EOTA With Or Without Mechanical Traction For Patients With Lumbar Spondylosis

NCT04747483 | Completed

• 1 other identifier: REC/00774 Aroosa Bibi
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this research is to find and compare the effect of extension oriented treatment approach with or without mechanical traction on pain, range of motion and disability in patients with lumbar spondylosis. Randomized controlled trial is being conducted at Women Institute of Rehabilitation sciences. The sample size is 70. The subjects are being divided in two groups, 35 subjects in extension oriented treatment approach (EOTA) group and 35 in EOTA + traction group. Study duration is of 6 months. Sampling technique being applied is purposive non probability sampling technique.Tools being used in the study are Numeric pain rating scale (NPRS), Goniometer and Oswestry disability index (ODI).

Conditions

Lumbar Spondylosis

Keywords

Lumbar Spondylosis, EOTA, Mechanical traction

Outcome Measures

Primary Outcomes (1)

• Oswestry Disability Index:

  The ODI is a 10-item questionnaire designed to assess disability in typical daily activities. Scoring ranges from 0 to 100, with higher scores 100 indicating greater disability.

  Three weeks

Secondary Outcomes (1)

• NPRS

  Three weeks

Other Outcomes (1)

• ROM Lumbar Spine

  three weeks

Study Arms (2)

Extension Oriented Treatment Approach

ACTIVE COMPARATOR

The EOTA intervention involves three components. The first component is a series of active extension- oriented exercises: Prone lying: Able to tolerate for 5 minutes, no pillow Prone lying on elbows: Able to tolerate for 5 minutes Prone press up exercise: 3 sets of 10 repetitions, move to end-range extension Repeated extension in standing: 3 sets of 10 repetitions, move to end-range extension. The second component of the EOTA is subject education. Subjects are being educated to maintain the natural lordosis of the lumbar spine while sitting, and are being instructed to avoid prolonged sitting for greater than 20-30 minutes whenever possible. The third component of the EOTA is mobilization of the lumbar spine to promote lumbar extension.The mobilization component consist of a series of up to 20 graded oscillatory mobilizations performed with the subject prone by using a grade I - IV mobilization force as described by Maitland.

Other: Extension Oriented Treatment Approach

EOTA+ Mechanical Traction

EXPERIMENTAL

Subjects in the EOTA + traction group receive the EOTA components described above with Mechanical lumbar traction. Intermittent traction being applied (30-sec hold, 10-sec rest) for 15 minutes. Traction started with 25% of the patients' body weight and increased until the patient indicated that the tolerance for pulling was reached, with a maximum of 50% of the total body weight. 2 sessions being given per week for 3 weeks.

Other: EOTA+ Traction

Interventions

Extension Oriented Treatment Approach OTHER

The EOTA intervention involves three components. The first component is a series of active extension- oriented exercises: Prone lying: Able to tolerate for 5 minutes, no pillow Prone lying on elbows: Able to tolerate for 5 minutes Prone press up exercise: 3 sets of 10 repetitions, move to end-range extension Repeated extension in standing: 3 sets of 10 repetitions, move to end-range extension The second component of the EOTA is subject education. Subjects are educated to maintain the natural lordosis of the lumbar spine while sitting, and are instructed to avoid prolonged sitting for greater than 20-30 minutes whenever possible. The third component of the EOTA is mobilization of the lumbar spine to promote lumbar extension. The mobilization component consist of a series of up to 20 graded oscillatory mobilizations performed with the subject prone by using a grade I - IV mobilization force as described by Maitland.

Also known as: EOTA

Extension Oriented Treatment Approach

EOTA+ Traction OTHER

Subjects in the EOTA + traction group receive the EOTA components described above with Mechanical lumbar traction. Intermittent traction being applied (30-sec hold, 10-sec rest) for 15 minutes. Traction started with 25% of the patients' body weight and increased until the patient indicated that the tolerance for pulling was reached, with a maximum of 50% of the total body weight. 2 sessions being given per week for 3 weeks.

EOTA+ Mechanical Traction

Eligibility Criteria

• Age: 40 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• \- Mild to moderate level chronic low back pain with or without radiation of pain History of slow, insidious onset of pain from three months
• On Physical examination:
• Limited ROMs of lumbar spine i.e. extension (\< 20 degrees), flexion (\< 40 degrees) or side flexion (\< 15 degrees).
• Extension may be more limited than other movements.
• Pain during extension like standing and relieved by flexion like sitting.
• Pins and needles sensations (two out of over four should be there).
• Nature of pain-aching pain, feeling of heaviness in legs, intermittent burning or numbness.
• No neurological deficits.
• Diagnosis confirmed by X-Ray /MRI showing signs of degeneration.

You may not qualify if:

• Fractures
• Evidence of central nervous system involvement, including symptoms of cauda equina syndrome (i-e loss of bowl or bladder control) in the physical examination
• Recent (within the past 2 weeks) LBP
• Pregnancy
• Malignancy
• Spondylolisthesis
• Mechanical strain
• Previous back surgery
• Other red flags (contraindications to surgery)

Sponsors & Collaborators

• Riphah International University: lead

Study Sites (1)

Women Institute of Rehabilitation Sciences

Abbottabad, KPK, Pakistan

Location

Related Publications (14)

• Sharma A, Alahmari K, Ahmed I. Efficacy of Manual Therapy versus Conventional Physical Therapy in Chronic Low Back Pain Due to Lumbar Spondylosis. A Pilot Study. Med Sci (Basel). 2015 Jun 26;3(3):55-63. doi: 10.3390/medsci3030055.

  PMID: 29083391 BACKGROUND

• Saetia K, Kuonsongtham V. Central Spinal Canal Decompression for Lumbar Spondylosis with Uniportal Full-Endoscopic Interlaminar Approach: Technical Note and Preliminary Results in Thailand. J Med Assoc Thai. 2016 Jun;99 Suppl 3:S16-22.

  PMID: 29901333 BACKGROUND

• George BA, Shinde SB. Effect of activity specific spinal stabilization exercises on pain and spinal mobility in lumbar spondylosis. Int J Health Sci Res. 2019; 9(7):174- 182.

  BACKGROUND

• Middleton K, Fish DE. Lumbar spondylosis: clinical presentation and treatment approaches. Curr Rev Musculoskelet Med. 2009 Jun;2(2):94-104. doi: 10.1007/s12178-009-9051-x. Epub 2009 Mar 25.

  PMID: 19468872 BACKGROUND

• Uduonu E. Cardiopulmonary adaptation to 6- weeks' skin traction and isometric exercise among Nigerian subjects with lumber spondylosis 2017.

  BACKGROUND

• Pergolizzi JV Jr, LeQuang JA. Rehabilitation for Low Back Pain: A Narrative Review for Managing Pain and Improving Function in Acute and Chronic Conditions. Pain Ther. 2020 Jun;9(1):83-96. doi: 10.1007/s40122-020-00149-5. Epub 2020 Jan 31.

  PMID: 32006236 BACKGROUND

• Browder DA, Childs JD, Cleland JA, Fritz JM. Effectiveness of an extension-oriented treatment approach in a subgroup of subjects with low back pain: a randomized clinical trial. Phys Ther. 2007 Dec;87(12):1608-18; discussion 1577-9. doi: 10.2522/ptj.20060297. Epub 2007 Sep 25.

  PMID: 17895350 BACKGROUND

• Ojha H, Egan W, Crane P. The addition of manipulation to an extension-oriented intervention for a patient with chronic LBP. J Man Manip Ther. 2013 Feb;21(1):40-7. doi: 10.1179/2042618612Y.0000000014.

  PMID: 24421612 BACKGROUND

• Tadano S, Tanabe H, Arai S, Fujino K, Doi T, Akai M. Lumbar mechanical traction: a biomechanical assessment of change at the lumbar spine. BMC Musculoskelet Disord. 2019 Apr 9;20(1):155. doi: 10.1186/s12891-019-2545-9.

  PMID: 30961554 BACKGROUND

• GŬLŞEN, MUSTAFA, et al.

  BACKGROUND

• Bilgilisoy Filiz M, Kilic Z, Uckun A, Cakir T, Koldas Dogan S, Toraman NF. Mechanical Traction for Lumbar Radicular Pain: Supine or Prone? A Randomized Controlled Trial. Am J Phys Med Rehabil. 2018 Jun;97(6):433-439. doi: 10.1097/PHM.0000000000000892.

  PMID: 29309314 BACKGROUND

• Ozturk B, Gunduz OH, Ozoran K, Bostanoglu S. Effect of continuous lumbar traction on the size of herniated disc material in lumbar disc herniation. Rheumatol Int. 2006 May;26(7):622-6. doi: 10.1007/s00296-005-0035-x. Epub 2005 Oct 25.

  PMID: 16249899 BACKGROUND

• Fritz JM, Thackeray A, Childs JD, Brennan GP. A randomized clinical trial of the effectiveness of mechanical traction for sub-groups of patients with low back pain: study methods and rationale. BMC Musculoskelet Disord. 2010 Apr 30;11:81. doi: 10.1186/1471-2474-11-81.

  PMID: 20433733 BACKGROUND

• Gagne AR, Hasson SM. Lumbar extension exercises in conjunction with mechanical traction for the management of a patient with a lumbar herniated disc. Physiother Theory Pract. 2010 May;26(4):256-66. doi: 10.3109/09593980903051495.

  PMID: 20397860 BACKGROUND

MeSH Terms

Conditions

Spondylosis

Condition Hierarchy (Ancestors)

Spinal Diseases; Bone Diseases; Musculoskeletal Diseases

Study Officials

• Asghar Khan, DScPT

  Riphah International University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 5, 2021
• First Posted: February 10, 2021
• Study Start: August 13, 2020
• Primary Completion: February 28, 2021
• Study Completion: February 28, 2021
• Last Updated: December 8, 2022

Record last verified: 2022-12

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)