Skip to main content
OpenTrials
Completed

NCT Number: NCT00694447

Acupuncture for Pain and Sleep Disturbance in Knee Osteoarthritis

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Sleep Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

55 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Wesley Woods Geriatric Hospital

Atlanta, Georgia, 30329, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Acupuncture

Procedure

Primary outcomes

  1. Sleep disturbances as recorded by wrist actigraph, including sleep duration and sleep efficiency. Pain as measured by 0-10 VAS and WOMAC pain scores.

    Time frame: at least 3 months

Secondary outcomes

  1. WOMAC disability scores, IDEEA gait patterns and activity levels, medication type and amount consumed, side effects, and medical care utilization.

    Time frame: at least 3 months

Sponsors and collaborators

Lead sponsor

Emory University

Other

Collaborators

  • Southeast Center of Excellence in Geriatric Medicine
  • The John A. Hartford Foundation

Registry information

Official study title

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

Important dates

Study start
2007
Primary completion
2008
First posted
Jun 10, 2008
Registry last updated
Nov 21, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.