OsteoporosisPhase 2NCT00079521
Therapeutic Touch for Wrist Fractures in Postmenopausal Women
A Phase 2 study testing Therapeutic Touch in people with Osteoporosis and Fractures, run by National Center for Complementary and Integrative Health (NCCIH) at 1 site in United States.
Trial summary
This study will evaluate the effectiveness of therapeutic touch in treating wrist fractures in women past menopause. Read more about this study
- Who is it for?
- Ages 40 to 85 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Osteoporosis, Fractures
- What is being tested?
- Therapeutic Touch
- Type of treatment
- Surgery or procedure
- How many people
- 125 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2003to Apr 2006
- Phase
- Phase 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 40 to 85 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Postmenopausal
- Wrist fracture within 1 week of study entry
- Able to travel to research center for daily treatment
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Connecticut Health Center
Farmington, Connecticut, 06030-5215
About this study
Official title: The Effect of Therapeutic Touch on Bone Formation in Postmenopausal Women After Wrist Fracture
This study will evaluate the effectiveness of therapeutic touch in treating wrist fractures in women past menopause.
Read the 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.
- Conditions
- Osteoporosis, Fractures
- Being tested
- Therapeutic Touch
- Keywords
- Bone Metabolism, Therapeutic Touch
- Medical subject headings
- Osteoporosis, Fractures, Bone
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Therapeutic TouchProcedure or surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2004 (estimated)
- Study startMar 2003
- Study completionApr 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OsteoporosisStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind
- Enrolment
- 125 participants
Sponsor and investigators
- Lead sponsor
- National Center for Complementary and Integrative Health (NCCIH)
- Sponsor type
- US National Institutes of Health
- Investigators
- Karen M. Prestwood, MD, Principal investigator, University of Connecticut
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00079521
- Sponsor's protocol ID
- P20AT000756-01P1
- Status last verified
- Aug 2006
- First submitted
- 9 Mar 2004
- Last updated
- 17 Aug 2006
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Aug 2006. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Therapeutic Touch on Bone Formation in Postmenopausal Women After Wrist Fracture
- ClinicalTrials.gov ID
- NCT00079521
- Acronym / sponsor ID
- P20AT000756-01P1
- Conditions
- Osteoporosis, Fractures
- Keywords
- Bone Metabolism, Therapeutic Touch
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 125 participants
- Lead sponsor
- National Center for Complementary and Integrative Health (NCCIH)US National Institutes of Health
- Study start
- Mar 2003
- Study completion
- Apr 2006
- First posted
- 10 Mar 2004 (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 evaluate the effectiveness of therapeutic touch in treating wrist fractures in women past menopause.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind
Who may qualify
- Ages
- 40 to 85 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Postmenopausal
- Wrist fracture within 1 week of study entry
- Able to travel to research center for daily treatment
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Therapeutic Touch | 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 17 Aug 2006.
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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 M. Prestwood, MD principal investigator
University of Connecticut
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Therapeutic Touch in people with Osteoporosis and Fractures, 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?
The sponsor lists 3 inclusion and 0 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 17 Aug 2006. 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 phase mean?
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 17 Aug 2006.