ABSTRACT
Background
Cervicogenic headache is a secondary headache which leads to decreased functional activity, quality of life and functional disability.
Objective
To determine the feasibility and acceptability of different physiotherapy interventions in the management of cervicogenic headache and to determine sample size for a full trial.
Trial design
A pilot randomized controlled trial.
Settings
Various physiotherapy outpatient department.
Methods
Participants suffering from cervicogenic headache with age 20- 60 years were randomly allocated into four groups. Sessions were given over 4 weeks 4 times a week (16 sessions). The primary outcomes were feasibility of participant recruitment, assessment procedure, retention, adherence, and acceptability. The secondary outcomes were headache impact test-6 for a headache disability, headache diary for headache intensity, frequency, duration, and neck disability index for neck pain, disability measured at baseline, 4th week, and follow up after 1 month.
Result
178 subjects were screened based on selection criteria. Out of them, 93 (52%) were eligible and 80 (86%) participated in the study. 96.25% of participants completed the final 8-week assessment. Overall 93.75% of participants completed the entire assessment item across all time points. 95% completed all treatment sessions. 97.5–100% of participants were satisfied with the treatment protocol. No adverse effects were reported by participants. Based on the data obtained from the pilot trial, sample size was determined as 35 participants in each group.
Conclusion
The results indicate that the trial methodology and intervention are feasible for implementing a full-powered randomized controlled trial to determine the effectiveness of physiotherapy intervention in the management of cervicogenic headache.
Ethical approval and clinical trial registration
This study was approved by the Institutional Ethical Committee vide letter number (PTY/2018/710A), and was registered in the trials registry of India (CTRI) (Registration Number CTRI/2018/12/016717).
Disclosure statement
No potential conflict of interest was reported by the authors.
Additional information
Funding
Notes on contributors
Monika Rani
Monika Rani is a research scholar physiotherapy student in Guru Jambheshwar University of Science & Technology, Hisar(A grade NAAC accredited, state government university). Her interest in research is neurological physiotherapy and evidence based practice. she has published articles in peer reviewed journals and presents papers in national and international conferences.
Jaspreet Kaur
Jaspreet Kaur is presently working as associate professor in Department of Physiotherapy, Guru Jambheshwar University of Science and technology (A grade NAAC accredited, state government university). She has done PhD in Physiotherapy and has more than 15 years of teaching and research experience. Presently she is supervising 05 PhD research scholars. She has guided more than 30 MPT dissertations. she has more than 41 publications and number of paper presentations. she has also delivered lectures as resource person in many national and international conferences.