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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

220 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-03-31

Study Completion Date

2017-02-28

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Chronic Neck Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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usual care waiting list

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

Group Type ACTIVE_COMPARATOR

ususal care

Intervention Type OTHER

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

Group Type EXPERIMENTAL

relaxation exercise

Intervention Type BEHAVIORAL

relaxation exercise

Interventions

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relaxation exercise

Intervention Type BEHAVIORAL

ususal care

Intervention Type OTHER

Other Intervention Names

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meditation waiting list

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No