Effectiveness of App-based Relaxation for Patients With Chronic Neck Pain

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.

Inclusion criteria

• female or male
• 18-65 years of age
• chronic neck pain for at least 12 weeks
• if additional back pain is reported, neck pain has to be predominant
• intensity of the average neck pain ≥ 4 on the numeric rating scale (NRS) in the last week
• presence of a smartphone (iphone, Android phone) and willingness to do data entry through a smart phone application (App)
• physical and mental ability to participate in the study
• willingness to be randomized, to apply study intervention according to the protocol, to complete the baseline questionnaire in paper form and electronic questionnaires and diaries provided by a smart phone application
• written and oral informed consent

Exclusion criteria

• neck pain caused by a known malignant disease
• neck pain caused by trauma
• known rheumatic disorder
• history or planned surgery of the spinal column of the neck in the next 6 months
• known neurological symptoms e.g radicular symptoms because of prolapsed vertebral disc
• regular intake of analgesics (>1x per week) because of additional diseases
• intake of centrally acting analgesics
• known severe acute or chronic disorder, that do not allow participation in the therapy
• other known diseases, that do not allow participation in the therapy
• known alcohol or substance abuse
• no sufficient German language skills
• current application for a benefit
• participation in another clinical trial during six months before the study and parallel to the study
• conducting regular relaxation techniques, mindfulness training or meditation six weeks before the study or planned in the next 6 months