Clinical trial NCT02019498: Effectiveness of App-based Relaxation for Patients With Chronic Low Back Pain (Relaxback)
Official title: A Randomized Pragmatic Trial About the Effectiveness of an App Based Relaxation Technique for Patients With Chronic Low Back Pain
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Chronic Low Back Pain
Keywords: low back pain
relaxation
Lead sponsor: Charite University, Berlin, Germany
Sponsor class: OTHER
First posted: 2013-12-24
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL

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.

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

Primary outcomes:
measure: Primary outcome is the mean pain intensity over 3 months measured by the daily pain intensity on the Numeric rating scale (NRS)
timeFrame: 3 months
Secondary outcomes:
measure: Mean pain intensity measured by the daily pain intensity on the NRS
timeFrame: 6 months
measure: Mean pain intensity measured weekly as the average pain intensity of the last seven days on a NRS
timeFrame: 3 and 6 months
measure: Pain acceptance
timeFrame: 3 and 6 months
measure: Stress
timeFrame: 3 and 6 months
measure: Suspected adverse reaction
timeFrame: 3 and 6 months
measure: Number of Serious adverse event
timeFrame: 3 and 6 months
measure: medication intake
timeFrame: 3 and 6 months
measure: Number of sick leave days
timeFrame: 3 and 6 months
Other outcomes:
Locations:
city: Berlin
country: Germany
facility: Charité Universitätsmedizin Berlin Berlin, Germany
Study officials:
affiliation: Charite University, Berlin, Germany
name: Claudia M Witt, Prof. Dr. med.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.