OsteoporosisNCT00730600
Effect of THAI Traditional Massage on Bone Markers
A study testing Thai Traditional massage in people with Osteoporosis, run by Mahidol University at 1 site in Thailand.
Trial summary
The purpose of this study is to explore the skeletal effect of Thai traditional massage by examining the changes in biochemical markers of bone turnover immediately after the massage. Read more about this study
- Who is it for?
- Ages 20 to 40 years, women only
- Conditions the study is for
- Osteoporosis
- What is being tested?
- Thai Traditional massage
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteThailand
- Study dates
- Jun 2007to Jul 2008
- 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 20 to 40 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Healthy Thai women aged 20 to 40 years
- Have been massaged by Thai Traditional massage style
Who cannot join
- Hyperparathyroidism, Thyrotoxicosis, Diabetes Mellitus, Rheumatoid Arthritis, Cancer
- Antiresorptive agent, Teriparatide and Glucocorticoid
- Swelling Joints
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Acute Changes in Biochemical Markers of Bone Resorption and Formation After THAI Traditional Massage
The purpose of this study is to explore the skeletal effect of Thai traditional massage by examining the changes in biochemical markers of bone turnover immediately after the massage.
Read the detailed description
Each subject received Thai traditional massage for 2 hours by a single masseuse.
- Conditions
- Osteoporosis
- Being tested
- Thai Traditional massage
- Keywords
- Thai Traditional massage, Bone Formation, Bone Resorption
- Medical subject headings
- Osteoporosis, Bone Resorption
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Thai Traditional massageProcedure or surgery
Also called Thai massagae
Thai traditional massage for 2 hours by a single masseuse.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | 1= THAI traditional massage Receives: Procedure: Thai Traditional massage |
What is being measured
The primary outcome is the main question the study is designed to answer.
Biochemical markers of bone resorption; C-terminal telopeptide of type I collagen (CTx-I) and of bone formation; total procollagen type 1 amino-terminal propeptide (P1NP)level
Measured: 2 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Aug 2008 (estimated)
- Study startJun 2007
- Primary completionSep 2007
- Study completionJul 2008
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.
- More trials run by Mahidol UniversityThe sponsor's other registered studies.
- 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
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mahidol University
- Sponsor type
- University, hospital or other
- Investigators
- Sunee - Saetung, Msc, Principal investigator, Ramathibodi Hospital, Mahidol University, Bangkok, Thailand 10400
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00730600
- Sponsor's protocol ID
- ID 02-50-30
- Status last verified
- Jul 2008
- First submitted
- 6 Aug 2008
- Last updated
- 8 Aug 2008
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Aug 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acute Changes in Biochemical Markers of Bone Resorption and Formation After THAI Traditional Massage
- ClinicalTrials.gov ID
- NCT00730600
- Acronym / sponsor ID
- ID 02-50-30
- Conditions
- Osteoporosis
- Keywords
- Thai Traditional massage, Bone Formation, Bone Resorption
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Mahidol UniversityUniversity, hospital or other
- Study start
- Jun 2007
- Primary completion
- Sep 2007 (actual)
- Study completion
- Jul 2008 (actual)
- First posted
- 8 Aug 2008 (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 purpose of this study is to explore the skeletal effect of Thai traditional massage by examining the changes in biochemical markers of bone turnover immediately after the massage.
Detailed description
Each subject received Thai traditional massage for 2 hours by a single masseuse.
Study design
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Procedure: Thai Traditional massage1= THAI traditional massage |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Healthy Thai women aged 20 to 40 years
- Have been massaged by Thai Traditional massage style
Key exclusion criteria (3 listed)
- Hyperparathyroidism, Thyrotoxicosis, Diabetes Mellitus, Rheumatoid Arthritis, Cancer
- Antiresorptive agent, Teriparatide and Glucocorticoid
- Swelling Joints
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 |
|---|---|---|
| Thai Traditional massageAlso: Thai massagaeThai traditional massage for 2 hours by a single masseuse. | Procedure or surgery | 1 |
Primary outcome
Biochemical markers of bone resorption; C-terminal telopeptide of type I collagen (CTx-I) and of bone formation; total procollagen type 1 amino-terminal propeptide (P1NP)level
Time frame: 2 hour
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 8 Aug 2008.
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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.
Sunee - Saetung, Msc principal investigator
Ramathibodi Hospital, Mahidol University, Bangkok, Thailand 10400
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Thai Traditional massage in people with Osteoporosis, run by Mahidol University at 1 site in Thailand.
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 2 inclusion and 3 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 8 Aug 2008. 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 Thailand. 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?
Biochemical markers of bone resorption; C-terminal telopeptide of type I collagen (CTx-I) and of bone formation; total procollagen type 1 amino-terminal propeptide (P1NP)level (time frame: 2 hour). 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 8 Aug 2008.