NCT02019498

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

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

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 50 (actual)
• Sponsor: Charite University, Berlin, Germany · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

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

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.

Conditions

• Chronic Low Back Pain

Interventions

Type	Name	Description
BEHAVIORAL	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
OTHER	ususal care	Participants allocated to the usual care waiting list group will continue with their usual care without receiving any additional therapy

Timeline

• Start date: 2014-04-01
• Primary completion: 2016-02-01
• Completion: 2016-07-01
• First posted: 2013-12-24
• Last updated: 2016-08-03

Locations

1 site across 1 country: Germany