Neck PainNCT01029951
Relative Effectiveness and Adverse Effects of Cervical Manipulation, Mobilisation and the Activator Instrument in Patients With Sub-acute Non-specific Neck Pain: a Pragmatic Randomised Trial
A study testing manipulation, Mobilisation and Activator instrument in people with Neck Pain, run by Anglo-European College of Chiropractic at 1 site in United Kingdom.
Trial summary
The primary purpose of this study was to compare the relative effectiveness of cervical manipulation, mobilisation and the Activator instrument in the treatment of subacute non-specific neck pain. The secondary purpose was to describe any adverse effects of these treatments. Read more about this study
- Who is it for?
- Ages 18 to 64 years
- Conditions the study is for
- Neck Pain
- What is being tested?
- manipulation, Mobilisation and Activator instrument
- Type of treatment
- Medical device, Surgery or procedure
- How many people
- 47 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Jan 2007to Mar 2009
- 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 to 64 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- age 18-64 years; a new or recurrent episode of neck pain present for more than 4 weeks, but no longer than 12 weeks;
- neck pain that could extend to the shoulder region or upper extremities, and be accompanied by headache, but neck pain was more painful;
- the patient agreed not to take medication or receive other treatment for neck pain during the course of the study (paracetamol 500 mg 4 times a day was allowed as rescue medication);
- and a baseline pain level of at least 4 on the 11-point numerical rating scale.
Who cannot join
- Exclusion criteria were treatment with any of the interventions during 6 months prior to recruitment to the study; specific neck pain due to fracture, neoplasm, infection, inflammatory arthropathy, radiculopathy or myelopathy;
- factors contraindicating manipulation, such as blood coagulation disorders, long-term use of corticosteroids, anticoagulant medications, history of neck surgery, stroke or transient ischaemic attacks; plans to relocate;
- inability to read or understand English;
- and third-party liability or workers' compensation claims.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Anglo-European College of Chiropractic Out Patient Clinic
Bournemouth, Dorset, BH5 2DF
About this study
Official title: Neck Pain Comparative Study
The primary purpose of this study was to compare the relative effectiveness of cervical manipulation, mobilisation and the Activator instrument in the treatment of subacute non-specific neck pain. The secondary purpose was to describe any adverse effects of these treatments.
Read the detailed description
Neck pain is a common disorder. About 70% of adults will experience neck pain during their lifetime. After low back pain, neck pain is the most common reason patients give for seeking chiropractic care, and the second most common reason for the use of spinal manipulation. Usually, the underlying cause of neck pain is non-specific and cannot be related to a particular pathology as a cause of the presenting symptoms. Due to the uncertainty of the results obtained in the limited number of studies of manipulation and mobilisation for neck pain, further studies are needed to compare the different therapies available for neck pain. Participants in the study were treated as they would normally be with the exception of the type of spinal manipulation. There were three groups: a manipulation group, a mobilisation group, and an Activator instrument group.
- Conditions
- Neck Pain
- Being tested
- manipulation, Mobilisation, Activator instrument
- Keywords
- Chiropractic; osteopathic physicians; manipulation; neck pain; adverse effects; randomized clinical trial, Subacute non-specific neck pain
- Medical subject headings
- Neck Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
manipulationProcedure or surgery
MobilisationProcedure or surgery
Activator instrumentDevice
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient Global Impression of Change
Measured: end of treatment, 3 months, 6 months and 12 months
Secondary outcomes (4)
Numerical rating scale for pain
Measured: end of treatment, 3 months, 6 months, and 12 months
Bournemouth Questionnaire
Measured: end of treatment, 3 months, 6 months, and 12 months
Adverse effects to treatment
Measured: end of treatment
SF-36 version 2
Measured: end of treatment, 3 months, 6 months and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Dec 2009 (estimated)
- Study startJan 2007
- Primary completionMar 2009
- Study completionMar 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 47 participants (actual)
Sponsor and investigators
- Lead sponsor
- Anglo-European College of Chiropractic
- Sponsor type
- University, hospital or other
- Collaborators
- European Chiropractors Union, National Institute for Chiropractic Research
- Investigators
- Hugh A Gemmell, DC. EdD, Principal investigator, Asociación Española contra el Cáncer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01029951
- Sponsor's protocol ID
- A.06-2
- Status last verified
- Jul 2006
- First submitted
- 9 Dec 2009
- Last updated
- 10 Dec 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Dec 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neck Pain Comparative Study
- ClinicalTrials.gov ID
- NCT01029951
- Acronym / sponsor ID
- A.06-2
- Conditions
- Neck Pain
- Keywords
- Chiropractic; osteopathic physicians; manipulation; neck pain; adverse effects; randomized clinical trial, Subacute non-specific neck pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 47 participants (actual)
- Lead sponsor
- Anglo-European College of ChiropracticUniversity, hospital or other
- Collaborators
- European Chiropractors Union, National Institute for Chiropractic Research
- Study start
- Jan 2007
- Primary completion
- Mar 2009 (actual)
- Study completion
- Mar 2009 (actual)
- First posted
- 10 Dec 2009 (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 primary purpose of this study was to compare the relative effectiveness of cervical manipulation, mobilisation and the Activator instrument in the treatment of subacute non-specific neck pain. The secondary purpose was to describe any adverse effects of these treatments.
Detailed description
Neck pain is a common disorder. About 70% of adults will experience neck pain during their lifetime. After low back pain, neck pain is the most common reason patients give for seeking chiropractic care, and the second most common reason for the use of spinal manipulation. Usually, the underlying cause of neck pain is non-specific and cannot be related to a particular pathology as a cause of the presenting symptoms. Due to the uncertainty of the results obtained in the limited number of studies of manipulation and mobilisation for neck pain, further studies are needed to compare the different therapies available for neck pain. Participants in the study were treated as they would normally be with the exception of the type of spinal manipulation. There were three groups: a manipulation group, a mobilisation group, and an Activator instrument group.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- age 18-64 years; a new or recurrent episode of neck pain present for more than 4 weeks, but no longer than 12 weeks;
- neck pain that could extend to the shoulder region or upper extremities, and be accompanied by headache, but neck pain was more painful;
- the patient agreed not to take medication or receive other treatment for neck pain during the course of the study (paracetamol 500 mg 4 times a day was allowed as rescue medication);
- and a baseline pain level of at least 4 on the 11-point numerical rating scale.
Key exclusion criteria (4 listed)
- Exclusion criteria were treatment with any of the interventions during 6 months prior to recruitment to the study; specific neck pain due to fracture, neoplasm, infection, inflammatory arthropathy, radiculopathy or myelopathy;
- factors contraindicating manipulation, such as blood coagulation disorders, long-term use of corticosteroids, anticoagulant medications, history of neck surgery, stroke or transient ischaemic attacks; plans to relocate;
- inability to read or understand English;
- and third-party liability or workers' compensation claims.
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 |
|---|---|---|
| manipulation | Procedure or surgery | – |
| Mobilisation | Procedure or surgery | – |
| Activator instrument | Device | – |
Primary outcome
Patient Global Impression of Change
Time frame: end of treatment, 3 months, 6 months and 12 months
4 secondary outcomes
Numerical rating scale for pain
Time frame: end of treatment, 3 months, 6 months, and 12 months
Bournemouth Questionnaire
Time frame: end of treatment, 3 months, 6 months, and 12 months
Adverse effects to treatment
Time frame: end of treatment
SF-36 version 2
Time frame: end of treatment, 3 months, 6 months and 12 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 10 Dec 2009.
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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.
Hugh A Gemmell, DC. EdD principal investigator
Asociación Española contra el Cáncer
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing manipulation, Mobilisation and Activator instrument in people with Neck Pain, run by Anglo-European College of Chiropractic at 1 site in United Kingdom.
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 4 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 10 Dec 2009. 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 United Kingdom. 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?
Patient Global Impression of Change (time frame: end of treatment, 3 months, 6 months and 12 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 10 Dec 2009.