Monika Rani1, Jaspreet Kaur1. 1. Department of Physiotherapy, Guru Jambheshwar University of Science & Technology, Hisar, Haryana, India.
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.
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.
Authors: Lehana Thabane; Jinhui Ma; Rong Chu; Ji Cheng; Afisi Ismaila; Lorena P Rios; Reid Robson; Marroon Thabane; Lora Giangregorio; Charles H Goldsmith Journal: BMC Med Res Methodol Date: 2010-01-06 Impact factor: 4.615