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

Kuopio University Hospital30 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Chronic Low-back Pain

Interventions

Home exercise

Outcomes

Primary Outcomes

The numerical pain rating scale (NRPS)

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

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)

Time frame: 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)

Time frame: 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)

Time frame: 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)

Time frame: 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)

Time frame: 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).

Time frame: 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)

Time frame: 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)

Time frame: 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).

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

Secondary Outcomes

Feasibility of intervention protocol, recruitment and enrollment

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

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

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).

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

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.