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

Primary Purpose

Lumbar Disc Herniation

Status
Completed
Phase
Not Applicable
Locations
Pakistan
Study Type
Interventional
Intervention
Conservative physical therapy management
ELDOA
Sponsored by
Riphah International University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Lumbar Disc Herniation focused on measuring Lumbar Disc Protrusion, ELDOA, Oswestry Disability Index

Eligibility Criteria

30 Years - 50 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Riphah International University

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Conservative physical therapy management

ELDOA

Arm Description

Tens and hot pack , Soft tissue mobilization , Maitland's Lumbar segmental mobilization, Traction, Neurodynamics, Active Stretching, McKenzie Prone Extension Exercises

Conservative physical therapy management + ELDOA positions

Outcomes

Primary Outcome Measures

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.
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.
Range of Motion (ROM) Lumbar Spine (Flexion)
Changes from the Baseline, ROM of lumbar spine flexion was taken with the help of inclinometer
ROM Lumbar Spine (extension)
ROM of Lumbar spine extension was taken with the help of inclinometer
ROM Lumbar Spine (Right side flexion)
ROM of Lumbar spine right side flexion was taken with the help of inclinometer
ROM Lumbar Spine (left side Flexion)
ROM of Lumbar spine left side flexion was taken with the help of inclinometer
Straight Leg Raising (SLR)
Straight Leg Raising range was taken with the help of inclinometer

Secondary Outcome Measures

Full Information

First Posted
August 1, 2019
Last Updated
August 1, 2019
Sponsor
Riphah International University
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1. Study Identification

Unique Protocol Identification Number
NCT04043611
Brief Title
Elongation Longitudinaux Avec Decoaption Osteo-Articulaire (ELDOA) in Lumbar Disc Protrusion
Official Title
Effect of Elongation Longitudinaux Avec Decoaption Osteo-Articulaire Exercises in Lumbar Disc Protrusion
Study Type
Interventional

2. Study Status

Record Verification Date
August 2019
Overall Recruitment Status
Completed
Study Start Date
March 1, 2019 (Actual)
Primary Completion Date
May 30, 2019 (Actual)
Study Completion Date
June 30, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Riphah International University

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
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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lumbar Disc Herniation
Keywords
Lumbar Disc Protrusion, ELDOA, Oswestry Disability Index

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
29 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Conservative physical therapy management
Arm Type
Active Comparator
Arm Description
Tens and hot pack , Soft tissue mobilization , Maitland's Lumbar segmental mobilization, Traction, Neurodynamics, Active Stretching, McKenzie Prone Extension Exercises
Arm Title
ELDOA
Arm Type
Experimental
Arm Description
Conservative physical therapy management + ELDOA positions
Intervention Type
Other
Intervention Name(s)
Conservative physical therapy management
Intervention Description
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
Intervention Type
Other
Intervention Name(s)
ELDOA
Intervention Description
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
Primary Outcome Measure Information:
Title
Oswestry disability index
Description
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.
Time Frame
4th day
Title
Numeric Pain rating scale
Description
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.
Time Frame
4th day
Title
Range of Motion (ROM) Lumbar Spine (Flexion)
Description
Changes from the Baseline, ROM of lumbar spine flexion was taken with the help of inclinometer
Time Frame
4th day
Title
ROM Lumbar Spine (extension)
Description
ROM of Lumbar spine extension was taken with the help of inclinometer
Time Frame
4th day
Title
ROM Lumbar Spine (Right side flexion)
Description
ROM of Lumbar spine right side flexion was taken with the help of inclinometer
Time Frame
4th day
Title
ROM Lumbar Spine (left side Flexion)
Description
ROM of Lumbar spine left side flexion was taken with the help of inclinometer
Time Frame
4th day
Title
Straight Leg Raising (SLR)
Description
Straight Leg Raising range was taken with the help of inclinometer
Time Frame
4th day

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: 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Abdul Ghafoor Sajjad, PhD*
Organizational Affiliation
Riphah International University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Riphah International University
City
Islamabad
ZIP/Postal Code
44000
Country
Pakistan

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
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Citation
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Elongation Longitudinaux Avec Decoaption Osteo-Articulaire (ELDOA) in Lumbar Disc Protrusion

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