CervicalgiaNCT02549274
Effectiveness of a Self-rehabilitation Program
A study testing self-rehabilitation + physiotherapy and physiotherapy in people with Cervicalgia, run by Centre Hospitalier Universitaire de Saint Etienne at 1 site in France.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cervicalgia
- What is being tested?
- self-rehabilitation + physiotherapy and physiotherapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 106 participants
- Where
- 1 siteFrance
- Study dates
- Mar 2011to Dec 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 9Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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
- Being tested
- self-rehabilitation + physiotherapy, physiotherapy
- Keywords
- Cervicalgia, self-rehabilitation, physiotherapy
- Medical subject headings
- Neck Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
self-rehabilitation + physiotherapyOther
2 training sessions in self-rehabilitation at the hospital and then a self-rehabilitation / day session + 14 physiotherapy sessions (2 by week)
physiotherapyOther
14 physiotherapy sessions (2 by week)
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: self-rehabilitation + physiotherapy |
| physiotherapy | Active comparator | Patients will have only conventional physiotherapy Receives: Other: physiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cervical pain
Verbal Scale Digital (EVN) cervical pain average 11 points (from 0-10) in the last week
Measured: 2 months
Secondary outcomes (2)
cervical pain
Verbal Scale Digital (EVN) cervical pain average 11 points (from 0-10) in the last week
Measured: 1 year
cervical pain
Verbal Scale Digital (EVN) cervical pain average 11 points (from 0-10) in the last week
Measured: 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2015 (estimated)
- Study startMar 2011
- Primary completionDec 2016
- Study completionDec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CervicalgiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 106 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Saint Etienne
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Christelle CREAC'H, MD, Principal investigator, CHU de SAINT-ETIENNE
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02549274
- Sponsor's protocol ID
- 1008155
- Other IDs
- 2010-A01369-30
- Status last verified
- Jan 2017
- First submitted
- 11 Sep 2015
- Last updated
- 18 Jan 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Active Home Exercises for Patients With Chronic Neck Pain: a Prospective Comparative Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT02549274
- Acronym / sponsor ID
- 1008155
- Conditions
- Cervicalgia
- Keywords
- Cervicalgia, self-rehabilitation, physiotherapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 106 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de Saint EtienneUniversity, hospital or other
- Study start
- Mar 2011
- Primary completion
- Dec 2016 (actual)
- Study completion
- Dec 2016 (actual)
- First posted
- 15 Sep 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| self-rehabilitation + physiotherapy | Experimental | Other: self-rehabilitation + physiotherapyPatients 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 comparator | Other: physiotherapyPatients will have only conventional physiotherapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| self-rehabilitation + physiotherapy2 training sessions in self-rehabilitation at the hospital and then a self-rehabilitation / day session + 14 physiotherapy sessions (2 by week) | Other | self-rehabilitation + physiotherapy |
| physiotherapy14 physiotherapy sessions (2 by week) | Other | physiotherapy |
Primary outcome
Cervical pain
Time frame: 2 months
Verbal Scale Digital (EVN) cervical pain average 11 points (from 0-10) in the last week
2 secondary outcomes
cervical pain
Time frame: 1 year
cervical pain
Time frame: 4 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jan 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Christelle CREAC'H, MD principal investigator
CHU de SAINT-ETIENNE
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing self-rehabilitation + physiotherapy and physiotherapy in people with Cervicalgia, run by Centre Hospitalier Universitaire de Saint Etienne at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Jan 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cervical pain (time frame: 2 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jan 2017.