search
Back to results

Effect of Decompression With and Without ELDOA in Lumber Disc Protrusion Patients (ELDOA)

Primary Purpose

Lumbar Disc Herniation

Status
Completed
Phase
Not Applicable
Locations
Pakistan
Study Type
Interventional
Intervention
Elongation Longitudinaux Avec Decoaption Osteo Articulaire
Decompression
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 ELDOA, Disc herniation, Decompression, LBP

Eligibility Criteria

25 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Both Gender
  • Age b/w 25 to 65
  • Limited ROM
  • Pain more than 3 on NPRS

Exclusion Criteria:

  • Malignancy.
  • Infection.
  • Trauma.

Sites / Locations

  • KKT Canada Orthopedic & Rehabilitation Centre

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Decompression

Experimental

Arm Description

It include the pre- Physiotherapy treatment than decompression and post physiotherapy treatment.

It includes the Pre physiotherapy treatment than ELDOA positions are guided and performed by patients before decompression Low back exercises guided i.e. knee to chest, pelvic rolling, bridging, SLR, piriformis exercises is guided for home plan along with precaution and Decoarctation of (C0/C1/C2),(C4/C5),(C5,C6),(C6/C7),(T4/T5),(T6/T7),(T8,/T9),(L4/L5),(L5/S1) then Neuro-oxy motorized lumbar spinal decompression therapy for 25 minutes and at last Post physiotherapy treatment

Outcomes

Primary Outcome Measures

Numeric pain rating scale
It is numeric pain rating scale for measuring pain intensity. it ranges from 0-10.In which 0 shows no pain,1-3 (mild pain),4-6(moderate pain) and 10 shows severe pain. As guided by the researcher, pain intensity was marked by the patient
Oswestry Disability Index (ODI)
Oswestry disability index is important tool in spinal disorders patients. Disability is measured by questioner related to activities of daily living. This tool is use for every type of patient acute or chronic with severe spinal disability. Each question contain 6 items from 0 to 5 i.e. no pain, mild , moderate, severe, very severe, worst.0 to 20 is minimal disability,21 to 40 is moderate,41 to 60 is severe,61 to 80 is crippled and 81 to 100 bed bound patient
Inclinometer
Inclinometer is an instrument to measure range of motion or angle of motion of spine. Two inclinometer is use to measure dynamic motion of spine. There is motion on both ends of spine .in order to find true angle One inclinometer is on upper spine and other is on lower spine and value of lower spine is subtracted from upper spine. The flexion,, extension and side bending towards the right and left will be checked.

Secondary Outcome Measures

Full Information

First Posted
June 11, 2021
Last Updated
September 2, 2021
Sponsor
Aqua Medical Services (Pvt) Ltd
search

1. Study Identification

Unique Protocol Identification Number
NCT04930523
Brief Title
Effect of Decompression With and Without ELDOA in Lumber Disc Protrusion Patients
Acronym
ELDOA
Official Title
Effect of Spinal Decompression With and Without ELDOA in Patients of Lumber Disc Protrusion
Study Type
Interventional

2. Study Status

Record Verification Date
September 2021
Overall Recruitment Status
Completed
Study Start Date
June 11, 2021 (Actual)
Primary Completion Date
July 11, 2021 (Actual)
Study Completion Date
July 20, 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
The study will be conducted to determine the effects of spinal decompression with and without ELDOA in patients of lumbar disc protrusion. A total of twenty patient with lumber disc protrusion will be taken after fulfilling the inclusion criteria. the patient will be divided in experimental group i.e. ELDOA along with decompression and control group. Both session got pre and post session along with general low back exs.home plan along with precautions was guided to every patient of control and experimental group.NPRS ,ODI is assess in first and fourth session. The data will be analyzed through IBM SPSS version 21.
Detailed Description
Low back pain due to lumber disc protrusion is common health problem in all population, which affects the normal activities of daily living by decreasing the functional status due to low back pain that rad to leg. Literature supports that decompression have significant effect in improving the functional status of patient with low back pain with radiation but reoccurrence of problem of this problem is common with this problem. So my study is aiming to find the effectiveness of ELDOA along with decompression to minimize the re occurrence of low back and functional status. ELDOA will help to tone up the fascia and strengthen the spinal muscles The intervertebral disc consists of an inner nucleus pulposus (NP) and an outer annulus fibroses (AF). The central NP area which facilitate water retention, creating hydrostatic pressure to resist axial compression of the spine. The NP is primarily composed of type II collagen, which accounts for 20% of its overall dry weight. In contrast, the AF functions to maintain the NP within the center of the disc with low amount of PG; 70% of its dry weight is comprised of primarily concentric type I collagen fibers . In LDH, narrowing of the space available for the thecal sac can be due to protrusion of disc through an intact AF, extrusion of the NP through the AF though still maintaining continuity with the disc space, or complete loss of continuity with the disc space and sequestration of a free fragment. Motorized table with mechanical space in between two parts of table. Pelvic and thoracic belt is tie at lumber and thoracic level to fasten the patient. Static, intermittent and cycling distractive force applied to lumber area for minute. Distraction(angle of pull) and relaxation force is monitored by therapist. Specific disc that cause pain and other symptoms are targeted .curves on computer help to reduce muscle spasm. Antigravity force applied on lumber area in the space and pull backward protrude disc. Biofeedback computer module in which number of session depends upon medical condition age .targeted level of spine is selected. neuro oxy spinal decompression non-surgical and cost effective Treatment that stimulate natural healing of injured and degenerative vertebra. Works on decompressing and lengthening the spine with chronic pains. These movement produce negative pressure in the disc as a result vacuum created as a result bulge, protrude part repositioned and align. Nourishment of injured area is restore by oxygen and nutrients. Pressure on nerve relives patient feel symptoms free. Special senses in machine that detect limitation and tension of patient results of spinal decompression is better than traditional traction. Other name of decompression is intervertebral differential dynamic therapy, mechanical spinal distraction therapy. Negative pressure is created between vertebras so that protruded part pull inward and nerve become free from pressure. Table has two parts which is separated with space where distractive force apply on spine. Two belts thoracic and lumber to fasten the patient. Pulling force is minimal last for a minute depend upon patient symptoms can be adjusted to static, intermittent and cycling control by therapist to induce relaxation. During treatment antigravity force applied at spine automatically by machine system and helps to move protruded part back to position as a result nerve get pressure free. Treatment is painless, gentle and intermittent. Guy voyer is the founder of Elongation longitudinaux avec decoaption osteoarticulaire or LOADS longitudinal osteo articular decoaptation stretching .This exercise specifically work on every spinal level. Fascial stretch along with tension at spinal level. Strength of the back muscles and stretching of paraspinal work to improve the tone. Concept is based that micro movement affects macro movement as a result function betters. Spine contains 24 segments c0/c1/c3 and end to L5/S1.Fascia attach to vertebral bodies anteriorly. Posteriorly osseous framework ,muscles attach with bones ,bony framework include zygapophyseal joints that guide movements , ligament structure restrict the movement.Disc that is sponge act as shock absorption. Neurological and circulatory system work to continue functioning. They effect body locally and generally. Local effects in reducing degeneration by mobilizing the zygapophyseal joints exchange of fluid with absorption, improve arterial and venous circulation that help to remove waste and improve circulation, improve tone ROM ,posture and alignment. General effects include postural correction by supporting systems ,limbs ,muscles. Improve respiratory mechanism that restore the flow of CSF,effect psychosomatic component make balance between mind and body,neurohormonal facilitation by improving autonomic function improvement and proper functioning,propioreception improvement by self-correcting poor posture, fascia work in coordinated chain manner and help to decrease the energy consumption.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lumbar Disc Herniation
Keywords
ELDOA, Disc herniation, Decompression, LBP

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Control group will be treated by decompression session while experimental group will be treated with ELDOA along with decompression.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Decompression
Arm Type
Active Comparator
Arm Description
It include the pre- Physiotherapy treatment than decompression and post physiotherapy treatment.
Arm Title
Experimental
Arm Type
Experimental
Arm Description
It includes the Pre physiotherapy treatment than ELDOA positions are guided and performed by patients before decompression Low back exercises guided i.e. knee to chest, pelvic rolling, bridging, SLR, piriformis exercises is guided for home plan along with precaution and Decoarctation of (C0/C1/C2),(C4/C5),(C5,C6),(C6/C7),(T4/T5),(T6/T7),(T8,/T9),(L4/L5),(L5/S1) then Neuro-oxy motorized lumbar spinal decompression therapy for 25 minutes and at last Post physiotherapy treatment
Intervention Type
Other
Intervention Name(s)
Elongation Longitudinaux Avec Decoaption Osteo Articulaire
Intervention Description
Pre physiotherapy treatment Gym (treadmill ,cycling,vibrator) according to ability and condition of patient Shortwave diathermy SWD for atleast 10 mins Decompression treatment i.e. Neuro-oxy motorized lumbar spinal decompression therapy for 25 minutes. Post physiotherapy treatment Conventional Tens and infrared heat for 10 minutes at low back region. TENS is modality to reduce pain and tension,by stimulating large diameter afferent fiber .IR give superficial heat for circulation and relaxation of muscles. No exercises or walk were guided for home (till 24 hrs) Low back exs guided i.e knee to chest, pelvic rolling, bridging, SLR, pirformis exs is guided for home plan along with precautions. No exertion ,drive carefully Avoid stairs climbing ,twisting ,bending ,weight lifting
Intervention Type
Other
Intervention Name(s)
Decompression
Intervention Description
Pre physiotherapy treatment Gym (treadmill ,cycling, vibrator) according to ability and condition of patient Shortwave diathermy SWD for at least 10 minutes. ELDOA positions are guided and performed by patients before decompression Low back exercises guided i.e. knee to chest, pelvic rolling, bridging, SLR, piriformis exercises is guided for home plan along with precautions. Decoarctation of (C0/C1/C2),(C4/C5),(C5,C6),(C6/C7),(T4/T5),(T6/T7),(T8,/T9),(L4/L5),(L5/S1) Neuro-oxy motorized lumbar spinal decompression therapy for 25 minutes. Post physiotherapy treatment Tens and infrared heat for 10 minutes at low back region. TENS is modality to reduce pain and tension, by stimulating large diameter afferent fiber .IR give superficial heat for circulation and relaxation of muscles. ELDOA exercises(positions)are guided for home plan after session (after 24 hrs) No exertion ,drive carefully Avoid stairs climbing, twisting bending, weight lifting
Primary Outcome Measure Information:
Title
Numeric pain rating scale
Description
It is numeric pain rating scale for measuring pain intensity. it ranges from 0-10.In which 0 shows no pain,1-3 (mild pain),4-6(moderate pain) and 10 shows severe pain. As guided by the researcher, pain intensity was marked by the patient
Time Frame
4th weeks
Title
Oswestry Disability Index (ODI)
Description
Oswestry disability index is important tool in spinal disorders patients. Disability is measured by questioner related to activities of daily living. This tool is use for every type of patient acute or chronic with severe spinal disability. Each question contain 6 items from 0 to 5 i.e. no pain, mild , moderate, severe, very severe, worst.0 to 20 is minimal disability,21 to 40 is moderate,41 to 60 is severe,61 to 80 is crippled and 81 to 100 bed bound patient
Time Frame
4th weeks
Title
Inclinometer
Description
Inclinometer is an instrument to measure range of motion or angle of motion of spine. Two inclinometer is use to measure dynamic motion of spine. There is motion on both ends of spine .in order to find true angle One inclinometer is on upper spine and other is on lower spine and value of lower spine is subtracted from upper spine. The flexion,, extension and side bending towards the right and left will be checked.
Time Frame
4th week

10. Eligibility

Sex
All
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Both Gender Age b/w 25 to 65 Limited ROM Pain more than 3 on NPRS Exclusion Criteria: Malignancy. Infection. Trauma.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kanza Rehman, MS-OMPT
Organizational Affiliation
Riphah International University
Official's Role
Principal Investigator
Facility Information:
Facility Name
KKT Canada Orthopedic & Rehabilitation Centre
City
Rawalpindi
State/Province
Capital
ZIP/Postal Code
44000
Country
Pakistan

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
19532001
Citation
Cheung KM, Karppinen J, Chan D, Ho DW, Song YQ, Sham P, Cheah KS, Leong JC, Luk KD. Prevalence and pattern of lumbar magnetic resonance imaging changes in a population study of one thousand forty-three individuals. Spine (Phila Pa 1976). 2009 Apr 20;34(9):934-40. doi: 10.1097/BRS.0b013e3181a01b3f.
Results Reference
background
PubMed Identifier
15564917
Citation
Battie MC, Videman T, Parent E. Lumbar disc degeneration: epidemiology and genetic influences. Spine (Phila Pa 1976). 2004 Dec 1;29(23):2679-90. doi: 10.1097/01.brs.0000146457.83240.eb.
Results Reference
background
PubMed Identifier
10707396
Citation
Luoma K, Riihimaki H, Luukkonen R, Raininko R, Viikari-Juntura E, Lamminen A. Low back pain in relation to lumbar disc degeneration. Spine (Phila Pa 1976). 2000 Feb 15;25(4):487-92. doi: 10.1097/00007632-200002150-00016.
Results Reference
background
Citation
Lee Y, Lee C-R, Cho M. Effect of decompression therapy combined with joint mobilization on patients with lumbar herniated nucleus pulposus. Journal of Physical Therapy Science. 2012;24(9):829-32.
Results Reference
background
PubMed Identifier
29872600
Citation
Rathod AK, Dhake RP. Radiographic Incidence of Lumbar Spinal Instability in Patients with Non-spondylolisthetic Low Backache. Cureus. 2018 Apr 4;10(4):e2420. doi: 10.7759/cureus.2420.
Results Reference
background
PubMed Identifier
27182265
Citation
Waqqar S, Shakil-Ur-Rehman S, Ahmad S. McKenzie treatment versus mulligan sustained natural apophyseal glides for chronic mechanical low back pain. Pak J Med Sci. 2016 Mar-Apr;32(2):476-9. doi: 10.12669/pjms.322.9127.
Results Reference
background
PubMed Identifier
25729196
Citation
Choi J, Lee S, Hwangbo G. Influences of spinal decompression therapy and general traction therapy on the pain, disability, and straight leg raising of patients with intervertebral disc herniation. J Phys Ther Sci. 2015 Feb;27(2):481-3. doi: 10.1589/jpts.27.481. Epub 2015 Feb 17.
Results Reference
background
PubMed Identifier
20615252
Citation
Apfel CC, Cakmakkaya OS, Martin W, Richmond C, Macario A, George E, Schaefer M, Pergolizzi JV. Restoration of disk height through non-surgical spinal decompression is associated with decreased discogenic low back pain: a retrospective cohort study. BMC Musculoskelet Disord. 2010 Jul 8;11:155. doi: 10.1186/1471-2474-11-155.
Results Reference
background

Learn more about this trial

Effect of Decompression With and Without ELDOA in Lumber Disc Protrusion Patients

We'll reach out to this number within 24 hrs