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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| usual care waiting list | Active Comparator | Patients allocated to the usual care waiting list group will continue with their usual care without receiving any additional therapy |
|
| relaxation exercise | 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| relaxation exercise | Behavioral | relaxation exercise |
|
| Measure | Description | Time Frame |
|---|---|---|
| Primary outcome is the mean pain intensity over 3 months measured by the daily pain intensity on the Numeric rating scale (NRS) | 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| Mean pain intensity measured by the daily pain intensity on the NRS | 6 months | |
| Mean pain intensity measured weekly as the average pain intensity of the last seven days on a NRS | 3 and 6 months | |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Claudia M Witt, Prof. Dr. med | Institute for Social Medicine, Epidemiology and Health Economics, Charité - Universitätsmedizin Berlin | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Charité Universitätsmedizin Berlin | Berlin | Germany |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34994708 | Derived | Pach D, Blodt S, Wang J, Keller T, Bergmann B, Rogge AA, Barth J, Icke K, Roll S, Witt CM. App-Based Relaxation Exercises for Patients With Chronic Neck Pain: Pragmatic Randomized Trial. JMIR Mhealth Uhealth. 2022 Jan 7;10(1):e31482. doi: 10.2196/31482. | |
| 25511185 | Derived | Blodt S, Pach D, Roll S, Witt CM. Effectiveness of app-based relaxation for patients with chronic low back pain (Relaxback) and chronic neck pain (Relaxneck): study protocol for two randomized pragmatic trials. Trials. 2014 Dec 15;15:490. doi: 10.1186/1745-6215-15-490. |
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| ID | Term |
|---|---|
| D019122 | Meditation |
| D014850 | Waiting Lists |
| ID | Term |
|---|---|
| D026441 | Mind-Body Therapies |
| D000529 | Complementary Therapies |
| D013812 | Therapeutics |
| D026443 | Spiritual Therapies |
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| ususal care | Other |
|
|
| Pain acceptance |
German version of Chronic Pain Acceptance Questionnaire |
| 3 and 6 months |
| Stress | NRS | 3 and 6 months |
| Suspected adverse reaction | 3 and 6 month |
| Number of serious adverse event | 3 and 6 month |
| medication intake | 3 and 6 months |
| Number of sick leave days | 3 and 6 months |
| D012064 |
| Relaxation Therapy |
| D001521 | Behavior Therapy |
| D011613 | Psychotherapy |
| D004191 | Behavioral Disciplines and Activities |
| D001071 | Appointments and Schedules |
| D009934 | Organization and Administration |
| D006298 | Health Services Administration |