Clinical trial NCT04747483: 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
Overall status: COMPLETED
Phase: NA
Conditions: Lumbar Spondylosis
Keywords: Lumbar Spondylosis, EOTA, Mechanical traction
Lead sponsor: Riphah International University
Sponsor class: OTHER
First posted: 2021-02-10
Enrollment: 70
Sex: ALL
Minimum age (years): 40
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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)

Primary outcomes:
measure: Oswestry Disability Index:
timeFrame: Three weeks
Secondary outcomes:
measure: NPRS
timeFrame: Three weeks
Other outcomes:
measure: ROM Lumbar Spine
timeFrame: three weeks
Locations:
city: Abbottabad
country: Pakistan
facility: Women Institute of Rehabilitation Sciences
state: KPK
Study officials:
affiliation: Riphah International University
name: Asghar Khan, DScPT
role: PRINCIPAL_INVESTIGATOR
References:
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.
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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.
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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.
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.
citation: GŬLŞEN, MUSTAFA, et al.
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.
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.
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.
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.