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

Chronic Low-back Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04107597
• Other study ID #: LBP_02
• Status: Completed
• Phase: N/A
• Start date: April 1, 2008
• Est. completion date: June 12, 2009

Study information

• Verified date: September 2019
• Source: ARCIM Institute Academic Research in Complementary and Integrative Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 124
• Est. completion date: June 12, 2009
• Est. primary completion date: December 18, 2008
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Back Pain
• Chronic Low-back Pain
• Low Back Pain
• Respiratory Aspiration

Intervention

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
• 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
• 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
• 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

Locations

Country	Name	City	State
Germany	Arcim Institute	Filderstadt	Baden-Württemberg

Sponsors (5)

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

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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
Secondary	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
Secondary	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
Secondary	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