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

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

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.

Study Overview

• Status: Completed
• Conditions: Chronic Low-back Pain
• Intervention / Treatment: 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

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.

• Study Type: Interventional
• Enrollment (Actual): 124
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Germany
  • Baden-Württemberg
    • Filderstadt, Baden-Württemberg, Germany, 70794
      • Arcim Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Core stabilization exercises; Patients with CLBP who practice core stabilization exercises	Other: Core stabilization exercises; 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
Experimental: Core stabilization exercises and paced breathing training; Patients with CLBP who practice core stabilization exercises combined with paced breathing training	Other: Core stabilization exercises and paced breathing training; 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
Experimental: Myofascial trigger point release; Patients with CLBP who receive myofascial trigger point release therapy	Other: Myofascial trigger point release; 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
Experimental: Myofascial trigger point release and paced breathing training; Patients with CLBP who receive myofascial trigger point release therapy combined with paced breathing training	Other: Myofascial trigger point release and paced breathing training; 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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: ARCIM Institute Academic Research in Complementary and Integrative Medicine
• Collaborators: University Hospital Tuebingen; Center für Integrative Therapie Christopher Gordon; Die Filderklinik; Orthopädisch-Unfallchirurgische Praxis Dr Lembeck & Dr Pampel

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2008
• Primary Completion (Actual): December 18, 2008
• Study Completion (Actual): June 12, 2009

Study Registration Dates

• First Submitted: September 23, 2019
• First Submitted That Met QC Criteria: September 26, 2019
• First Posted (Actual): September 27, 2019

Study Record Updates

• Last Update Posted (Actual): September 27, 2019
• Last Update Submitted That Met QC Criteria: September 26, 2019
• Last Verified: September 1, 2019

More Information

Terms related to this study

• Keywords: Anxiety; Heart Rate Variability; Core Stabilization Exercises; Pain Severity; Chronic Low-back Pain; Myofascial Trigger Point Release; Paced Breathing Training
• Additional Relevant MeSH Terms: Pathologic Processes; Respiratory Tract Diseases; Respiration Disorders; Pain; Neurologic Manifestations; Back Pain; Low Back Pain; Respiratory Aspiration
• Other Study ID Numbers: LBP_02

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Deidentified individual participant data will be made available, in addition to study protocol and informed consent form.
• IPD Sharing Time Frame: The data will be made available upon publication for a duration of three months.
• IPD Sharing Access Criteria: The data will be made available to researchers who provide a methodologically sound proposal for use in achieving the goals of the approved proposal.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No