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

Not Applicable

Completed

• Conditions: Chronic Low Back Pain

• Registration Number: NCT03676062
• Lead Sponsor: Hacettepe University

Brief Summary

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

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.

Study Timeline

• Study Start: 2015-03
• Primary Completion: 2016-08
• Study Completion: 2016-08
• Study First Submitted: 2018-08-06
• Status Verified: 2018-09
• Study First Submitted QC: 2018-09-15
• Study First Posted: 2018-09-18
• Last Update Submitted: 2018-09-18
• Last Update Posted: 2018-09-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 44

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Changes in pain severity	change from baseline in pain severity at 6 weeks.	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.

Secondary Outcome Measures

Name	Time	Method
Changes of functional status	change from baseline in functional status at 6 weeks	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.
Changes in quality of life	Change from baseline in life quality levels at 6 weeks.	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.
Changes of stress level	change from baseline in stress level at 6 weeks	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.
Changes of stress related biomarkers	change from baseline in serum level at 6 weeks	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.

Trial Locations

Locations (1)

Hacettepe University, Health Sciences Faculty; 🇹🇷 Ankara, Altındag, Turkey