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Completed

NCT Number: NCT05268822

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

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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Key information

Conditions

Chronic Low-back Pain

Age range

18 year–68 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Private Clinic of principal investigator

Helsinki, Uusimaa, 00100, Finland

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Home exercise

Other

Movement control exercise with or without specific breathing techniques

Primary outcomes

  1. The numerical pain rating scale (NRPS)

    Time frame: 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)

  2. Well-Being in Pain Questionnaire

    Time frame: 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)

  3. The Roland Morris Disability Questionnaire (RMDQ)

    Time frame: 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)

  4. Central Sensitization Inventory (CSI)

    Time frame: 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)

  5. The 5-level EQ-5D version of the EuroQol

    Time frame: 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)

  6. The Generalised Anxiety Disorder Assessment (GAD-7)

    Time frame: 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)

  7. The Tampa Scale of Kinesiophobia (TSK)

    Time frame: 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).

  8. The Pain Catastrophizing Scale (PCS)

    Time frame: 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)

  9. The Pain and Sleep Questionnaire Three-Item Index (PSQ-3)

    Time frame: 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)

  10. The Pain Self-Efficacy Questionnaire (PSEQ)

    Time frame: 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).

Secondary outcomes

  1. Feasibility of intervention protocol, recruitment and enrollment

    Time frame: Through study completion, an average of 2 mothns

    To assess the feasibility of the intervention protocol and subject recruitment and enrollment.

  2. Responsiveness

    Time frame: 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).

  3. Quantifying

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Kuopio University Hospital

Other

Collaborators

  • University of Southern Denmark

Registry information

Official study 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

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Mar 7, 2022
Registry last updated
Mar 9, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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