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

Primary Purpose

Chronic Low-back Pain

Status

Completed

Phase

Not Applicable

Locations

Finland

Study Type

Interventional

Intervention

Home exercise

About this trial

This is an interventional treatment trial for Chronic Low-back Pain

Eligibility Criteria

18 Years - 68 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

Private Clinic of principal investigator

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Arm Label

Movement control exercise with specific breathing techniques

Movement control exercise without specific breathing techniques

Arm Description

Movement control exercise with specific breathing techniques (experimental group)

Movement control exercise without specific breathing techniques (control group)

Outcomes

Primary Outcome Measures

The numerical pain rating scale (NRPS)

Eleven-point numerical pain scale. Scale from 0 (no pain) to 10 (worst imaginable)

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)

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)

Central Sensitization Inventory (CSI)

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

Health status. Scale from 0 (dead) to 1 (full health)

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)

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).

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)

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)

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).

Secondary Outcome Measures

Feasibility of intervention protocol, recruitment and enrollment

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

Responsiveness

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

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.

Full Information

NCT ID

NCT05268822

First Posted

February 8, 2022

Last Updated

March 7, 2023

Sponsor

Kuopio University Hospital

Collaborators

University of Southern Denmark

1. Study Identification

Unique Protocol Identification Number

NCT05268822

Brief Title

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

2. Study Status

Record Verification Date

March 2023

Overall Recruitment Status

Completed

Study Start Date

February 8, 2022 (Actual)

Primary Completion Date

November 14, 2022 (Actual)

Study Completion Date

November 14, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Kuopio University Hospital

Collaborators

University of Southern Denmark

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Chronic Low-back Pain

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

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)

Masking

ParticipantOutcomes Assessor

Allocation

Randomized

Enrollment

30 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Movement control exercise with specific breathing techniques

Arm Type

Active Comparator

Arm Description

Movement control exercise with specific breathing techniques (experimental group)

Arm Title

Movement control exercise without specific breathing techniques

Arm Type

Active Comparator

Arm Description

Movement control exercise without specific breathing techniques (control group)

Intervention Type

Other

Intervention Name(s)

Home exercise

Intervention Description

Movement control exercise with or without specific breathing techniques

Primary Outcome Measure Information:

Title

The numerical pain rating scale (NRPS)

Description

Eleven-point numerical pain scale. Scale from 0 (no pain) to 10 (worst imaginable)

Time Frame

Change from Baseline The numerical pain rating scale at 2 months

Title

Well-Being in Pain Questionnaire

Description

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)

Time Frame

Change from Baseline Well-Being in Pain Questionnaire at 2 months

Title

The Roland Morris Disability Questionnaire (RMDQ)

Description

Questionnaire measuring disability in chronic low back pain populations. Scale from 0 (no disability) to 24 (maximum low back pain related disability)

Time Frame

Change from Baseline The Roland Morris Disability Questionnaire at 2 months

Title

Central Sensitization Inventory (CSI)

Description

Screening of central sensitization phenomenon. Scale from 0 (no central sensitization) to 100 (worst imaginable central sensitization)

Time Frame

Change from Baseline Central Sensitization Inventory at two months

Title

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

Description

Health status. Scale from 0 (dead) to 1 (full health)

Time Frame

Change from Baseline The 5-level EQ-5D version of the EuroQol at 2 months

Title

The Generalised Anxiety Disorder Assessment (GAD-7)

Description

Measure of generalised anxiety disorder related symptoms. Scale from 0 (the most minimal anxiety) to 21 (the most severe anxiety)

Time Frame

Change from Baseline The Generalised Anxiety Disorder Assessment at two months

Title

The Tampa Scale of Kinesiophobia (TSK)

Description

Assessment of subjective kinesiophobia (fear of movement). Scale from 17 (the minimal kinesophobia) to 68 (the most maximum kinesiophobia).

Time Frame

Change from Baseline The Tampa scale of Kinesiophobia at two months

Title

The Pain Catastrophizing Scale (PCS)

Description

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)

Time Frame

Change from Baseline he Pain Catastrophizing Scale at two months

Title

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

Description

Effect of pain on sleep. Scale from 0 (pain have no any effect on sleep) to 30 (pain have maximum effect on sleep)

Time Frame

Change from Baseline The Pain and Sleep Questionnaire Three-Item Index at two months

Title

The Pain Self-Efficacy Questionnaire (PSEQ)

Description

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).

Time Frame

Change from Baseline The Pain and Sleep Questionnaire Three-Item Index at two months

Secondary Outcome Measure Information:

Title

Feasibility of intervention protocol, recruitment and enrollment

Description

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

Time Frame

Through study completion, an average of 2 mothns

Title

Responsiveness

Description

Time Frame

Through study completion, an average of 2 months

Title

Quantifying

Description

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.

Time Frame

Through study completion, an average of 2 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

68 Years

Accepts Healthy Volunteers

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.

Facility Information:

Facility Name

Private Clinic of principal investigator

City

Helsinki

State/Province

Uusimaa

ZIP/Postal Code

00100

Country

Finland

12. IPD Sharing Statement

Plan to Share IPD

Undecided

Links:

URL

http://selkakuntoutus.fi/tutkimus-2022/

Description

Study web page

Learn more about this trial

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

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