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

NCT00665236 is a NA study that has completed, run by University of North Carolina, Chapel Hill. The registered enrollment target is 66 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (95% lower). According to ClinicalTrials.gov, the official US trial registry.

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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 finished NCT00665236 record still lists

NCT00665236 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 66 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (95% lower).

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

NCT00665236 does not publish any study locations in the registry export this page uses.

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.

How this trial's enrollment target compares

Where NCT00665236's enrollment target sits among peer trials

66 1139th of 2000 higher than 857 of 2,000 other NA trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT00665236, the US trial registry maintained by the National Library of Medicine. NCT00665236 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.