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

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ClinicalTrials.gov Identifier: NCT04044092
Recruitment Status : Completed
First Posted : August 5, 2019
Last Update Posted : August 5, 2019
Sponsor:
Information provided by (Responsible Party):
Riphah International University

Brief Summary:
The aim of this research is to find and compare the effect of conventional physical therapy and ELDOA stretching exercise on pain, range of motion and disability in patients with cervical disc protrusion. The Randomized controlled trials done at Armed Forces Institute of Rehabilitation Medicine, Rawalpindi. The sample size was 20. The subjects were divided in two groups, 10 subjects in conventional physical therapy group and 10 in ELDOA stretching exercise group. Study duration was of 6 months. Sampling technique applied was Convenient Sampling technique randomization in group through Lottery method (sealed envelope). Only 30-60 years individuals with cervical disc protrusion were included. Tools used in the study were measurement of ROM by bubble inclinometer, Numeric pain rating scale (NPRS) and neck disability index (NDI). Data was analyzed using SPSS 21.

Condition or disease Intervention/treatment Phase
Cervical Disc Herniation Other: Conservative physical therapy Other: ELDOA stretching exercise Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effects of Elongation Longitudinaux Avec Decoaption Osteo-Articulaire (ELDOA) in Cervical Disc Protrusion
Actual Study Start Date : January 15, 2019
Actual Primary Completion Date : June 20, 2019
Actual Study Completion Date : June 30, 2019

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Arm Intervention/treatment
Active Comparator: Conservative physical therapy
Moist hot packs, TENS, Cervical Traction, Neural Mobilization, Cervical Spine strengthening exercises
Other: Conservative physical therapy
Moist hot packs, TENS, Cervical Traction, Neural Mobilization on alternate days Cervical Spine strengthening exercises 10 repetitions×1 set, 4 days/week. Total of 4 sessions were given each consisting of 40 mins.

Experimental: ELDOA stretching exercise
ELDOA stretching exercise protocol along with Conservative physical therapy
Other: ELDOA stretching exercise
Experimental group was given ELDOA stretching exercise protocol along with the moist hot packs, TENS, Cervical Traction, and Neural Mobilization on alternate days Cervical Spine strengthening exercises 10 repetitions×1 set, 4 days/week. Total of 4 sessions were given each consisting of 40 mins.




Primary Outcome Measures :
  1. Neck disability index [ Time Frame: 4th day ]
    Changes from base line: Northwick disability index was developed first in Northwick Park hospital, England. It was designed to measure the neck pain and disability over time. It consists of 10, five parts sections. At the end, score is calculated by dividing the obtained score by total (50) multiplied by 100. As the driving section was missing in most of the female patients, total score was considered as 45 instead of 50.

  2. Numeric Pain rating scale (NPRS) [ Time Frame: 4th day ]
    Changes from base Line: Numeric Pain rating scale is a scale for pain starting from 0-10, where 0 indicate no pain and 10 indicate worst possible pain.

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

  4. ROM Cervical Spine (Extension) [ Time Frame: 4th day ]
    Changes from the Baseline ROM: Range of Motion of Cervical spine extension was taken with the help of bubble inclinometer

  5. ROM Cervical Spine (Right side flexion) [ Time Frame: 4th day ]
    Changes from the Baseline ROM: Range of Motion of Cervical spine right side flexion was taken with the help of bubble inclinometer

  6. ROM Cervical Spine (Left side Flexion) [ Time Frame: 4th day ]
    Changes from the Baseline ROM: Range of Motion of Cervical spine left side flexion was taken with the help of bubble inclinometer

  7. ROM Cervical Spine (Right rotation) [ Time Frame: 4th day ]
    Changes from the Baseline ROM: Range of Motion of Cervical spine right rotation was taken with the help of bubble inclinometer

  8. ROM Cervical Spine (Left rotation) [ Time Frame: 4th day ]
    Changes from the Baseline ROM: Range of Motion of Cervical spine left rotation was taken with the help of bubble inclinometer



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Ages Eligible for Study:   30 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • MRI with grading of disc protrusion
  • Radiculopathy
  • Limited ROM (measured by bubble Inclinometer)
  • Pain more than 3 on NPRS

Exclusion Criteria:

  • Malignancy,
  • Infection,
  • Trauma,
  • Bone deformities,
  • Severe osteoporosis
  • With marked bony and soft tissue disease
  • Taking other treatment in the same period of the research

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): NCT04044092


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: NCT04044092    
Other Study ID Numbers: RiphahIU Muhammad Safdar Ch
First Posted: August 5, 2019    Key Record Dates
Last Update Posted: August 5, 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:
Cervical Disc Protrusion
ELDOA,
Neck Pain
Neck Disability
Additional relevant MeSH terms:
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Hernia
Pathological Conditions, Anatomical