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
  Purpose

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.


Condition Intervention
Osteoarthritis, Knee
Other: Periosteal stimulation
Other: Control-Periosteal Stimulation

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: Efficacy of Periosteal Stimulation and Boosters for Advanced Knee OA Pain

Resource links provided by NLM:


Further study details as provided by Department of Veterans Affairs:

Primary Outcome Measures:
  • Pain (WOMAC) [ Time Frame: baseline, post-10 week intervention, 6 months ] [ Designated as safety issue: No ]

Enrollment: 191
Study Start Date: November 2009
Study Completion Date: September 2013
Primary Completion Date: September 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm 1
PST once a week for 10 weeks, then tapering over 6 months
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.
Active Comparator: Arm 2
PST once a week for 10 weeks, then control-PST tapering over 6 months
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.
Placebo Comparator: Arm 3
control-PST for 10 weeks
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.

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.

  Eligibility

Ages Eligible for Study:   50 Years to 89 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00865046

Locations
United States, Pennsylvania
Geriatric Research, Education, and Clinical Center
Pittsburgh, Pennsylvania, United States, 15206
Sponsors and Collaborators
Investigators
Principal Investigator: Debra K. Weiner, MD Geriatric Research, Education, and Clinical Center
  More Information

Publications:
Responsible Party: Department of Veterans Affairs
ClinicalTrials.gov Identifier: NCT00865046     History of Changes
Other Study ID Numbers: A6614-R
Study First Received: March 17, 2009
Last Updated: December 3, 2013
Health Authority: United States: Federal Government

Keywords provided by Department of Veterans Affairs:
acupuncture

Additional relevant MeSH terms:
Osteoarthritis
Osteoarthritis, Knee
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases

ClinicalTrials.gov processed this record on July 24, 2014