Chronic Low-back PainNCT04107597
Myofascial Trigger Point Release and Paced Breathing Training for Chronic Low Back Pain
A study testing Core stabilization exercises, Core stabilization exercises and paced breathing training and Myofascial trigger point release in people with Chronic Low-back Pain, run by ARCIM Institute Academic Research in Complementary and Integrative Medicine at 1 site in Germany.
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. Read more about this study
- Who is it for?
- Ages 20 to 70 years
- Conditions the study is for
- Chronic Low-back Pain
- What is being tested?
- Core stabilization exercises, Core stabilization exercises and paced breathing training and Myofascial trigger point release
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 124 participants
- Where
- 1 siteGermany
- Study dates
- 1 Apr 2008to 12 Jun 2009
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 13Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Chronic Low-back Pain
- Being tested
- Core stabilization exercises, Core stabilization exercises and paced breathing training, Myofascial trigger point release, Myofascial trigger point release and paced breathing training
- Keywords
- Chronic Low-back Pain, Myofascial Trigger Point Release, Core Stabilization Exercises, Paced Breathing Training, Pain Severity, Anxiety, Heart Rate Variability
- Medical subject headings
- Pain, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Core stabilization exercisesOther
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 trainingOther
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 releaseOther
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 trainingOther
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
| Study group | Role | What they receive |
|---|---|---|
| Core stabilization exercises | Experimental | Patients with CLBP who practice core stabilization exercises Receives: Other: Core stabilization exercises |
| Core stabilization exercises and paced breathing training | Experimental | Patients with CLBP who practice core stabilization exercises combined with paced breathing training Receives: Other: Core stabilization exercises and paced breathing training |
| Myofascial trigger point release | Experimental | Patients with CLBP who receive myofascial trigger point release therapy Receives: Other: Myofascial trigger point release |
| Myofascial trigger point release and paced breathing training | Experimental | Patients with CLBP who receive myofascial trigger point release therapy combined with paced breathing training Receives: Other: Myofascial trigger point release and paced breathing training |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 5 weeks
Secondary outcomes (12)
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: 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: 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: 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: 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: 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: 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: 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: 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
Measured: 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
Measured: 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
Measured: 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
Measured: Assessed at baseline (pre-intervention), 5 weeks (post-intervention), three- and six-month follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Sep 2019
- Study start1 Apr 2008
- Primary completion18 Dec 2008
- Study completion12 Jun 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Low-back PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 124 participants (actual)
Sponsor and investigators
- Lead sponsor
- ARCIM Institute Academic Research in Complementary and Integrative Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- Center für Integrative Therapie Christopher Gordon, University Hospital Tuebingen, Die Filderklinik, Orthopädisch-Unfallchirurgische Praxis Dr Lembeck & Dr Pampel
- Responsible party
- Sponsor
- Investigators
- Jan Vagedes, Dr., Principal investigator, Arcim Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04107597
- Sponsor's protocol ID
- LBP_02
- Status last verified
- Sep 2019
- First submitted
- 23 Sep 2019
- Last updated
- 27 Sep 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Deidentified individual participant data will be made available, in addition to study protocol and informed consent form.
Study at a glance
From the registry record, last updated by the sponsor on 27 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Myofascial Trigger Point Release and Paced Breathing Training for Chronic Low Back Pain: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04107597
- Acronym / sponsor ID
- LBP_02
- 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
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 124 participants (actual)
- Lead sponsor
- ARCIM Institute Academic Research in Complementary and Integrative MedicineUniversity, hospital or other
- Collaborators
- Center für Integrative Therapie Christopher Gordon, University Hospital Tuebingen, Die Filderklinik, Orthopädisch-Unfallchirurgische Praxis Dr Lembeck & Dr Pampel
- Study start
- 1 Apr 2008 (actual)
- Primary completion
- 18 Dec 2008 (actual)
- Study completion
- 12 Jun 2009 (actual)
- First posted
- 27 Sep 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Core stabilization exercises | Experimental | Other: Core stabilization exercisesPatients with CLBP who practice core stabilization exercises |
| Core stabilization exercises and paced breathing training | Experimental | Other: Core stabilization exercises and paced breathing trainingPatients with CLBP who practice core stabilization exercises combined with paced breathing training |
| Myofascial trigger point release | Experimental | Other: Myofascial trigger point releasePatients with CLBP who receive myofascial trigger point release therapy |
| Myofascial trigger point release and paced breathing training | Experimental | Other: Myofascial trigger point release and paced breathing trainingPatients with CLBP who receive myofascial trigger point release therapy combined with paced breathing training |
Who may qualify
- Ages
- 20 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (13 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Core stabilization exercisesTwelve 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 | Other | Core stabilization exercises |
| Core stabilization exercises and paced breathing trainingTwelve 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 | Other | Core stabilization exercises and paced breathing training |
| Myofascial trigger point releaseA 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 | Other | Myofascial trigger point release |
| Myofascial trigger point release and paced breathing trainingA 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 | Other | Myofascial trigger point release and paced breathing training |
Primary outcome
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.
12 secondary outcomes
Pain severity at three-month follow-up
Time frame: Measured at three-month follow-up
Pain severity at six-month follow-up
Time frame: Measured at six-month follow-up
Change in pain interference
Time frame: Measured at baseline (pre-intervention), 5 weeks (post-intervention), three- and six-month follow-up
Change in anxiety
Time frame: Measured at baseline (pre-intervention), 5 weeks (post-intervention), three- and six-month follow-up
Change in depression
Time frame: Measured at baseline (pre-intervention), 5 weeks (post-intervention), three- and six-month follow-up
Change in patients' belief in therapists' expertise
Time frame: Measured at baseline (pre-intervention) and 5 weeks (post-intervention)
Change in patients' expectation of improvement
Time frame: Measured at baseline (pre-intervention) and 5 weeks (post-intervention)
Change in therapists' expectation of improvement
Time frame: Measured at baseline (pre-intervention) and 5 weeks (post-intervention)
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
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
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
Change in the use of analgesic medication
Time frame: Assessed at baseline (pre-intervention), 5 weeks (post-intervention), three- and six-month follow-up
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Sep 2019.
- Individual participant dataSharing planned: Yes. Deidentified individual participant data will be made available, in addition to study protocol and informed consent form.
Related trials for Chronic Low-back Pain
Recruiting
Effects of Virtual Reality Exergames Versus Spinal Manipulation in Chronic Nonspecific Low Back Pain
Chronic Nonspecific Low-back Pain, CNSLBP
Not yet recruiting
Radiofrequency and Pelvic Floor-Core Exercise for Chronic Low Back Pain in Women With Pelvic Floor Dysfunction
Chronic Low Back Pain, Urinary Incontinence
Recruiting
Meditation for Older Adults With Chronic Low Back Pain
Chronic Low Back Pain
Not yet recruiting
Effects of Dead Bug Exercises With and Without Diaphragmatic Breathing in Patients With Chronic Non-specific Low Back Pain.
Non-specific Chronic Low Back Pain
Not yet recruiting
Hybrid mHealth for Low Back Pain
Chronic Low-back Pain (cLBP), Non-specific Low Back Pain (NSLBP)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jan Vagedes, Dr. principal investigator
Arcim Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Core stabilization exercises, Core stabilization exercises and paced breathing training and Myofascial trigger point release in people with Chronic Low-back Pain, run by ARCIM Institute Academic Research in Complementary and Integrative Medicine at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Post-intervention pain severity (time frame: 5 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Sep 2019.