Effects of Craniosacral Therapy on Chronic Neck Pain (CranioS)

February 20, 2019 updated by: Heidemarie Haller, Universität Duisburg-Essen

Effects of Craniosacral Therapy on Chronic Neck Pain: A Randomized Controlled Trial

The purpose of this randomized controlled trial is to determinate the efficacy and safety of Craniosacral Therapy in the treatment of chronic unspecific neck pain.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Craniosacral Therapy (CST) is a variation of osteopathic manipulation with an integrative approach. By soft manual palpation of the craniosacral and fascia system sensory, motor, cognitive, and emotional processes can be influenced. In the prevention and treatment of chronic pain syndromes Craniosacral Therapy is demonstrated to be effective in clinical practice and quite a few scientific trials. But yet there are no randomized controlled studies concerning to chronic neck pain. So the aim of this study is to investigate whether a total of 8 CST units of 45 minutes will be effective in patients suffering from chronic nonspecific neck pain in contrast to sham therapy of the same extent. The prospective study design includes measurement points at baseline, post treatment, and 3 months follow-up.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
54

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
    • NRW
      • Essen, NRW, Germany, 45276
        • Kliniken Essen-Mitte

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 65 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Chronic unspecific neck pain for at least 3 months
  • Mean neck pain of moderate intensity (>/=45mm on VAS)
  • Therapy-naive subjects

Exclusion Criteria:

  • Specific neck pain due to severe deformity of the spine, prolapse, rheumatic or neurological disorder, trauma, operation or cancer
  • other severe somatic or psychiatric comorbidity
  • pregnancy
  • regular intake of opiates, corticosteroids (>10mg prednisolon), muscle relaxants or antidepressants
  • recent invasive or manipulative treatment of the spine
  • participation in other clinical trials

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: TRIPLE

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
EXPERIMENTAL: Craniosacral Therapy (CST)
Each participant of the experimental group receives 8 Craniosacral Therapy units once a week of 45 minutes.
Procedure: Craniosacral Therapy
Standardized therapy protocol (according to Upledger): Still point technique, diaphragm release, compression-decompression and lift techniques of the cranial bones, facial balancing in the region of shoulder and pelvis and somato-emotional unwinding
SHAM_COMPARATOR: Sham Craniosacral Therapy (SHAM)
Each participant of the sham group receives 8 sham therapy units once a week of 45 minutes.
Procedure: Sham Craniosacral Therapy
Standardized sham protocol: Placing hands on various parts of the clothed body for two minutes each time without therapeutic intention

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Pain intensity
Time Frame: week 8
Pain intensity on a 100mm visual analogue scale (VAS)
week 8

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Pain intensity in motion
Time Frame: week 8
Pain intensity induced by flexion, extension, lateral flexion and rotation of the head on a 100mm visual analogue scale (VAS)
week 8
Pressure pain threshold
Time Frame: week 8
Pressure pain threshold (PPT) measured with an algometer on predefined muscles and the pain maximum
week 8
Disability
Time Frame: week 8
Measured by the Neck Disability Indx (NDI)
week 8
Quality of life
Time Frame: week 8
Measured by the Short-Form Health Survey (SF-12)
week 8
Well being
Time Frame: week 8
Measured by the Questionnaire for Assessing Subjective Physical Well-Being (FEW-16)
week 8
Anxiety and depression
Time Frame: week 8
Measured by the Hospital Anxiety and Depression Scale (HADS)
week 8
Stress perception
Time Frame: week 8
Measured by the Perceived Stress Questionnaire (PSQ-20)
week 8
Pain acceptance
Time Frame: week 8
Measured by the Emotional and Rational Disease Acceptance Questionnaire (ERDA)
week 8
Body awareness
Time Frame: week 8
Measured by the Scale of Body Connection (SBC)
week 8
Global Impression
Time Frame: week 8
Measured by the Patient Global Impression of Improvement Questionnaire (PGI-I)
week 8
Safety
Time Frame: week 8
All adverse events are recorded
week 8

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Universität Duisburg-Essen

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Gustav Dobos, Prof. MD, Department of Internal and Integrative Medicine, Kliniken Essen-Mitte, Faculty of Medicine, University Duisburg-Essen, Germany

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 1, 2012

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2012

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 1, 2013

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 1, 2012

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 1, 2012

First Posted (ESTIMATE)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 3, 2012

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 21, 2019

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 20, 2019

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 11-4850

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