Acupuncture for Pain and Sleep Disturbance in Knee Osteoa... | NCT00694447

Studies
Acupuncture for Pain and Sleep Disturbance in Knee Osteoarthritis

NCT00694447

Sponsor

Emory University

Status

Completed

Last Update Posted

Nov 21, 2013Estimated

Enrollment

Not provided

Phase

Not Applicable

Conditions

Sleep
Pain

Interventions

Acupuncture

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

ID	Type	Description	Link
Grant #97333-G

Status Module

Record Verification Date

Nov 2013

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

Feb 2007

Primary Completion Date

Apr 2008Actual

Completion Date

Not provided

First Submitted Date

Jun 6, 2008

First Submission Date that Met QC Criteria

Jun 9, 2008

First Posted Date

Jun 10, 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

Nov 19, 2013

Last Update Posted Date

Nov 21, 2013Estimated

Name	Class
Southeast Center of Excellence in Geriatric Medicine	UNKNOWN
The John A. Hartford Foundation	OTHER

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

The hypotheses of this study are: In the older population with knee OA,

When acupoints are chosen for both sleep and pain, there are additive effects on sleep improvement and pain relief (i.e. no interaction).
Main effects of acupuncture on sleep improvement and pain relief are anticipated when acupoints are separately targeted for sleep and for pain, respectively.

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

No data available

No data is available for this block.

Biospecimen

No data available

No data is available for this block.

Enrollment

Not provided

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Real acupuncture	Experimental	Real acupuncture	Procedure: Acupuncture
Sham acupuncture	Sham Comparator	Sham acupuncture	Procedure: Acupuncture

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Acupuncture	Procedure		Real acupuncture Sham acupuncture

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Sleep disturbances as recorded by wrist actigraph, including sleep duration and sleep efficiency. Pain as measured by 0-10 VAS and WOMAC pain scores.		at least 3 months

Secondary Outcomes

Measure	Description	Time Frame
WOMAC disability scores, IDEEA gait patterns and activity levels, medication type and amount consumed, side effects, and medical care utilization.		at least 3 months

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients with knee osteoarthritis, diagnosed by the ACR clinical diagnosis criteria for idiopathic OA, with at least Kellgren and Lawrence grading II and above. AND,
Present with knee pain at least half of the time. AND,
Complain of sleep disturbances associated with knee OA, with Pittsburgh Sleep Quality Index > 5 [36].

Exclusion Criteria:

Patients with diagnosis of obstructive sleep apnea (OSA). OR,
Patients with dense hemiplegia secondary to cerebrovascular accident. OR,
NYHA Class III - patients with heart failure condition limited by minimal activity. OR,
Severe COPD with shortness of breath at minimal exertion. OR,
Peripheral vascular disease with severe claudication. OR,
Dementia with Mini Mental Status Exam score of 20 or less. OR,
Patients who received knee intra-articular corticosteroid injection within 4 weeks prior to the study or who received acupuncture treatment within 6 months. OR,
Unwilling to come off narcotic pain medication. OR,
History of bleeding diathesis or currently on anticoagulation. OR,
Patients currently engaged in medical legal cases related to OA or disability.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

55 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

ID	Term
D009461	Neurologic Manifestations
D012816	Signs and Symptoms
D013568	Pathological Conditions, Signs and Symptoms

ID	Term
D000529	Complementary Therapies
D013812	Therapeutics