Acupuncture for Pain and Sleep Disturbance in Knee Osteoarthritis

Exploring Outcomes and Mechanisms of Acupuncture in Treating Pain and Sleep Disturbance in Knee Osteoarthritis

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00694447

Enrollment

Unknown

Registered

2008-06-10

Start date

2007-02-28

Completion date

Unknown

Last updated

2013-11-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pain, Sleep

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.

Interventions

PROCEDUREAcupuncture

Eligibility

Sex/Gender

ALL

Age

55 Years to No maximum

Healthy volunteers

Inclusion criteria

1. 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, 2. Present with knee pain at least half of the time. AND, 3. Complain of sleep disturbances associated with knee OA, with Pittsburgh Sleep Quality Index \> 5 \[36\].

Exclusion criteria

1. Patients with diagnosis of obstructive sleep apnea (OSA). OR, 2. Patients with dense hemiplegia secondary to cerebrovascular accident. OR, 3. NYHA Class III - patients with heart failure condition limited by minimal activity. OR, 4. Severe COPD with shortness of breath at minimal exertion. OR, 5. Peripheral vascular disease with severe claudication. OR, 6. Dementia with Mini Mental Status Exam score of 20 or less. OR, 7. Patients who received knee intra-articular corticosteroid injection within 4 weeks prior to the study or who received acupuncture treatment within 6 months. OR, 8. Unwilling to come off narcotic pain medication. OR, 9. History of bleeding diathesis or currently on anticoagulation. OR, 10. Patients currently engaged in medical legal cases related to OA or disability.

Design outcomes

Primary

Measure	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

Measure	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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026