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Decompression With ELDOA on Lumbar Disc Protrusion Patient

Primary Purpose

Lumbar Disc Herniation, Spinal Disk Injury, Protrusion

Status
Completed
Phase
Not Applicable
Locations
Pakistan
Study Type
Interventional
Intervention
Control Group
Decompression Group
ELDOA
Sponsored by
Aqua Medical Services (Pvt) Ltd
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, Spinal Decompression, Rehabilitation

Eligibility Criteria

30 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • MRI of the lumbar spine showing lumbar disc bulge
  • Localized and radiating pain more than 5 on NPRS

Exclusion Criteria:

  • Lumbar spondylolisthesis
  • Spinal stenosis
  • Fracture of the lumbar spine
  • Spinal tumor
  • Ankylosing spondylitis
  • Patients taking blood thinner medication

Sites / Locations

  • Aqua research Center

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Active Comparator

Arm Label

Control Group

Decompression

ELDOA

Arm Description

Pre-physiotherapy session: Tens Infrared/Moist Heat heat for 10 minutes at the low back region. Lumbar Mobilization (Maitland) CPA 3 sets of 10 reps Stretching Exercises (Calf, Hams, Back Extensors) 3 sets of 8-10 reps Strengthening Exercises (Back Extensors) 3 sets of 8-10 reps Postural Education Home Plan with lumbar Sacral Support Bed rest after the controlled treatment is recommended for this group.

Pre-physiotherapy session: Tens Infrared/Moist Heat heat for 10 minutes at the low back region. Lumbar Mobilization (Maitland) CPA 3 sets of 10 reps Stretching Exercises (Calf, Hams, Back Extensors) 3 sets of 8-10 reps Strengthening Exercises (Back Extensors) 3 sets of 8-10 reps Postural Education Home Plan Decompression therapy session after the controlled treatment is recommended for this group.

Pre-physiotherapy session: Tens Infrared/Moist Heat heat for 10 minutes at low back region. Lumbar Mobilization (Maitland) CPA 3 sets of 10 reps Stretching Exercises (Calf, Hams, Back Extensors) 3 sets of 8-10 reps Strengthening Exercises (Back Extensors) 3 sets of 8-10 reps Postural Education Home Plan Segmental Spinal ELDOA Exercise after the controlled treatment is recommended for this group.

Outcomes

Primary Outcome Measures

Numeric Pain Rating Scale
The scale of pain. The patient will be asked to report pain on a 1-10 numbering scale. 1 means minimum pain and 10 means extreme pain.
Oswestry disability index
The scale of disability. The patient will be asked the referenced questions and the assessor will tick the answers. The maximum score of the Oswestry disability index is 100 percent which means complete disability whereas the minimum score is 0 percent which means no disability at all.

Secondary Outcome Measures

Full Information

First Posted
February 4, 2021
Last Updated
September 2, 2021
Sponsor
Aqua Medical Services (Pvt) Ltd
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1. Study Identification

Unique Protocol Identification Number
NCT04760210
Brief Title
Decompression With ELDOA on Lumbar Disc Protrusion Patient
Official Title
Compare the Effects of Decompression With ELDOA on Lumbar Disc Protrusion Patient
Study Type
Interventional

2. Study Status

Record Verification Date
September 2021
Overall Recruitment Status
Completed
Study Start Date
January 1, 2019 (Actual)
Primary Completion Date
February 28, 2021 (Actual)
Study Completion Date
February 28, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Aqua Medical Services (Pvt) Ltd

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Decompression therapy is a result-oriented approach but it expensive and minimum availability in Pakistan. In physical therapy, we use different exercises to solve multiple spine problems. Some exercises used to treat orthogenic components such as mobilization, manipulation, SNAGS, and traction. Some exercises used to treat myogenic components such as muscle energy technique, neuromuscular reeducation, active isolated stretch, etc. Some exercises used to treat neurogenic components such as Neurodynamics, Active release technique, etc. As we know the fascia is an important component in our body most of the time the fascia restriction makes the patient condition verse. A researcher introduced the systems of exercise more the 35 years ago which works especially on the spine at every intervertebral level including costal and pelvic articulation. These exercises are called Elongation Longitudinaux Avec Decoaption Osteo-Articulaire (ELDOA) or simply Longitudinal Osteo-Articular De-coaptation Stretching (LOADS). It can be described as a fascial stretch that's localized tension at the level of a specific spinal segment and create decompression. In which he combined improving the tone of the intrinsic muscles of the spine along with reinforcing the extrinsic muscles related to the spine aim the back and stretching the interlinking paraspinal muscles. ELDOA exercise is designed for every level of the spine from the base of the skull to the sacroiliac joint. In each ELDOA exercise, we create fascial tension above and below the joint or disc that one is trying to "open up" or decompress. The outcomes include; Release vertebral compression, improved blood circulation, Disc re-hydration, improve muscle tone, and awareness. One of my studies also proved that ELDOA Exercises improve the pain and functional level in spinal disc protrusion patients.
Detailed Description
Low back pain is the common problem of our society, 80% of people experience back pain at some stage of their life. Low Back pain lifetime prevalence is 65% to 80% and It is estimated that 28% experience disabling low back pain sometime during their lives. Point prevalence ranged from 12% to 33%, the 1-year prevalence ranged from 22% to 65%, and lifetime prevalence ranged from 11% to 84%. Back pain peak prevalence age is 40-50, First episode of start in the '20s and recurrence rates between 39-71%. Women tend to be affected more in cervical spine problems than men and men tend to more affected in lumbar spine problems than women. The majority (80-90%) of low back disorders occur at the L4/5 and/or L5/S1. The occupational risk factor include driving (P<0.001), lifting, carrying, pulling, pushing, and twisting (P<0.001 for all variables) as well as nondriving vibrational exposure (P<0.001). Maitland divides lumbar spine problems into two groups, in the first group the L4/5 and L5/S1 intervertebral discs are frequently a source of symptoms and the second group has postural, muscle balance, muscle weakness, muscles spasm degenerative changes, and mechanical movement disorders problems. The L5-S1 Segment is the most common site of problem in the spine because this level bears more weight, Center of gravity passes directly through this vertebra, transition L5 Mobile and S1 Stable, Large angle B/w L5 & S1 and a great amount of movement. The intervertebral disk makes up 1/3 of the total length of the vertebral column. The disc contains 85% to 90% of water, but the amount decreases up to 65% with age. The water-binding capacity of the disc decrease with age and degenerative changes begin to occur after 2nd decade of life. The Facet joint carries 20-25% axial body load but this may reach 70% with degeneration of the Disc. The most significant biochemical change to occur in disc degeneration is the loss of proteoglycan. This loss is responsible for a fall in the osmotic pressure of the disc matrix and therefore a loss of hydration. Loading may thus lead to inappropriate stress concentrations along the endplate or in the annulus. CT Classification of Annular Tears There are five possible severities of the radial annular tear as seen on an axial CT image. The grade 0 is a normal disc, where no contrast material injected in the center of the disc has leaked from the confines of the nucleus pulposus. The grade 1 tear has leaked contrast material but only into the inner one-third of the annulus. In the grade 2 tear, the contrast has leaked from the nucleus into the outer two-thirds of the annulus. The grade 3 tear has leaked contrast completely through all three zones of the annulus. The grade 4 tear the contrast has spread circumferentially around the disc, often resembling a ship's anchor. Pathologically, this represents the merging of a full-thickness radial tear with a concentric annular tear. The grade 5 tear completely ruptured the outer layers of the disc and is leaking contrast material from the disc into the epidural space. This type of tear is thought to have the ability to induce a severe inflammatory reaction in the adjacent neural structures. In some patients, this inflammatory process is so severe that it causes painful chemical radiculopathy and sciatica without the presence of nerve root compression. Low-back pain with leg pain may be caused by a herniated intervertebral disc exerting pressure on the nerve root. Most patients will respond to conservative treatment, but in carefully selected patients, a surgical discectomy may provide faster relief of symptoms. The Patient's history and physical examination along with MRI confirm the disc herniation diagnosis. In the case of spinal disc herniation, the management is Surgical and conservative. In surgery, we have percutaneous procedures such as chymopapain injections, Annuloplasty, Percutaneous disc decompression, and Endoscopic percutaneous discectomy and Open Surgery such as Laminectomy, Discectomy/Microdiscectomy, Artificial disc surgery, and Spinal fusion. The Conservative Management includes Oral Analgesic, Gentle traction, Spinal Decompression, Spinal Stabilization, Exercise, and Fascia Stretching (ELDOA).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lumbar Disc Herniation, Spinal Disk Injury, Protrusion
Keywords
Lumbar Disc Protrusion, Spinal Decompression, Rehabilitation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
180 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Control Group
Arm Type
Active Comparator
Arm Description
Pre-physiotherapy session: Tens Infrared/Moist Heat heat for 10 minutes at the low back region. Lumbar Mobilization (Maitland) CPA 3 sets of 10 reps Stretching Exercises (Calf, Hams, Back Extensors) 3 sets of 8-10 reps Strengthening Exercises (Back Extensors) 3 sets of 8-10 reps Postural Education Home Plan with lumbar Sacral Support Bed rest after the controlled treatment is recommended for this group.
Arm Title
Decompression
Arm Type
Active Comparator
Arm Description
Pre-physiotherapy session: Tens Infrared/Moist Heat heat for 10 minutes at the low back region. Lumbar Mobilization (Maitland) CPA 3 sets of 10 reps Stretching Exercises (Calf, Hams, Back Extensors) 3 sets of 8-10 reps Strengthening Exercises (Back Extensors) 3 sets of 8-10 reps Postural Education Home Plan Decompression therapy session after the controlled treatment is recommended for this group.
Arm Title
ELDOA
Arm Type
Active Comparator
Arm Description
Pre-physiotherapy session: Tens Infrared/Moist Heat heat for 10 minutes at low back region. Lumbar Mobilization (Maitland) CPA 3 sets of 10 reps Stretching Exercises (Calf, Hams, Back Extensors) 3 sets of 8-10 reps Strengthening Exercises (Back Extensors) 3 sets of 8-10 reps Postural Education Home Plan Segmental Spinal ELDOA Exercise after the controlled treatment is recommended for this group.
Intervention Type
Other
Intervention Name(s)
Control Group
Other Intervention Name(s)
Group A
Intervention Description
Treatment for this group is conventional physical therapy along with the bed rest.
Intervention Type
Other
Intervention Name(s)
Decompression Group
Other Intervention Name(s)
Group B
Intervention Description
Treatment for this is conventional physical therapy along with the spinal decompression.
Intervention Type
Other
Intervention Name(s)
ELDOA
Other Intervention Name(s)
Group C
Intervention Description
Treatment for this is conventional physical therapy along with the ELDOA.
Primary Outcome Measure Information:
Title
Numeric Pain Rating Scale
Description
The scale of pain. The patient will be asked to report pain on a 1-10 numbering scale. 1 means minimum pain and 10 means extreme pain.
Time Frame
Up to 3 weeks
Title
Oswestry disability index
Description
The scale of disability. The patient will be asked the referenced questions and the assessor will tick the answers. The maximum score of the Oswestry disability index is 100 percent which means complete disability whereas the minimum score is 0 percent which means no disability at all.
Time Frame
Up to 3 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: MRI of the lumbar spine showing lumbar disc bulge Localized and radiating pain more than 5 on NPRS Exclusion Criteria: Lumbar spondylolisthesis Spinal stenosis Fracture of the lumbar spine Spinal tumor Ankylosing spondylitis Patients taking blood thinner medication
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Abdul Ghafoor Sajjad, MSPT
Organizational Affiliation
Shifa Tameer-e-Millat University Islamabad
Official's Role
Principal Investigator
Facility Information:
Facility Name
Aqua research Center
City
Islamabad
State/Province
Federal
ZIP/Postal Code
44000
Country
Pakistan

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
Citation
Archaeos Projects. (1999). Preliminary Site Report of the Oriental Institute of the University of Vienna and Archaeos: Excavation Project at Tell Arbid, Sector D Retrieved 04/09/2004, 2004, from http://www.archaeos.org/html/repor2js.htm
Results Reference
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Results Reference
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Citation
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Citation
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Results Reference
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Citation
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Citation
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Citation
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Decompression With ELDOA on Lumbar Disc Protrusion Patient

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