Telemedicine to Manage Chronic Neck Pain at Home

NCT02736851 | Completed DMC

• 1 other identifier: Delibera 6863,CTS 7 April 2009
• Study Type: interventional
• Target: 94
• Locations: 0 countries
• Sites: N/A

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 .

Conditions

Adherence

Keywords

disability; home; stretching exercises

Outcome Measures

Primary Outcomes (1)

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

  Number of exercise sessions/week

  Change between 15 days and 6 months after the end of the outpatient rehabilitation

Secondary Outcomes (2)

• Change in Pain

  Change between entry and 6 months after the end of the outpatient rehabilitation

• Change in Disability

  Change between entry and 6 months after the end of the outpatient rehabilitation

Study Arms (2)

Control group

NO INTERVENTION

Usual care

Home-based telemedicine group

ACTIVE COMPARATOR

Nurse-tutor support at home for 6 months

Other: Home-based telemedicine group

Interventions

Home-based telemedicine group OTHER

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.

Home-based telemedicine group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Fondazione Salvatore Maugeri: lead

Related Publications (1)

• 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.

  PMID: 27584139 RESULT

Study Officials

• Simonetta Scalvini, MD

  Fondazione Salvatore Maugeri

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Coordinator

Study Record Dates

• First Submitted: March 16, 2016
• First Posted: April 13, 2016
• Study Start: January 1, 2009
• Primary Completion: December 1, 2013
• Study Completion: June 1, 2014
• Last Updated: September 28, 2016

Record last verified: 2016-09

Data Sharing

• IPD Sharing: Will share