Clinical trial NCT04199091: Craniosacral Therapy as a Self-help Strategy for Patients With Chronic Non-specific Back Pain
Official title: Craniosacral Therapy Versus Progressive Muscle Relaxation as Self-help Strategies for Patients With Chronic Non-specific Back Pain: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Low Back Pain, Mechanical
Complementary Therapies
Progressive Muscle Relaxation
Keywords: Craniosacral Therapy
Low Back Pain, Chronic
Randomized Controlled Trial
Self-help
Lead sponsor: Universität Duisburg-Essen
Sponsor class: OTHER
First posted: 2019-12-13
Enrollment: 76
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Craniosacral Therapy (CST) is a non-manipulative, very gentle manual treatment method. Although the mechanisms of action have not yet been investigated sufficiently, initial clinical trials support CST efficacy/effectiveness in chronic pain disorders such as back pain, neck pain, and fibromyalgia. In clinical practice, therapists also report pain alleviating effects of CST self-help techniques, offered to patients within a group concept. Yet, the effectiveness of teaching CST self-help techniques to medical laypersons has not yet been scientifically investigated.

Therefore, this study aims at collecting quantifiable data on the effectiveness and safety of a CST self-help group concept, developed for patients with chronic non-specific low back pain. The intervention group will receive 24 lessons of education and practice in CST self-help techniques over 12 weeks, while the control group will receive the same amount of self-help (education and practice) in progressive muscle relaxation. Six and 12 months after randomization, longer-term effects will be investigated.


Eligibility criteria: Inclusion Criteria:

* Chronic non-specific / functional lower back pain for at least 3 months
* Functional impairment: minimal 11 and maximal 41 points on the ODI
* Willingness to participate in the group program and practice at home

Exclusion Criteria:

* Specific back pain due to:
* Severe congenital or acute degenerative diseases
* Severe inflammatory musculoskeletal or rheumatic diseases
* Neurological diseases
* Status after actue trauma/whiplash
* Status after neoplasms in the area of the spinal column
* Acute severe comorbid mental illness or other acute severe comorbid somatic illness
* Pregnancy
* Current pension application
* Regular use of corticosteroids, opiates, muscle relaxants, or antidepressants
* Simultaneous participation in other clinical trials

Primary outcomes:
measure: Functional Impairment
timeFrame: Week 12
Secondary outcomes:
measure: Functional Impairment
timeFrame: Week 26
measure: Functional Impairment
timeFrame: Week 52
measure: Pain Intensity
timeFrame: Week 12
measure: Pain Intensity
timeFrame: Week 26
measure: Pain Intensity
timeFrame: Week 52
measure: Health-related Quality of Life
timeFrame: Week 12
measure: Health-related Quality of Life
timeFrame: Week 26
measure: Health-related Quality of Life
timeFrame: Week 52
measure: Severity of Depressive Symptoms
timeFrame: Week 12
measure: Severity of Depressive Symptoms
timeFrame: Week 26
measure: Severity of Depressive Symptoms
timeFrame: Week 52
measure: Severity of Anxious Symptoms
timeFrame: Week 12
measure: Severity of Anxious Symptoms
timeFrame: Week 26
measure: Severity of Anxious Symptoms
timeFrame: Week 52
measure: Global Improvement
timeFrame: Week 12
measure: Global Improvement
timeFrame: Week 26
measure: Global Improvement
timeFrame: Week 52
measure: Number of Patients with Adverse Events
timeFrame: Week 12
measure: Total Number (and Type) of Adverse Events
timeFrame: Week 12
Other outcomes:
measure: Body Awareness
timeFrame: Week 12
measure: Body Awareness
timeFrame: Week 26
measure: Body Awareness
timeFrame: Week 52
measure: Fear-related Avoidance Beliefs
timeFrame: Week 12
measure: Fear-related Avoidance Beliefs
timeFrame: Week 26
measure: Fear-related Avoidance Beliefs
timeFrame: Week 52
measure: Pain Acceptance
timeFrame: Week 12
measure: Pain Acceptance
timeFrame: Week 26
measure: Pain Acceptance
timeFrame: Week 52
measure: Use of Pain Medication
timeFrame: Week 1-12
measure: Freuqnecy of Homework
timeFrame: Week 1-12
measure: Treatment Expectations
timeFrame: Week 1
measure: Treamtent Credibility
timeFrame: Week 12
measure: Therapist-Patient-Relationship
timeFrame: Week 12
measure: Interview
timeFrame: Week 12
measure: Craniosacral-specific Quality of Life
timeFrame: Week 12
measure: Craniosacral-specific Quality of Life
timeFrame: Week 26
measure: Craniosacral-specific Quality of Life
timeFrame: Week 52
Locations:
city: Essen
country: Germany
facility: Center for Integrative Medicine and Planetary Health, University Hospital Essen, University of Duisburg-Essen
state: NRW
Study officials:
affiliation: Center for Integrative Medicine and Planetary Health, University Hospital Essen, University of Duisburg-Essen
name: Gustav Dobos, Prof. MD
role: STUDY_DIRECTOR
References: