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

NCT ID: NCT05268822

Last Updated: 2023-03-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-02-08

Study Completion Date

2022-11-14

Brief Summary

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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.

Detailed Description

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Conditions

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Chronic Low-back Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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 Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Movement control exercise with specific breathing techniques

Movement control exercise with specific breathing techniques (experimental group)

Group Type ACTIVE_COMPARATOR

Home exercise

Intervention Type OTHER

Movement control exercise with or without specific breathing techniques

Movement control exercise without specific breathing techniques

Movement control exercise without specific breathing techniques (control group)

Group Type ACTIVE_COMPARATOR

Home exercise

Intervention Type OTHER

Movement control exercise with or without specific breathing techniques

Interventions

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Home exercise

Movement control exercise with or without specific breathing techniques

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

68 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Southern Denmark

OTHER

Sponsor Role collaborator

Kuopio University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Jani Mikkonen

Principal Investigator / PhD student at Institute of Clinical Medicine

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Private Clinic of principal investigator

Helsinki, Uusimaa, Finland

Site Status

Countries

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Finland

References

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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.

Reference Type DERIVED
PMID: 39031339 (View on PubMed)

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.

Reference Type DERIVED
PMID: 37147638 (View on PubMed)

Related Links

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Other Identifiers

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KuopioUH_2022

Identifier Type: -

Identifier Source: org_study_id

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