NCT01526447

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
54

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Feb 2012

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 1, 2012

Completed
Same day until next milestone

Study Start

First participant enrolled

February 1, 2012

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 3, 2012

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2012

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2013

Completed
Last Updated

February 21, 2019

Status Verified

February 1, 2019

Enrollment Period

10 months

First QC Date

February 1, 2012

Last Update Submit

February 20, 2019

Conditions

Neck Pain

Keywords

Neck PainCraniosacral ManipulationComplementary TherapiesRandomized Controlled TrialSensory ThresholdsQuality of Life

Outcome Measures

Primary Outcomes (1)

  • Pain intensity

    Pain intensity on a 100mm visual analogue scale (VAS)

    week 8

Secondary Outcomes (11)

  • Pain intensity in motion

    week 8

  • Pressure pain threshold

    week 8

  • Disability

    week 8

  • Quality of life

    week 8

  • Well being

    week 8

  • +6 more secondary outcomes

Study Arms (2)

Craniosacral Therapy (CST)

EXPERIMENTAL

Each participant of the experimental group receives 8 Craniosacral Therapy units once a week of 45 minutes.

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.

Procedure: Sham Craniosacral Therapy

Interventions

Craniosacral TherapyPROCEDURE

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

Craniosacral Therapy (CST)
Sham Craniosacral TherapyPROCEDURE

Standardized sham protocol: Placing hands on various parts of the clothed body for two minutes each time without therapeutic intention

Sham Craniosacral Therapy (SHAM)

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kliniken Essen-Mitte

Essen, North Rhine-Westphalia, 45276, Germany

Location

Related Publications (2)

  • 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.

    PMID: 25453528BACKGROUND

  • Haller 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.

    PMID: 26340656RESULT

MeSH Terms

Conditions

Neck Pain

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Gustav Dobos, Prof. MD

    Department of Internal and Integrative Medicine, Kliniken Essen-Mitte, Faculty of Medicine, University Duisburg-Essen, Germany

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Postdoctoral Research Fellow

Study Record Dates

First Submitted

February 1, 2012

First Posted

February 3, 2012

Study Start

February 1, 2012

Primary Completion

December 1, 2012

Study Completion

April 1, 2013

Last Updated

February 21, 2019

Record last verified: 2019-02

Locations

DE(1)