Craniosacral therapy for migraine: Protocol development for an exploratory controlled clinical trial

Table 3 Summary of Measures and Timing of Administration for Clinical Feasibility Trial of Craniosacral Therapy, 2006–2008

	Week 0	Weeks 1 to 8	Weeks 8 to 16	Weeks 16 to 20
Variable or Instrument	Baseline Assessments	Baseline with Usual Care	Usual Care plus CST or LSSM	Post-treatment Assessments
Demographic/Clinical Data	Week 0
	ICHD* Diagnosis	Week 0
Functional status – MOS SF-36	Week 0			Week 20
Expectation of benefit/Credibility †			(post 1^st treatment)
Headache QOL – HIT-6 §	Week 0	Week 8		Week 16
Headache Diary: Frequency		Daily	Daily
Perceived clinical change		Week 8		Week 16
Headache disability – MIDAS #	Week 0			Week 20
Headache Diary: Intensity and Duration		Daily	Daily	Daily
Headache Diary: Medication Use/Cost		Daily	Daily	Daily
Headache Diary: Health care visits		Daily	Daily	Daily
Satisfaction with care	Week 0	Week 8		Weeks 16, 20
Blood pressure and heart rate	Week 0		Weekly
Therapist – Subject Interaction Analysis Videotaping Encounters**			Weeks 9,11, 13 & 15

* International Classification of Headache Disorders, defined by expert members of the International Headache Society
† Based on a measure developed by Borkovec and Nau to measure credibility of psychological interventions [38,39].
§ Headache Impact Test was developed to measure headache-related quality of life [33].
# Migraine disability assessment score assesses the number of days of missed work or school in the past 3 months [36,37].
† Noldus 'Observer' Video-Pro System software facilitates the analysis of videotaped behaviors [42,43].

ISSN: 2662-7671