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

Primary Purpose

Chronic Low Back Pain

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
exercise
Sponsored by
Hacettepe University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Low Back Pain focused on measuring exercise, pain, yoga

Eligibility Criteria

25 Years - 55 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Hacettepe University, Health Sciences Faculty

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Active Comparator

Arm Label

stabilization exercise group

yoga group

home exercise group

Arm Description

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

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

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.
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.
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.

Full Information

First Posted
August 6, 2018
Last Updated
September 18, 2018
Sponsor
Hacettepe University
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1. Study Identification

Unique Protocol Identification Number
NCT03676062
Brief Title
The Effect of Yoga and Stabilization Exercise in Patients With Chronic Low Back Pain
Official Title
Kronik Bel Ağrılı Bireylerde Yoga ve Spinal Stabilizasyon Egzersizlerinin Ağrı, Fonksiyon ve Stres Üzerine Etkisinin Karşılaştırılması
Study Type
Interventional

2. Study Status

Record Verification Date
September 2018
Overall Recruitment Status
Completed
Study Start Date
March 2015 (Actual)
Primary Completion Date
August 2016 (Actual)
Study Completion Date
August 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hacettepe University

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Low Back Pain
Keywords
exercise, pain, yoga

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
44 (Actual)

8. Arms, Groups, and Interventions

Arm Title
stabilization exercise group
Arm Type
Active Comparator
Arm Description
Spinal stabilization exercise were applied all patients additional with hotpack, TENS application in this group accompanied by physiotherapist.
Arm Title
yoga group
Arm Type
Active Comparator
Arm Description
Yoga program were applied all patients in this group accompanied by physiotherapist. Sessions included selected breathing exercises, warm up, asana and relaxation.
Arm Title
home exercise group
Arm Type
Active Comparator
Arm Description
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 Type
Other
Intervention Name(s)
exercise
Intervention Description
All exercises programs applied three sessions per week, totally six week.
Primary Outcome Measure Information:
Title
Changes in pain severity
Description
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.
Time Frame
change from baseline in pain severity at 6 weeks.
Secondary Outcome Measure Information:
Title
Changes in quality of life
Description
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.
Time Frame
Change from baseline in life quality levels at 6 weeks.
Title
Changes of functional status
Description
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.
Time Frame
change from baseline in functional status at 6 weeks
Title
Changes of stress level
Description
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.
Time Frame
change from baseline in stress level at 6 weeks
Title
Changes of stress related biomarkers
Description
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.
Time Frame
change from baseline in serum level at 6 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Müzeyyen ÖZ, MSc
Organizational Affiliation
Hacettepe University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Özlem ÜLGER, Asc. Proff
Organizational Affiliation
Hacettepe University
Official's Role
Study Director
Facility Information:
Facility Name
Hacettepe University, Health Sciences Faculty
City
Ankara
State/Province
Altındag
ZIP/Postal Code
06100
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
23411647
Citation
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.
Results Reference
result
PubMed Identifier
25035607
Citation
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.
Results Reference
result
PubMed Identifier
20628332
Citation
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.
Results Reference
result
PubMed Identifier
26180363
Citation
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.
Results Reference
result

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

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