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

NCT04000685 | Completed

• 1 other identifier: KA-19029
• Study Type: interventional
• Target: 81
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Low-back Pain

Keywords

low back pain; exercise; cognitive; aerobic; yoga

Outcome Measures

Primary Outcomes (2)

• Changes in pain severity

  Patients' average resting, activity and night 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 8 weeks

• 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 8 weeks

Secondary Outcomes (7)

• Changes in quality of life

  Change from baseline in life quality levels at 8 weeks

• Changes in gait parameters

  Change from baseline in gait parameters at 8 weeks

• Changes in metabolic capacity

  Change from baseline in metabolic capacity at 8 weeks

• Changes in cognitive level

  Change from baseline in cognitive level at 8 weeks

• Changes in alexithymia

  Change from baseline in alexithymia at 8 weeks

Study Arms (3)

Yoga exercise group

ACTIVE COMPARATOR

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

Other: Yoga exercise program

Spinal stabilization exercise group

ACTIVE COMPARATOR

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

Other: Spinal stabilization exercise program

aerobic walking exercise group

ACTIVE COMPARATOR

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

Other: Aerobic walking program

Interventions

Yoga exercise program OTHER

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

Yoga exercise group

Spinal stabilization exercise program OTHER

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

Spinal stabilization exercise group

Aerobic walking program OTHER

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

aerobic walking exercise group

Eligibility Criteria

• Age: 25 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hacettepe University: lead

Study Sites (1)

Hacettepe University, Faculty of Physical Therapy and Rehabilitation

Ankara, Altındag, 06100, Turkey (Türkiye)

Location

Related Publications (4)

• 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.

  PMID: 25299528 BACKGROUND

• 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.

  PMID: 23411647 BACKGROUND

• 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.

  PMID: 27231715 BACKGROUND

• 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.

  PMID: 18188660 BACKGROUND

MeSH Terms

Conditions

Low Back Pain; Motor Activity

Condition Hierarchy (Ancestors)

Back Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavior

Study Officials

• Müzeyyen ÖZ, MSc

  Hacettepe University

  PRINCIPAL INVESTIGATOR

• Özlem Ülger, Prof

  Hacettepe University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Single
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Assistant, Neck and Low Back Health Unit, Principal Investigator, MSc

Model Details: Parallel Assignment

Study Record Dates

• First Submitted: June 23, 2019
• First Posted: June 27, 2019
• Study Start: December 30, 2019
• Primary Completion: May 1, 2023
• Study Completion: May 1, 2023
• Last Updated: June 2, 2023

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)