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出境医 / 临床实验 / The Effects of Different Exercise Approaches in Patients With Chronic Low Back Pain

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

Study Description
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.

Condition or disease Intervention/treatment Phase
Chronic Low-back Pain Other: Yoga exercise program Other: Spinal stabilization exercise program Other: Aerobic walking program Not Applicable

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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 24 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Parallel Assignment
Masking: Single (Outcomes Assessor)
Masking Description: Single
Primary Purpose: Treatment
Official Title: The Effects of Different Exercise Approaches on Physical and Cognitive Variables in Patients With Chronic Low Back Pain
Actual Study Start Date : December 30, 2019
Estimated Primary Completion Date : December 2021
Estimated Study Completion Date : September 2022
Arms and Interventions
Arm Intervention/treatment
Active Comparator: Yoga exercise group
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
Yoga exercise program will be applied two sessions per week, totally eight week.
Active Comparator: Spinal stabilization exercise group
Spinal stabilization exercise with three different progressive phases were applied all patients in this group accompanied by physiotherapist.
 Other: Spinal stabilization exercise program
Spinal stabilization exercise program will be applied two sessions per week, totally eight week.
Active Comparator: aerobic walking exercise group
Aerobic walking exercise program applied all patients in this group accompanied by physiotherapist.
 Other: Aerobic walking program
Aerobic walking program will be applied two sessions per week, totally eight week.
Outcome Measures
Primary Outcome Measures :
  1. Changes in pain severity [ Time Frame: change from baseline in pain severity at 8 weeks ]
    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.

  2. Changes of functional status [ Time Frame: change from baseline in functional status at 8 weeks ]
    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.


Secondary Outcome Measures :
  1. Changes in quality of life [ Time Frame: Change from baseline in life quality levels at 8 weeks ]
    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.

  2. Changes in gait parameters [ Time Frame: Change from baseline in gait parameters at 8 weeks ]
    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.

  3. Changes in metabolic capacity [ Time Frame: Change from baseline in metabolic capacity at 8 weeks ]
    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.

  4. Changes in cognitive level [ Time Frame: Change from baseline in cognitive level at 8 weeks ]
    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.

  5. Changes in alexithymia [ Time Frame: Change from baseline in alexithymia at 8 weeks ]
    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.

  6. Changes in kinesiophobia. [ Time Frame: Change from baseline in kinesiophobia at 8 weeks ]
    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.

  7. Changes in back awareness [ Time Frame: Change from baseline in back awareness at 8 weeks ]
    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.


Eligibility Criteria
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Ages Eligible for Study:   25 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations

Contacts
Layout table for location contacts
Contact: Müzeyyen ÖZ, MSc +903123051577 ext 168 oz_muzeyyen@hotmail.com
Contact: Özlem ÜLGER, professor +903123051577 ext 128 ozlemulger@yahoo.com

Locations
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Turkey
Hacettepe University, Faculty of Physical Therapy and Rehabilitation Recruiting
Ankara, Altındag, Turkey, 06100
Contact: Müzeyyen Öz, MSc    +903123051577 ext 168    oz_muzeyyen@hotmail.com   
Sponsors and Collaborators
Hacettepe University
Investigators
Layout table for investigator information
Principal Investigator: Müzeyyen ÖZ, MSc Hacettepe University
Study Director: Özlem Ülger, Prof Hacettepe University
Tracking Information
First Submitted Date  ICMJE June 23, 2019
First Posted Date  ICMJE June 27, 2019
Last Update Posted Date March 23, 2021
Actual Study Start Date  ICMJE December 30, 2019
Estimated Primary Completion Date December 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 26, 2019)
  • Changes in pain severity [ Time Frame: change from baseline in pain severity at 8 weeks ]
    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.
  • Changes of functional status [ Time Frame: change from baseline in functional status at 8 weeks ]
    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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 26, 2019)
  • Changes in quality of life [ Time Frame: Change from baseline in life quality levels at 8 weeks ]
    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.
  • Changes in gait parameters [ Time Frame: Change from baseline in gait parameters at 8 weeks ]
    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.
  • Changes in metabolic capacity [ Time Frame: Change from baseline in metabolic capacity at 8 weeks ]
    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.
  • Changes in cognitive level [ Time Frame: Change from baseline in cognitive level at 8 weeks ]
    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.
  • Changes in alexithymia [ Time Frame: Change from baseline in alexithymia at 8 weeks ]
    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.
  • Changes in kinesiophobia. [ Time Frame: Change from baseline in kinesiophobia at 8 weeks ]
    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.
  • Changes in back awareness [ Time Frame: Change from baseline in back awareness at 8 weeks ]
    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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE The Effects of Different Exercise Approaches in Patients With Chronic Low Back Pain
Official Title  ICMJE The Effects of Different Exercise Approaches on Physical and Cognitive Variables in Patients With Chronic Low Back Pain
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
Parallel Assignment
Masking: Single (Outcomes Assessor)
Masking Description:
Single
Primary Purpose: Treatment
Condition  ICMJE Chronic Low-back Pain
Intervention  ICMJE
  • Other: Yoga exercise program
    Yoga exercise program will be applied two sessions per week, totally eight week.
  • Other: Spinal stabilization exercise program
    Spinal stabilization exercise program will be applied two sessions per week, totally eight week.
  • Other: Aerobic walking program
    Aerobic walking program will be applied two sessions per week, totally eight week.
Study Arms  ICMJE
  • Active Comparator: Yoga exercise group
    Yoga program were applied all patients in this group accompanied by physiotherapist. Sessions included selected breathing, warm up and relaxation exercises.
    Intervention: Other: Yoga exercise program
  • Active Comparator: Spinal stabilization exercise group
    Spinal stabilization exercise with three different progressive phases were applied all patients in this group accompanied by physiotherapist.
    Intervention: Other: Spinal stabilization exercise program
  • Active Comparator: aerobic walking exercise group
    Aerobic walking exercise program applied all patients in this group accompanied by physiotherapist.
    Intervention: Other: Aerobic walking program
Publications *
  • 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.
  • 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.
  • 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.
  • Koldaş Doğan S, Sonel Tur B, Kurtaiş 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: June 26, 2019) 		24
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE September 2022
Estimated Primary Completion Date December 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 25 Years to 55 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Müzeyyen ÖZ, MSc +903123051577 ext 168 oz_muzeyyen@hotmail.com
Contact: Özlem ÜLGER, professor +903123051577 ext 128 ozlemulger@yahoo.com
Listed Location Countries  ICMJE Turkey
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04000685
Other Study ID Numbers  ICMJE KA-19029
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Muzeyyen Oz, Hacettepe University
Study Sponsor  ICMJE Hacettepe University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Müzeyyen ÖZ, MSc Hacettepe University
Study Director: Özlem Ülger, Prof Hacettepe University
PRS Account Hacettepe University
Verification Date March 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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