Back to resultsEffectiveness of a Self-rehabilitation Program
Primary Purpose
Cervicalgia
Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
self-rehabilitation + physiotherapy
physiotherapy
Sponsored by
About this trial
This is an interventional treatment trial for Cervicalgia focused on measuring Cervicalgia, self-rehabilitation, physiotherapy
Eligibility Criteria
Inclusion Criteria:
- Non-specific neck pain * ≥ 15 days / month for more than 3 months
- Consultation first line in the pain center
- Subject able to complete questionnaires
- Subject able to understand and perform exercises
Exclusion Criteria:
- History of stroke
- History of carotid or vertebral arterial dissection
- "Whiplash" for less than six months
- Cervicobrachial neuralgia for less than 3 months
- Syndrome of thoracic outlet diagnosed
- Tumor and infectious syndromes
- Polyarthritis or major cervical spondylosis against known-indicating active mobilization of the cervical spine
- Unbound bone trauma
- Patients with cognitive impairment prevents proper application instructions
Sites / Locations
- CHU de SAINT-ETIENNE
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
self-rehabilitation + physiotherapy
physiotherapy
Arm Description
Patients will have, in addition to conventional physiotherapy, to visit two training sessions in self-rehabilitation at the hospital. They will then perform a self-rehabilitation / day session.
Patients will have only conventional physiotherapy
Outcomes
Primary Outcome Measures
Cervical pain
Verbal Scale Digital (EVN) cervical pain average 11 points (from 0-10) in the last week
Secondary Outcome Measures
cervical pain
Verbal Scale Digital (EVN) cervical pain average 11 points (from 0-10) in the last week
cervical pain
Verbal Scale Digital (EVN) cervical pain average 11 points (from 0-10) in the last week
Full Information
NCT ID
NCT02549274
First Posted
September 11, 2015
Last Updated
January 16, 2017
Sponsor
Centre Hospitalier Universitaire de Saint Etienne
1. Study Identification
Unique Protocol Identification Number
NCT02549274
Brief Title
Effectiveness of a Self-rehabilitation Program
Official Title
Effectiveness of Active Home Exercises for Patients With Chronic Neck Pain: a Prospective Comparative Randomized Clinical Trial
Study Type
Interventional
2. Study Status
Record Verification Date
January 2017
Overall Recruitment Status
Completed
Study Start Date
March 2011 (undefined)
Primary Completion Date
December 2016 (Actual)
Study Completion Date
December 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Universitaire de Saint Etienne
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The prevalence of non-specific neck pain is 12.1 / 1000 patients / year. Their support is most often based on analgesics combined with physical therapy. More recently authors have advocated the use of self-rehabilitation, that is to say, the use by the patient himself of physiotherapy exercises to perform at home regularly. However, if there are currently many studies on the effectiveness of self-rehabilitation for low back pain, there are few data on neck pain.
In this context we have chosen to implement a prospective, randomized study, on the effectiveness of self-rehabilitation in patients with chronic neck pain.
Detailed Description
Patients included in the "self-rehabilitation" group will, in addition to conventional physiotherapy, to visit two training sessions in self-rehabilitation at the hospital. Each patient received a booklet including advices to perform different kinds of exercises at home. The patients learn the exercises with the help of the physiotherapist and have to traine daily at home.
Patients will have to answer questionnaires about their pain at follow-usual consultations of their disease at 2 months and 4 months after the start physical therapy and during a phone call after 1 year.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cervicalgia
Keywords
Cervicalgia, self-rehabilitation, physiotherapy
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
106 (Actual)
8. Arms, Groups, and Interventions
Arm Title
self-rehabilitation + physiotherapy
Arm Type
Experimental
Arm Description
Patients will have, in addition to conventional physiotherapy, to visit two training sessions in self-rehabilitation at the hospital. They will then perform a self-rehabilitation / day session.
Arm Title
physiotherapy
Arm Type
Active Comparator
Arm Description
Patients will have only conventional physiotherapy
Intervention Type
Other
Intervention Name(s)
self-rehabilitation + physiotherapy
Intervention Description
2 training sessions in self-rehabilitation at the hospital and then a self-rehabilitation / day session + 14 physiotherapy sessions (2 by week)
Intervention Type
Other
Intervention Name(s)
physiotherapy
Intervention Description
14 physiotherapy sessions (2 by week)
Primary Outcome Measure Information:
Title
Cervical pain
Description
Verbal Scale Digital (EVN) cervical pain average 11 points (from 0-10) in the last week
Time Frame
2 months
Secondary Outcome Measure Information:
Title
cervical pain
Description
Verbal Scale Digital (EVN) cervical pain average 11 points (from 0-10) in the last week
Time Frame
1 year
Title
cervical pain
Description
Verbal Scale Digital (EVN) cervical pain average 11 points (from 0-10) in the last week
Time Frame
4 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Non-specific neck pain * ≥ 15 days / month for more than 3 months
Consultation first line in the pain center
Subject able to complete questionnaires
Subject able to understand and perform exercises
Exclusion Criteria:
History of stroke
History of carotid or vertebral arterial dissection
"Whiplash" for less than six months
Cervicobrachial neuralgia for less than 3 months
Syndrome of thoracic outlet diagnosed
Tumor and infectious syndromes
Polyarthritis or major cervical spondylosis against known-indicating active mobilization of the cervical spine
Unbound bone trauma
Patients with cognitive impairment prevents proper application instructions
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Christelle CREAC'H, MD
Organizational Affiliation
CHU de SAINT-ETIENNE
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHU de SAINT-ETIENNE
City
Saint-etienne
ZIP/Postal Code
42000
Country
France
12. IPD Sharing Statement
Learn more about this trial
Effectiveness of a Self-rehabilitation Program
We'll reach out to this number within 24 hrs