Effectiveness of a Self-rehabilitation Program
Effectiveness of Active Home Exercises for Patients With Chronic Neck Pain: a Prospective Comparative Randomized Clinical Trial
2 other identifiers
interventional
106
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Mar 2011
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2011
CompletedFirst Submitted
Initial submission to the registry
September 11, 2015
CompletedFirst Posted
Study publicly available on registry
September 15, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2016
CompletedJanuary 18, 2017
January 1, 2017
5.8 years
September 11, 2015
January 16, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Cervical pain
Verbal Scale Digital (EVN) cervical pain average 11 points (from 0-10) in the last week
2 months
Secondary Outcomes (2)
cervical pain
1 year
cervical pain
4 months
Study Arms (2)
self-rehabilitation + physiotherapy
EXPERIMENTALPatients 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.
physiotherapy
ACTIVE COMPARATORPatients will have only conventional physiotherapy
Interventions
2 training sessions in self-rehabilitation at the hospital and then a self-rehabilitation / day session + 14 physiotherapy sessions (2 by week)
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
CHU de SAINT-ETIENNE
Saint-Etienne, 42000, France
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Christelle CREAC'H, MD
CHU de SAINT-ETIENNE
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 11, 2015
First Posted
September 15, 2015
Study Start
March 1, 2011
Primary Completion
December 1, 2016
Study Completion
December 1, 2016
Last Updated
January 18, 2017
Record last verified: 2017-01