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

Lumbar Disc Herniation Clinical Trial

Official title:

Effect of Elongation Longitudinaux Avec Decoaption Osteo-Articulaire Exercises in Lumbar Disc Protrusion

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04043611
• Other study ID #: RiphahIU Nida Rahim Malik
• Status: Completed
• Phase: N/A
• Start date: March 1, 2019
• Est. completion date: June 30, 2019

Study information

• Verified date: August 2019
• Source: Riphah International University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Description:

The study is aimed at determining the effects of ELDOA in treating disc protrusion at lumbar region and is being conducted in Max Rehab & Physical Therapy Centre Islamabad and Pakistan Railway General Hospital, Rawalpindi (March 2019-June 2019). Sample size of the study is 34 with confidence interval of 95% and power of 0.8. 30 patients were screened and 29 were included in the study on the basis of inclusion criteria. Sealed envelope contained total 34 questionnaires, 17 for each group. Patients were allocated randomly on the basis of group mentioned on the Performa. Similar conservative rehabilitation protocol was designed for both control and experimental group except for experimental group had ELDOA Exercises in addition. Patients were examined at 1st visit before administration of any treatment and at 4th visit which was also the last one (after completing 4 sessions at alternate days). Baseline evaluation for demographics and symptomatology was taken. Self-reported questionnaire, ODI, NPRS, lumbar ROM and SLR were recorded at first and fourth visit for comparison. 26 patients completed the study while 1 patient from control group and 2 patients from experiment group were lost to follow up and were considered drop outs.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 29
• Est. completion date: June 30, 2019
• Est. primary completion date: May 30, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 30 Years to 50 Years

Eligibility

Inclusion Criteria:

• Limited ROM (hip/lumbar spine)

• Pain more than 3 on NPRS

• Pain = 3 months

Exclusion Criteria:

• Recurrent disc protrusion

• Spondylolisthesis

• Spondylosis

• Malignancy

• Infection

• Trauma

• Marked bony deformities

Related Conditions & MeSH terms

• Lumbar Disc Herniation

Intervention

Other:
• 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 McKenzie Prone Extension Exercises
• ELDOA
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

Locations

Country	Name	City	State
Pakistan	Riphah International University	Islamabad

Sponsors (1)

Lead Sponsor	Collaborator
Riphah International University

Country where clinical trial is conducted

Pakistan, 

References & Publications (10)

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. — View Citation

Coppieters MW, Andersen LS, Johansen R, Giskegjerde PK, Høivik 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. — View Citation

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. — View Citation

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. Review. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	ROM Lumbar Spine (extension)	ROM of Lumbar spine extension was taken with the help of inclinometer	4th day
Primary	ROM Lumbar Spine (Right side flexion)	ROM of Lumbar spine right side flexion was taken with the help of inclinometer	4th day
Primary	ROM Lumbar Spine (left side Flexion)	ROM of Lumbar spine left side flexion was taken with the help of inclinometer	4th day
Primary	Straight Leg Raising (SLR)	Straight Leg Raising range was taken with the help of inclinometer	4th day