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

NCT05268822 | Completed

• 1 other identifier: KuopioUH_2022
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Low-back Pain

Outcome Measures

Primary Outcomes (10)

• 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

• 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

Secondary Outcomes (3)

• Feasibility of intervention protocol, recruitment and enrollment

  Through study completion, an average of 2 mothns

• Responsiveness

  Through study completion, an average of 2 months

• Quantifying

  Through study completion, an average of 2 months

Study Arms (2)

Movement control exercise with specific breathing techniques

ACTIVE COMPARATOR

Movement control exercise with specific breathing techniques (experimental group)

Other: Home exercise

Movement control exercise without specific breathing techniques

ACTIVE COMPARATOR

Movement control exercise without specific breathing techniques (control group)

Other: Home exercise

Interventions

Home exercise OTHER

Movement control exercise with or without specific breathing techniques

Movement control exercise with specific breathing techniques; Movement control exercise without specific breathing techniques

Eligibility Criteria

• Age: 18 Years - 68 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Kuopio University Hospital: lead
• University of Southern Denmark: collaborator

Study Sites (1)

Private Clinic of principal investigator

Helsinki, Uusimaa, 00100, Finland

Location

Related Publications (2)

• 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.

  PMID: 39031339 DERIVED

• 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.

  PMID: 37147638 DERIVED

Related Links

• Study web page

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator / PhD student at Institute of Clinical Medicine

Model Details: 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)

Study Record Dates

• First Submitted: February 8, 2022
• First Posted: March 7, 2022
• Study Start: February 8, 2022
• Primary Completion: November 14, 2022
• Study Completion: November 14, 2022
• Last Updated: March 9, 2023

Record last verified: 2023-03

Locations

FI (1)