Periosteal Electrical Dry Needling for Knee Osteoarthritis
1 other identifier
interventional
586
1 country
1
Brief Summary
The purpose of this research is to treat patients with knee osteoarthritis (OA) with periosteal electric dry needling (PEDN). It is also to determine the optimal "maintenance" regiment (i.e. maintenance treatments, one maintenance treatment every other month, or one maintenance treatment per month) required to maintain improvements in pain and function following PEDN. Physical therapists commonly use PEDN to treat knee OA, and previous studies suggest that this treatment is useful for reducing pain and improving function in patients with osteoarthritis. However, an appropriate maintenance treatment strategy to maintain these outcomes is presently unknown.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable knee-osteoarthritis
Started Mar 2021
Longer than P75 for not_applicable knee-osteoarthritis
1 active site
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
Study Start
First participant enrolled
March 1, 2021
CompletedFirst Submitted
Initial submission to the registry
April 13, 2022
CompletedFirst Posted
Study publicly available on registry
May 9, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2024
CompletedJune 12, 2024
June 1, 2024
3.2 years
April 13, 2022
June 11, 2024
Conditions
Outcome Measures
Primary Outcomes (1)
Change in WOMAC Knee Osteoarthritis Index (Total Score)
24 questions each worth 0-4 points with maximum score of 96 points possible. The greater the score, the worse the symptoms of knee OA
baseline, 6 weeks, 14 weeks, 22 weeks, 30 weeks
Secondary Outcomes (6)
Change in WOMAC Knee Osteoarthritis Index (Pain)
baseline, 6 weeks, 14 weeks, 22 weeks, 30 weeks
Change in WOMAC Knee Osteoarthritis Index (Stiffness)
baseline, 6 weeks, 14 weeks, 22 weeks, 30 weeks
Change in WOMAC Knee Osteoarthritis Index (Physical Function)
baseline, 6 weeks, 14 weeks, 22 weeks, 30 weeks
Change in knee pain
baseline, 6 weeks, 14 weeks, 22 weeks, 30 weeks
Change in GROC (Global Rating of Change score)
6 weeks, 14 weeks, 22 weeks, 30 weeks
- +1 more secondary outcomes
Study Arms (3)
Periosteal electrical dry needling followed by no maintenance treatments
EXPERIMENTALPeriosteal electrical dry needling followed by no maintenance treatments
Periosteal electrical dry needling followed by maintenance treatments every other month
ACTIVE COMPARATORPeriosteal electrical dry needling followed by maintenance treatments every other month
Periosteal electrical dry needling followed by monthly maintenance treatments
ACTIVE COMPARATORPeriosteal electrical dry needling followed by monthly maintenance treatments
Interventions
periosteal electrical dry needling
periosteal electrical dry needling with maintenance treatments every other month
periosteal electrical dry needling with monthly maintenance treatments
Eligibility Criteria
You may qualify if:
- Adult over the age of 18 years old:
- Report of knee pain of at least 2/10 per NPRS (0---10 scale) for \>3 months
- Report of at least 3 of the following per Altman et al. (1986) (sensitivity = 95% / specificity = 69%)
- Over 50 Years of age
- Less than 30 minutes of morning stiffness
- Crepitus on active motion
- Bony tenderness
- Bony enlargement
- No palpable warmth of Synovium
You may not qualify if:
- Report of red flags to manual physical therapy to include: hypertension, infection, diabetes, peripheral neuropathy, heart disease, stroke, chronic ischemia, edema, severe varicosities, tumor, metabolic disease, prolonged steroid use, fracture, RA, osteoporosis, severe vascular disease, malignancy, etc.
- History of physical therapy, massage therapy, chiropractic treatment, or injections for knee pain in last 4 weeks.
- History of a partial or total knee replacement on the painful lower extremity.
- History of a surgical procedure on either lower extremity in last 12 months.
- Two or more positive neurologic signs consistent with nerve root compression, including any two of the following:
- Weakness involving a major muscle group of the lower extremity.
- Diminished patella or achilles tendon reflex
- Diminished or absent sensation to pinprick in lower extremity dermatome.
- Involvement in litigation or worker's compensation regarding knee pain.
- Any condition that might contraindicate the use of periosteal electric dry needling
- The patient is pregnant.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Team Rehabilitation
Chamblee, Georgia, 30341, United States
Related Publications (1)
Dunning J, Young I, Taylor N, Mourad F, Bliton P, Butts R, Escaloni J, Gorby P, Varghese R, Maselli F, Fernandez-de-Las-Penas C. Effect of dose interval of periosteal and intraarticular electrical dry needling boosters on pain and disability in patients with knee osteoarthritis: a multi-center randomized clinical trial. Physiother Theory Pract. 2025 Oct 17:1-14. doi: 10.1080/09593985.2025.2575837. Online ahead of print.
PMID: 41104706DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
James Dunning, PhD DPT
American Academy of Manipulative Therapy
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
April 13, 2022
First Posted
May 9, 2022
Study Start
March 1, 2021
Primary Completion
May 1, 2024
Study Completion
May 1, 2024
Last Updated
June 12, 2024
Record last verified: 2024-06