Clinical trial NCT04043611: 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
Overall status: COMPLETED
Phase: NA
Conditions: Lumbar Disc Herniation
Keywords: Lumbar Disc Protrusion
ELDOA
Oswestry Disability Index
Lead sponsor: Riphah International University
Sponsor class: OTHER
First posted: 2019-08-02
Enrollment: 29
Sex: ALL
Minimum age (years): 30
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Oswestry disability index
timeFrame: 4th day
measure: Numeric Pain rating scale
timeFrame: 4th day
measure: Range of Motion (ROM) Lumbar Spine (Flexion)
timeFrame: 4th day
measure: ROM Lumbar Spine (extension)
timeFrame: 4th day
measure: ROM Lumbar Spine (Right side flexion)
timeFrame: 4th day
measure: ROM Lumbar Spine (left side Flexion)
timeFrame: 4th day
measure: Straight Leg Raising (SLR)
timeFrame: 4th day
Secondary outcomes:
Other outcomes:
Locations:
city: Islamabad
country: Pakistan
facility: Riphah International University
Study officials:
affiliation: Riphah International University
name: Abdul Ghafoor Sajjad, PhD*
role: PRINCIPAL_INVESTIGATOR
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