Periosteal Stimulation for Knee Osteoarthritis

NCT ID: NCT00865046

Last Updated: 2015-01-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 190 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-11-30
• Study Completion Date: 2013-09-30

Brief 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.

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.

Conditions

Osteoarthritis, Knee

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

PST + PST boosters

PST once a week for 10 weeks, then tapering over 6 months

Group Type: EXPERIMENTAL

Periosteal stimulation

Intervention Type: 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.

PST + control-PST boosters

PST once a week for 10 weeks, then control-PST tapering over 6 months

Group Type: ACTIVE_COMPARATOR

Periosteal stimulation

Intervention Type: 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

Intervention Type: OTHER

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

Control-PST

control-PST for 10 weeks

Group Type: PLACEBO_COMPARATOR

Control-Periosteal Stimulation

Intervention Type: OTHER

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

Interventions

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.

Intervention Type: 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.

Intervention Type: OTHER

Eligibility 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

• Minimum Eligible Age: 50 Years
• Maximum Eligible Age: 89 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

US Department of Veterans Affairs

FED

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Debra K. Weiner, MD

Role: PRINCIPAL_INVESTIGATOR

Geriatric Research, Education, and Clinical Center

Locations

Geriatric Research, Education, and Clinical Center

Pittsburgh, Pennsylvania, United States

Countries

United States

References

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.2013.09.025. Epub 2013 Nov 1.

Reference Type: RESULT

PMID: 24184053 (View on PubMed)

Other Identifiers

A6614-R

Identifier Type: -

Identifier Source: org_study_id