Movement Control Exercises With and Without Specific Breathing Techniques for the Treatment of Chronic Low Back Pain
Study Details
Study Description
Brief Summary
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Active Comparator: Movement control exercise with specific breathing techniques Movement control exercise with specific breathing techniques (experimental group) |
Other: Home exercise
Movement control exercise with or without specific breathing techniques
|
| Active Comparator: Movement control exercise without specific breathing techniques Movement control exercise without specific breathing techniques (control group) |
Other: Home exercise
Movement control exercise with or without specific breathing techniques
|
Outcome Measures
Primary Outcome Measures
- The numerical pain rating scale (NRPS) [Change from Baseline The numerical pain rating scale at 2 months]
Eleven-point numerical pain scale. Scale from 0 (no pain) to 10 (worst imaginable)
- Well-Being in Pain Questionnaire [Change from Baseline Well-Being in Pain Questionnaire at 2 months]
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)
- The Roland Morris Disability Questionnaire (RMDQ) [Change from Baseline The Roland Morris Disability Questionnaire at 2 months]
Questionnaire measuring disability in chronic low back pain populations. Scale from 0 (no disability) to 24 (maximum low back pain related disability)
- Central Sensitization Inventory (CSI) [Change from Baseline Central Sensitization Inventory at two months]
Screening of central sensitization phenomenon. Scale from 0 (no central sensitization) to 100 (worst imaginable central sensitization)
- The 5-level EQ-5D version of the EuroQol [Change from Baseline The 5-level EQ-5D version of the EuroQol at 2 months]
Health status. Scale from 0 (dead) to 1 (full health)
- The Generalised Anxiety Disorder Assessment (GAD-7) [Change from Baseline The Generalised Anxiety Disorder Assessment at two months]
Measure of generalised anxiety disorder related symptoms. Scale from 0 (the most minimal anxiety) to 21 (the most severe anxiety)
- The Tampa Scale of Kinesiophobia (TSK) [Change from Baseline The Tampa scale of Kinesiophobia at two months]
Assessment of subjective kinesiophobia (fear of movement). Scale from 17 (the minimal kinesophobia) to 68 (the most maximum kinesiophobia).
- The Pain Catastrophizing Scale (PCS) [Change from Baseline he Pain Catastrophizing Scale at two months]
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)
- The Pain and Sleep Questionnaire Three-Item Index (PSQ-3) [Change from Baseline The Pain and Sleep Questionnaire Three-Item Index at two months]
Effect of pain on sleep. Scale from 0 (pain have no any effect on sleep) to 30 (pain have maximum effect on sleep)
Secondary Outcome Measures
- Feasibility of intervention protocol, recruitment and enrollment [Through study completion, an average of 2 mothns]
To assess the feasibility of the intervention protocol and subject recruitment and enrollment.
- Responsiveness [Through study completion, an average of 2 months]
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).
- Quantifying [Through study completion, an average of 2 months]
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.
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Adults aged 18-68-years-old
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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:
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Any history of malignant cancer
-
Neurological disease affecting the central nervous system (MS, dementia)
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Rheumatic disease (fibromyalgia, ankylosing spondylitis/rheumatoid arthritis)
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Chronic obstructive pulmonary disease,
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Spinal surgery in the last 12 months
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A cardiac pacemaker
-
Signs and symptoms of nerve root pathology during the clinic visits.
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Women who become pregnant during the data collection will also be excluded from the study.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Private Clinic of principal investigator | Helsinki | Uusimaa | Finland | 00100 |
Sponsors and Collaborators
- Kuopio University Hospital
- University of Southern Denmark
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- KuopioUH_2022