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

NCT ID: NCT04930523

Last Updated: 2021-09-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-06-11
• Study Completion Date: 2021-07-20

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.

Conditions

Lumbar Disc Herniation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Decompression

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

Group Type: ACTIVE_COMPARATOR

Decompression

Intervention Type: OTHER

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

Experimental

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

Group Type: EXPERIMENTAL

Elongation Longitudinaux Avec Decoaption Osteo Articulaire

Intervention Type: OTHER

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

Interventions

Elongation Longitudinaux Avec Decoaption Osteo Articulaire

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

Decompression

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

Intervention Type: OTHER

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.

• Minimum Eligible Age: 25 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Aqua Medical Services (Pvt) Ltd

INDUSTRY

Sponsor Role: lead

Responsible Party

Mir Arif Hussain

Research Head

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Kanza Rehman, MS-OMPT

Role: PRINCIPAL_INVESTIGATOR

Riphah International University

Locations

KKT Canada Orthopedic & Rehabilitation Centre

Rawalpindi, Capital, Pakistan

Countries

Pakistan

References

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.

Reference Type: BACKGROUND

PMID: 19532001 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 15564917 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 10707396 (View on PubMed)

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.

Reference Type: BACKGROUND

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.

Reference Type: BACKGROUND

PMID: 29872600 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 27182265 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 25729196 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 20615252 (View on PubMed)

Other Identifiers

Kenza Rehman 00379

Identifier Type: -

Identifier Source: org_study_id