Neck PainPhase 1/2NCT00065416
Evaluating Therapeutic Massage for Chronic Neck Pain
A Phase 1/2 study testing massage in people with Neck Pain and Cervicalgia, run by National Center for Complementary and Integrative Health (NCCIH) at 1 site in United States.
Trial summary
This study will provide the basis for a full-scale trial to evaluate the effectiveness and safety of therapeutic massage for chronic neck pain (CNP). Read more about this study
- Who is it for?
- Ages 20 to 64 years
- Conditions the study is for
- Neck Pain, Cervicalgia
- What is being tested?
- massage
- Type of treatment
- Surgery or procedure
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- Start not givento not given
- Phase
- Phase 1/2
- 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 20 to 64 years
- All sexes
- No healthy volunteers
- Adult
The inclusion and exclusion criteria will be developed through consultation with a medical expert on neck pain and several massage consultants
Trial locations and contacts
1 site in 1 country.
United States1 site
Group Health Cooperative, Center for Health Studies
Seattle, Washington
About this study
This study will provide the basis for a full-scale trial to evaluate the effectiveness and safety of therapeutic massage for chronic neck pain (CNP).
Read the detailed description
Neck pain is one of the most common problems affecting the health of Americans and is a leading reason for using complementary or alternative medical (CAM) therapies. Therapeutic massage is one of the most popular CAM treatments for neck pain, but little is known about its effectiveness. This study will lay the groundwork for a full-scale trial that evaluates the effectiveness of therapeutic massage for chronic neck pain.
The study will involve two phases. During Phase I, researchers will develop and pre-test key components for a randomized clinical trial. In Phase II, the safety and efficacy of massage for CNP will be evaluated. The changes in symptoms, function, and quality of life in massage and self care groups will be evaluated midway through treatment, at the end of treatment and at 6 months post randomization.
- Conditions
- Neck Pain, Cervicalgia
- Being tested
- massage
- Keywords
- neck pain, cervicalgia, massage
- Medical subject headings
- Neck Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
massageProcedure or surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2003 (estimated)
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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Enrolment
- 60 participants
Sponsor and investigators
- Lead sponsor
- National Center for Complementary and Integrative Health (NCCIH)
- Sponsor type
- US National Institutes of Health
- Investigators
- Karen J Sherman, PhD, Principal investigator, Group Health Cooperative Center for Health Studies
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00065416
- Sponsor's protocol ID
- R21AT001584-01
- Status last verified
- Oct 2004
- First submitted
- 22 Jul 2003
- Last updated
- 24 Jun 2005
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2005. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating Therapeutic Massage for Chronic Neck Pain
- ClinicalTrials.gov ID
- NCT00065416
- Acronym / sponsor ID
- R21AT001584-01
- Conditions
- Neck Pain, Cervicalgia
- Keywords
- neck pain, cervicalgia, massage
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants
- Lead sponsor
- National Center for Complementary and Integrative Health (NCCIH)US National Institutes of Health
- First posted
- 23 Jul 2003 (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.
This study will provide the basis for a full-scale trial to evaluate the effectiveness and safety of therapeutic massage for chronic neck pain (CNP).
Detailed description
Neck pain is one of the most common problems affecting the health of Americans and is a leading reason for using complementary or alternative medical (CAM) therapies. Therapeutic massage is one of the most popular CAM treatments for neck pain, but little is known about its effectiveness. This study will lay the groundwork for a full-scale trial that evaluates the effectiveness of therapeutic massage for chronic neck pain.
The study will involve two phases. During Phase I, researchers will develop and pre-test key components for a randomized clinical trial. In Phase II, the safety and efficacy of massage for CNP will be evaluated. The changes in symptoms, function, and quality of life in massage and self care groups will be evaluated midway through treatment, at the end of treatment and at 6 months post randomization.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
Who may qualify
- Ages
- 20 to 64 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
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 |
|---|---|---|
| massage | Procedure or surgery | – |
Primary outcome
Not reported in the source record.
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 24 Jun 2005.
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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.
Karen J Sherman, PhD principal investigator
Group Health Cooperative Center for Health Studies
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing massage in people with Neck Pain and Cervicalgia, run by National Center for Complementary and Integrative Health (NCCIH) at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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 24 Jun 2005. 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 States. 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.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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.
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 24 Jun 2005.