NCT04760210

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
180

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2019

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2019

Completed
2.1 years until next milestone

First Submitted

Initial submission to the registry

February 4, 2021

Completed
14 days until next milestone

First Posted

Study publicly available on registry

February 18, 2021

Completed
10 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 28, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 28, 2021

Completed
Last Updated

September 5, 2021

Status Verified

September 1, 2021

Enrollment Period

2.2 years

First QC Date

February 4, 2021

Last Update Submit

September 2, 2021

Conditions

Lumbar Disc HerniationSpinal Disk InjuryProtrusion

Keywords

Lumbar Disc ProtrusionSpinal DecompressionRehabilitation

Outcome Measures

Primary Outcomes (2)

  • 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.

    Up to 3 weeks

  • 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.

    Up to 3 weeks

Study Arms (3)

Control Group

ACTIVE COMPARATOR

Pre-physiotherapy session: 1. Tens 2. Infrared/Moist Heat heat for 10 minutes at the low back region. 3. Lumbar Mobilization (Maitland) CPA 3 sets of 10 reps 4. Stretching Exercises (Calf, Hams, Back Extensors) 3 sets of 8-10 reps 5. Strengthening Exercises (Back Extensors) 3 sets of 8-10 reps 6. Postural Education 7. Home Plan with lumbar Sacral Support Bed rest after the controlled treatment is recommended for this group.

Other: Control Group

Decompression

ACTIVE COMPARATOR

Pre-physiotherapy session: 1. Tens 2. Infrared/Moist Heat heat for 10 minutes at the low back region. 3. Lumbar Mobilization (Maitland) CPA 3 sets of 10 reps 4. Stretching Exercises (Calf, Hams, Back Extensors) 3 sets of 8-10 reps 5. Strengthening Exercises (Back Extensors) 3 sets of 8-10 reps 6. Postural Education 7. Home Plan Decompression therapy session after the controlled treatment is recommended for this group.

Other: Decompression Group

ELDOA

ACTIVE COMPARATOR

Pre-physiotherapy session: 1. Tens 2. Infrared/Moist Heat heat for 10 minutes at low back region. 3. Lumbar Mobilization (Maitland) CPA 3 sets of 10 reps 4. Stretching Exercises (Calf, Hams, Back Extensors) 3 sets of 8-10 reps 5. Strengthening Exercises (Back Extensors) 3 sets of 8-10 reps 6. Postural Education 7. Home Plan Segmental Spinal ELDOA Exercise after the controlled treatment is recommended for this group.

Other: ELDOA

Interventions

Control GroupOTHER

Treatment for this group is conventional physical therapy along with the bed rest.

Also known as: Group A
Control Group
Decompression GroupOTHER

Treatment for this is conventional physical therapy along with the spinal decompression.

Also known as: Group B
Decompression
ELDOAOTHER

Treatment for this is conventional physical therapy along with the ELDOA.

Also known as: Group C
ELDOA

Eligibility Criteria

Age30 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Aqua research Center

Islamabad, Federal, 44000, Pakistan

Location

Related Publications (12)

  • 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

    BACKGROUND

  • Atlas SJ, Keller RB, Wu YA, Deyo RA, Singer DE. Long-term outcomes of surgical and nonsurgical management of lumbar spinal stenosis: 8 to 10 year results from the maine lumbar spine study. Spine (Phila Pa 1976). 2005 Apr 15;30(8):936-43. doi: 10.1097/01.brs.0000158953.57966.c0.

    PMID: 15834339BACKGROUND

  • Breslau, A. M., & Gabe, M. (1962). Ergebnisse der Polysaccharidhistochemie, Microorganismen, Invertebraten : mit 25. Stuttgart: Fischer.

    BACKGROUND

  • Delauche-Cavallier MC, Budet C, Laredo JD, Debie B, Wybier M, Dorfmann H, Ballner I. Lumbar disc herniation. Computed tomography scan changes after conservative treatment of nerve root compression. Spine (Phila Pa 1976). 1992 Aug;17(8):927-33.

    PMID: 1387974BACKGROUND

  • Dvorak J, Gauchat MH, Valach L. The outcome of surgery for lumbar disc herniation. I. A 4-17 years' follow-up with emphasis on somatic aspects. Spine (Phila Pa 1976). 1988 Dec;13(12):1418-22. doi: 10.1097/00007632-198812000-00015.

    PMID: 3212575BACKGROUND

  • Frymoyer JW, Pope MH, Costanza MC, Rosen JC, Goggin JE, Wilder DG. Epidemiologic studies of low-back pain. Spine (Phila Pa 1976). 1980 Sep-Oct;5(5):419-23. doi: 10.1097/00007632-198009000-00005.

    PMID: 6450452BACKGROUND

  • Hammer, W. I. (2007). Functional soft-tissue examination and treatment by manual methods: Jones & Bartlett Learning.

    BACKGROUND

  • Khan, A. G. S. G. A., & Khan, A. (2016). Fascia Stretching Improve the Pain and Functional Level in Disc Protrusion Patients. Journal of Riphah College of Rehabilitaion Sciences, 4(1), 7-10.

    BACKGROUND

  • Krause M, Refshauge KM, Dessen M, Boland R. Lumbar spine traction: evaluation of effects and recommended application for treatment. Man Ther. 2000 May;5(2):72-81. doi: 10.1054/math.2000.0235.

    PMID: 10903582BACKGROUND

  • Saal JA, Saal JS. Nonoperative treatment of herniated lumbar intervertebral disc with radiculopathy. An outcome study. Spine (Phila Pa 1976). 1989 Apr;14(4):431-7. doi: 10.1097/00007632-198904000-00018.

    PMID: 2718047BACKGROUND

  • van der Windt DA, Simons E, Riphagen II, Ammendolia C, Verhagen AP, Laslett M, Deville W, Deyo RA, Bouter LM, de Vet HC, Aertgeerts B. Physical examination for lumbar radiculopathy due to disc herniation in patients with low-back pain. Cochrane Database Syst Rev. 2010 Feb 17;(2):CD007431. doi: 10.1002/14651858.CD007431.pub2.

    PMID: 20166095BACKGROUND

  • Weber H. Lumbar disc herniation. A controlled, prospective study with ten years of observation. Spine (Phila Pa 1976). 1983 Mar;8(2):131-40.

    PMID: 6857385BACKGROUND

MeSH Terms

Conditions

Intervertebral Disc Displacement

Interventions

Control Groups

Condition Hierarchy (Ancestors)

Spinal DiseasesBone DiseasesMusculoskeletal DiseasesHerniaPathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Epidemiologic Research DesignEpidemiologic MethodsInvestigative TechniquesResearch DesignMethods

Study Officials

  • Abdul Ghafoor Sajjad, MSPT

    Shifa Tameer-e-Millat University Islamabad

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

February 4, 2021

First Posted

February 18, 2021

Study Start

January 1, 2019

Primary Completion

February 28, 2021

Study Completion

February 28, 2021

Last Updated

September 5, 2021

Record last verified: 2021-09

Data Sharing

IPD Sharing
Will not share

Locations

PA(1)