Neck PainNCT00566930
Preventive Care of Chronic Cervical Pain and Disabilities
A study testing spinal manipulation and Spinal manipulation + exercises in people with Neck Pain, run by Université du Québec à Trois-Rivières at 1 site in Canada.
Trial summary
The aim of this study is to determine which of tertiary prevention spinal manipulative therapy (SMT) or a home exercise program is the more efficient approach to reduce pain and increase functional capacity, quality of life and general health condition. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Neck Pain
- What is being tested?
- spinal manipulation and Spinal manipulation + exercises
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 117 participants
- Where
- 1 siteCanada
- Study dates
- Oct 2007to Sep 2008
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Adults between 18 and 60 years old from the city and the surrounding Trois-Rivières with chronic cervical pain of non-traumatic origin (chronic or recurrent cervical pain that lasted at least 6 months)
Who cannot join
- Surgery to the cervical spine
- Neoplasms
- Severe osteoarthritis
- Ankylosing spondylitis
- Hypertension
- Referred pain in the cervical area
Show all 14Show fewer
- Central or peripheric nervous system dysfunction
- Vascular disease
- Treated cardiovascular disease
- Inflammatory or infectious disease of the cervical spine
- Metabolic or endocrine diseases
- Pregnancy
- Specific rehabilitation training for the neck or already under manual therapy for neck pain
- Patient suffering from dizziness, vertigo or headache suspected to be cervicogenic or of unknown origin will not be involved in the study.
Trial locations and contacts
1 site in 1 country.
Canada1 site
Université du Québec à Trois-Rivières
Trois-Rivières, Quebec, G9A 1R2
About this study
Official title: Preventive Care of Chronic Cervical Pain and Disabilities; Comparison of Spinal Manipulative Therapy and Individualized Home Exercise Programs
The aim of this study is to determine which of tertiary prevention spinal manipulative therapy (SMT) or a home exercise program is the more efficient approach to reduce pain and increase functional capacity, quality of life and general health condition. To do so, 60 participants with chronic cervical pain, will be recruited and divided into 3 groups according to the intervention they will receive: control group, experimental group 1 who will receive preventive chiropractic care in the form of spinal manipulations and experimental group 2 will have to perform an individualized home exercise program on a daily basis. We hypothesize that a group of patient receiving SMT + a home exercise program will present less pain and functional disabilities over a 1 year period. The innovative value of this project is mainly related to the fact that it will generate new and potentially very useful data concerning the clinical significance of preventive chiropractic care. Moreover, such data will be beneficial to our profession as chiropractic makes a step towards prevention, wellness and public health.
- Conditions
- Neck Pain
- Being tested
- spinal manipulation, Spinal manipulation + exercises
- Medical subject headings
- Neck Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
spinal manipulationOther
Monthly cervical spinal manipulation
Spinal manipulation + exercisesOther
Monthly cervical spine manipulation and daily home exercises
| Study group | Role | What they receive |
|---|---|---|
| 1 | No intervention | Not described |
| 2 | Active comparator | spinal manipulation Receives: Other: spinal manipulation |
| 3 | Experimental | Spinal manipulation + exercises Receives: Other: Spinal manipulation + exercises |
What is being measured
The primary outcome is the main question the study is designed to answer.
Neck Pain
Visual analog pain scale (score 0-10 cm; 0 being no neck pain and 10 extreme neck pain)
Measured: Up to 10 months
Secondary outcomes (1)
Fear Avoidance Belief, Quality of Life, Range of Motion
Measured: One year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2007 (estimated)
- Study startOct 2007
- Primary completionSep 2008
- Study completionSep 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Neck PainStudies 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
- Factorial
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 117 participants (actual)
Sponsor and investigators
- Lead sponsor
- Université du Québec à Trois-Rivières
- Sponsor type
- University, hospital or other
- Collaborators
- Foundation for Chiropractic Education and Research (FCER)
- Responsible party
- Principal investigator, Martin Descarreaux, Université du Québec à Trois-Rivières
- Investigators
- Martin Descarreaux, PhD, Principal investigator, Université du Québec à Trois-Rivières
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00566930
- Sponsor's protocol ID
- Chronic cervical pain UQTR
- Other IDs
- FCER Grant #06-03-02
- Status last verified
- Sep 2012
- First submitted
- 30 Nov 2007
- Last updated
- 28 Sep 2012
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Martel J, Dugas C, Dubois JD, Descarreaux M. A randomised controlled trial of preventive spinal manipulation with and without a home exercise program for patients with chronic neck pain. BMC Musculoskelet Disord. 2011 Feb 8;12:41. doi: 10.1186/1471-2474-12-41.
PubMed 21303529
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preventive Care of Chronic Cervical Pain and Disabilities; Comparison of Spinal Manipulative Therapy and Individualized Home Exercise Programs
- ClinicalTrials.gov ID
- NCT00566930
- Acronym / sponsor ID
- Chronic cervical pain UQTR
- Conditions
- Neck Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 117 participants (actual)
- Lead sponsor
- Université du Québec à Trois-RivièresUniversity, hospital or other
- Collaborators
- Foundation for Chiropractic Education and Research (FCER)
- Study start
- Oct 2007
- Primary completion
- Sep 2008 (actual)
- Study completion
- Sep 2008 (actual)
- First posted
- 4 Dec 2007 (estimated)
- Results
- Posted 14 Sep 2012
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of this study is to determine which of tertiary prevention spinal manipulative therapy (SMT) or a home exercise program is the more efficient approach to reduce pain and increase functional capacity, quality of life and general health condition. To do so, 60 participants with chronic cervical pain, will be recruited and divided into 3 groups according to the intervention they will receive: control group, experimental group 1 who will receive preventive chiropractic care in the form of spinal manipulations and experimental group 2 will have to perform an individualized home exercise program on a daily basis. We hypothesize that a group of patient receiving SMT + a home exercise program will present less pain and functional disabilities over a 1 year period. The innovative value of this project is mainly related to the fact that it will generate new and potentially very useful data concerning the clinical significance of preventive chiropractic care. Moreover, such data will be beneficial to our profession as chiropractic makes a step towards prevention, wellness and public health.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1 | No intervention | – |
| 2 | Active comparator | Other: spinal manipulationspinal manipulation |
| 3 | Experimental | Other: Spinal manipulation + exercisesSpinal manipulation + exercises |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Adults between 18 and 60 years old from the city and the surrounding Trois-Rivières with chronic cervical pain of non-traumatic origin (chronic or recurrent cervical pain that lasted at least 6 months)
Key exclusion criteria (14 listed)
- Surgery to the cervical spine
- Neoplasms
- Severe osteoarthritis
- Ankylosing spondylitis
- Hypertension
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 |
|---|---|---|
| spinal manipulationMonthly cervical spinal manipulation | Other | 2 |
| Spinal manipulation + exercisesMonthly cervical spine manipulation and daily home exercises | Other | 3 |
Primary outcome
Neck Pain
Time frame: Up to 10 months
Visual analog pain scale (score 0-10 cm; 0 being no neck pain and 10 extreme neck pain)
1 secondary outcome
Fear Avoidance Belief, Quality of Life, Range of Motion
Time frame: One year
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Sep 2012.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 21303529Martel J, Dugas C, Dubois JD, Descarreaux M. A randomised controlled trial of preventive spinal manipulation with and without a home exercise program for patients with chronic neck pain. BMC Musculoskelet Disord. 2011 Feb 8;12:41. doi: 10.1186/1471-2474-12-41.
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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.
Martin Descarreaux, PhD principal investigator
Université du Québec à Trois-Rivières
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing spinal manipulation and Spinal manipulation + exercises in people with Neck Pain, run by Université du Québec à Trois-Rivières at 1 site in Canada.
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 1 inclusion and 14 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 28 Sep 2012. 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 Canada. 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?
Yes. Results are posted in the registry (first posted 14 Sep 2012). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Neck Pain (time frame: Up to 10 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00566930, which also lists 1 linked publication.
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 28 Sep 2012.