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| Tracking Information | |||||
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| First Received Date ICMJE | March 9, 2004 | ||||
| Last Updated Date | August 16, 2006 | ||||
| Start Date ICMJE | March 2003 | ||||
| Primary Completion Date | |||||
| Current Primary Outcome Measures ICMJE | |||||
| Original Primary Outcome Measures ICMJE | |||||
| Change History | Complete list of historical versions of study NCT00079521 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE | |||||
| Original Secondary Outcome Measures ICMJE | |||||
| Descriptive Information | |||||
| Brief Title ICMJE | Therapeutic Touch for Wrist Fractures in Postmenopausal Women | ||||
| Official Title ICMJE | The Effect of Therapeutic Touch on Bone Formation in Postmenopausal Women After Wrist Fracture | ||||
| Brief Summary | This study will evaluate the effectiveness of therapeutic touch in treating wrist fractures in women past menopause. |
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| Detailed Description | In the United States, the use of complementary and alternative medicine (CAM) increased by approximately 25% between 1990 and 1997. The number of visits to CAM practitioners exceeded visits to primary care physicians by about 250 million in 1997. Energy medicine modalities, including therapeutic touch, healing touch, and reiki, are commonly utilized for conditions ranging from headache to cancer, yet understanding of the human energy field and how it may be used in healing is limited. This study will examine the effect of therapeutic touch on fracture healing in postmenopausal women. Women will be enrolled in the study within one week of a wrist fracture and will receive either therapeutic touch or a sham (placebo) treatment daily for 3 weeks. Assessments will include blood and urine analysis and measures of pain and function in the affected wrist. |
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| Study Phase | Phase II | ||||
| Study Type ICMJE | Interventional | ||||
| Study Design ICMJE | Treatment, Randomized, Double-Blind, Placebo Control, Factorial Assignment, Efficacy Study | ||||
| Condition ICMJE |
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| Intervention ICMJE | Procedure: Therapeutic Touch | ||||
| 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 | 125 | ||||
| Completion Date | April 2006 | ||||
| Primary Completion Date | |||||
| Eligibility Criteria ICMJE | Inclusion Criertia:
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| Gender | Female | ||||
| Ages | 40 Years to 85 Years | ||||
| Accepts Healthy Volunteers | Yes | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | United States | ||||
| Administrative Information | |||||
| NCT ID ICMJE | NCT00079521 | ||||
| Responsible Party | |||||
| Study ID Numbers ICMJE | P20 AT000756-01P1 | ||||
| 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 | August 2006 | ||||
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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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