Clinical trial NCT05268822: Movement Control Exercises With and Without Specific Breathing Techniques for the Treatment of Chronic Low Back Pain
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Low-back Pain
Lead sponsor: Kuopio University Hospital
Sponsor class: OTHER
Collaborators: name: University of Southern Denmark
First posted: 2022-03-07
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 68
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
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)
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: The numerical pain rating scale (NRPS)
timeFrame: Change from Baseline The numerical pain rating scale at 2 months
measure: Well-Being in Pain Questionnaire
timeFrame: Change from Baseline Well-Being in Pain Questionnaire at 2 months
measure: The Roland Morris Disability Questionnaire (RMDQ)
timeFrame: Change from Baseline The Roland Morris Disability Questionnaire at 2 months
measure: Central Sensitization Inventory (CSI)
timeFrame: Change from Baseline Central Sensitization Inventory at two months
measure: The 5-level EQ-5D version of the EuroQol
timeFrame: Change from Baseline The 5-level EQ-5D version of the EuroQol at 2 months
measure: The Generalised Anxiety Disorder Assessment (GAD-7)
timeFrame: Change from Baseline The Generalised Anxiety Disorder Assessment at two months
measure: The Tampa Scale of Kinesiophobia (TSK)
timeFrame: Change from Baseline The Tampa scale of Kinesiophobia at two months
measure: The Pain Catastrophizing Scale (PCS)
timeFrame: Change from Baseline he Pain Catastrophizing Scale at two months
measure: The Pain and Sleep Questionnaire Three-Item Index (PSQ-3)
timeFrame: Change from Baseline The Pain and Sleep Questionnaire Three-Item Index at two months
measure: The Pain Self-Efficacy Questionnaire (PSEQ)
timeFrame: Change from Baseline The Pain and Sleep Questionnaire Three-Item Index at two months
Secondary outcomes:
measure: Feasibility of intervention protocol, recruitment and enrollment
timeFrame: Through study completion, an average of 2 mothns
measure: Responsiveness
timeFrame: Through study completion, an average of 2 months
measure: Quantifying
timeFrame: Through study completion, an average of 2 months
Other outcomes:
Locations:
city: Helsinki
country: Finland
facility: Private Clinic of principal investigator
state: Uusimaa
Study officials:
References: