliation
Dow University of Health Sciences
Official's Role
Study Director
Facility Information:
Facility Name
Dow University of Health Sciences
City
Karachi
State/Province
Sindh
ZIP/Postal Code
74200
Country
Pakistan
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Positional Distraction and Stabilization Exercises in Adults With Lumbar Radiculopathy.
We'll reach out to this number within 24 hrs