Clinical trial NCT00865046: Periosteal Stimulation for Knee Osteoarthritis
Official title: Efficacy of Periosteal Stimulation and Boosters for Advanced Knee OA Pain
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Osteoarthritis, Knee
Keywords: acupuncture
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
First posted: 2009-03-19
Enrollment: 190
Sex: ALL
Minimum age (years): 50
Maximum age (years): 89
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 185 veterans with chronic knee pain and advanced knee osteoarthritis will be recruited to participate in this study designed to test the effectiveness of a special type of electrical acupuncture called periosteal stimulation (PST). Participants will be divided into three groups. They will receive PST or a control condition once a week for 10 weeks. Two-thirds of the participants will receive booster sessions periodically over the course of the next 6 months. Everyone will be called monthly during the 6 month period and then will be asked to return for an evaluation on site at the end of this period.

Detailed description: We have performed a promising initial trial of periosteal stimulation (PST, that is, electrical stimulation of 4 acupuncture needles around the knee that touch periosteum) as an analgesic for older veterans with advanced knee osteoarthritis (OA) and daily pain. The primary aim of the proposed trial is to optimize and sustain the efficacy of PST for reducing pain in veterans with advanced knee OA and unrelieved pain by combining it with booster PST. Our secondary aims are to 1) improve physical performance in these individuals, and 2) ascertain the physical and psychological predictors of response to PST. In a randomized controlled clinical trial, 180 veterans (age 50 and older) with persistent knee pain who have x-ray evidence of advanced OA will be assigned to one of three intervention groups: 1) control PST once a week for 10 weeks (i.e., needle placement with brief stimulation of non-periosteal needles), 2) PST once a week for 10 weeks followed by tapering PST boosters over 6 months, or 3) PST once a week for 10 weeks followed by tapering control-PST boosters over 6 months. Prior to initiating the intervention, immediately after the last session, and 6 months later, the following parameters will be assessed: 1) pain severity (WOMAC), 3) physical performance (gait velocity, stair climb, repetitive chair rise, timed up and go), and 4) psychological function (mood, coping, self-efficacy). Monthly telephone calls will assess pain, interim illness and physical activity.

Eligibility criteria: Inclusion Criteria:

* English speaking,
* Knee pain on most days of the past 3 months that is more severe than pain in other parts of the lower body,
* Advanced knee OA by x-ray,
* age 50-89

Exclusion Criteria:

* Non-ambulatory or severely impaired mobility (i.e., require the use of a walker),
* Folstein MMSE \< 24,
* Severe uncorrected visual or hearing impairment,
* Knee pain due to factors other than OA,
* Large knee effusion,
* History of corticosteroid or hyaluronic acid injection in the affected knee(s) during the preceding 3 months,
* Acute or terminal illness,
* Immune suppression,
* Anticoagulation therapy,
* Pacemaker,
* Prior PST treatment
* Active participation in other studies currently
* Age \>89

Primary outcomes:
measure: Pain (WOMAC)
timeFrame: 9 months following baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Pittsburgh
country: United States
facility: Geriatric Research, Education, and Clinical Center
state: Pennsylvania
Study officials:
affiliation: Geriatric Research, Education, and Clinical Center
name: Debra K. Weiner, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Weiner DK, Moore CG, Morone NE, Lee ES, Kent Kwoh C. Efficacy of periosteal stimulation for chronic pain associated with advanced knee osteoarthritis: a randomized, controlled clinical trial. Clin Ther. 2013 Nov;35(11):1703-20.e5. doi: 10.1016/j.clinthera.2013.09.025. Epub 2013 Nov 1.