Effectiveness of App-based Relaxation for Patients With Chronic Neck Pain (Relaxneck)

July 20, 2017 updated by: Claudia M. Witt, Charite University, Berlin, Germany

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

The aim of the pragmatic randomized study is to evaluate whether additional relaxation technique is more effective in the reduction of chronic neck pain compared to usual care alone.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Objective: To evaluate whether additional relaxation technique is more effective in the reduction of chronic neck 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) neck 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)

220

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Berlin, Germany
        • Charité Universitätsmedizin Berlin

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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 neck pain for at least 12 weeks
  • if additional back pain is reported, neck pain has to be predominant
  • intensity of the average neck 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)
  • physical and mental ability to participate in the study
  • 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 a smart phone application
  • written and oral informed consent

Exclusion Criteria:

  • neck 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 neck 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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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
Other Names:
  • waiting list
Experimental: 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
Behavioral: relaxation exercise
relaxation exercise
Other Names:
  • meditation

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)
Time Frame: 3 months
3 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mean pain intensity measured by the daily pain intensity on the NRS
Time Frame: 6 months
6 months
Mean pain intensity measured weekly as the average pain intensity of the last seven days on a NRS
Time Frame: 3 and 6 months
3 and 6 months
Pain acceptance
Time Frame: 3 and 6 months
German version of Chronic Pain Acceptance Questionnaire
3 and 6 months
Stress
Time Frame: 3 and 6 months
NRS
3 and 6 months
medication intake
Time Frame: 3 and 6 months
3 and 6 months
Number of sick leave days
Time Frame: 3 and 6 months
3 and 6 months
Suspected adverse reaction
Time Frame: 3 and 6 month
3 and 6 month
Number of serious adverse event
Time Frame: 3 and 6 month
3 and 6 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Charite University, Berlin, Germany

Investigators

  • Principal Investigator: Claudia M Witt, Prof. Dr. med, Institute for Social Medicine, Epidemiology and Health Economics, Charité - Universitätsmedizin Berlin

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 31, 2014

Primary Completion (Actual)

November 1, 2016

Study Completion (Actual)

February 1, 2017

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 (Actual)

July 21, 2017

Last Update Submitted That Met QC Criteria

July 20, 2017

Last Verified

July 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Relaxneck-13

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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