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

Chronic Low Back Pain Clinical Trial

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

Status Terminated

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Back Pain
• Chronic Low Back Pain
• Low Back Pain

• NCT number: NCT02019498
• Study type: Interventional
• Source: Charite University, Berlin, Germany
• Status: Terminated
• Phase: N/A
• Start date: April 2014
• Completion date: July 2016