Effectiveness of a Self-rehabilitation Program

Cervicalgia Clinical Trial

Official title:

Effectiveness of Active Home Exercises for Patients With Chronic Neck Pain: a Prospective Comparative Randomized Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02549274
• Other study ID #: 1008155
• Secondary ID: 2010-A01369-30
• Status: Completed
• Phase: N/A
• First received: September 11, 2015
• Last updated: January 16, 2017
• Start date: March 2011
• Est. completion date: December 2016

Study information

• Verified date: January 2017
• Source: Centre Hospitalier Universitaire de Saint Etienne
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 106
• Est. completion date: December 2016
• Est. primary completion date: December 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cervicalgia
• Neck Pain

Intervention

Other:
• self-rehabilitation + physiotherapy
2 training sessions in self-rehabilitation at the hospital and then a self-rehabilitation / day session + 14 physiotherapy sessions (2 by week)
• physiotherapy
14 physiotherapy sessions (2 by week)

Locations

Country	Name	City	State
France	CHU de SAINT-ETIENNE	Saint-etienne

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Saint Etienne

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cervical pain	Verbal Scale Digital (EVN) cervical pain average 11 points (from 0-10) in the last week	2 months
Secondary	cervical pain	Verbal Scale Digital (EVN) cervical pain average 11 points (from 0-10) in the last week	1 year
Secondary	cervical pain	Verbal Scale Digital (EVN) cervical pain average 11 points (from 0-10) in the last week	4 months