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

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified September 2013 by Charite University, Berlin, Germany
Sponsor:
Information provided by (Responsible Party):
Claudia M. Witt, Charite University, Berlin, Germany
ClinicalTrials.gov Identifier:
NCT02019134
First received: December 18, 2013
Last updated: March 28, 2014
Last verified: September 2013
  Purpose

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.


Condition Intervention
Chronic Neck Pain
Behavioral: relaxation exercise
Other: ususal care

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Official Title: A Randomized Pragmatic Trial About the Effectiveness of an App Based Relaxation Technique for Patients With Chronic Neck Pain

Resource links provided by NLM:


Further study details as provided by Charite University, Berlin, Germany:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Mean pain intensity measured by the daily pain intensity on the NRS [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Mean pain intensity measured weekly as the average pain intensity of the last seven days on a NRS [ Time Frame: 3 and 6 months ] [ Designated as safety issue: No ]
  • Pain acceptance [ Time Frame: 3 and 6 months ] [ Designated as safety issue: No ]
    German version of Chronic Pain Acceptance Questionnaire

  • Stress [ Time Frame: 3 and 6 months ] [ Designated as safety issue: No ]
    NRS

  • Suspected adverse reaction [ Time Frame: 3 and 6 month ] [ Designated as safety issue: Yes ]
  • Number of serious adverse event [ Time Frame: 3 and 6 month ] [ Designated as safety issue: Yes ]
  • medication intake [ Time Frame: 3 and 6 months ] [ Designated as safety issue: No ]
  • Number of sick leave days [ Time Frame: 3 and 6 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 220
Study Start Date: April 2014
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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 Name: meditation

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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02019134

Locations
Germany
Charité Universitätsmedizin Berlin Not yet recruiting
Berlin, Germany
Principal Investigator: Claudia M Witt, Prof. Dr.         
Sponsors and Collaborators
Charite University, Berlin, Germany
Investigators
Principal Investigator: Claudia M Witt, Prof. Dr. med Institute for Social Medicine, Epidemiology and Health Economics, Charité - Universitätsmedizin Berlin
  More Information

No publications provided

Responsible Party: Claudia M. Witt, Prof Dr. Claudia M. Witt, Charite University, Berlin, Germany
ClinicalTrials.gov Identifier: NCT02019134     History of Changes
Other Study ID Numbers: Relaxneck-13
Study First Received: December 18, 2013
Last Updated: March 28, 2014
Health Authority: Germany: Ethics Committee

Keywords provided by Charite University, Berlin, Germany:
chronic neck pain
relaxation technique
comparative effectiveness research

Additional relevant MeSH terms:
Neck Pain
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms

ClinicalTrials.gov processed this record on October 19, 2014