Osteoarthritis in the KneeNCT00759512
Effects of Therapeutic Touch on Osteoarthritis of the Knee
A study testing Therapeutic Touch in people with Osteoarthritis in the Knee, run by University of Toledo Health Science Campus at 1 site in United States.
Trial summary
This study is to evaluate the efficacy of the Kreiger/Kunz method of Therapeutic Touch on function, pain perception and quality of life in persons with Osteoarthritis in the knee. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Osteoarthritis in the Knee
- What is being tested?
- Therapeutic Touch
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2003to Aug 2005
- 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 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Persons diagnosed with or exhibiting signs of osteoarthritis of at least one knee.
Who cannot join
- Persons with connective tissue disorder
- Persons with bilateral total joint replacement of the knee
- Persons with dementia
- Persons with a systemic illness producing joint symptoms
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Toledo, Health Science Campus
Toledo, Ohio, 43606
About this study
This study is to evaluate the efficacy of the Kreiger/Kunz method of Therapeutic Touch on function, pain perception and quality of life in persons with Osteoarthritis in the knee.
- Conditions
- Osteoarthritis in the Knee
- Being tested
- Therapeutic Touch
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Therapeutic TouchOther
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 | Active comparator | This arm received the Kreiger/Kunz method of Therapeutic Touch in addition to Standard of Care Receives: Other: Therapeutic Touch |
| Arm 2 | No intervention | Standard of Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
SF36
Measured: 8, 12, 16 weeks
WOMAC
Measured: 8, 12 and 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2008 (estimated)
- Study startAug 2003
- Primary completionAug 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Osteoarthritis in the KneeStudies 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 N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Care provider
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Toledo Health Science Campus
- Sponsor type
- University, hospital or other
- Investigators
- Ann Smith, PhD, Principal investigator, UT, Health Science Campus
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00759512
- Sponsor's protocol ID
- UTHSC - 09
- Status last verified
- Feb 2009
- First submitted
- 24 Sep 2008
- Last updated
- 4 Feb 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Feb 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Therapeutic Touch on Osteoarthritis of the Knee
- ClinicalTrials.gov ID
- NCT00759512
- Acronym / sponsor ID
- UTHSC - 09
- Conditions
- Osteoarthritis in the Knee
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- University of Toledo Health Science CampusUniversity, hospital or other
- Study start
- Aug 2003
- Primary completion
- Aug 2005 (actual)
- First posted
- 25 Sep 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.
This study is to evaluate the efficacy of the Kreiger/Kunz method of Therapeutic Touch on function, pain perception and quality of life in persons with Osteoarthritis in the knee.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm 1 | Active comparator | Other: Therapeutic TouchThis arm received the Kreiger/Kunz method of Therapeutic Touch in addition to Standard of Care |
| Arm 2 | No intervention | –Standard of Care |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Persons diagnosed with or exhibiting signs of osteoarthritis of at least one knee.
Key exclusion criteria (4 listed)
- Persons with connective tissue disorder
- Persons with bilateral total joint replacement of the knee
- Persons with dementia
- Persons with a systemic illness producing joint symptoms
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 | Other | Arm 1 |
Primary outcome
SF36
Time frame: 8, 12, 16 weeks
WOMAC
Time frame: 8, 12 and 16 weeks
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 4 Feb 2009.
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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.
Ann Smith, PhD principal investigator
UT, Health Science Campus
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Therapeutic Touch in people with Osteoarthritis in the Knee, run by University of Toledo Health Science Campus 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 1 inclusion and 4 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 4 Feb 2009. 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.
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?
SF36 (time frame: 8, 12, 16 weeks). The study lists 2 primary outcomes in all. 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 4 Feb 2009.