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

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

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.

Study Overview

• Status: Terminated
• Conditions: Chronic Low Back Pain
• Intervention / Treatment: Behavioral: Relaxation exercise; Other: ususal care

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.

• Study Type: Interventional
• Enrollment (Actual): 50
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Germany
  • Berlin, Germany
    • Charité Universitätsmedizin Berlin Berlin, Germany

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: Charite University, Berlin, Germany
• Investigators: Principal Investigator: Claudia M Witt, Prof. Dr. med., Charite University, Berlin, Germany

Publications and helpful links

General Publications

• Blodt S, Pach D, Roll S, Witt CM. Effectiveness of app-based relaxation for patients with chronic low back pain (Relaxback) and chronic neck pain (Relaxneck): study protocol for two randomized pragmatic trials. Trials. 2014 Dec 15;15:490. doi: 10.1186/1745-6215-15-490.

Study record dates

Study Major Dates

• Study Start: April 1, 2014
• Primary Completion (Actual): February 1, 2016
• Study Completion (Actual): July 1, 2016

Study Registration Dates

• First Submitted: December 18, 2013
• First Submitted That Met QC Criteria: December 18, 2013
• First Posted (Estimate): December 24, 2013

Study Record Updates

• Last Update Posted (Estimate): August 3, 2016
• Last Update Submitted That Met QC Criteria: August 2, 2016
• Last Verified: February 1, 2016

More Information

Terms related to this study

• Keywords: low back pain; relaxation
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Back Pain; Low Back Pain
• Other Study ID Numbers: RelaxLWS-13