Overview

This trial is active, not recruiting.

Condition chronic neck pain
Treatments relaxation exercise, ususal care
Sponsor Charite University, Berlin, Germany
Start date April 2014
End date October 2016
Trial size 220 participants
Trial identifier NCT02019134, Relaxneck-13

Summary

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking open label
Arm
(Active Comparator)
Patients allocated to the usual care waiting list group will continue with their usual care without receiving any additional therapy
ususal care waiting list
(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
relaxation exercise meditation
relaxation exercise

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)
time frame: 3 months

Secondary Outcomes

Measure
Mean pain intensity measured by the daily pain intensity on the NRS
time frame: 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
Pain acceptance
time frame: 3 and 6 months
Stress
time frame: 3 and 6 months
Suspected adverse reaction
time frame: 3 and 6 month
Number of serious adverse event
time frame: 3 and 6 month
medication intake
time frame: 3 and 6 months
Number of sick leave days
time frame: 3 and 6 months

Eligibility Criteria

Male or female participants from 18 years up to 65 years old.

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

Additional Information

Official title A Randomized Pragmatic Trial About the Effectiveness of an App Based Relaxation Technique for Patients With Chronic Neck Pain
Principal investigator Claudia M Witt, Prof. Dr. med
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.
Trial information was received from ClinicalTrials.gov and was last updated in July 2016.
Information provided to ClinicalTrials.gov by Charite University, Berlin, Germany.