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
NCT number | NCT04000685 |
Other study ID # | KA-19029 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | December 30, 2019 |
Est. completion date | May 1, 2023 |
Verified date | June 2023 |
Source | Hacettepe University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Identification of the effects of yoga, stabilization exercise and aerobic exercise approaches on physical and cognitive variables in individuals with low back pain.
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 |
Country | Name | City | State |
---|---|---|---|
Turkey | Hacettepe University, Faculty of Physical Therapy and Rehabilitation | Ankara | Altindag |
Lead Sponsor | Collaborator |
---|---|
Hacettepe University |
Turkey,
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
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 |
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT05963451 -
Brain, Psychological and Epigenetic Determinants for Optimizing the Treatment of Chronic Low Back Pain
|
||
Completed |
NCT04283370 -
A Study Protocol Comparing a Home Rehabilitation Program Versus e-Health Program in Low Back Pain
|
N/A | |
Completed |
NCT04824547 -
Evaluation of Long-Term Continuity of Exercises in Low Back Pain Individuals
|
N/A | |
Completed |
NCT04046419 -
In Turkish Version "Health Care Providers and Impairment Relationship Scale (HC-PAIRS)"
|
||
Completed |
NCT04399772 -
COgNitive FuncTional Therapy+ for Chronic Low Back paIn
|
N/A | |
Recruiting |
NCT05780021 -
Motivational Support Program in Chronic Low Back Pain After Multidisciplinary Functional Rehabilitation
|
N/A | |
Completed |
NCT04555278 -
Combining Non-invasive Brain Stimulation and Exercise to Treat Low Back Pain
|
N/A | |
Completed |
NCT04530071 -
Evaluation of Safety, Tolerability, and Efficacy of CordSTEM-DD in Patients With Chronic Low Back Pain
|
Phase 1/Phase 2 | |
Not yet recruiting |
NCT06080464 -
Clinician Satisfaction With the VERABANDâ„¢
|
N/A | |
Not yet recruiting |
NCT06347328 -
The Benefits of Posterior Joint Infiltration in Chronic Low Back Pain
|
N/A | |
Not yet recruiting |
NCT04940715 -
Efficacy of Passive Joint Mobilization vs Mobilization With Movement on Pain Processing in Patients With Chronic Low Back Pain
|
N/A | |
Recruiting |
NCT04683718 -
A First in Human Feasibility Study to Evaluate the Safety and Effectiveness of the BIOTRONIK Prospera SCS System With HomeStream Remote Management
|
N/A | |
Recruiting |
NCT05724160 -
Using Non-Weightbearing Stationary Elliptical Machines for Patients With Chronic Low Back Pain
|
N/A | |
Recruiting |
NCT06030128 -
Core Stabilization Exercise Therapy in Chronic Lower Back Back Management in Community Dwelling Older Adults
|
N/A | |
Recruiting |
NCT05846087 -
Mobile App-delivered Sleep Therapy (SleepFix) for Individuals With Chronic Low Back Pain and Insomnia
|
N/A | |
Active, not recruiting |
NCT05396014 -
The BEST Trial: Biomarkers for Evaluating Spine Treatments
|
Phase 4 | |
Active, not recruiting |
NCT06140862 -
Ankle Spine Syndrome "RAFFET Syndrome II
|
N/A | |
Completed |
NCT05512338 -
Motivation and Adherence to Exercise Recommendations
|
N/A | |
Recruiting |
NCT05021146 -
Essential Oil for Chronic Low Back Pain
|
N/A | |
Completed |
NCT05120921 -
Osteopathic Single CAse Research for Patients With Chronic Low Back Pain
|
N/A |