Telemedicine to Manage Chronic Neck Pain at Home
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|ClinicalTrials.gov Identifier: NCT02736851|
Recruitment Status : Completed
First Posted : April 13, 2016
Last Update Posted : September 28, 2016
The aim of the study is to investigate if a home-based structured physician-directed, nurse-managed telemedicine program can increase adherence to a home exercise program and decrease neck pain and disability.
The study is carried out in 100 consecutive patients with chronic non-specific neck pain.
All patients referred to a rehabilitation Institute for an out-.patient visit complete a stretching exercise program and are instructed and encouraged to perform exercises regularly once at home. At the end of the rehabilitation, the patients are randomized into two groups of 50 patients each. Patients of the first Group are allocated to a home-based telemedicine (HBT), while those of the second group receive only the recommendation to continue exercising at home (Control group). The HBT intervention consists of fortnightly scheduled phone calls to patients over the 6-month course of the study. A nurse-tutor encourages the patient to perform regularly physical activity and prescribes exercises.
Adherence to home exercises is evaluated 15 days and 6 months after the end of the outpatient rehabilitation, while pain intensity and neck disability are assessed and compared in the two groups at entry and 6 months after the end of the outpatient rehabilitation .
|Condition or disease||Intervention/treatment||Phase|
|Adherence||Other: Home-based telemedicine group||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||94 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Home-Based Telemedicine Management of Patients Affected by Chronic Neck Pain|
|Study Start Date :||January 2009|
|Actual Primary Completion Date :||December 2013|
|Actual Study Completion Date :||June 2014|
No Intervention: Control group
Active Comparator: Home-based telemedicine group
Nurse-tutor support at home for 6 months
Other: Home-based telemedicine group
All patients referring to the rehabilitation service as out-patients underwent in-hospital a specific exercise program for the neck. Patients are instructed individually by a physical therapist to perform several types of exercises and, from the first rehabilitation session, are encouraged to exercise regularly at home. Written and illustrated material reporting home exercises is provided to all patients.
At the end of out-rehabilitation program, according to a randomization list, patients are randomized in 2 groups and those included in a Home-Based Telemedicine (HBT) program are followed up by a nurse tutor at home for a 6-month period.
- Change in Adherence as assessed by number of exercise sessions/week [ Time Frame: Change between 15 days and 6 months after the end of the outpatient rehabilitation ]Number of exercise sessions/week
- Change in Pain [ Time Frame: Change between entry and 6 months after the end of the outpatient rehabilitation ]Evaluation by a Visual Analogue Scale (VAS)
- Change in Disability [ Time Frame: Change between entry and 6 months after the end of the outpatient rehabilitation ]Evaluation by the Neck Disability Index
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02736851
|Study Director:||Simonetta Scalvini, MD||Fondazione Salvatore Maugeri|