Clinical trial NCT03676062: 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
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Low Back Pain
Keywords: exercise, pain, yoga
Lead sponsor: Hacettepe University
Sponsor class: OTHER
First posted: 2018-09-18
Enrollment: 44
Sex: ALL
Minimum age (years): 25
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Changes in pain severity
timeFrame: change from baseline in pain severity at 6 weeks.
Secondary outcomes:
measure: Changes in quality of life
timeFrame: Change from baseline in life quality levels at 6 weeks.
measure: Changes of functional status
timeFrame: change from baseline in functional status at 6 weeks
measure: Changes of stress level
timeFrame: change from baseline in stress level at 6 weeks
measure: Changes of stress related biomarkers
timeFrame: change from baseline in serum level at 6 weeks
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Hacettepe University, Health Sciences Faculty
state: Altındag
Study officials:
affiliation: Hacettepe University
name: Müzeyyen ÖZ, MSc
role: PRINCIPAL_INVESTIGATOR
affiliation: Hacettepe University
name: Özlem ÜLGER, Asc. Proff
role: STUDY_DIRECTOR
References:
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.
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.
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.
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.