- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05659342
Comparison of ELDOA and Mechanical Traction Technique on Pain and Disability in Patients With Lumbar Disc Herniation
To compare the effect of ELDOA and Mechanical traction technique on pain in patients with lumbar disc herniation.
To compare the effect of ELDOA and Mechanical traction technique on disability in patients with lumbar disc herniation.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
KP
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Peshawar, KP, Pakistan, 25000
- Lady Reading Hospital - Medical Teaching Institution
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Age: 20-65 years, Both gender Male & Female, Patients having Lumbar radiculopathy diagnosed with lumbar disc herniation.
Exclusion Criteria:
- Patients presented with motor deficit, qauda equina syndrome, lumbar fracture, spinal stenosis, osteophyte formation, facet joint pathology, spondylolisthesis. malignancy, degenerative disorders, recent back surgery and patient whom surgery for lumbar disc herniation/prolapse intervertebral disc already advised by neurosurgeon
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: ELDOA Technique
ELDOA positions (hold for 1 minute, 3 alternative days for 4 weeks).
Hot pack (10-15 minutes) McKenzie extension Exercises
|
the patients treated with ELDOA technique, followed for 3 alternative days for 4 weeks. the ELDOA techniques for level L4/L5 and L5/S1 were applied. the ELDOA positions hold for one minute, 3 alternative days for 4 weeks under supervision. Hot pack (10-15 minutes) McKenzie Extension Exercises |
|
Experimental: Mechanical Lumbar Traction
Mechanical Lumbar Traction (50% of body weight was applied, in supine position, the hip and knee at 90- degree flexion, and the legs were supported. Hot pack (10-15 minutes) McKenzie extension Exercises |
Mechanical Traction Technique: traction unit, 50% of body weight was applied with the patients lying in supine position, with the hip and knee at 90 degree flexion, and legs were supported. Traction were applied for 3 alternative days for 4 weeks. Hot pack (10-15 minutes) McKenzie Extension Exercises |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
lumbar ROM by inclinometer.
Time Frame: 4 weeks
|
Flexion 60 Extension 25 Left Lat Flex 25 Right Lat Flex 25
|
4 weeks
|
|
pain on Numeric pain rating scale
Time Frame: 4 Weeks
|
Changes from baseline, Pain was measured through Numeric pain rating scale.It comprises of a continuous scale of 10cm line.0 to 1 represent no pain, 1 to 3 represent mild pain ,4 to 6 represent moderate pain, 7 to 10 represent severe pain
|
4 Weeks
|
|
Modified Oswestry low back pain disability questionnaire
Time Frame: 4th Week
|
0% to 20%: minimal disability: The patient can cope with most living activities.
Usually no treatment is indicated apart from advice on lifting sitting and exercise.
21%-40%: moderate disability: The patient experiences more pain and difficulty with sitting, lifting and standing.
Travel and social life are more difficult and they may be disabled from work.
Personal care, sexual activity and sleeping are not grossly affected and the patient can usually be managed by conservative means.
41%-60%: severe disability: Pain remains the main problem in this group but activities of daily living are affected.
These patients require a detailed investigation.
61%-80%: crippled: Back pain impinges on all aspects of the patient's life.
Positive intervention is required.
81%-100%:These patients are either bed-bound or exaggerating their symptoms
|
4th Week
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Asghar Khan, DCS-PT, Riphah International University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Abid ullah
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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-
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