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

NCT02019498 | Terminated

• 1 other identifier: RelaxLWS-13
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Low Back Pain

Keywords

low back pain; relaxation

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (8)

• 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

  3 and 6 months

• Stress

  3 and 6 months

• Suspected adverse reaction

  3 and 6 months

Study Arms (2)

relaxation

EXPERIMENTAL

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

Usual care waiting list

ACTIVE COMPARATOR

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

Other: ususal care

Interventions

Relaxation exercise 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

Also known as: meditation

relaxation

ususal care OTHER

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

Also known as: waiting list

Usual care waiting list

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• female or male
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Charite University, Berlin, Germany: lead

Study Sites (1)

Charité Universitätsmedizin Berlin Berlin, Germany

Berlin, Germany

Location

Related Publications (1)

• 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.

  PMID: 25511185 DERIVED

MeSH Terms

Conditions

Low Back Pain

Interventions

Meditation; Waiting Lists

Condition Hierarchy (Ancestors)

Back Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Mind-Body Therapies; Complementary Therapies; Therapeutics; Spiritual Therapies; Relaxation Therapy; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities; Appointments and Schedules; Organization and Administration; Health Services Administration

Study Officials

• Claudia M Witt, Prof. Dr. med.

  Charite University, Berlin, Germany

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. Dr. med.

Study Record Dates

• First Submitted: December 18, 2013
• First Posted: December 24, 2013
• Study Start: April 1, 2014
• Primary Completion: February 1, 2016
• Study Completion: July 1, 2016
• Last Updated: August 3, 2016

Record last verified: 2016-02

Locations

DE (1)