Clinical trial NCT04000685: The Effects of Different Exercise Approaches in Patients With Chronic Low Back Pain
Official title: The Effects of Different Exercise Approaches on Physical and Cognitive Variables in Patients With Chronic Low Back Pain
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Low-back Pain
Keywords: low back pain
exercise
cognitive
aerobic
yoga
Lead sponsor: Hacettepe University
Sponsor class: OTHER
First posted: 2019-06-27
Enrollment: 81
Sex: ALL
Minimum age (years): 25
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Parallel Assignment
Primary purpose: TREATMENT

Brief summary: Identification of the effects of yoga, stabilization exercise and aerobic exercise approaches on physical and cognitive variables in individuals with low back pain.

Detailed description: Patients participating in the study were divided three parallel groups. The patients in the stabilization exercise group were instructed to perform 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 aerobic exercise group were instructed to perform aerobic walking training. The severity of the pain evaluated through visual analog scale, functional status and quality of life, alexithymia, kinesiophobia, catastrophic pain, back awareness, cognitive function evaluated through Oswestry Disability Index(ODI), Nottingham Health Profile (NHP), Toronto Alexithymia Scale, Fear Avoidance Beliefs Questionnaire, Pain Catastrophizing Scale, Fremantle Back Awareness Scale, Montreal Cognitive Assessment respectively. Assessments were repeated before and after the treatment.

Eligibility criteria: Inclusion Criteria:

* Non-specific low back pain
* Must be pain at least 3 months

Exclusion Criteria:

* History of any lumbar spine surgery
* Presence of neurological deficit
* Having been diagnosed with cardiovascular or systemic diseases that would prevent him / her from taking exercise training.
* The presence of persistent severe pain
* Pain below the knee
* Severe/progressive scoliosis
* Spinal stenosis
* Spondylolisthesis
* Cancer
* Diabetes
* Metabolic syndrome
* Inflammatory, infectious or tumoral disease of the vertebra

Primary outcomes:
measure: Changes in pain severity
timeFrame: change from baseline in pain severity at 8 weeks
measure: Changes of functional status
timeFrame: change from baseline in functional status at 8 weeks
Secondary outcomes:
measure: Changes in quality of life
timeFrame: Change from baseline in life quality levels at 8 weeks
measure: Changes in gait parameters
timeFrame: Change from baseline in gait parameters at 8 weeks
measure: Changes in metabolic capacity
timeFrame: Change from baseline in metabolic capacity at 8 weeks
measure: Changes in cognitive level
timeFrame: Change from baseline in cognitive level at 8 weeks
measure: Changes in alexithymia
timeFrame: Change from baseline in alexithymia at 8 weeks
measure: Changes in kinesiophobia.
timeFrame: Change from baseline in kinesiophobia at 8 weeks
measure: Changes in back awareness
timeFrame: Change from baseline in back awareness at 8 weeks
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Hacettepe University, Faculty of Physical Therapy and Rehabilitation
state: Altındag
Study officials:
affiliation: Hacettepe University
name: Müzeyyen ÖZ, MSc
role: PRINCIPAL_INVESTIGATOR
affiliation: Hacettepe University
name: Özlem Ülger, Prof
role: STUDY_DIRECTOR
References:
citation: Meng XG, Yue SW. Efficacy of aerobic exercise for treatment of chronic low back pain: a meta-analysis. Am J Phys Med Rehabil. 2015 May;94(5):358-65. doi: 10.1097/PHM.0000000000000188.
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: Chang DG, Holt JA, Sklar M, Groessl EJ. Yoga as a treatment for chronic low back pain: A systematic review of the literature. J Orthop Rheumatol. 2016 Jan 1;3(1):1-8.
citation: Koldas Dogan S, Sonel Tur B, Kurtais Y, Atay MB. Comparison of three different approaches in the treatment of chronic low back pain. Clin Rheumatol. 2008 Jul;27(7):873-81. doi: 10.1007/s10067-007-0815-7. Epub 2008 Jan 11.