An interventional study of Core stabilization exercises and Core stabilization exercises and paced breathing training in Chronic Low-back Pain, sponsored by ARCIM Institute Academic Research in Complementary and Integrative Medicine. Completed at 1 site in Germany. Open to participants aged 20 Years to 70 Years. Per ClinicalTrials.gov, last updated 2019-09-27.
Sponsored by ARCIM Institute Academic Research in Complementary and Integrative Medicine · Not applicable, Interventional, and Treatment
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.
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.
2,450 studies on the registry are indexed under Pain; 945 are open to participants now.
This study's enrollment of 124 is above the median of 70 across 2,101 interventional studies indexed under Pain.
Browse Pain studies →ARCIM Institute Academic Research in Complementary and Integrative Medicine is the lead sponsor of 32 studies on the registry; 1 is open to participants now.
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Exclusion Criteria:
Patients with CLBP who practice core stabilization exercises
Other: Core stabilization exercises
Patients with CLBP who practice core stabilization exercises combined with paced breathing training
Other: Core stabilization exercises and paced breathing training
Patients with CLBP who receive myofascial trigger point release therapy
Other: Myofascial trigger point release
Patients with CLBP who receive myofascial trigger point release therapy combined with paced breathing training
Other: Myofascial trigger point release 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
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
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
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
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.
Time frame: 5 weeks
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.
Time frame: 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.
Time frame: 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.
Time frame: 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)
Time frame: 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)
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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
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
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
HRV analysis: Change in RMSSD
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
Change in the use of analgesic medication
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
Plan to share: Yes — Deidentified individual participant data will be made available, in addition to study protocol and informed consent form.
Supporting information: Study protocol, Informed consent form
Time frame: The data will be made available upon publication for a duration of three months.
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.
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This study is completed, as verified in Sep 2019. You cannot join it, but the record below documents what was studied.
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ARCIM Institute Academic Research in Complementary and Integrative Medicine