Telemedicine to Manage Chronic Neck Pain at Home

NCT ID: NCT02736851

Last Updated: 2016-09-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 94 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-01-31
• Study Completion Date: 2014-06-30

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.

Conditions

Adherence

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Control group

Usual care

Group Type: NO_INTERVENTION

No interventions assigned to this group

Home-based telemedicine group

Nurse-tutor support at home for 6 months

Group Type: ACTIVE_COMPARATOR

Home-based telemedicine group

Intervention Type: 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.

Interventions

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.

Intervention Type: OTHER

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Fondazione Salvatore Maugeri

OTHER

Sponsor Role: lead

Responsible Party

Bernardo Gialanella

Coordinator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Simonetta Scalvini, MD

Role: STUDY_DIRECTOR

Fondazione Salvatore Maugeri

References

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.

Reference Type: RESULT

PMID: 27584139 (View on PubMed)

Other Identifiers

Delibera 6863,CTS 7 April 2009

Identifier Type: -

Identifier Source: org_study_id