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Telemedicine to Manage Chronic Neck Pain at Home

Primary Purpose

Adherence

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Home-based telemedicine group
Sponsored by
Fondazione Salvatore Maugeri
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Adherence focused on measuring disability, home, stretching exercises

Eligibility Criteria

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

Inclusion Criteria:

  • chronic non-specific neck pain duration more than 6 months.

Exclusion Criteria:

  • pain duration less than 6 months
  • willingness to sign the informed consent form (unable to read or write)
  • cognitive deficit (e.g. Alzheimer disease or senile dementia)
  • patient unable to attend all sessions of exercises
  • inflammatory rheumatic diseases
  • history of fracture or operations around the neck region
  • neurological diseases that may lead to neck pain, infections or tumours
  • pregnancy
  • rehabilitation sessions for neck pain since less than 12 months.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    No Intervention

    Active Comparator

    Arm Label

    Control group

    Home-based telemedicine group

    Arm Description

    Usual care

    Nurse-tutor support at home for 6 months

    Outcomes

    Primary Outcome Measures

    Change in Adherence as assessed by number of exercise sessions/week
    Number of exercise sessions/week

    Secondary Outcome Measures

    Change in Pain
    Evaluation by a Visual Analogue Scale (VAS)
    Change in Disability
    Evaluation by the Neck Disability Index

    Full Information

    First Posted
    March 16, 2016
    Last Updated
    September 27, 2016
    Sponsor
    Fondazione Salvatore Maugeri
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02736851
    Brief Title
    Telemedicine to Manage Chronic Neck Pain at Home
    Official Title
    Home-Based Telemedicine Management of Patients Affected by Chronic Neck Pain
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    September 2016
    Overall Recruitment Status
    Completed
    Study Start Date
    January 2009 (undefined)
    Primary Completion Date
    December 2013 (Actual)
    Study Completion Date
    June 2014 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Fondazione Salvatore Maugeri

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    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 .
    Detailed Description
    Systematic reviews have concluded that exercises taught individually and prescribed to be performed at home, are effective in decreasing neck pain and avoiding recurrence of neck pain (re-exacerbations) if patients adhere to the home exercise program. Conversely, inadequate adherence to a home-based exercise program reduces the treatment's efficacy. Telemedicine is already employed in many fields of medicine to evaluate health status, treatment, education, and to monitor patients' care needs but not in management of the patients with chronic neck pain. Studies available in the literature have not yet clearly defined if a phone surveillance program is effective in decreasing pain in these patients. Conversely, we think that telemedicine may be a useful tool for physicians in management of chronic neck pain because it can increase adherence to home exercises program thus reducing neck pain and disability in these patients. To verify this hypothesis we perform this prospective randomized controlled study. The study is performed in 100 consecutive patients with chronic non-specific neck pain referred to the outpatient facility of our Rehabilitation Department. Patients have to be > 18 years and with neck pain duration more than 6 months. Exclusion criteria are: pain duration < 6 months, cognitive deficit, history of fracture or operations around the neck region, presence of inflammatory rheumatic diseases, neurological diseases that could lead to neck pain, infections or tumors, pregnancy, previous rehabilitation for neck pain undergone within the last 12 months, and inability to attend all exercise sessions of our outpatient rehabilitation program. All patients have to complete, as outpatients, an exercise program consisting of 10 sessions, spread over a 2-week period (5 days/week), and including six stretching exercises for the neck. Patients are instructed individually by a physical therapist on how to perform each exercise and, after the first rehabilitation session, are encouraged to exercise regularly at home. Written and illustrated material explaining the home exercises are provided to all patients. At the end of the outpatient rehabilitation program, patients are randomized (using a randomization list provided by the statistical consultant) into two groups of 50 patients each. Patients of the first group are allocated to a home-based telemedicine (HBT) program for 6 months (HBT group), while those of the second group receive only recommendations to continue the exercises 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 collects information on: disease status, pain, disability, prodromal symptoms of exacerbation, number of home exercise sessions performed, and use of non-steroidal anti-inflammatory drugs. In consultation with the physiatrist, the nurse gives advice on solutions for persistent pain and any symptoms of exacerbation. The patient is always encouraged to perform regularly the physical activity and the exercises prescribed. The physiatrist is involved as a second-opinion consultant. The patients are evaluated at entry and 6 months after the end of the outpatient rehabilitation by the same qualified physiatrist. At entry, scales of demonstrated reliability, validity and sensitivity are administered to assess comorbidity (evaluated with Cumulative Illness Rating Scale-Geriatrics), pain severity (10-point analogue scale), neck range of motion (manual goniometer), and neck disability (Neck Disability Index). Adherence to home exercises is evaluated 15 days and 6 months after the end of the outpatient rehabilitation and is self-reported. Differences in adherence to home exercises, pain intensity and neck disability, between baseline and 6-month follow up, are assessed and compared in the two groups.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Adherence
    Keywords
    disability, home, stretching exercises

    7. Study Design

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

    8. Arms, Groups, and Interventions

    Arm Title
    Control group
    Arm Type
    No Intervention
    Arm Description
    Usual care
    Arm Title
    Home-based telemedicine group
    Arm Type
    Active Comparator
    Arm Description
    Nurse-tutor support at home for 6 months
    Intervention Type
    Other
    Intervention Name(s)
    Home-based telemedicine group
    Intervention Description
    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.
    Primary Outcome Measure Information:
    Title
    Change in Adherence as assessed by number of exercise sessions/week
    Description
    Number of exercise sessions/week
    Time Frame
    Change between 15 days and 6 months after the end of the outpatient rehabilitation
    Secondary Outcome Measure Information:
    Title
    Change in Pain
    Description
    Evaluation by a Visual Analogue Scale (VAS)
    Time Frame
    Change between entry and 6 months after the end of the outpatient rehabilitation
    Title
    Change in Disability
    Description
    Evaluation by the Neck Disability Index
    Time Frame
    Change between entry and 6 months after the end of the outpatient rehabilitation

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: chronic non-specific neck pain duration more than 6 months. Exclusion Criteria: pain duration less than 6 months willingness to sign the informed consent form (unable to read or write) cognitive deficit (e.g. Alzheimer disease or senile dementia) patient unable to attend all sessions of exercises inflammatory rheumatic diseases history of fracture or operations around the neck region neurological diseases that may lead to neck pain, infections or tumours pregnancy rehabilitation sessions for neck pain since less than 12 months.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Simonetta Scalvini, MD
    Organizational Affiliation
    Fondazione Salvatore Maugeri
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Plan to Share IPD
    Yes
    IPD Sharing Plan Description
    The research was supported by a grant from Lombardy Region. A final report was provided to Lombardy Region.
    Citations:
    PubMed Identifier
    27584139
    Citation
    Gialanella B, Ettori T, Faustini S, Baratti D, Bernocchi P, Comini L, Scalvini S. Home-Based Telemedicine in Patients with Chronic Neck Pain. Am J Phys Med Rehabil. 2017 May;96(5):327-332. doi: 10.1097/PHM.0000000000000610.
    Results Reference
    result

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