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Completed

NCT Number: NCT04107597

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

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.

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Key information

Conditions

Chronic Low-back Pain Anxiety Disorders Mental Disorders Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

20 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Arcim Institute

Filderstadt, Baden-Wurttemberg, 70794, Germany

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

core stabilization exercises

Other

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

Other

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

Other

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

Other

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

Primary outcomes

  1. Post-intervention pain severity

    Time frame: 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 outcomes

  1. Pain severity at three-month follow-up

    Time frame: 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.

  2. Pain severity at six-month follow-up

    Time frame: 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.

  3. Change in pain interference

    Time frame: 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.

  4. Change in anxiety

    Time frame: 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)

  5. Change in depression

    Time frame: 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)

  6. Change in patients' belief in therapists' expertise

    Time frame: 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).

  7. Change in patients' expectation of improvement

    Time frame: 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).

  8. Change in therapists' expectation of improvement

    Time frame: 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).

  9. HRV analysis: Change in LF/HF ratio

    Time frame: 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

  10. HRV analysis: Change in SDNN

    Time frame: 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

  11. HRV analysis: Change in RMSSD

    Time frame: 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

  12. Change in the use of analgesic medication

    Time frame: 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

Sponsors and collaborators

Lead sponsor

ARCIM Institute Academic Research in Complementary and Integrative Medicine

Other

Collaborators

  • Center für Integrative Therapie Christopher Gordon
  • Die Filderklinik
  • Orthopädisch-Unfallchirurgische Praxis Dr Lembeck & Dr Pampel
  • University Hospital Tuebingen

Registry information

Official study title

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

Important dates

Study start
2008
Primary completion
2008
Study completion
2009
First posted
Sep 27, 2019
Registry last updated
Sep 27, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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