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

Chronic Low-back Pain Clinical Trial

Official title:

The Effects of Different Exercise Approaches on Physical and Cognitive Variables in Patients With Chronic Low Back Pain

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04000685
• Other study ID #: KA-19029
• Status: Completed
• Phase: N/A
• Start date: December 30, 2019
• Est. completion date: May 1, 2023

Study information

• Verified date: June 2023
• 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 aerobic exercise approaches on physical and cognitive variables in individuals with low back pain.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 81
• Est. completion date: May 1, 2023
• Est. primary completion date: May 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 25 Years to 55 Years

Eligibility

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

Related Conditions & MeSH terms

• Back Pain
• Chronic Low-back Pain
• Low Back Pain

Intervention

Other:
• Yoga exercise program
Yoga exercise program will be applied two sessions per week, totally eight week.
• Spinal stabilization exercise program
Spinal stabilization exercise program will be applied two sessions per week, totally eight week.
• Aerobic walking program
Aerobic walking program will be applied two sessions per week, totally eight week.

Locations

Country	Name	City	State
Turkey	Hacettepe University, Faculty of Physical Therapy and Rehabilitation	Ankara	Altindag

Sponsors (1)

Lead Sponsor	Collaborator
Hacettepe University

Country where clinical trial is conducted

Turkey, 

References & Publications (4)

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. — 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/BMR-2012-0348. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	Changes in quality of life	Health-related quality of life assessed by Nottingham Health Profile (NHP). The NHP 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 8 weeks
Secondary	Changes in gait parameters	Gait assessment will be recorded with OptoGait for one minute while participants walked their preferred speed on the treadmill. Patients asked to walk on level surface. Assessment were recorded during one minute.	Change from baseline in gait parameters at 8 weeks
Secondary	Changes in metabolic capacity	Metabolic capacity testing will be performed according to the Modified Bruce protocol on the Treadmill. At 3 minute intervals, the inclination increase by %2 with a concomitant increase in speed.	Change from baseline in metabolic capacity at 8 weeks
Secondary	Changes in cognitive level	The Montreal Cognitive Assessment Questionnaire (MoCA) will be used to assess the cognitive levels of individuals. MoCA was developed as a rapid screening test for mild cognitive impairment. MoCA assesses various cognitive functions such as attention and concentration, creative functions, memory, language, visual structuring skills, abstract thinking, computation and orientation. The application of MoCA takes about 10 minutes. The maximum total score of the test is 30. A score of 21 or above is considered normal.	Change from baseline in cognitive level at 8 weeks
Secondary	Changes in alexithymia	The alexithymia will be assessed by the Toronto Alexithymia Scale (TAS). The scale is a Likert-type self-assessment scale consisting of 20 items and scored between 1-5. Difficulties in recognizing emotions (TAS-1), difficulty in speaking emotions (TAS-2), extroverted thinking (TAS-3) subscales. The individual is asked to select the best option for each item from "Never", "Rarely", "Sometimes", "Often" and "Always". The higher the score, the higher the level of alexithymia.	Change from baseline in alexithymia at 8 weeks
Secondary	Changes in kinesiophobia.	Fear-Avoidance-Beliefs Questionnaire will be applied to evaluate kinesiophobia which is fear of movement due to low back pain.This questionnaire has 2 sub-sections related to physical activity and work. There are 4 questions scored in the physical activity section and 7 questions in the work section. 0-6 points are obtained for each question. The total score will be recorded. The higher the score, the higher the kinesiophobia.	Change from baseline in kinesiophobia at 8 weeks
Secondary	Changes in back awareness	The Fremantle Back Awareness Questionnaire will be used to evaluate how individuals perceive the back according to their body. The questionnaire includes 9 questions that measure how individuals perceive their back according to their body and how they perceive their body position. Questions is answered Likert type as "0" I never feel like this, "4" always or often feel like this.	Change from baseline in back awareness at 8 weeks