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NCT00665236 · ClinicalTrials.gov registry record · NA

Craniosacral Therapy in Migraine: A Feasibility Study

A NA study, sponsored by University of North Carolina, Chapel Hill.

Completed
Registry status
NA
Development phase
66
Enrollment target

NCT00665236 is a NA study that has completed, run by University of North Carolina, Chapel Hill. The registered enrollment target is 66 participants.

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The verdict

NCT00665236, a NA study, has completed, sponsored by University of North Carolina, Chapel Hill.

COMPLETED
Registry status
NA
Development phase
66 participants
Enrollment target

Study Summary

Treatment of migraine continues to be a major health problem today, despite many new pharmacological therapies. Limited clinical experience suggests that craniosacral therapy (CST) may be effective in the treatment of headache, including migraine. The primary aim of this proposal is to gather quality preliminary data on the usefulness of CST as an adjunct to conventional care for patients with migraine and to determine the feasibility of a larger, randomized clinical trial of CST in patients with migraine. Craniosacral therapists use a technique of gentle palpation of the head, neck and spine to release restrictions in cranial and peri-spinal tissues that are believed to contribute to a variety of health problems including headache. It is estimated that more than 2 million visits to CST practitioners are made each year, with more than 10 per cent of those for the complaint of headache. There has been no rigorous research examining the usefulness of CST for patients with migraine despite the impression of beneficial effects. Our limited preliminary data show significant, sustained benefit of CST in a small group of patients with migraine. The First Specific Aim is to determine the feasibility of developing a clinical trial comparing craniosacral therapy versus low-strength static magnets (attention-control complementary therapy) as a treatment for preventing migraine headaches. Patients with migraine, with or without aura, under care of a neurologist will be studied. After an 8-week baseline period, they will be randomized to one of two groups: 1) usual medical care plus 8 weeks of CST; or 2) usual medical care plus 8 weeks of attention-control complementary treatment. Primary outcome measures will include: 1) headache-related quality of life, 2) headache frequency, and 3) perceived benefit in those receiving treatment. The Second Specific Aim is to identify relevant secondary outcomes associated with usual care plus adjunctive craniosacral therapy for migraine. Data

Interventions

  • OTHER Craniosacral therapy
  • PROCEDURE Low strength static magnets

Trial Details

FieldValue
Enrollment Target 66 participants
Start Date 2006-09
Est. Completion 2010-09
Phase NA

What the Registry Record Tells You About NCT00665236

The ClinicalTrials.gov registry entry for NCT00665236 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 66 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of North Carolina, Chapel Hill, which has 1,109 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 2 interventions - of which Craniosacral therapy is the first listed.

NCT00665236 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT00665236 about?

NCT00665236 is a clinical study titled "Craniosacral Therapy in Migraine: A Feasibility Study". Treatment of migraine continues to be a major health problem today, despite many new pharmacological therapies. Limited clinical experience suggests that craniosacral therapy (CST) may be effective in the treatment of headache, including migraine. The primary aim of this proposal is to gather qualit...

What is the current status of trial NCT00665236?

This trial is currently completed. It is a NA study. The enrollment target is 66 participants. The study started on 2006-09. Estimated completion is 2010-09.

What interventions are being tested in trial NCT00665236?

The interventions under investigation include: Craniosacral therapy (OTHER), Low strength static magnets (PROCEDURE).

Who is sponsoring clinical trial NCT00665236?

This trial is sponsored by University of North Carolina, Chapel Hill, which has 1,109 total clinical trials registered on ClinicalTrials.gov.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.