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

Chronic Low Back Pain Clinical Trial

— Relaxback  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02019498
• Other study ID #: RelaxLWS-13
• Status: Terminated
• Phase: N/A
• First received: December 18, 2013
• Last updated: August 2, 2016
• Start date: April 2014
• Est. completion date: July 2016

Study information

• Verified date: February 2016
• Source: Charite University, Berlin, Germany
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Ethics Committee
• Study type: Interventional

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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 50
• Est. completion date: July 2016
• Est. primary completion date: February 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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 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

Intervention

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

Locations

Country	Name	City	State
Germany	Charité Universitätsmedizin Berlin Berlin, Germany	Berlin

Sponsors (1)

Lead Sponsor	Collaborator
Charite University, Berlin, Germany

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Primary outcome is the mean pain intensity over 3 months measured by the daily pain intensity on the Numeric rating scale (NRS)		3 months	No
Secondary	Mean pain intensity measured by the daily pain intensity on the NRS		6 months	No
Secondary	Mean pain intensity measured weekly as the average pain intensity of the last seven days on a NRS		3 and 6 months	No
Secondary	Pain acceptance	German version of Chronic Pain Acceptance Questionnaire	3 and 6 months	No
Secondary	Stress	NRS	3 and 6 months	No
Secondary	Suspected adverse reaction		3 and 6 months	Yes
Secondary	Number of Serious adverse event		3 and 6 months	Yes
Secondary	medication intake		3 and 6 months	No
Secondary	Number of sick leave days		3 and 6 months	No