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

Chronic Neck Pain Clinical Trial

— Relaxneck  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02019134
• Other study ID #: Relaxneck-13
• Status: Completed
• Phase: N/A
• First received: December 18, 2013
• Last updated: July 20, 2017
• Start date: March 31, 2014
• Est. completion date: February 2017

Study information

• Verified date: July 2017
• Source: Charite University, Berlin, Germany
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 220
• Est. completion date: February 2017
• Est. primary completion date: November 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Chronic Neck Pain
• Neck Pain

Intervention

Behavioral:
• relaxation exercise
relaxation exercise

Other:
• ususal care

Locations

Country	Name	City	State
Germany	Charité Universitätsmedizin Berlin	Berlin

Sponsors (1)

Lead Sponsor	Collaborator
Charite University, Berlin, Germany

Country where clinical trial is conducted

Germany, 

Outcome

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