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

NCT03676062 | Completed

• 1 other identifier: GO15/81
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Low Back Pain

Keywords

exercise, pain, yoga

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• 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

Study Arms (3)

stabilization exercise group

ACTIVE COMPARATOR

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

Other: exercise

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.

Other: exercise

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.

Other: exercise

Interventions

exercise OTHER

All exercises programs applied three sessions per week, totally six week.

home exercise group; stabilization exercise group; yoga group

Eligibility Criteria

• Age: 25 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Must be pain at least 3 months
• Must be visual analog scale rating 3 or more

You may not qualify if:

• 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

Sponsors & Collaborators

• Hacettepe University: lead

Study Sites (1)

Hacettepe University, Health Sciences Faculty

Ankara, Altındag, 06100, Turkey (Türkiye)

Location

Related Publications (4)

• Inani SB, Selkar SP. Effect of core stabilization exercises versus conventional exercises on pain and functional status in patients with non-specific low back pain: a randomized clinical trial. J Back Musculoskelet Rehabil. 2013;26(1):37-43. doi: 10.3233/BMR-2012-0348.

  PMID: 23411647 RESULT

• Nambi GS, Inbasekaran D, Khuman R, Devi S, Shanmugananth, Jagannathan K. Changes in pain intensity and health related quality of life with Iyengar yoga in nonspecific chronic low back pain: A randomized controlled study. Int J Yoga. 2014 Jan;7(1):48-53. doi: 10.4103/0973-6131.123481.

  PMID: 25035607 RESULT

• Shirado O, Doi T, Akai M, Hoshino Y, Fujino K, Hayashi K, Marui E, Iwaya T; Japan Low back-pain Exercise Therapy Study; Investigators Japanese Orthopaedic Association; Japanese Society for Musculoskeletal Rehabilitation; Japanese Clinical Orthopaedic Association. Multicenter randomized controlled trial to evaluate the effect of home-based exercise on patients with chronic low back pain: the Japan low back pain exercise therapy study. Spine (Phila Pa 1976). 2010 Aug 1;35(17):E811-9. doi: 10.1097/BRS.0b013e3181d7a4d2.

  PMID: 20628332 RESULT

• Cho I, Jeon C, Lee S, Lee D, Hwangbo G. Effects of lumbar stabilization exercise on functional disability and lumbar lordosis angle in patients with chronic low back pain. J Phys Ther Sci. 2015 Jun;27(6):1983-5. doi: 10.1589/jpts.27.1983. Epub 2015 Jun 30.

  PMID: 26180363 RESULT

MeSH Terms

Conditions

Motor Activity; Pain

Interventions

Exercise

Condition Hierarchy (Ancestors)

Behavior; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Müzeyyen ÖZ, MSc

  Hacettepe University

  PRINCIPAL INVESTIGATOR

• Özlem ÜLGER, Asc. Proff

  Hacettepe University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Assistant

Study Record Dates

• First Submitted: August 6, 2018
• First Posted: September 18, 2018
• Study Start: March 1, 2015
• Primary Completion: August 1, 2016
• Study Completion: August 1, 2016
• Last Updated: September 19, 2018

Record last verified: 2018-09

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)