NCT02549274

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

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
106

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2011

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2011

Completed
4.5 years until next milestone

First Submitted

Initial submission to the registry

September 11, 2015

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 15, 2015

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2016

Completed
Last Updated

January 18, 2017

Status Verified

January 1, 2017

Enrollment Period

5.8 years

First QC Date

September 11, 2015

Last Update Submit

January 16, 2017

Conditions

Keywords

Cervicalgiaself-rehabilitationphysiotherapy

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

EXPERIMENTAL

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

physiotherapy

ACTIVE COMPARATOR

Patients will have only conventional physiotherapy

Other: physiotherapy

Interventions

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

self-rehabilitation + physiotherapy

14 physiotherapy sessions (2 by week)

physiotherapy

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

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

Location

MeSH Terms

Conditions

Neck Pain

Interventions

Physical Therapy Modalities

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

TherapeuticsRehabilitation

Study Officials

  • Christelle CREAC'H, MD

    CHU de SAINT-ETIENNE

    PRINCIPAL INVESTIGATOR

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

Locations