Evaluation of Long-Term Continuity of Exercises in Low Back Pain Individuals
Primary Purpose
Chronic Low-back Pain
Status
Active
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
exercise
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Low-back Pain focused on measuring exercise, pain, yoga, function
Eligibility Criteria
Inclusion Criteria:
- Must be low back pain at least 3 months
- Must be visual analog scale rating 3 or more
Exclusion Criteria:
- History of any lumbar spine surgery
- Severe/progressive scoliosis
- Spinal stenosis
- Spondylolisthesis
- Cancer
- Diabetes
- Metabolic syndrome
- History of exercise programs or yoga at least 12 weeks before the onset of study
Sites / Locations
- Hacettepe University Faculty of Physical Therapy and Rehabilitation
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Stabilization exercise group
yoga group
Arm Description
Spinal stabilization exercise will be applied all patients accompanied by physiotherapist. Sessions will be included selected exercises according to motor learning phases.
Yoga program will be applied all patients in this group accompanied by physiotherapist. Sessions will be included selected breathing exercises, warm up, asana and relaxation.
Outcomes
Primary Outcome Measures
Changes in pain severity
Patients' average pain intensities will be assessed by Visual Analog Scale (VAS). Participants asked to mark the intensity of pain on a 10 cm long line, explaining that the leftmost of the line does not have pain, that the pain increases while moving to the right, and that the pain is unbearable on the far right.
Changes of functional status
Patient's pain related functional status will be 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 traveling. The total score is between 0 and 100. The higher the score, the higher the level of disability.
Secondary Outcome Measures
Changes in quality of life
Health-related quality of life will be 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 sub-area adds up to 100. Lower scores denoting a better quality of life.
Changes in Exercise Compliance
Exercise Adherence Rating Scale (EARS) will be used to evaluate the exercise compliance of individuals. The result score of the questionnaire is between 0 and 64. A higher score indicates greater compliance with exercise.
Changes in the gait
The gait of individuals will be evaluated by the valid and reliable OPTOGait photoelectric cell and the treadmill system. The gait of individuals on flat ground at their own pace will be recorded for 1 minute. The effects of the exercises on gait will be determined.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04824547
Brief Title
Evaluation of Long-Term Continuity of Exercises in Low Back Pain Individuals
Official Title
Bel Ağrılı Bireylerde Egzersizlerin Uzun Dönem Devamlılığının Değerlendirilmesi
Study Type
Interventional
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
September 30, 2021 (Actual)
Primary Completion Date
December 1, 2023 (Anticipated)
Study Completion Date
December 1, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hacettepe University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
Identification of the long term effects of exercises in individuals with low back pain.
Detailed Description
Individuals with low back pain who will participate in the study will be divided into two groups. In the stabilization exercise group will be instructed to perform spinal stabilization exercises and in the yoga group will be instructed to perform yoga program consisting of breathing, relaxation and flexibility exercises. The intensity of the pain will be evaluated through visual analog scale, functional status and quality of life will be evaluated through Oswestry Disability Index(ODI), Nottingham Health Profile (NHP), respectively. The exercise adherence will evaluated Exercise Adherence Rating Scale (EARS). The time-distance characteristics of the gait will be evaluated by the OPTOGAIT photoelectric cell (OPTOGait, Microgate, Italy, 2010) and the treadmill system. Assessments will be repeated before, after the treatment, 6 and 12 month follow-up. Also,the number of back pain attacks of the individuals will be questioned and recorded.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Low-back Pain
Keywords
exercise, pain, yoga, function
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
104 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Stabilization exercise group
Arm Type
Active Comparator
Arm Description
Spinal stabilization exercise will be applied all patients accompanied by physiotherapist.
Sessions will be included selected exercises according to motor learning phases.
Arm Title
yoga group
Arm Type
Active Comparator
Arm Description
Yoga program will be applied all patients in this group accompanied by physiotherapist. Sessions will be included selected breathing exercises, warm up, asana and relaxation.
Intervention Type
Other
Intervention Name(s)
exercise
Intervention Description
All exercises programs will applied two sessions per week, totally eight week..
Primary Outcome Measure Information:
Title
Changes in pain severity
Description
Patients' average pain intensities will be assessed by Visual Analog Scale (VAS). Participants asked to mark the intensity of pain on a 10 cm long line, explaining that the leftmost of the line does not have pain, that the pain increases while moving to the right, and that the pain is unbearable on the far right.
Time Frame
change from baseline in pain intensity at 8 weeks, 6 and 12 month follow-up.
Title
Changes of functional status
Description
Patient's pain related functional status will be 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 traveling. The total score is between 0 and 100. The higher the score, the higher the level of disability.
Time Frame
change from baseline in functional status at 8 weeks, 6 and 12 month follow-up.
Secondary Outcome Measure Information:
Title
Changes in quality of life
Description
Health-related quality of life will be 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 sub-area adds up to 100. Lower scores denoting a better quality of life.
Time Frame
Change from baseline in life quality levels at 8 weeks, 6 and 12 month follow-up.
Title
Changes in Exercise Compliance
Description
Exercise Adherence Rating Scale (EARS) will be used to evaluate the exercise compliance of individuals. The result score of the questionnaire is between 0 and 64. A higher score indicates greater compliance with exercise.
Time Frame
Change from baseline in exercise compliance at 8 weeks, 6 and 12 month follow-up.
Title
Changes in the gait
Description
The gait of individuals will be evaluated by the valid and reliable OPTOGait photoelectric cell and the treadmill system. The gait of individuals on flat ground at their own pace will be recorded for 1 minute. The effects of the exercises on gait will be determined.
Time Frame
Change from baseline in gait at 8 weeks, 6 and 12 month follow-up.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Must be low back pain at least 3 months
Must be visual analog scale rating 3 or more
Exclusion Criteria:
History of any lumbar spine surgery
Severe/progressive scoliosis
Spinal stenosis
Spondylolisthesis
Cancer
Diabetes
Metabolic syndrome
History of exercise programs or yoga at least 12 weeks before the onset of study
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Muzeyyen OZ, MSc
Organizational Affiliation
Hacettepe University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Ozlem ULGER, Proffessor
Organizational Affiliation
Hacettepe University
Official's Role
Study Director
Facility Information:
Facility Name
Hacettepe University Faculty of Physical Therapy and Rehabilitation
City
Ankara
State/Province
Altindag
ZIP/Postal Code
06100
Country
Turkey
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
29067082
Citation
Akhtar MW, Karimi H, Gilani SA. Effectiveness of core stabilization exercises and routine exercise therapy in management of pain in chronic non-specific low back pain: A randomized controlled clinical trial. Pak J Med Sci. 2017 Jul-Aug;33(4):1002-1006. doi: 10.12669/pjms.334.12664.
Results Reference
background
PubMed Identifier
28631003
Citation
Saper RB, Lemaster C, Delitto A, Sherman KJ, Herman PM, Sadikova E, Stevans J, Keosaian JE, Cerrada CJ, Femia AL, Roseen EJ, Gardiner P, Gergen Barnett K, Faulkner C, Weinberg J. Yoga, Physical Therapy, or Education for Chronic Low Back Pain: A Randomized Noninferiority Trial. Ann Intern Med. 2017 Jul 18;167(2):85-94. doi: 10.7326/M16-2579. Epub 2017 Jun 20.
Results Reference
background
PubMed Identifier
32870936
Citation
Zhu F, Zhang M, Wang D, Hong Q, Zeng C, Chen W. Yoga compared to non-exercise or physical therapy exercise on pain, disability, and quality of life for patients with chronic low back pain: A systematic review and meta-analysis of randomized controlled trials. PLoS One. 2020 Sep 1;15(9):e0238544. doi: 10.1371/journal.pone.0238544. eCollection 2020.
Results Reference
background
PubMed Identifier
31666220
Citation
Owen PJ, Miller CT, Mundell NL, Verswijveren SJJM, Tagliaferri SD, Brisby H, Bowe SJ, Belavy DL. Which specific modes of exercise training are most effective for treating low back pain? Network meta-analysis. Br J Sports Med. 2020 Nov;54(21):1279-1287. doi: 10.1136/bjsports-2019-100886. Epub 2019 Oct 30.
Results Reference
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Evaluation of Long-Term Continuity of Exercises in Low Back Pain Individuals
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