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NCT04199091Completed

Craniosacral Therapy as a Self-help Strategy for Patients With Chronic Non-specific Back Pain

Craniosacral Therapy Versus Progressive Muscle Relaxation as Self-help Strategies for Patients With Chronic Non-specific Back Pain: a Randomized Controlled Trial

Source: ClinicalTrials.gov · Last updated 24 Nov 2025

Brief summary (registry, in English)

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.

Status (registry)
Completed
Study type
Interventional
Enrollment
76 (actual)
First submitted
9 Dec 2019
Start date
1 Aug 2023
Primary completion date
10 Jan 2025
Lead sponsor
Universität Duisburg-Essen
NCT number
NCT04199091

What you commit to

  • Study type: Interventional
  • Participants enrolled: 76
  • From 1 Aug 2023 to the primary completion date, 10 Jan 2025
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Regular use of corticosteroids, opiates, muscle relaxants, or antidepressants

Other illness

  • Severe congenital or acute degenerative diseases
  • Severe inflammatory musculoskeletal or rheumatic diseases
  • Neurological diseases
  • Acute severe comorbid mental illness or other acute severe comorbid somatic illness

Other

  • Specific back pain due to:
  • Status after actue trauma/whiplash
  • Status after neoplasms in the area of the spinal column
  • Pregnancy
  • Current pension application
  • Simultaneous participation in other clinical trials

Who the study is looking for

  • 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

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Center for Integrative Medicine and Planetary Health, University Hospital Essen, University of Duisburg-Essen
Coordinator of this site? Confirm its status
EssenGermanyUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.