The aim of the pragmatic randomized study is to evaluate whether additional relaxation technique is more effective in the reduction of chronic low back pain compared to usual care alone.
Objective: To evaluate whether additional relaxation technique is more effective in the reduction of chronic low back 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) low back 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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Masking
NONE
Enrollment
50
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
Participants allocated to the usual care waiting list group will continue with their usual care without receiving any additional therapy
Charité Universitätsmedizin Berlin Berlin, Germany
Berlin, Germany
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
German version of Chronic Pain Acceptance Questionnaire
Time frame: 3 and 6 months
Stress
NRS
Time frame: 3 and 6 months
Suspected adverse reaction
Time frame: 3 and 6 months
Number of Serious adverse event
Time frame: 3 and 6 months
medication intake
Time frame: 3 and 6 months
Number of sick leave days
Time frame: 3 and 6 months
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