Myofascial Trigger Point Release and Paced Breathing Training for Chronic Low Back Pain
- Conditions
- Chronic Low-back Pain
- Interventions
- Other: Core stabilization exercises and paced breathing trainingOther: Myofascial trigger point release and paced breathing trainingOther: Core stabilization exercisesOther: Myofascial trigger point release
- Registration Number
- NCT04107597
- Lead Sponsor
- ARCIM Institute Academic Research in Complementary and Integrative Medicine
- Brief Summary
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
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 124
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Core stabilization exercises and paced breathing training Core stabilization exercises and paced breathing training Patients with CLBP who practice core stabilization exercises combined with paced breathing training Myofascial trigger point release and paced breathing training Myofascial trigger point release and paced breathing training Patients with CLBP who receive myofascial trigger point release therapy combined with paced breathing training Core stabilization exercises Core stabilization exercises Patients with CLBP who practice core stabilization exercises Myofascial trigger point release Myofascial trigger point release Patients with CLBP who receive myofascial trigger point release therapy
- Primary Outcome Measures
Name Time Method Post-intervention pain severity 5 weeks 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.
- Secondary Outcome Measures
Name Time Method HRV analysis: Change in RMSSD 24-hour ECG measurements taken at baseline (pre-intervention), 5 weeks (post-intervention), three- and six-month follow-up Root mean square of successive differences (ms). HRV data are obtained from 24-hour ECG measurements
Pain severity at three-month follow-up Measured 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.
Pain severity at six-month follow-up Measured 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.
Change in patients' belief in therapists' expertise Measured at baseline (pre-intervention) and 5 weeks (post-intervention) 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).
Change in the use of analgesic medication Assessed at baseline (pre-intervention), 5 weeks (post-intervention), three- and six-month follow-up Amount of analgesic medication according to the medication records kept by the participants
Change in anxiety Measured at baseline (pre-intervention), 5 weeks (post-intervention), three- and six-month follow-up 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)
Change in therapists' expectation of improvement Measured at baseline (pre-intervention) and 5 weeks (post-intervention) 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).
HRV analysis: Change in LF/HF ratio 24-hour ECG measurements taken at baseline (pre-intervention), 5 weeks (post-intervention), three- and six-month follow-up 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
Change in patients' expectation of improvement Measured at baseline (pre-intervention) and 5 weeks (post-intervention) 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).
HRV analysis: Change in SDNN 24-hour ECG measurements taken at baseline (pre-intervention), 5 weeks (post-intervention), three- and six-month follow-up Standard deviation of normal to normal (NN) intervals (ms). HRV data are obtained from 24-hour ECG measurements
Change in pain interference Measured at baseline (pre-intervention), 5 weeks (post-intervention), three- and six-month follow-up 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.
Change in depression Measured at baseline (pre-intervention), 5 weeks (post-intervention), three- and six-month follow-up 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)
Trial Locations
- Locations (1)
Arcim Institute
🇩🇪Filderstadt, Baden-Württemberg, Germany