Periosteal Stimulation for Knee Osteoarthritis (PST)
January 22, 2015 updated by: US Department of Veterans Affairs
Efficacy of Periosteal Stimulation and Boosters for Advanced Knee OA Pain
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Actual)
190
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Pennsylvania
-
Pittsburgh, Pennsylvania, United States, 15206
- Geriatric Research, Education, and Clinical Center
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
50 years to 89 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: PST + PST boosters
PST once a week for 10 weeks, then tapering over 6 months
|
Four acupuncture needles are placed around the knee to the level of the periosteum and two needles are placed pretibially in the soft tissue.
All needles are stimulated with 100 Hz current.
The stimulation of the needles in the soft tissue is discontinued after one minute.
|
|
Active Comparator: PST + control-PST boosters
PST once a week for 10 weeks, then control-PST tapering over 6 months
|
Four acupuncture needles are placed around the knee to the level of the periosteum and two needles are placed pretibially in the soft tissue.
All needles are stimulated with 100 Hz current.
The stimulation of the needles in the soft tissue is discontinued after one minute.
Acupuncture needles are placed as per the PST intervention, but only the soft tissue needles receive electrical stimulation for one minute.
|
|
Placebo Comparator: Control-PST
control-PST for 10 weeks
|
Acupuncture needles are placed as per the PST intervention, but only the soft tissue needles receive electrical stimulation for one minute.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Pain (WOMAC)
Time Frame: 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) |
9 months following baseline
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Debra K. Weiner, MD, Geriatric Research, Education, and Clinical Center
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
November 1, 2009
Primary Completion (Actual)
September 1, 2013
Study Completion (Actual)
September 1, 2013
Study Registration Dates
First Submitted
March 17, 2009
First Submitted That Met QC Criteria
March 18, 2009
First Posted (Estimate)
March 19, 2009
Study Record Updates
Last Update Posted (Estimate)
January 26, 2015
Last Update Submitted That Met QC Criteria
January 22, 2015
Last Verified
January 1, 2015
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- A6614-R
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