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EOTA With Or Without Mechanical Traction For Patients With Lumbar Spondylosis

Primary Purpose

Lumbar Spondylosis

Status
Completed
Phase
Not Applicable
Locations
Pakistan
Study Type
Interventional
Intervention
Extension Oriented Treatment Approach
EOTA+ Traction
Sponsored by
Riphah International University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Lumbar Spondylosis focused on measuring Lumbar Spondylosis, EOTA, Mechanical traction

Eligibility Criteria

40 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

- 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.

Exclusion Criteria:

  • 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)

Sites / Locations

  • Women Institute of Rehabilitation Sciences

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Extension Oriented Treatment Approach

EOTA+ Mechanical Traction

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

NPRS
Changes from base Line Numeric Pain rating scale is a scale for pain starting from 0-10. Where 0 indicate no pain and 10 indicate severe pain.

Full Information

First Posted
February 5, 2021
Last Updated
December 7, 2022
Sponsor
Riphah International University
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1. Study Identification

Unique Protocol Identification Number
NCT04747483
Brief Title
EOTA With Or Without Mechanical Traction For Patients With Lumbar Spondylosis
Official Title
Effects of Extension Oriented Treatment Approach (EOTA) With Or Without Mechanical Traction For Patients With Lumbar Spondylosis
Study Type
Interventional

2. Study Status

Record Verification Date
December 2022
Overall Recruitment Status
Completed
Study Start Date
August 13, 2020 (Actual)
Primary Completion Date
February 28, 2021 (Actual)
Study Completion Date
February 28, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Riphah International University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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).
Detailed Description
Lumbar spondylosis is a degenerative condition of lower lumbar spine that presents with chronic low back pain that last from more than three months and is aching in nature and radiates to lower limbs. Lumbar region pain, range of motion restriction and limitation in functions are features of lumbar spondylosis. Symptoms of lumbar spondylosis include low back pain, radicular pain, numbness of leg, weakness of leg and neurogenic claudication. Lumbar spine degenerative disorders are normal, age related phenomena. Repetitive loading of the spine, abnormal working postures and repeated movements can all lead to the degenerative changes in the spine. Low back pain due to degenerative changes disturb the individual functional activities. Mechanistically spondylosis is the hypertrophic response of adjoining vertebral bone to degenerative disk. The term spondylosis nonspecifically can be applied to degenerative changes affecting the discs and vertebral bodies and associated joints of the lumbar spine. Decrease in the height of disk lead to increase in loads on the facet joints. In LBP rehabilitation the challenge is to arrive at any basic general rehabilitation care paradigms that would apply to most sub populations of low back. The goals of physical therapy management for patients with low back pain are to control pain, restore function and prevent future functional deficits. Substantial variation in management by conservative and invasive approaches exists between practitioners throughout the country. Treatment options for the management of chronic low back pain syndromes include: physical therapy (and associated modalities and behavioral techniques), pharmacotherapy, injection therapy, and surgical intervention. Exercise therapy (ET) remains one of the conservative mainstays of treatment for chronic lumbar spine pain, and may be tailored to include aerobic exercise, muscle strengthening, and stretching exercises. TENS, Back School (concepts of posture, ergonomics, and appropriate back exercises), Lumbar back supports, traction and spine manipulation are other treatment methods commonly used for treating low back pain. Delito and colleagues described the treatment based classification system (TBC) is a classification approach for low back pain. The treatment based classification system includes subgroup of subjects with lumbar conditions that benefits from an Extension oriented treatment approach. EOTA includes active and passive activities combination to promote lumbar spine extension. EOTA exercises are used to reduce leg symptoms or promote centralization. Several studies provided evidence that subgrouping classification methods use for the physical therapist management of LBP patients provide better outcomes than physical therapy management that is not based on classification. Randomized controlled trials using TBC for patients with LBP of acute and sub-acute have reported significant outcomes compared with usual care or random interventions. Lumbar traction is a popular modality used for patients with chronic LBP. Many healthcare and physical therapist utilized it for treating chronic LBP. Research suggests that certain LBP patients benefit from lumbar traction. Traction mechanical effects involve lordosis reduction, separating the facets, intervertebral foramen opening and eliminating muscles spasms. Pressure caused by gravity and soft tissues reduced by traction therapy, and adequate tension allows intervertebral disc, vertebra, and spinal nerves separation. It is suggested that elongation of spine inhibits nociceptive impulses by increases intervertebral space and reducing lumbar lordosis and also, releases adhesions around the zygapophysial joint and the annulus fibrosus and decreases mechanical stress. Evidence of Physiotherapy with traction versus physiotherapy without traction showed lower mean pain intensity in the traction group (a difference of 7.96 points on the VAS, 95% CI -16.53 to 0.61) at one to two weeks' follow-up. Most previous studies have not examined effects of an EOTA with or without traction for patients with lumbar spondylosis. The purpose of this study is to examine the effects of an EOTA with or without traction for patients with lumbar spondylosis. Sharma A, Alahmari K, Ahmed I conducted a research Efficacy of Manual Therapy versus Conventional Physical Therapy in Chronic Low Back Pain Due to Lumbar Spondylosis. Total of 30 samples of subjects were assigned into two groups in this study. Group -I received Maitland mobilization and lumbar stabilization exercises and group-II received conventional physical therapy (traction, strengthening, stretching exercises). Then outcomes were assessed. The results showed that managing low back pain, range of motion and function of the lumbar spine manual therapy interventions are more effective than conventional physical therapy. Research by David A Browder, John D Childs, Joshua A Cleland, and Julie M Fritz which is the Effectiveness of an Extension-Oriented Treatment Approach in a Subgroup of Subjects with Low Back showed that the EOTA group demonstrated greater change in pain at the 1-week follow-up only. An EOTA was more effective than trunk strengthening exercise in a subgroup of subjects hypothesized to benefit from this treatment approach. In a study by Anne Thackeray et al which is to examine the effectiveness of mechanical traction in patients with lumbar nerve root compression and within a predefined subgroup. In this study criteria of predefined subgrouping was used and patients were randomized to receive an extension oriented treatment approach with or without the mechanical traction addition. The results of this study concluded that there is no evidence that addition of lumbar mechanical traction with an extension oriented treatment is more beneficial to extension oriented treatment alone for the predefined subgroup of patient's management. A case report by Allison R. Gagne & Scott M. Hasson (2010) Lumbar extension exercises in conjunction with mechanical traction for the management of a patient with a lumbar herniated disc. In this case report mechanical traction in addition with lumbar extension exercises was used for a patient with lumbar herniated disc and purpose was to describe and discuss its use. The results indicated that goals for the patient were achieved and the patient complaint of numbness and tingling was no more present. Patient improvement of pain and prior function level was achieved with lumbar extension exercises in addition with mechanical traction this case report data suggests.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lumbar Spondylosis
Keywords
Lumbar Spondylosis, EOTA, Mechanical traction

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
70 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Extension Oriented Treatment Approach
Arm Type
Active Comparator
Arm Description
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.
Arm Title
EOTA+ Mechanical Traction
Arm Type
Experimental
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Extension Oriented Treatment Approach
Other Intervention Name(s)
EOTA
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
EOTA+ Traction
Intervention Description
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.
Primary Outcome Measure Information:
Title
Oswestry Disability Index:
Description
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.
Time Frame
Three weeks
Secondary Outcome Measure Information:
Title
NPRS
Description
Changes from base Line Numeric Pain rating scale is a scale for pain starting from 0-10. Where 0 indicate no pain and 10 indicate severe pain.
Time Frame
Three weeks
Other Pre-specified Outcome Measures:
Title
ROM Lumbar Spine
Description
Changes from the Baseline ROM range of Motion of Lumbar spine ROM being taken with the Help of Goniometer.
Time Frame
three weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: - 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. Exclusion Criteria: 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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Asghar Khan, DScPT
Organizational Affiliation
Riphah International University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Women Institute of Rehabilitation Sciences
City
Abbottabad
State/Province
KPK
Country
Pakistan

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
29083391
Citation
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.
Results Reference
background
PubMed Identifier
29901333
Citation
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.
Results Reference
background
Citation
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.
Results Reference
background
PubMed Identifier
19468872
Citation
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.
Results Reference
background
Citation
Uduonu E. Cardiopulmonary adaptation to 6- weeks' skin traction and isometric exercise among Nigerian subjects with lumber spondylosis 2017.
Results Reference
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PubMed Identifier
32006236
Citation
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.
Results Reference
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PubMed Identifier
17895350
Citation
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.
Results Reference
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PubMed Identifier
24421612
Citation
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.
Results Reference
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PubMed Identifier
30961554
Citation
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.
Results Reference
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Citation
GŬLŞEN, MUSTAFA, et al.
Results Reference
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PubMed Identifier
29309314
Citation
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.
Results Reference
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PubMed Identifier
16249899
Citation
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.
Results Reference
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PubMed Identifier
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Citation
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.
Results Reference
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PubMed Identifier
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Citation
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.
Results Reference
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EOTA With Or Without Mechanical Traction For Patients With Lumbar Spondylosis

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