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| Tracking Information | |||||
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| First Received Date ICMJE | July 22, 2003 | ||||
| Last Updated Date | June 23, 2005 | ||||
| Start Date ICMJE | |||||
| Primary Completion Date | |||||
| Current Primary Outcome Measures ICMJE | |||||
| Original Primary Outcome Measures ICMJE | |||||
| Change History | Complete list of historical versions of study NCT00065416 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE | |||||
| Original Secondary Outcome Measures ICMJE | |||||
| Descriptive Information | |||||
| Brief Title ICMJE | Evaluating Therapeutic Massage for Chronic Neck Pain | ||||
| Official Title ICMJE | |||||
| Brief 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). |
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| 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. |
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| Study Phase | Phase I, Phase II | ||||
| Study Type ICMJE | Interventional | ||||
| Study Design ICMJE | Treatment, Randomized, Placebo Control, Parallel Assignment, Safety/Efficacy Study | ||||
| Condition ICMJE |
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| Intervention ICMJE | Procedure: massage | ||||
| Study Arms / Comparison Groups | |||||
| Publications * | |||||
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* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Enrollment ICMJE | 60 | ||||
| Completion Date | |||||
| Primary Completion Date | |||||
| Eligibility Criteria ICMJE | The inclusion and exclusion criteria will be developed through consultation with a medical expert on neck pain and several massage consultants |
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| Gender | Both | ||||
| Ages | 20 Years to 64 Years | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | United States | ||||
| Administrative Information | |||||
| NCT ID ICMJE | NCT00065416 | ||||
| Responsible Party | |||||
| Study ID Numbers ICMJE | R21 AT001584-01 | ||||
| Study Sponsor ICMJE | National Center for Complementary and Alternative Medicine (NCCAM) | ||||
| Collaborators ICMJE | |||||
| Investigators ICMJE |
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| Information Provided By | National Center for Complementary and Alternative Medicine (NCCAM) | ||||
| Verification Date | October 2004 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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