Chronic Low-back Pain
Conditions
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.
Interventions
OTHERHome exercise
Movement control exercise with or without specific breathing techniques
Sponsors
University of Southern Denmark
Kuopio University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Intervention 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)
Eligibility
Sex/Gender
ALL
Age
18 Years to 68 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The Pain Self-Efficacy Questionnaire (PSEQ) | Change from Baseline The Pain and Sleep Questionnaire Three-Item Index at two months | 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). |
| 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) |
| 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 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) |
| 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) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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. |
Countries
Finland
Outcome results
None listed