Neck PainCranioSNCT01526447
Effects of Craniosacral Therapy on Chronic Neck Pain
A study testing Craniosacral Therapy in people with Neck Pain, run by Universität Duisburg-Essen at 1 site in Germany.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Neck Pain
- What is being tested?
- Craniosacral Therapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 54 participants
- Where
- 1 siteGermany
- Study dates
- Feb 2012to Apr 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Chronic unspecific neck pain for at least 3 months
- Mean neck pain of moderate intensity (>/=45mm on VAS)
- Therapy-naive subjects
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Neck Pain
- Being tested
- Craniosacral Therapy, Sham Craniosacral Therapy
- Keywords
- Neck Pain, Craniosacral Manipulation, Complementary Therapies, Randomized Controlled Trial, Sensory Thresholds, Quality of Life
- Medical subject headings
- Neck Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Craniosacral TherapyProcedure or surgery
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 Craniosacral TherapyProcedure or surgery
Standardized sham protocol: Placing hands on various parts of the clothed body for two minutes each time without therapeutic intention
| Study group | Role | What they receive |
|---|---|---|
| Craniosacral Therapy (CST) | Experimental | Each participant of the experimental group receives 8 Craniosacral Therapy units once a week of 45 minutes. Receives: Procedure: Craniosacral Therapy |
| Sham Craniosacral Therapy (SHAM) | Sham comparator | Each participant of the sham group receives 8 sham therapy units once a week of 45 minutes. Receives: Procedure: Sham Craniosacral Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain intensity
Pain intensity on a 100mm visual analogue scale (VAS)
Measured: week 8
Secondary outcomes (11)
Pain intensity in motion
Pain intensity induced by flexion, extension, lateral flexion and rotation of the head on a 100mm visual analogue scale (VAS)
Measured: week 8
Pressure pain threshold
Pressure pain threshold (PPT) measured with an algometer on predefined muscles and the pain maximum
Measured: week 8
Disability
Measured by the Neck Disability Indx (NDI)
Measured: week 8
Quality of life
Measured by the Short-Form Health Survey (SF-12)
Measured: week 8
Well being
Measured by the Questionnaire for Assessing Subjective Physical Well-Being (FEW-16)
Measured: week 8
Anxiety and depression
Measured by the Hospital Anxiety and Depression Scale (HADS)
Measured: week 8
Stress perception
Measured by the Perceived Stress Questionnaire (PSQ-20)
Measured: week 8
Pain acceptance
Measured by the Emotional and Rational Disease Acceptance Questionnaire (ERDA)
Measured: week 8
Body awareness
Measured by the Scale of Body Connection (SBC)
Measured: week 8
Global Impression
Measured by the Patient Global Impression of Improvement Questionnaire (PGI-I)
Measured: week 8
Safety
All adverse events are recorded
Measured: week 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Feb 2012 (estimated)
- Study startFeb 2012
- Primary completionDec 2012
- Study completionApr 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Neck PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 54 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universität Duisburg-Essen
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Heidemarie Haller, Universität Duisburg-Essen
- Investigators
- Gustav Dobos, Prof. MD, Study director, Department of Internal and Integrative Medicine, Kliniken Essen-Mitte, Faculty of Medicine, University Duisburg-Essen, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01526447
- Sponsor's protocol ID
- 11-4850
- Acronym
- CranioS
- Status last verified
- Feb 2019
- First submitted
- 1 Feb 2012
- Last updated
- 21 Feb 2019
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Haller H, Ostermann T, Lauche R, Cramer H, Dobos G. Credibility of a comparative sham control intervention for Craniosacral Therapy in patients with chronic neck pain. Complement Ther Med. 2014 Dec;22(6):1053-9. doi: 10.1016/j.ctim.2014.09.007. Epub 2014 Oct 6.
PubMed 25453528Haller H, Lauche R, Cramer H, Rampp T, Saha FJ, Ostermann T, Dobos G. Craniosacral Therapy for the Treatment of Chronic Neck Pain: A Randomized Sham-controlled Trial. Clin J Pain. 2016 May;32(5):441-9. doi: 10.1097/AJP.0000000000000290.
PubMed 26340656
Study at a glance
From the registry record, last updated by the sponsor on 21 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Craniosacral Therapy on Chronic Neck Pain: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT01526447
- Acronym / sponsor ID
- CranioS / 11-4850
- Conditions
- Neck Pain
- Keywords
- Neck Pain, Craniosacral Manipulation, Complementary Therapies, Randomized Controlled Trial, Sensory Thresholds, Quality of Life
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 54 participants (actual)
- Lead sponsor
- Universität Duisburg-EssenUniversity, hospital or other
- Study start
- Feb 2012
- Primary completion
- Dec 2012 (actual)
- Study completion
- Apr 2013 (actual)
- First posted
- 3 Feb 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Craniosacral Therapy (CST) | Experimental | Procedure: Craniosacral TherapyEach participant of the experimental group receives 8 Craniosacral Therapy units once a week of 45 minutes. |
| Sham Craniosacral Therapy (SHAM) | Sham comparator | Procedure: Sham Craniosacral TherapyEach participant of the sham group receives 8 sham therapy units once a week of 45 minutes. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Chronic unspecific neck pain for at least 3 months
- Mean neck pain of moderate intensity (>/=45mm on VAS)
- Therapy-naive subjects
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Craniosacral TherapyStandardized 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 | Procedure or surgery | Craniosacral Therapy (CST) |
| Sham Craniosacral TherapyStandardized sham protocol: Placing hands on various parts of the clothed body for two minutes each time without therapeutic intention | Procedure or surgery | Sham Craniosacral Therapy (SHAM) |
Primary outcome
Pain intensity
Time frame: week 8
Pain intensity on a 100mm visual analogue scale (VAS)
11 secondary outcomes
Pain intensity in motion
Time frame: week 8
Pressure pain threshold
Time frame: week 8
Disability
Time frame: week 8
Quality of life
Time frame: week 8
Well being
Time frame: week 8
Anxiety and depression
Time frame: week 8
Stress perception
Time frame: week 8
Pain acceptance
Time frame: week 8
Body awareness
Time frame: week 8
Global Impression
Time frame: week 8
Safety
Time frame: week 8
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Feb 2019.
- Background: PubMed 25453528Haller H, Ostermann T, Lauche R, Cramer H, Dobos G. Credibility of a comparative sham control intervention for Craniosacral Therapy in patients with chronic neck pain. Complement Ther Med. 2014 Dec;22(6):1053-9. doi: 10.1016/j.ctim.2014.09.007. Epub 2014 Oct 6.
- Results publication: PubMed 26340656Haller H, Lauche R, Cramer H, Rampp T, Saha FJ, Ostermann T, Dobos G. Craniosacral Therapy for the Treatment of Chronic Neck Pain: A Randomized Sham-controlled Trial. Clin J Pain. 2016 May;32(5):441-9. doi: 10.1097/AJP.0000000000000290.
Related trials for Neck Pain
Not yet recruiting
Effects of Whole-Body Vibration and Cervical Stabilization With Core Stabilization in Young Adults With Non-Specific Low Back Pain
Nonspecific Low Back Pain
Recruiting
Strain Counter Strain and Conventional Stretching in School-aged Children With Mechanical Neck Pain Due to Prolong Screen Use
Mechanical Neck Pain
Recruiting
Effects of Alexander Technique Versus Feldenkrais Somatic Training in Patients With Text Neck Syndrome
Text Neck Syndrome
Recruiting
Longitudinal Stripping Massage vs. Percussion Device for Neck Pain: Ultrasound Study.
Chronic Neck Pain
RecruitingPhase 2
Effectiveness of Phenotype-based Pain Management Guidelines for Head and Neck Cancer Related Pain: a Pilot Study
Cancer Pain, Orofacial Pain
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gustav Dobos, Prof. MD study director
Department of Internal and Integrative Medicine, Kliniken Essen-Mitte, Faculty of Medicine, University Duisburg-Essen, Germany
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Craniosacral Therapy in people with Neck Pain, run by Universität Duisburg-Essen at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain intensity (time frame: week 8). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01526447, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Feb 2019.