Effectiveness of a Self-rehabilitation Program

NCT ID: NCT02549274

Last Updated: 2017-01-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 106 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-03-31
• Study Completion Date: 2016-12-31

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.

Conditions

Cervicalgia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

self-rehabilitation + physiotherapy

Intervention Type: OTHER

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

physiotherapy

Patients will have only conventional physiotherapy

Group Type: ACTIVE_COMPARATOR

physiotherapy

Intervention Type: OTHER

14 physiotherapy sessions (2 by week)

Interventions

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)

Intervention Type: OTHER

physiotherapy

14 physiotherapy sessions (2 by week)

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Centre Hospitalier Universitaire de Saint Etienne

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Christelle CREAC'H, MD

Role: PRINCIPAL_INVESTIGATOR

CHU de SAINT-ETIENNE

Locations

CHU de SAINT-ETIENNE

Saint-Etienne, , France

Countries

France

Other Identifiers

2010-A01369-30

Identifier Type: OTHER

Identifier Source: secondary_id

1008155

Identifier Type: -

Identifier Source: org_study_id