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

Primary Purpose

Chronic Neck Pain

Status
Completed
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
relaxation exercise
ususal care
Sponsored by
Charite University, Berlin, Germany
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Chronic Neck Pain focused on measuring chronic neck pain, relaxation technique, comparative effectiveness research

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Charité Universitätsmedizin Berlin

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

usual care waiting list

relaxation exercise

Arm Description

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

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

Outcomes

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)

Secondary Outcome Measures

Mean pain intensity measured by the daily pain intensity on the NRS
Mean pain intensity measured weekly as the average pain intensity of the last seven days on a NRS
Pain acceptance
German version of Chronic Pain Acceptance Questionnaire
Stress
NRS
Suspected adverse reaction
Number of serious adverse event
medication intake
Number of sick leave days

Full Information

First Posted
December 18, 2013
Last Updated
July 20, 2017
Sponsor
Charite University, Berlin, Germany
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1. Study Identification

Unique Protocol Identification Number
NCT02019134
Brief Title
Effectiveness of App-based Relaxation for Patients With Chronic Neck Pain
Acronym
Relaxneck
Official Title
A Randomized Pragmatic Trial About the Effectiveness of an App Based Relaxation Technique for Patients With Chronic Neck Pain
Study Type
Interventional

2. Study Status

Record Verification Date
July 2017
Overall Recruitment Status
Completed
Study Start Date
March 31, 2014 (Actual)
Primary Completion Date
November 2016 (Actual)
Study Completion Date
February 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Charite University, Berlin, Germany

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Neck Pain
Keywords
chronic neck pain, relaxation technique, comparative effectiveness research

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
220 (Actual)

8. Arms, Groups, and Interventions

Arm Title
usual care waiting list
Arm Type
Active Comparator
Arm Description
Patients allocated to the usual care waiting list group will continue with their usual care without receiving any additional therapy
Arm Title
relaxation exercise
Arm Type
Experimental
Arm Description
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
Intervention Type
Behavioral
Intervention Name(s)
relaxation exercise
Other Intervention Name(s)
meditation
Intervention Description
relaxation exercise
Intervention Type
Other
Intervention Name(s)
ususal care
Other Intervention Name(s)
waiting list
Primary Outcome Measure Information:
Title
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 Outcome Measure Information:
Title
Mean pain intensity measured by the daily pain intensity on the NRS
Time Frame
6 months
Title
Mean pain intensity measured weekly as the average pain intensity of the last seven days on a NRS
Time Frame
3 and 6 months
Title
Pain acceptance
Description
German version of Chronic Pain Acceptance Questionnaire
Time Frame
3 and 6 months
Title
Stress
Description
NRS
Time Frame
3 and 6 months
Title
Suspected adverse reaction
Time Frame
3 and 6 month
Title
Number of serious adverse event
Time Frame
3 and 6 month
Title
medication intake
Time Frame
3 and 6 months
Title
Number of sick leave days
Time Frame
3 and 6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Claudia M Witt, Prof. Dr. med
Organizational Affiliation
Institute for Social Medicine, Epidemiology and Health Economics, Charité - Universitätsmedizin Berlin
Official's Role
Principal Investigator
Facility Information:
Facility Name
Charité Universitätsmedizin Berlin
City
Berlin
Country
Germany

12. IPD Sharing Statement

Citations:
PubMed Identifier
34994708
Citation
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.
Results Reference
derived
PubMed Identifier
25511185
Citation
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.
Results Reference
derived

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

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