Effectiveness of App-based Relaxation for Patients With Chronic Low Back Pain (Relaxback)

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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A Randomized Pragmatic Trial About the Effectiveness of an App Based Relaxation Technique for Patients With Chronic Low Back Pain

Conditions
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Chronic Low Back Pain

Intervention / Treatment
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* Behavioral: Relaxation exercise
* Other: ususal care


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: female or male 18-65 years of age chronic low back pain for at least 12 weeks if additional back pain is reported, low back pain has to be predominant intensity of the average low back 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) 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 an App physical and mental ability to participate in the study written and oral informed consent Exclusion Criteria: low back 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 low back 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: relaxation<br>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<br>* 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<br>* Other names: meditation;|
| Active Comparator: Usual care waiting list<br>Patients allocated to the usual care waiting list group will continue with their usual care without receiving any additional therapy | Other: ususal care<br>* Participants allocated to the usual care waiting list group will continue with their usual care without receiving any additional therapy<br>* Other names: waiting list;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Primary outcome is the mean pain intensity over 3 months measured by the daily pain intensity on the Numeric rating scale (NRS) |  | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean pain intensity measured by the daily pain intensity on the NRS |  | 6 months | 
| Mean pain intensity measured weekly as the average pain intensity of the last seven days on a NRS |  | 3 and 6 months | 
| Pain acceptance | German version of Chronic Pain Acceptance Questionnaire | 3 and 6 months | 
| Stress | NRS | 3 and 6 months | 
| Suspected adverse reaction |  | 3 and 6 months | 
| Number of Serious adverse event |  | 3 and 6 months | 
| medication intake |  | 3 and 6 months | 
| Number of sick leave days |  | 3 and 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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low back pain, relaxation