Myofascial Trigger Point Release and Paced Breathing Training for Chronic Low Back Pain

Study Overview
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Brief Summary
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A study to explore whether two different treatment approaches, myofascial trigger point release and core stabilization exercises, both with and without additional paced breathing training, can help patients with chronic low back pain (CLBP) and whether one of the two treatments is superior.

Detailed Description
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This is a randomized controlled trial to evaluate the effect of myofascial trigger point release therapy compared to core stabilization exercises, both with and without additional paced breathing training, on patients with chronic low back pain (CLBP). The main focus is on changes in pain severity, anxiety and depression, heart rate variability, and use of analgesic medication. Outcomes are measured at baseline (pre-intervention), after ten treatments (post-intervention), at three- and at six-month follow-up.

Official Title
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Myofascial Trigger Point Release and Paced Breathing Training for Chronic Low Back Pain: A Randomized Controlled Trial

Conditions
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Chronic Low-back Pain

Intervention / Treatment
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* Other: Core stabilization exercises
* Other: Core stabilization exercises and paced breathing training
* Other: Myofascial trigger point release
* Other: Myofascial trigger point release and paced breathing training


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Written informed consent Age between 20 and 70 years LBP at least once a week during the last three months Pain intensity rated at least 4 on an 11-point scale (0=no pain, 10=worst pain imaginable) Muscular pain during flexion, extension and lateral flexion Exclusion Criteria: Acute hernia Acute local or generalized inflammation Neurological disorders such as multiple sclerosis, Parkinson's disease, hemiplegia Fibromyalgia Radicular symptoms (Lasègue's sign, weakness of foot dorsiflexion muscle, needles or tingling in the legs) Paraspinal tumors or metastases Cancer under chemo- or radio-surgical treatment or requiring such during the next 12 months Leg prostheses Rheumatic, cardiovascular or chronic pulmonary condition precluding 45-minute physical therapy (contraindication declared by a physician) Severe depression or severe anxiety currently requiring psychotherapy and/or pharmacotherapy Suicidal tendencies Drug abuse or addiction Pregnancy existing or planned during the study period

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Core stabilization exercises<br>Patients with CLBP who practice core stabilization exercises | Other: Core stabilization exercises<br>* Twelve specific exercises following a standard protocol aiming at an intersegmental stabilization of the spine and strengthening and stabilization of specific muscle groups. The exercises are performed under instruction and supervision by a physiotherapist twice per week for 45 minutes<br>|
| Experimental: Core stabilization exercises and paced breathing training<br>Patients with CLBP who practice core stabilization exercises combined with paced breathing training | Other: Core stabilization exercises and paced breathing training<br>* Twelve specific exercises following a standard protocol aiming at an intersegmental stabilization of the spine and strengthening and stabilization of specific muscle groups. The exercises are performed under instruction and supervision by a physiotherapist twice per week for 45 minutes. In addition, the participants practice paced breathing training (before and during the CSE sessions as well as 15 minutes twice per day at home) which has a modulating effect on the autonomic nervous system<br>|
| Experimental: Myofascial trigger point release<br>Patients with CLBP who receive myofascial trigger point release therapy | Other: Myofascial trigger point release<br>* A standard protocol of 12 myofascial and trigger point release grips followed by so-called roll-down maneuvers and manual rhythmical oscillation, applied to specific muscles and muscle groups. The treatment is applied twice per week for 45 minutes<br>|
| Experimental: Myofascial trigger point release and paced breathing training<br>Patients with CLBP who receive myofascial trigger point release therapy combined with paced breathing training | Other: Myofascial trigger point release and paced breathing training<br>* A standard protocol of 12 myofascial and trigger point release grips followed by so-called roll-down maneuvers and manual rhythmical oscillation, applied to specific muscles and muscle groups. The treatment is applied twice per week for 45 minutes. In addition, the participants practice paced breathing training (before and during the MTPR sessions as well as 15 minutes twice per day at home) which has a modulating effect on the autonomic nervous system<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Post-intervention pain severity | Self-reported severity of LBP after ten treatments with the assigned intervention, assessed with the 4-item pain severity score of the Brief Pain Inventory (BPI). The items are rated on an 11-point scale (0=no pain, 10=worst pain imaginable), the score is reported as the mean of the corresponding items. | 5 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain severity at three-month follow-up | Self-reported severity of LBP at three-month follow-up, assessed with the 4-item pain severity score of the Brief Pain Inventory (BPI). The items are rated on an 11-point scale (0=no pain, 10=worst pain imaginable), the score is reported as the mean of the corresponding items. | Measured at three-month follow-up | 
| Pain severity at six-month follow-up | Self-reported severity of LBP at six-month follow-up, assessed with the 4-item pain severity score of the Brief Pain Inventory (BPI). The items are rated on an 11-point scale (0=no pain, 10=worst pain imaginable), the score is reported as the mean of the corresponding items. | Measured at six-month follow-up | 
| Change in pain interference | Self-reported LBP-related functional impairment, assessed with the 7-item pain interference score of the Brief Pain Inventory (BPI). The items are rated on an 11-point scale (0=no interference, 10=interferes completely), the score is reported as the mean of the corresponding items. | Measured at baseline (pre-intervention), 5 weeks (post-intervention), three- and six-month follow-up | 
| Change in anxiety | Assessed with the 7-item subscale Anxiety of the self-reporting Hospital Anxiety and Depression Scale. The items are rated on a 4-point scale (0=positive, 3=negative) and added to a score between 0 (insignificant; non-cases) and 21 (severe) | Measured at baseline (pre-intervention), 5 weeks (post-intervention), three- and six-month follow-up | 
| Change in depression | Assessed with the 7-item subscale Depression of the self-reporting Hospital Anxiety and Depression Scale. The items are rated on a 4-point scale (0=positive, 3=negative) and added to a score between 0 (insignificant; non-cases) and 21 (severe) | Measured at baseline (pre-intervention), 5 weeks (post-intervention), three- and six-month follow-up | 
| Change in patients' belief in therapists' expertise | Assessed with the 6-item subscale Patients' Belief in Therapists' Expertise of the Questionnaire for Measuring Common Factors in Psychotherapy (Fragebogen zur Erfassung relevanter Therapiebedingungen, FERT). The items are rated on a seven-point Likert scale (1=totally disagree, 7=totally agree; score between 6 and 42). | Measured at baseline (pre-intervention) and 5 weeks (post-intervention) | 
| Change in patients' expectation of improvement | Assessed with the 3-item subscale Patients' Expectation of Improvement of the Questionnaire for Measuring Common Factors in Psychotherapy (Fragebogen zur Erfassung relevanter Therapiebedingungen, FERT). The items are rated on a seven-point Likert scale (1=totally disagree, 7=totally agree; score between 3 and 21). | Measured at baseline (pre-intervention) and 5 weeks (post-intervention) | 
| Change in therapists' expectation of improvement | Assessed with the 3-item scale Therapists' Expectation of Improvement. The items are rated on a seven-point Likert scale (1=totally disagree, 7=totally agree; score between 3 and 21). | Measured at baseline (pre-intervention) and 5 weeks (post-intervention) | 
| HRV analysis: Change in LF/HF ratio | LF/HF ratio = ratio of two bands from frequency domain analysis: LF band (0.04-0.15 Hz), HF band (0.15-0.40 Hz). HRV data are obtained from 24-hour ECG measurements | 24-hour ECG measurements taken at baseline (pre-intervention), 5 weeks (post-intervention), three- and six-month follow-up | 
| HRV analysis: Change in SDNN | Standard deviation of normal to normal (NN) intervals (ms). HRV data are obtained from 24-hour ECG measurements | 24-hour ECG measurements taken at baseline (pre-intervention), 5 weeks (post-intervention), three- and six-month follow-up | 
| HRV analysis: Change in RMSSD | Root mean square of successive differences (ms). HRV data are obtained from 24-hour ECG measurements | 24-hour ECG measurements taken at baseline (pre-intervention), 5 weeks (post-intervention), three- and six-month follow-up | 
| Change in the use of analgesic medication | Amount of analgesic medication according to the medication records kept by the participants | Assessed at baseline (pre-intervention), 5 weeks (post-intervention), three- and six-month follow-up | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Chronic Low-back Pain, Myofascial Trigger Point Release, Core Stabilization Exercises, Paced Breathing Training, Pain Severity, Anxiety, Heart Rate Variability