Back to resultsMyofascial Trigger Point Release and Paced Breathing Training for Chronic Low Back Pain
Primary Purpose
Chronic Low-back Pain
Status
Completed
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Core stabilization exercises
Core stabilization exercises and paced breathing training
Myofascial trigger point release
Myofascial trigger point release and paced breathing training
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Low-back Pain focused on measuring Chronic Low-back Pain, Myofascial Trigger Point Release, Core Stabilization Exercises, Paced Breathing Training, Pain Severity, Anxiety, Heart Rate Variability
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
Sites / Locations
- Arcim Institute
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Experimental
Experimental
Experimental
Arm Label
Core stabilization exercises
Core stabilization exercises and paced breathing training
Myofascial trigger point release
Myofascial trigger point release and paced breathing training
Arm Description
Patients with CLBP who practice core stabilization exercises
Patients with CLBP who practice core stabilization exercises combined with paced breathing training
Patients with CLBP who receive myofascial trigger point release therapy
Patients with CLBP who receive myofascial trigger point release therapy combined with paced breathing training
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
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.
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.
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)
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)
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).
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).
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).
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
HRV analysis: Change in SDNN
Standard deviation of normal to normal (NN) intervals (ms). HRV data are obtained from 24-hour ECG measurements
HRV analysis: Change in RMSSD
Root mean square of successive differences (ms). HRV data are obtained from 24-hour ECG measurements
Change in the use of analgesic medication
Amount of analgesic medication according to the medication records kept by the participants
Full Information
NCT ID
NCT04107597
First Posted
September 23, 2019
Last Updated
September 26, 2019
Sponsor
ARCIM Institute Academic Research in Complementary and Integrative Medicine
Collaborators
Center für Integrative Therapie Christopher Gordon, University Hospital Tuebingen, Die Filderklinik, Orthopädisch-Unfallchirurgische Praxis Dr Lembeck & Dr Pampel
1. Study Identification
Unique Protocol Identification Number
NCT04107597
Brief Title
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
2. Study Status
Record Verification Date
September 2019
Overall Recruitment Status
Completed
Study Start Date
April 1, 2008 (Actual)
Primary Completion Date
December 18, 2008 (Actual)
Study Completion Date
June 12, 2009 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
ARCIM Institute Academic Research in Complementary and Integrative Medicine
Collaborators
Center für Integrative Therapie Christopher Gordon, University Hospital Tuebingen, Die Filderklinik, Orthopädisch-Unfallchirurgische Praxis Dr Lembeck & Dr Pampel
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
124 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Core stabilization exercises
Arm Type
Experimental
Arm Description
Patients with CLBP who practice core stabilization exercises
Arm Title
Core stabilization exercises and paced breathing training
Arm Type
Experimental
Arm Description
Patients with CLBP who practice core stabilization exercises combined with paced breathing training
Arm Title
Myofascial trigger point release
Arm Type
Experimental
Arm Description
Patients with CLBP who receive myofascial trigger point release therapy
Arm Title
Myofascial trigger point release and paced breathing training
Arm Type
Experimental
Arm Description
Patients with CLBP who receive myofascial trigger point release therapy combined with paced breathing training
Intervention Type
Other
Intervention Name(s)
Core stabilization exercises
Intervention Description
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
Intervention Type
Other
Intervention Name(s)
Core stabilization exercises and paced breathing training
Intervention Description
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
Intervention Type
Other
Intervention Name(s)
Myofascial trigger point release
Intervention Description
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
Intervention Type
Other
Intervention Name(s)
Myofascial trigger point release and paced breathing training
Intervention Description
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 Outcome Measure Information:
Title
Post-intervention pain severity
Description
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.
Time Frame
5 weeks
Secondary Outcome Measure Information:
Title
Pain severity at three-month follow-up
Description
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.
Time Frame
Measured at three-month follow-up
Title
Pain severity at six-month follow-up
Description
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.
Time Frame
Measured at six-month follow-up
Title
Change in pain interference
Description
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.
Time Frame
Measured at baseline (pre-intervention), 5 weeks (post-intervention), three- and six-month follow-up
Title
Change in anxiety
Description
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)
Time Frame
Measured at baseline (pre-intervention), 5 weeks (post-intervention), three- and six-month follow-up
Title
Change in depression
Description
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)
Time Frame
Measured at baseline (pre-intervention), 5 weeks (post-intervention), three- and six-month follow-up
Title
Change in patients' belief in therapists' expertise
Description
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).
Time Frame
Measured at baseline (pre-intervention) and 5 weeks (post-intervention)
Title
Change in patients' expectation of improvement
Description
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).
Time Frame
Measured at baseline (pre-intervention) and 5 weeks (post-intervention)
Title
Change in therapists' expectation of improvement
Description
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).
Time Frame
Measured at baseline (pre-intervention) and 5 weeks (post-intervention)
Title
HRV analysis: Change in LF/HF ratio
Description
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
Time Frame
24-hour ECG measurements taken at baseline (pre-intervention), 5 weeks (post-intervention), three- and six-month follow-up
Title
HRV analysis: Change in SDNN
Description
Standard deviation of normal to normal (NN) intervals (ms). HRV data are obtained from 24-hour ECG measurements
Time Frame
24-hour ECG measurements taken at baseline (pre-intervention), 5 weeks (post-intervention), three- and six-month follow-up
Title
HRV analysis: Change in RMSSD
Description
Root mean square of successive differences (ms). HRV data are obtained from 24-hour ECG measurements
Time Frame
24-hour ECG measurements taken at baseline (pre-intervention), 5 weeks (post-intervention), three- and six-month follow-up
Title
Change in the use of analgesic medication
Description
Amount of analgesic medication according to the medication records kept by the participants
Time Frame
Assessed at baseline (pre-intervention), 5 weeks (post-intervention), three- and six-month follow-up
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jan Vagedes, Dr.
Organizational Affiliation
Arcim Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
Arcim Institute
City
Filderstadt
State/Province
Baden-Württemberg
ZIP/Postal Code
70794
Country
Germany
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing 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.
Learn more about this trial
Myofascial Trigger Point Release and Paced Breathing Training for Chronic Low Back Pain
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