Effectiveness of App-based Relaxation for Patients With Chronic Neck Pain (Relaxneck)
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
|Official Title:||A Randomized Pragmatic Trial About the Effectiveness of an App Based Relaxation Technique for Patients With Chronic Neck Pain|
- Primary outcome is the mean pain intensity over 3 months measured by the daily pain intensity on the Numeric rating scale (NRS) [ Time Frame: 3 months ]
- Mean pain intensity measured by the daily pain intensity on the NRS [ Time Frame: 6 months ]
- Mean pain intensity measured weekly as the average pain intensity of the last seven days on a NRS [ Time Frame: 3 and 6 months ]
- Pain acceptance [ Time Frame: 3 and 6 months ]German version of Chronic Pain Acceptance Questionnaire
- Stress [ Time Frame: 3 and 6 months ]NRS
- Suspected adverse reaction [ Time Frame: 3 and 6 month ]
- Number of serious adverse event [ Time Frame: 3 and 6 month ]
- medication intake [ Time Frame: 3 and 6 months ]
- Number of sick leave days [ Time Frame: 3 and 6 months ]
|Study Start Date:||April 2014|
|Estimated Study Completion Date:||January 2017|
|Estimated Primary Completion Date:||October 2016 (Final data collection date for primary outcome measure)|
Active Comparator: usual care waiting list
Patients allocated to the usual care waiting list group will continue with their usual care without receiving any additional therapy
Other: ususal care
Other Name: waiting list
Experimental: relaxation exercise
Participants allocated to the relaxation group will apply daily but at least five days a week a 15-minutes relaxation exercise, guided by a smartphone application (App). On a daily basis, participants can select one out of the three exercises (guided imagery, mindfulness based training, autogenic training) which they want to apply
Behavioral: relaxation exercise
Other Name: meditation
Objective: To evaluate whether additional relaxation technique is more effective in the reduction of chronic neck pain compared to usual care alone.
Study design: Open single-centered randomized two-armed pragmatic trial.
Participants: 220 patients aged 18-65 years with chronic (>12 weeks) neck pain and a mean pain score ≥ 4 on a Numeric Rating scale (NRS) in the last week before randomization who will be randomly allocated to two groups (relaxation, usual care alone as waiting list)
Intervention: Participants apply either a daily 15-minute relaxation exercise guided by a smartphone application ("app"). or apply no additional intervention. The exercise should be applied daily, (minimally, five days per week) for 6 months. The app contains audios to guide autogenic training, muscle relaxation training and guided imagery. On a daily basis, participants can select one of the three exercises which they want to apply.
Main outcome measure: The primary outcome is the mean pain intensity after 3 months measured by the daily pain intensity on the NRS.
Please refer to this study by its ClinicalTrials.gov identifier: NCT02019134
|Charité Universitätsmedizin Berlin|
|Principal Investigator:||Claudia M Witt, Prof. Dr. med||Institute for Social Medicine, Epidemiology and Health Economics, Charité - Universitätsmedizin Berlin|