The Effect of Yoga and Stabilization Exercise in Patients With Chronic Low Back Pain

Study Overview
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Brief Summary
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Identification of the effects of yoga, stabilization exercise and home exercise approaches on pain, function,stress and quality of life in individuals with low back pain.

Detailed Description
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44 patients participating in the study were divided three groups. The patients in the stabilization exercise group were instructed to perform hotpack, Trans-cutaneous Electric Nerve Stimulation (TENS) and spinal stabilization exercises, the patients in the yoga group were instructed to perform yoga program consisting of breathing, relaxation and flexibility exercises. The patients in the home exercise group were instructed to perform stabilization exercise. The severity of the pain evaluated through visual analog scale, functional status and quality of life evaluated through Oswestry Disability Index(ODI), Nottingham Health Profile (NHP), respectively. Assessments were repeated before and after the treatment.

Official Title
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Kronik Bel Ağrılı Bireylerde Yoga ve Spinal Stabilizasyon Egzersizlerinin Ağrı, Fonksiyon ve Stres Üzerine Etkisinin Karşılaştırılması

Conditions
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Chronic Low Back Pain

Intervention / Treatment
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* Other: exercise


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Must be pain at least 3 months Must be visual analog scale rating 3 or more Exclusion Criteria: History of any lumbar spine surgery Severe/progressive scoliosis Spinal stenosis Spondylolisthesis Cancer Diabetes Metabolic syndrome History of exercise programs or yoga at least 12 weeks before the onset of study

Ages Eligible for Study
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Minimum Age: 25 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: stabilization exercise group<br>Spinal stabilization exercise were applied all patients additional with hotpack, TENS application in this group accompanied by physiotherapist. | Other: exercise<br>* All exercises programs applied three sessions per week, totally six week.<br>|
| Active Comparator: yoga group<br>Yoga program were applied all patients in this group accompanied by physiotherapist. Sessions included selected breathing exercises, warm up, asana and relaxation. | Other: exercise<br>* All exercises programs applied three sessions per week, totally six week.<br>|
| Active Comparator: home exercise group<br>Home exercise were applied all patients in this group supervised, controlled by physiotherapist every week.To make compliance easier for patients; a booklet including suggestions to prevent low back pain and description of exercises, were given. Prescribed exercises were selected in this booklet and checked&progressed in each control sessions. | Other: exercise<br>* All exercises programs applied three sessions per week, totally six week.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in pain severity | Patients' average resting and activity pain intensities assessed by Visual Analog Scale. The visual analog scale is an 11-point scale ranging from 0 to 10, in which 0 defines absence of pain and 10 describes unbearable pain. Participants asked to rate the average pain levels a horizontal 10 cm straight line on a white sheet from, before and after treatment. | change from baseline in pain severity at 6 weeks. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in quality of life | Health-related quality of life assessed by Nottingham Health Profile (NHP). The NSP contain 38 questions in 6 subareas: pain, physical abilities, energy level, sleep, social isolation and emotional reaction. The scores range from 0 to 100, with each question assigned a weighted value; the sum of all weighted values in a given subarea adds up to 100. Lower scores denoting a better quality of life. | Change from baseline in life quality levels at 6 weeks. | 
| Changes of functional status | Patient's permanent functional disability measured by Oswestry Disability Index. The scale is considered the 'gold standard' of low back functional outcome tools. This scale contain questions related to functional activities of pain intensity, personal care, lifting, walking, sitting, standing, sleeping, sex life, social life and travelling.Interpretation of scale are 0% to 20% for minimal disability, 21% to 40% for moderate disability, 41 % to 60 % for severe disability 61% to 80 % for crippled and 81 % to 100 % Bed-bound. | change from baseline in functional status at 6 weeks | 
| Changes of stress level | Patients' stress levels were measured with State Trait Anxiety Inventory. State anxiety scale questions how does a person feel in a given moment and situation, mean while trait anxiety scale questions how does a person usually feel without depending on situation and moment. Scale contain 40 questions, minimum and maximum score 20-80, respectively. Scores below 36 accepted as no-anxiety, between 37-42 accepted as low-anxiety, 42 and above accepted as high-anxiety. | change from baseline in stress level at 6 weeks | 
| Changes of stress related biomarkers | Venous blood samples were taken from antecubital area between 08.30-09.00 am and stress related markers (DHEA(S) and cortisol) were analyzed. All analyses were performed in the same laboratory. | change from baseline in serum level at 6 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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exercise, pain, yoga