NCT00865046

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
190

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Nov 2009

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 17, 2009

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 19, 2009

Completed
8 months until next milestone

Study Start

First participant enrolled

November 1, 2009

Completed
3.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2013

Completed
1.4 years until next milestone

Results Posted

Study results publicly available

January 26, 2015

Completed
Last Updated

January 26, 2015

Status Verified

January 1, 2015

Enrollment Period

3.8 years

First QC Date

March 17, 2009

Results QC Date

December 10, 2014

Last Update Submit

January 22, 2015

Conditions

Osteoarthritis, Knee

Keywords

acupuncture

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (3)

PST + PST boosters

EXPERIMENTAL

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

Other: Periosteal stimulation

PST + control-PST boosters

ACTIVE COMPARATOR

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

Other: Periosteal stimulationOther: Control-Periosteal Stimulation

Control-PST

PLACEBO COMPARATOR

control-PST for 10 weeks

Other: Control-Periosteal Stimulation

Interventions

Periosteal stimulationOTHER

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 + PST boostersPST + control-PST boosters
Control-Periosteal StimulationOTHER

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

Control-PSTPST + control-PST boosters

Eligibility Criteria

Age50 Years - 89 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Geriatric Research, Education, and Clinical Center

Pittsburgh, Pennsylvania, 15206, United States

Location

Related 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.2013.09.025. Epub 2013 Nov 1.

    PMID: 24184053RESULT

MeSH Terms

Conditions

Osteoarthritis, Knee

Condition Hierarchy (Ancestors)

OsteoarthritisArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Results Point of Contact

Title
Dr. Debra K. Weiner
Organization
VA Pittsburgh Healthcare System
debra.weiner@va.gov
412-360-2920

Study Officials

  • Debra K. Weiner, MD

    Geriatric Research, Education, and Clinical Center

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
FED
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 17, 2009

First Posted

March 19, 2009

Study Start

November 1, 2009

Primary Completion

September 1, 2013

Study Completion

September 1, 2013

Last Updated

January 26, 2015

Results First Posted

January 26, 2015

Record last verified: 2015-01

Locations

US(1)