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Clinical Trials/NCT03676062
NCT03676062CompletedNot Applicable

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

Hacettepe University1 site in 1 country44 target enrollmentStarted: March 1, 2015Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
44
Locations
1
Primary Endpoint
Changes in pain severity

Study Overview

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 Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Single (Outcomes Assessor)

Eligibility Criteria

Ages
25 Years to 55 Years (Adult)
Sex
All
Accepts Healthy Volunteers
Yes

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
  • •Metabolic syndrome
  • •History of exercise programs or yoga at least 12 weeks before the onset of study

Arms & Interventions

stabilization exercise group

Active Comparator

Spinal stabilization exercise were applied all patients additional with hotpack, TENS application in this group accompanied by physiotherapist.

Intervention: exercise (Other)

yoga group

Active Comparator

Yoga program were applied all patients in this group accompanied by physiotherapist. Sessions included selected breathing exercises, warm up, asana and relaxation.

Intervention: exercise (Other)

home exercise group

Active Comparator

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.

Intervention: exercise (Other)

Outcomes

Primary Outcomes

Changes in pain severity

Time Frame: 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 Outcomes

  • Changes in quality of life(Change from baseline in life quality levels at 6 weeks.)
  • Changes of functional status(change from baseline in functional status at 6 weeks)
  • Changes of stress level(change from baseline in stress level at 6 weeks)
  • Changes of stress related biomarkers(change from baseline in serum level at 6 weeks)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Muzeyyen Oz

Research Assistant

Hacettepe University

Study Sites (1)

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