Clinical trial NCT04107597: Myofascial Trigger Point Release and Paced Breathing Training for Chronic Low Back Pain
Official title: Myofascial Trigger Point Release and Paced Breathing Training for Chronic Low Back Pain: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Low-back Pain
Keywords: Chronic Low-back Pain
Myofascial Trigger Point Release
Core Stabilization Exercises
Paced Breathing Training
Pain Severity
Anxiety
Heart Rate Variability
Lead sponsor: ARCIM Institute Academic Research in Complementary and Integrative Medicine
Sponsor class: OTHER
Collaborators: name: Center für Integrative Therapie Christopher Gordon
name: University Hospital Tuebingen
name: Die Filderklinik
name: Orthopädisch-Unfallchirurgische Praxis Dr Lembeck & Dr Pampel
First posted: 2019-09-27
Enrollment: 124
Sex: ALL
Minimum age (years): 20
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Post-intervention pain severity
timeFrame: 5 weeks
Secondary outcomes:
measure: Pain severity at three-month follow-up
timeFrame: Measured at three-month follow-up
measure: Pain severity at six-month follow-up
timeFrame: Measured at six-month follow-up
measure: Change in pain interference
timeFrame: Measured at baseline (pre-intervention), 5 weeks (post-intervention), three- and six-month follow-up
measure: Change in anxiety
timeFrame: Measured at baseline (pre-intervention), 5 weeks (post-intervention), three- and six-month follow-up
measure: Change in depression
timeFrame: Measured at baseline (pre-intervention), 5 weeks (post-intervention), three- and six-month follow-up
measure: Change in patients' belief in therapists' expertise
timeFrame: Measured at baseline (pre-intervention) and 5 weeks (post-intervention)
measure: Change in patients' expectation of improvement
timeFrame: Measured at baseline (pre-intervention) and 5 weeks (post-intervention)
measure: Change in therapists' expectation of improvement
timeFrame: Measured at baseline (pre-intervention) and 5 weeks (post-intervention)
measure: HRV analysis: Change in LF/HF ratio
timeFrame: 24-hour ECG measurements taken at baseline (pre-intervention), 5 weeks (post-intervention), three- and six-month follow-up
measure: HRV analysis: Change in SDNN
timeFrame: 24-hour ECG measurements taken at baseline (pre-intervention), 5 weeks (post-intervention), three- and six-month follow-up
measure: HRV analysis: Change in RMSSD
timeFrame: 24-hour ECG measurements taken at baseline (pre-intervention), 5 weeks (post-intervention), three- and six-month follow-up
measure: Change in the use of analgesic medication
timeFrame: Assessed at baseline (pre-intervention), 5 weeks (post-intervention), three- and six-month follow-up
Other outcomes:
Locations:
city: Filderstadt
country: Germany
facility: Arcim Institute
state: Baden-Württemberg
Study officials:
affiliation: Arcim Institute
name: Jan Vagedes, Dr.
role: PRINCIPAL_INVESTIGATOR
References: