The Effects of Different Exercise Approaches in Patients With Chronic Low Back Pain

NCT ID: NCT04000685

Last Updated: 2023-06-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

81 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-12-30

Study Completion Date

2023-05-01

Brief Summary

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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

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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.

Conditions

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Chronic Low-back Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Parallel Assignment
Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors
Single

Study Groups

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Yoga exercise group

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

Group Type ACTIVE_COMPARATOR

Yoga exercise program

Intervention Type OTHER

Yoga exercise program will be applied two sessions per week, totally eight week.

Spinal stabilization exercise group

Spinal stabilization exercise with three different progressive phases were applied all patients in this group accompanied by physiotherapist.

Group Type ACTIVE_COMPARATOR

Spinal stabilization exercise program

Intervention Type OTHER

Spinal stabilization exercise program will be applied two sessions per week, totally eight week.

aerobic walking exercise group

Aerobic walking exercise program applied all patients in this group accompanied by physiotherapist.

Group Type ACTIVE_COMPARATOR

Aerobic walking program

Intervention Type OTHER

Aerobic walking program will be applied two sessions per week, totally eight week.

Interventions

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Yoga exercise program

Yoga exercise program will be applied two sessions per week, totally eight week.

Intervention Type OTHER

Spinal stabilization exercise program

Spinal stabilization exercise program will be applied two sessions per week, totally eight week.

Intervention Type OTHER

Aerobic walking program

Aerobic walking program will be applied two sessions per week, totally eight week.

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

25 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hacettepe University

OTHER

Sponsor Role lead

Responsible Party

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Muzeyyen Oz

Research Assistant, Neck and Low Back Health Unit, Principal Investigator, MSc

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Müzeyyen ÖZ, MSc

Role: PRINCIPAL_INVESTIGATOR

Hacettepe University

Özlem Ülger, Prof

Role: STUDY_DIRECTOR

Hacettepe University

Locations

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Hacettepe University, Faculty of Physical Therapy and Rehabilitation

Ankara, Altındag, Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

References

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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.

Reference Type BACKGROUND
PMID: 25299528 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 23411647 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 27231715 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 18188660 (View on PubMed)

Other Identifiers

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KA-19029

Identifier Type: -

Identifier Source: org_study_id

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