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

NCT ID: NCT02019498

Last Updated: 2016-08-03

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-04-30
• Study Completion Date: 2016-07-31

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Blinding Strategy: NONE

Study Groups

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

Group Type: EXPERIMENTAL

Relaxation exercise

Intervention Type: BEHAVIORAL

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

Usual care waiting list

Patients allocated to the usual care waiting list group will continue with their usual care without receiving any additional therapy

Group Type: ACTIVE_COMPARATOR

ususal care

Intervention Type: OTHER

Participants allocated to the usual care waiting list group will continue with their usual care without receiving any additional therapy

Interventions

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

Intervention Type: BEHAVIORAL

ususal care

Participants allocated to the usual care waiting list group will continue with their usual care without receiving any additional therapy

Intervention Type: OTHER

Other Intervention Names

meditation; waiting list

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Charite University, Berlin, Germany

OTHER

Sponsor Role: lead

Responsible Party

Claudia M. Witt

Prof. Dr. med.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Claudia M Witt, Prof. Dr. med.

Role: PRINCIPAL_INVESTIGATOR

Charite University, Berlin, Germany

Locations

Charité Universitätsmedizin Berlin Berlin, Germany

Berlin, , Germany

Countries

Germany

References

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.

Reference Type: DERIVED

PMID: 25511185 (View on PubMed)

Other Identifiers

RelaxLWS-13

Identifier Type: -

Identifier Source: org_study_id