Chronic Low-back Pain
Conditions
Keywords
Chronic Low-back Pain, Myofascial Trigger Point Release, Core Stabilization Exercises, Paced Breathing Training, Pain Severity, Anxiety, Heart Rate Variability
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.
Interventions
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
OTHERCore stabilization exercises
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
OTHERCore stabilization exercises 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. 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
OTHERMyofascial trigger point release and paced breathing training
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
Sponsors
Center für Integrative Therapie Christopher Gordon
University Hospital Tuebingen
Die Filderklinik
Orthopädisch-Unfallchirurgische Praxis Dr Lembeck & Dr Pampel
ARCIM Institute Academic Research in Complementary and Integrative Medicine
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
20 Years to 70 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Post-intervention pain severity | 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
| Measure | Time frame | Description |
|---|---|---|
| Pain severity at six-month follow-up | 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. |
| Change in pain interference | 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. |
| Change in anxiety | 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) |
| Change in depression | 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) |
| Change in patients' belief in therapists' expertise | 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). |
| Pain severity at three-month follow-up | 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. |
| Change in therapists' expectation of improvement | 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). |
| HRV analysis: Change in LF/HF ratio | 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 |
| HRV analysis: Change in SDNN | 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 |
| HRV analysis: Change in RMSSD | 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 |
| Change in the use of analgesic medication | 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 |
| Change in patients' expectation of improvement | 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). |
Countries
Germany
Outcome results
None listed