AdherenceNCT02736851
Telemedicine to Manage Chronic Neck Pain at Home
A study testing Home-based telemedicine group in people with Adherence, run by Fondazione Salvatore Maugeri.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Adherence
- What is being tested?
- Home-based telemedicine group
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 94 participants
- Where
- No sites listed yet
- Study dates
- Jan 2009to Jun 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- chronic non-specific neck pain duration more than 6 months.
Who cannot join
- 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
Show all 9Show fewer
- neurological diseases that may lead to neck pain, infections or tumours
- pregnancy
- rehabilitation sessions for neck pain since less than 12 months.
About this study
Official title: Home-Based Telemedicine Management of Patients Affected by Chronic Neck Pain
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.
Read more
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 .
Read the 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
- Being tested
- Home-based telemedicine group
- Keywords
- disability, home, stretching exercises
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Home-based telemedicine groupOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Control group | No intervention | Usual care |
| Home-based telemedicine group | Active comparator | Nurse-tutor support at home for 6 months Receives: Other: Home-based telemedicine group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Adherence as assessed by number of exercise sessions/week
Number of exercise sessions/week
Measured: Change between 15 days and 6 months after the end of the outpatient rehabilitation
Secondary outcomes (2)
Change in Pain
Evaluation by a Visual Analogue Scale (VAS)
Measured: Change between entry and 6 months after the end of the outpatient rehabilitation
Change in Disability
Evaluation by the Neck Disability Index
Measured: Change between entry and 6 months after the end of the outpatient rehabilitation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2016 (estimated)
- Study startJan 2009
- Primary completionDec 2013
- Study completionJun 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for AdherenceStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 94 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fondazione Salvatore Maugeri
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Bernardo Gialanella, Fondazione Salvatore Maugeri
- Investigators
- Simonetta Scalvini, MD, Study director, Fondazione Salvatore Maugeri
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02736851
- Sponsor's protocol ID
- Delibera 6863,CTS 7 April 2009
- Status last verified
- Sep 2016
- First submitted
- 16 Mar 2016
- Last updated
- 28 Sep 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Yes: The research was supported by a grant from Lombardy Region. A final report was provided to Lombardy Region.
Publications
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.
PubMed 27584139
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Home-Based Telemedicine Management of Patients Affected by Chronic Neck Pain
- ClinicalTrials.gov ID
- NCT02736851
- Acronym / sponsor ID
- Delibera 6863,CTS 7 April 2009
- Conditions
- Adherence
- Keywords
- disability, home, stretching exercises
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 94 participants (actual)
- Lead sponsor
- Fondazione Salvatore MaugeriUniversity, hospital or other
- Study start
- Jan 2009
- Primary completion
- Dec 2013 (actual)
- Study completion
- Jun 2014 (actual)
- First posted
- 13 Apr 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control group | No intervention | –Usual care |
| Home-based telemedicine group | Active comparator | Other: Home-based telemedicine groupNurse-tutor support at home for 6 months |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- chronic non-specific neck pain duration more than 6 months.
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Home-based telemedicine groupAll 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. | Other | Home-based telemedicine group |
Primary outcome
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
2 secondary outcomes
Change in Pain
Time frame: Change between entry and 6 months after the end of the outpatient rehabilitation
Change in Disability
Time frame: Change between entry and 6 months after the end of the outpatient rehabilitation
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Sep 2016.
- Results publication: PubMed 27584139Gialanella 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.
- Individual participant dataSharing planned: Yes. The research was supported by a grant from Lombardy Region. A final report was provided to Lombardy Region.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Simonetta Scalvini, MD study director
Fondazione Salvatore Maugeri
Questions about this trial
What is this clinical trial studying?
A study testing Home-based telemedicine group in people with Adherence, run by Fondazione Salvatore Maugeri.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Sep 2016. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02736851, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Sep 2016.