Elongation Longitudinaux Avec Decoaption Osteo-Articulaire (ELDOA) in Lumbar Disc Protrusion

Study Overview
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Brief Summary
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The aim of this randomized controlled trial will be to determine the effectiveness of ELDOA for treating lumbar disc protrusion. Two randomized groups of patients with lumbar disc protrusion will be treated with conservative physical therapy and the experimental group will be given ELDOA, in addition. Both, male and female patients meeting the inclusion criteria will be included. Patients having concurrent malignancy, infection, trauma or any bony deformity will be excluded

Detailed Description
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The study is aimed at determining the effects of ELDOA in treating disc protrusion at lumbar region and is being conducted in Max Rehab & Physical Therapy Centre Islamabad and Pakistan Railway General Hospital, Rawalpindi (March 2019-June 2019). Sample size of the study is 34 with confidence interval of 95% and power of 0.8. 30 patients were screened and 29 were included in the study on the basis of inclusion criteria. Sealed envelope contained total 34 questionnaires, 17 for each group. Patients were allocated randomly on the basis of group mentioned on the Performa. Similar conservative rehabilitation protocol was designed for both control and experimental group except for experimental group had ELDOA Exercises in addition. Patients were examined at 1st visit before administration of any treatment and at 4th visit which was also the last one (after completing 4 sessions at alternate days). Baseline evaluation for demographics and symptomatology was taken. Self-reported questionnaire, ODI, NPRS, lumbar ROM and SLR were recorded at first and fourth visit for comparison. 26 patients completed the study while 1 patient from control group and 2 patients from experiment group were lost to follow up and were considered drop outs.

Official Title
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Effect of Elongation Longitudinaux Avec Decoaption Osteo-Articulaire Exercises in Lumbar Disc Protrusion

Conditions
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Lumbar Disc Herniation

Intervention / Treatment
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* Other: Conservative physical therapy management
* Other: ELDOA


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Limited ROM (hip/lumbar spine) Pain more than 3 on NPRS Pain ≥ 3 months Exclusion Criteria: Recurrent disc protrusion Spondylolisthesis Spondylosis Malignancy Infection Trauma Marked bony deformities

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Conservative physical therapy management<br>Tens and hot pack , Soft tissue mobilization , Maitland's Lumbar segmental mobilization, Traction, Neurodynamics, Active Stretching, McKenzie Prone Extension Exercises | Other: Conservative physical therapy management<br>* Tens and hot pack for at least 10 minutes at low back Soft tissue mobilization (Myofascial Release Technique) Maitland's Lumbar segmental mobilization (Grade I & II for pain, Grade III & IV for ROM) Traction (Manual general traction) Neurodynamics (Tensioner technique) Home plan after session (Guided low back exercises):Active Stretching (5-10 repetition with 15-20 second hold), Hamstring, Piriformis McKenzie Prone Extension Exercises<br>|
| Experimental: ELDOA<br>Conservative physical therapy management + ELDOA positions | Other: ELDOA<br>* ELDOA positions (hold for 1 minute,4 alternate days a week) under supervision during session Conservative physical therapy management Tens and hot pack for at least 10 minutes at low back Soft tissue mobilization (Myofascial Release Technique) Maitland's Lumbar segmental mobilization (Grade I & II for pain, Grade III & IV for ROM) Traction (Manual general traction) Neurodynamics (Tensioner technique) Home plan after session (Guided low back exercises):Active Stretching (5-10 repetition with 15-20 second hold),Hamstring,Piriformis<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Oswestry disability index | Changes from the Baseline, Oswestry disability index (ODI) was developed in order to assess disability related to pain in individuals with acute, sub-acute, or chronic LBP. The total score of ODI range from 0 (no disability) to 100 (maximum disability). Scores from 0-20 to indicate minimal disability, 20-40 to indicate moderate disability, 40-60 to indicate severe disability, 60-80 to indicate housebound, and 80-100 to indicate bedbound. The ODI score is recommended as a back pain-specific measure of disability. | 4th day | 
| Numeric Pain rating scale | Changes from the Baseline, Numeric Pain rating scale (NPRS) is a scale for pain starting from 0-10. where 0 indicate no pain and 10 indicate severe pain. | 4th day | 
| Range of Motion (ROM) Lumbar Spine (Flexion) | Changes from the Baseline, ROM of lumbar spine flexion was taken with the help of inclinometer | 4th day | 
| ROM Lumbar Spine (extension) | ROM of Lumbar spine extension was taken with the help of inclinometer | 4th day | 
| ROM Lumbar Spine (Right side flexion) | ROM of Lumbar spine right side flexion was taken with the help of inclinometer | 4th day | 
| ROM Lumbar Spine (left side Flexion) | ROM of Lumbar spine left side flexion was taken with the help of inclinometer | 4th day | 
| Straight Leg Raising (SLR) | Straight Leg Raising range was taken with the help of inclinometer | 4th day | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Lumbar Disc Protrusion, ELDOA, Oswestry Disability Index