Periosteal Stimulation for Knee Osteoarthritis

Not Applicable

Completed

Conditions: Osteoarthritis, Knee

Interventions: Other: Periosteal stimulation
Other: Control-Periosteal Stimulation

Registration Number: NCT00865046

Lead Sponsor: US Department of Veterans Affairs

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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 190

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
PST + PST boosters	Periosteal stimulation	PST once a week for 10 weeks, then tapering over 6 months
PST + control-PST boosters	Periosteal stimulation	PST once a week for 10 weeks, then control-PST tapering over 6 months
Control-PST	Control-Periosteal Stimulation	control-PST for 10 weeks
PST + control-PST boosters	Control-Periosteal Stimulation	PST once a week for 10 weeks, then control-PST tapering over 6 months

Primary Outcome Measures

Name	Time	Method
Pain (WOMAC)	9 months following baseline	The Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) consists of 24 items divided into 3 subscales: Pain (5 items), score range 0-20 Stiffness (2 items): score range 0-8 Physical Function (17 items): score range 0-68 Total score ranges from 0 (best possible outcome) to 96 (worst possible outcome)

Secondary Outcome Measures