Effects of Therapeutic Touch on Osteoarthritis of the Knee | NCT00759512

Studies
Effects of Therapeutic Touch on Osteoarthritis of the Knee

NCT00759512

Sponsor

University of Toledo Health Science Campus

Status

Completed

Last Update Posted

Feb 4, 2009Estimated

Enrollment

60Actual

Phase

Not Applicable

Conditions

Osteoarthritis in the Knee

Interventions

Therapeutic Touch

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2009

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 2003

Primary Completion Date

Aug 2005Actual

Completion Date

Not provided

First Submitted Date

Sep 24, 2008

First Submission Date that Met QC Criteria

Sep 24, 2008

First Posted Date

Sep 25, 2008Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 2, 2009

Last Update Posted Date

Feb 4, 2009Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

60Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Arm 1	Active Comparator	This arm received the Kreiger/Kunz method of Therapeutic Touch in addition to Standard of Care	Other: Therapeutic Touch
Arm 2	No Intervention	Standard of Care

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Therapeutic Touch	Other		Arm 1

Measure	Description	Time Frame
SF36		8, 12, 16 weeks
WOMAC		8, 12 and 16 weeks

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Persons diagnosed with or exhibiting signs of osteoarthritis of at least one knee.

Exclusion Criteria:

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

50 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Ann Smith, PhD	UT, Health Science Campus	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University of Toledo, Health Science Campus		Toledo	Ohio	43606	United States

Intervention Browse Module

MeSH Terms

ID	Term
D019124	Therapeutic Touch

Ancestor Terms

ID	Term
D026441	Mind-Body Therapies
D000529	Complementary Therapies
D013812	Therapeutics
D026443	Spiritual Therapies

Browse Leaves

Not provided

Browse Branches

Not provided