Movement Control Exercises With and Without Specific Breathing Techniques for the Treatment of Chronic Low Back Pain

Study Overview
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Brief Summary
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Chronic low back pain (CLBP) is a leading disability globally. Exercise therapies are one of the most commonly prescribed treatment options for CLBP. Specific breathing techniques have been shown to enhance brain-based pain modulation and autonomic nervous system balance; these changes have been shown to improve clinical effectiveness in terms of pain management and psychological factors compared to general exercise. However, no previous studies have added a specific breathing technique protocol to an evidence-based exercise program for CLBP.

Official Title
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Movement Control Exercises With and Without Specific Breathing Techniques for the Treatment of Chronic Low Back Pain: an Open-label Feasibility Study With 2-month

Conditions
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Chronic Low-back Pain

Intervention / Treatment
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* Other: Home exercise


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adults aged 18-68-years-old Low back pain lasting more than 3 months (pain sensation more than 3 days per week) A numerical pain scale of more than 3 ≥ 2/6 positive low back movement control tests (as described by Luomajoki et al.) Roland-Morris Disability Questionnaire score of five or greater Who are physically able to perform movement control tests and provide written informed consent. Exclusion Criteria: Any history of malignant cancer Neurological disease affecting the central nervous system (MS, dementia) Rheumatic disease (fibromyalgia, ankylosing spondylitis/rheumatoid arthritis) Chronic obstructive pulmonary disease, Spinal surgery in the last 12 months A cardiac pacemaker Signs and symptoms of nerve root pathology during the clinic visits. Women who become pregnant during the data collection will also be excluded from the study.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 68 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: An open-label feasibility study with study subject allocated to movement control exercise with specific breathing techniques (experimental group) or movement control exercise without specific breathing techniques (control group)
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Movement control exercise with specific breathing techniques<br>Movement control exercise with specific breathing techniques (experimental group) | Other: Home exercise<br>* Movement control exercise with or without specific breathing techniques<br>|
| Active Comparator: Movement control exercise without specific breathing techniques<br>Movement control exercise without specific breathing techniques (control group) | Other: Home exercise<br>* Movement control exercise with or without specific breathing techniques<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The numerical pain rating scale (NRPS) | Eleven-point numerical pain scale. Scale from 0 (no pain) to 10 (worst imaginable) | Change from Baseline The numerical pain rating scale at 2 months | 
| Well-Being in Pain Questionnaire | Self-developed questionnaire to screen the effects of pain on a person's biopsychosocial well-being. Scale from 0 (no subjective well-being in pain) to 60 (maximum subjective well-being in pain) | Change from Baseline Well-Being in Pain Questionnaire at 2 months | 
| The Roland Morris Disability Questionnaire (RMDQ) | Questionnaire measuring disability in chronic low back pain populations. Scale from 0 (no disability) to 24 (maximum low back pain related disability) | Change from Baseline The Roland Morris Disability Questionnaire at 2 months | 
| Central Sensitization Inventory (CSI) | Screening of central sensitization phenomenon. Scale from 0 (no central sensitization) to 100 (worst imaginable central sensitization) | Change from Baseline Central Sensitization Inventory at two months | 
| The 5-level EQ-5D version of the EuroQol | Health status. Scale from 0 (dead) to 1 (full health) | Change from Baseline The 5-level EQ-5D version of the EuroQol at 2 months | 
| The Generalised Anxiety Disorder Assessment (GAD-7) | Measure of generalised anxiety disorder related symptoms. Scale from 0 (the most minimal anxiety) to 21 (the most severe anxiety) | Change from Baseline The Generalised Anxiety Disorder Assessment at two months | 
| The Tampa Scale of Kinesiophobia (TSK) | Assessment of subjective kinesiophobia (fear of movement). Scale from 17 (the minimal kinesophobia) to 68 (the most maximum kinesiophobia). | Change from Baseline The Tampa scale of Kinesiophobia at two months | 
| The Pain Catastrophizing Scale (PCS) | Assessment of catastrophizing (tendency to magnify the threat value of a pain stimulus) related to pain. Scale from 0 (no catastrophizing thoughts) to 52 (maximum catastrophizing thoughts) | Change from Baseline he Pain Catastrophizing Scale at two months | 
| The Pain and Sleep Questionnaire Three-Item Index (PSQ-3) | Effect of pain on sleep. Scale from 0 (pain have no any effect on sleep) to 30 (pain have maximum effect on sleep) | Change from Baseline The Pain and Sleep Questionnaire Three-Item Index at two months | 
| The Pain Self-Efficacy Questionnaire (PSEQ) | assess the self-efficacy of people in pain have in daily activities. The scale is from 0 points (not at all confident) to 6 points (completely confident). | Change from Baseline The Pain and Sleep Questionnaire Three-Item Index at two months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Feasibility of intervention protocol, recruitment and enrollment | To assess the feasibility of the intervention protocol and subject recruitment and enrollment. | Through study completion, an average of 2 mothns | 
| Responsiveness | To quantify the changes in and determine the responsiveness of the outcome measures, in order to calculate the sample size for a randomized controlled trial (RCT) based on the chosen primary outcome measure(s). | Through study completion, an average of 2 months | 
| Quantifying | To quantify the changes in self-adherence levels to home exercise and monitor possible pain medication usage, and side effects, adverse events and injuries during exercise. | Through study completion, an average of 2 months |