Periosteal Stimulation for Knee Osteoarthritis (PST)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Department of Veterans Affairs
ClinicalTrials.gov Identifier:
NCT00865046
First received: March 17, 2009
Last updated: December 3, 2013
Last verified: December 2013

March 17, 2009
December 3, 2013
November 2009
September 2013   (final data collection date for primary outcome measure)
Pain (WOMAC) [ Time Frame: baseline, post-10 week intervention, 6 months ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00865046 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Periosteal Stimulation for Knee Osteoarthritis
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.

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Osteoarthritis, Knee
  • 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.
  • Other: Control-Periosteal Stimulation
    Acupuncture needles are placed as per the PST intervention, but only the soft tissue needles receive electrical stimulation for one minute.
  • Experimental: Arm 1
    PST once a week for 10 weeks, then tapering over 6 months
    Intervention: Other: Periosteal stimulation
  • Active Comparator: Arm 2
    PST once a week for 10 weeks, then control-PST tapering over 6 months
    Interventions:
    • Other: Periosteal stimulation
    • Other: Control-Periosteal Stimulation
  • Placebo Comparator: Arm 3
    control-PST for 10 weeks
    Intervention: Other: Control-Periosteal Stimulation
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):1703-1720.e5. doi: 10.1016/j.clinthera.2013.09.025. Epub 2013 Nov 1.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
191
September 2013
September 2013   (final data collection date for primary outcome measure)

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
Both
50 Years to 89 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00865046
A6614-R
No
Department of Veterans Affairs
Department of Veterans Affairs
Not Provided
Principal Investigator: Debra K. Weiner, MD Geriatric Research, Education, and Clinical Center
Department of Veterans Affairs
December 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP