Elongation Longitudinaux Avec Decoaption Osteo-Articulaire (ELDOA) in Lumbar Disc Protrusion

NCT04043611 | Completed DMC

• 1 other identifier: RiphahIU Nida Rahim Malik
• Study Type: interventional
• Target: 29
• Locations: 1 country
• Sites: 1

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

Conditions

Lumbar Disc Herniation

Keywords

Lumbar Disc Protrusion; ELDOA; Oswestry Disability Index

Outcome Measures

Primary Outcomes (7)

• Oswestry disability index

  Changes from the Baseline, Oswestry disability index (ODI) was developed in order to assess disability related to pain in individuals with acute, sub-acute, or chronic LBP. The total score of ODI range from 0 (no disability) to 100 (maximum disability). Scores from 0-20 to indicate "minimal disability," 20-40 to indicate "moderate disability," 40-60 to indicate "severe disability," 60-80 to indicate "housebound," and 80-100 to indicate "bedbound". The ODI score is recommended as a back pain-specific measure of disability.

  4th day

• Numeric Pain rating scale

  Changes from the Baseline, Numeric Pain rating scale (NPRS) is a scale for pain starting from 0-10. where 0 indicate no pain and 10 indicate severe pain.

  4th day

• Range of Motion (ROM) Lumbar Spine (Flexion)

  Changes from the Baseline, ROM of lumbar spine flexion was taken with the help of inclinometer

  4th day

• ROM Lumbar Spine (extension)

  ROM of Lumbar spine extension was taken with the help of inclinometer

  4th day

• ROM Lumbar Spine (Right side flexion)

  ROM of Lumbar spine right side flexion was taken with the help of inclinometer

  4th day

• ROM Lumbar Spine (left side Flexion)

  ROM of Lumbar spine left side flexion was taken with the help of inclinometer

  4th day

• Straight Leg Raising (SLR)

  Straight Leg Raising range was taken with the help of inclinometer

  4th day

Study Arms (2)

Conservative physical therapy management

ACTIVE COMPARATOR

Tens and hot pack , Soft tissue mobilization , Maitland's Lumbar segmental mobilization, Traction, Neurodynamics, Active Stretching, McKenzie Prone Extension Exercises

Other: Conservative physical therapy management

ELDOA

EXPERIMENTAL

Conservative physical therapy management + ELDOA positions

Other: ELDOA

Interventions

Conservative physical therapy management OTHER

Tens and hot pack for at least 10 minutes at low back Soft tissue mobilization (Myofascial Release Technique) Maitland's Lumbar segmental mobilization (Grade I \& II for pain, Grade III \& IV for ROM) Traction (Manual general traction) Neurodynamics (Tensioner technique) Home plan after session (Guided low back exercises):Active Stretching (5-10 repetition with 15-20 second hold), Hamstring, Piriformis McKenzie Prone Extension Exercises

Conservative physical therapy management

ELDOA OTHER

ELDOA positions (hold for 1 minute,4 alternate days a week) under supervision during session Conservative physical therapy management Tens and hot pack for at least 10 minutes at low back Soft tissue mobilization (Myofascial Release Technique) Maitland's Lumbar segmental mobilization (Grade I \& II for pain, Grade III \& IV for ROM) Traction (Manual general traction) Neurodynamics (Tensioner technique) Home plan after session (Guided low back exercises):Active Stretching (5-10 repetition with 15-20 second hold),Hamstring,Piriformis

ELDOA

Eligibility Criteria

• Age: 30 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Limited ROM (hip/lumbar spine)
• Pain more than 3 on NPRS
• Pain ≥ 3 months

You may not qualify if:

• Recurrent disc protrusion
• Spondylolisthesis
• Spondylosis
• Malignancy
• Infection
• Trauma
• Marked bony deformities

Sponsors & Collaborators

• Riphah International University: lead

Study Sites (1)

Riphah International University

Islamabad, 44000, Pakistan

Location

Related Publications (10)

• Vroomen PC, de Krom MC, Knottnerus JA. Predicting the outcome of sciatica at short-term follow-up. Br J Gen Pract. 2002 Feb;52(475):119-23.

  PMID: 11887877 BACKGROUND

• Peul WC, van den Hout WB, Brand R, Thomeer RT, Koes BW; Leiden-The Hague Spine Intervention Prognostic Study Group. Prolonged conservative care versus early surgery in patients with sciatica caused by lumbar disc herniation: two year results of a randomised controlled trial. BMJ. 2008 Jun 14;336(7657):1355-8. doi: 10.1136/bmj.a143. Epub 2008 May 23.

  PMID: 18502911 BACKGROUND

• Tampier C, Drake JD, Callaghan JP, McGill SM. Progressive disc herniation: an investigation of the mechanism using radiologic, histochemical, and microscopic dissection techniques on a porcine model. Spine (Phila Pa 1976). 2007 Dec 1;32(25):2869-74. doi: 10.1097/BRS.0b013e31815b64f5.

  PMID: 18246010 BACKGROUND

• Vroomen PC, de Krom MC, Wilmink JT, Kester AD, Knottnerus JA. Diagnostic value of history and physical examination in patients suspected of lumbosacral nerve root compression. J Neurol Neurosurg Psychiatry. 2002 May;72(5):630-4. doi: 10.1136/jnnp.72.5.630.

  PMID: 11971050 BACKGROUND

• Fardon DF, Milette PC; Combined Task Forces of the North American Spine Society, American Society of Spine Radiology, and American Society of Neuroradiology. Nomenclature and classification of lumbar disc pathology. Recommendations of the Combined task Forces of the North American Spine Society, American Society of Spine Radiology, and American Society of Neuroradiology. Spine (Phila Pa 1976). 2001 Mar 1;26(5):E93-E113. doi: 10.1097/00007632-200103010-00006. No abstract available.

  PMID: 11242399 BACKGROUND

• Kim SH, Kim HS, Kim SW. Lumbar disc herniation in tae kwon do athletic child. J Korean Neurosurg Soc. 2010 Dec;48(6):538-40. doi: 10.3340/jkns.2010.48.6.538. Epub 2010 Dec 31.

  PMID: 21430983 BACKGROUND

• Bronfort G, Haas M, Evans R, Leininger B, Triano J. Effectiveness of manual therapies: the UK evidence report. Chiropr Osteopat. 2010 Feb 25;18:3. doi: 10.1186/1746-1340-18-3.

  PMID: 20184717 BACKGROUND

• Herzog W. The biomechanics of spinal manipulation. J Bodyw Mov Ther. 2010 Jul;14(3):280-6. doi: 10.1016/j.jbmt.2010.03.004.

  PMID: 20538226 BACKGROUND

• Wegner I, Widyahening IS, van Tulder MW, Blomberg SE, de Vet HC, Bronfort G, Bouter LM, van der Heijden GJ. Traction for low-back pain with or without sciatica. Cochrane Database Syst Rev. 2013 Aug 19;2013(8):CD003010. doi: 10.1002/14651858.CD003010.pub5.

  PMID: 23959683 BACKGROUND

• Coppieters MW, Andersen LS, Johansen R, Giskegjerde PK, Hoivik M, Vestre S, Nee RJ. Excursion of the Sciatic Nerve During Nerve Mobilization Exercises: An In Vivo Cross-sectional Study Using Dynamic Ultrasound Imaging. J Orthop Sports Phys Ther. 2015 Oct;45(10):731-7. doi: 10.2519/jospt.2015.5743. Epub 2015 Aug 24.

  PMID: 26304637 BACKGROUND

MeSH Terms

Conditions

Intervertebral Disc Displacement

Condition Hierarchy (Ancestors)

Spinal Diseases; Bone Diseases; Musculoskeletal Diseases; Hernia; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Officials

• Abdul Ghafoor Sajjad, PhD*

  Riphah International University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 1, 2019
• First Posted: August 2, 2019
• Study Start: March 1, 2019
• Primary Completion: May 30, 2019
• Study Completion: June 30, 2019
• Last Updated: August 2, 2019

Record last verified: 2019-08

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)