Periosteal Stimulation for Knee Osteoarthritis

Osteoarthritis, Knee Clinical Trial

— PST  

Official title:

Efficacy of Periosteal Stimulation and Boosters for Advanced Knee OA Pain

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00865046
• Other study ID #: A6614-R
• Status: Completed
• Phase: N/A
• First received: March 17, 2009
• Last updated: January 22, 2015
• Start date: November 2009
• Est. completion date: September 2013

Study information

• Verified date: January 2015
• Source: VA Office of Research and Development
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 190
• Est. completion date: September 2013
• Est. primary completion date: September 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 50 Years to 89 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Osteoarthritis
• Osteoarthritis, Knee

Intervention

Other:
• Periosteal stimulation
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.
• Control-Periosteal Stimulation
Acupuncture needles are placed as per the PST intervention, but only the soft tissue needles receive electrical stimulation for one minute.

Locations

Country	Name	City	State
United States	Geriatric Research, Education, and Clinical Center	Pittsburgh	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
VA Office of Research and Development

Country where clinical trial is conducted

United States, 

References & Publications (1)

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 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain (WOMAC)	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	No