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Completed

NCT Number: NCT01526447

Effects of Craniosacral Therapy on Chronic Neck Pain

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.

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Key information

Conditions

Neck Pain Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Kliniken Essen-Mitte

Essen, North Rhine-Westphalia, 45276, Germany

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Craniosacral Therapy

Procedure

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 Therapy

Procedure

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

Primary outcomes

  1. Pain intensity

    Time frame: week 8

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

Secondary outcomes

  1. 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)

  2. Pressure pain threshold

    Time frame: week 8

    Pressure pain threshold (PPT) measured with an algometer on predefined muscles and the pain maximum

  3. Disability

    Time frame: week 8

    Measured by the Neck Disability Indx (NDI)

  4. Quality of life

    Time frame: week 8

    Measured by the Short-Form Health Survey (SF-12)

  5. Well being

    Time frame: week 8

    Measured by the Questionnaire for Assessing Subjective Physical Well-Being (FEW-16)

  6. Anxiety and depression

    Time frame: week 8

    Measured by the Hospital Anxiety and Depression Scale (HADS)

  7. Stress perception

    Time frame: week 8

    Measured by the Perceived Stress Questionnaire (PSQ-20)

  8. Pain acceptance

    Time frame: week 8

    Measured by the Emotional and Rational Disease Acceptance Questionnaire (ERDA)

  9. Body awareness

    Time frame: week 8

    Measured by the Scale of Body Connection (SBC)

  10. Global Impression

    Time frame: week 8

    Measured by the Patient Global Impression of Improvement Questionnaire (PGI-I)

  11. Safety

    Time frame: week 8

    All adverse events are recorded

Sponsors and collaborators

Lead sponsor

Universität Duisburg-Essen

Other

Registry information

Official study title

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

Acronym: CranioS

Important dates

Study start
2012
Primary completion
2012
Study completion
2013
First posted
Feb 3, 2012
Registry last updated
Feb 21, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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