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

Chronic Low Back Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03676062
• Other study ID #: GO15/81
• Status: Completed
• Phase: N/A
• Start date: March 2015
• Est. completion date: August 2016

Study information

• Verified date: September 2018
• Source: Hacettepe University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 44
• Est. completion date: August 2016
• Est. primary completion date: August 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 25 Years to 55 Years

Eligibility

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

Related Conditions & MeSH terms

• Back Pain
• Chronic Low Back Pain
• Low Back Pain

Intervention

Other:
• exercise
All exercises programs applied three sessions per week, totally six week.

Locations

Country	Name	City	State
Turkey	Hacettepe University, Health Sciences Faculty	Ankara	Altindag

Sponsors (1)

Lead Sponsor	Collaborator
Hacettepe University

Country where clinical trial is conducted

Turkey, 

References & Publications (4)

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 — View 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/ — View 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. d — View 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 Asso — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.
Secondary	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
Secondary	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
Secondary	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