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Completed

NCT Number: NCT00865046

Periosteal Stimulation for Knee Osteoarthritis

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.

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Key information

Age range

50 year–89 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Geriatric Research, Education, and Clinical Center

Pittsburgh, Pennsylvania, 15206, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

Periosteal stimulation

Other

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

Other

Acupuncture needles are placed as per the PST intervention, but only the soft tissue needles receive electrical stimulation for one minute.

Primary outcomes

  1. 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)

Sponsors and collaborators

Lead sponsor

US Department of Veterans Affairs

Fed

Registry information

Official study title

Efficacy of Periosteal Stimulation and Boosters for Advanced Knee OA Pain

Acronym: PST

Important dates

Study start
2009
Primary completion
2013
Study completion
2013
First posted
Mar 19, 2009
Registry last updated
Jan 26, 2015

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.

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