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| Name | Class |
|---|---|
| University of Southern Denmark | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Movement control exercise with specific breathing techniques | Active Comparator | Movement control exercise with specific breathing techniques (experimental group) |
|
| Movement control exercise without specific breathing techniques | Active Comparator | Movement control exercise without specific breathing techniques (control group) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Home exercise | Other | Movement control exercise with or without specific breathing techniques |
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Private Clinic of principal investigator | Helsinki | Uusimaa | 00100 | Finland |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39031339 | Derived | Mikkonen J, Luomajoki H, Airaksinen O, Goubert L, Pratscher S, Leinonen V. Identical movement control exercises with and without synchronized breathing for chronic non-specific low back pain:A randomized pilot trial. J Back Musculoskelet Rehabil. 2024;37(6):1561-1571. doi: 10.3233/BMR-230413. | |
| 37147638 | Derived |
| Label | URL |
|---|---|
| Study web page | View source |
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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)
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| 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 |
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 |
| Mikkonen J, Luomajoki H, Airaksinen O, Goubert L, Leinonen V. Protocol of identical exercise programs with and without specific breathing techniques for the treatment of chronic non-specific low back pain: randomized feasibility trial with two-month follow-up. BMC Musculoskelet Disord. 2023 May 5;24(1):354. doi: 10.1186/s12891-023-06434-6. |