Effectiveness of a Self-rehabilitation Program

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

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.

Study Overview

• Status: Completed
• Conditions: Cervicalgia
• Intervention / Treatment: Other: self-rehabilitation + physiotherapy; Other: physiotherapy

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.

• Study Type: Interventional
• Enrollment (Actual): 106
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Saint-etienne, France, 42000
    • CHU DE SAINT-ETIENNE

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: self-rehabilitation + physiotherapy; 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.	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)
Active Comparator: physiotherapy; Patients will have only conventional physiotherapy	Other: physiotherapy; 14 physiotherapy sessions (2 by week)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cervical pain	Verbal Scale Digital (EVN) cervical pain average 11 points (from 0-10) in the last week	2 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
cervical pain	Verbal Scale Digital (EVN) cervical pain average 11 points (from 0-10) in the last week	1 year
cervical pain	Verbal Scale Digital (EVN) cervical pain average 11 points (from 0-10) in the last week	4 months

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire de Saint Etienne
• Investigators: Principal Investigator: Christelle CREAC'H, MD, CHU DE SAINT-ETIENNE

Study record dates

Study Major Dates

• Study Start: March 1, 2011
• Primary Completion (Actual): December 1, 2016
• Study Completion (Actual): December 1, 2016

Study Registration Dates

• First Submitted: September 11, 2015
• First Submitted That Met QC Criteria: September 11, 2015
• First Posted (Estimate): September 15, 2015

Study Record Updates

• Last Update Posted (Estimate): January 18, 2017
• Last Update Submitted That Met QC Criteria: January 16, 2017
• Last Verified: January 1, 2017

More Information

Terms related to this study

• Keywords: physiotherapy; Cervicalgia; self-rehabilitation
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Neck Pain
• Other Study ID Numbers: 1008155; 2010-A01369-30 (Other Identifier: ANSM)