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

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ClinicalTrials.gov Identifier: NCT04043611
Recruitment Status : Completed
First Posted : August 2, 2019
Last Update Posted : August 2, 2019
Sponsor:
Information provided by (Responsible Party):
Riphah International University

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

Condition or disease Intervention/treatment Phase
Lumbar Disc Herniation Other: Conservative physical therapy management Other: ELDOA Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 29 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Effect of Elongation Longitudinaux Avec Decoaption Osteo-Articulaire Exercises in Lumbar Disc Protrusion
Actual Study Start Date : March 1, 2019
Actual Primary Completion Date : May 30, 2019
Actual Study Completion Date : June 30, 2019

Arm Intervention/treatment
Active Comparator: Conservative physical therapy management
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
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

Experimental: ELDOA
Conservative physical therapy management + ELDOA positions
Other: ELDOA
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 Measures :
  1. Oswestry disability index [ Time Frame: 4th day ]
    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.

  2. Numeric Pain rating scale [ Time Frame: 4th day ]
    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.

  3. Range of Motion (ROM) Lumbar Spine (Flexion) [ Time Frame: 4th day ]
    Changes from the Baseline, ROM of lumbar spine flexion was taken with the help of inclinometer

  4. ROM Lumbar Spine (extension) [ Time Frame: 4th day ]
    ROM of Lumbar spine extension was taken with the help of inclinometer

  5. ROM Lumbar Spine (Right side flexion) [ Time Frame: 4th day ]
    ROM of Lumbar spine right side flexion was taken with the help of inclinometer

  6. ROM Lumbar Spine (left side Flexion) [ Time Frame: 4th day ]
    ROM of Lumbar spine left side flexion was taken with the help of inclinometer

  7. Straight Leg Raising (SLR) [ Time Frame: 4th day ]
    Straight Leg Raising range was taken with the help of inclinometer



Information from the National Library of Medicine

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Ages Eligible for Study:   30 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04043611


Locations
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Pakistan
Riphah International University
Islamabad, Pakistan, 44000
Sponsors and Collaborators
Riphah International University
Investigators
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Principal Investigator: Abdul Ghafoor Sajjad, PhD* Riphah International University
Publications:

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Responsible Party: Riphah International University
ClinicalTrials.gov Identifier: NCT04043611    
Other Study ID Numbers: RiphahIU Nida Rahim Malik
First Posted: August 2, 2019    Key Record Dates
Last Update Posted: August 2, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Riphah International University:
Lumbar Disc Protrusion
ELDOA
Oswestry Disability Index
Additional relevant MeSH terms:
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Hernia
Pathological Conditions, Anatomical