Periosteal Electrical Dry Needling for Knee Osteoarthritis

Periosteal Electrical Dry Needling With no Maintenance Treatments vs. Maintenance Treatments Every Other Month vs. Maintenance Treatments Once Per Month for Knee Osteoarthritis

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.

Study Overview

• Status: Recruiting
• Conditions: Knee Osteoarthritis
• Intervention / Treatment: Other: periosteal electrical dry needling with no maintenance treatments; Other: periosteal electrical dry needling with maintenance treatments every other month; Other: periosteal electrical dry needling with monthly maintenance treatments

Detailed Description

Patients with knee osteoarthritis will be randomized to receive periosteal electrical dry needling 1-2 treatments per week for 6 weeks (up to 10 sessions total) followed by either: 1. no maintenance treatments, 2. one maintenance treatment every other month or 3. one maintenance treatment per month.

• Study Type: Interventional
• Enrollment (Estimated): 120
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: James Dunning, PhD DPT; Phone Number: 801-707-9056; Email: jamesdunning@hotmail.com
• Study Contact Backup: Name: Raymond Butts, PhD DPT; Phone Number: 803-422-3954; Email: buttsraymond@yahoo.com

Study Locations

• United States
  • Georgia
    • Chamblee, Georgia, United States, 30341
      • Recruiting
      • Team Rehabilitation
      • Contact: Denise Daisy, DPT

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Adult over the age of 18 years old:
2. Report of knee pain of at least 2/10 per NPRS (0---10 scale) for >3 months

3. Report of at least 3 of the following per Altman et al. (1986) (sensitivity = 95% / specificity = 69%)

   1. Over 50 Years of age
   2. Less than 30 minutes of morning stiffness
   3. Crepitus on active motion
   4. Bony tenderness
   5. Bony enlargement
   6. No palpable warmth of Synovium

Exclusion Criteria:

1. 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.
2. History of physical therapy, massage therapy, chiropractic treatment, or injections for knee pain in last 4 weeks.
3. History of a partial or total knee replacement on the painful lower extremity.
4. History of a surgical procedure on either lower extremity in last 12 months.

5. Two or more positive neurologic signs consistent with nerve root compression, including any two of the following:

   1. Weakness involving a major muscle group of the lower extremity.
   2. Diminished patella or achilles tendon reflex
   3. Diminished or absent sensation to pinprick in lower extremity dermatome.
6. Involvement in litigation or worker's compensation regarding knee pain.
7. Any condition that might contraindicate the use of periosteal electric dry needling
8. The patient is pregnant.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Periosteal electrical dry needling followed by no maintenance treatments	Other: periosteal electrical dry needling with no maintenance treatments; periosteal electrical dry needling
Active Comparator: Periosteal electrical dry needling followed by maintenance treatments every other month	Other: periosteal electrical dry needling with maintenance treatments every other month; periosteal electrical dry needling with maintenance treatments every other month
Active Comparator: Periosteal electrical dry needling followed by monthly maintenance treatments	Other: periosteal electrical dry needling with monthly maintenance treatments; periosteal electrical dry needling with monthly maintenance treatments

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in WOMAC Knee Osteoarthritis Index (Pain)	5 questions each worth 0-4 points with maximum score of 20 points possible. The greater the score, the worse the pain.	baseline, 6 weeks, 14 weeks, 22 weeks, 30 weeks
Change in WOMAC Knee Osteoarthritis Index (Stiffness)	2 questions each worth 0-4 points with maximum score of 8 points possible. The greater the score, the worse the stiffness.	baseline, 6 weeks, 14 weeks, 22 weeks, 30 weeks
Change in WOMAC Knee Osteoarthritis Index (Physical Function)	17 questions each worth 0-4 points with maximum score of 68 points possible. The greater the score, the worse the physical function.	baseline, 6 weeks, 14 weeks, 22 weeks, 30 weeks
Change in knee pain	Average Numeric Pain Rating Score. Higher score means greater pain	baseline, 6 weeks, 14 weeks, 22 weeks, 30 weeks
Change in GROC (Global Rating of Change score)	GROC (ranges from -7 to +7). Global Rating of Change score	6 weeks, 14 weeks, 22 weeks, 30 weeks
Change in Medication Intake (Frequency of medication intake during last time period)	Frequency of medication intake during last time period	baseline, 30 weeks

Collaborators and Investigators

• Sponsor: Alabama Physical Therapy & Acupuncture
• Collaborators: Universidad Rey Juan Carlos
• Investigators: Principal Investigator: James Dunning, PhD DPT, American Academy of Manipulative Therapy

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2021
• Primary Completion (Estimated): March 1, 2024
• Study Completion (Estimated): March 1, 2024

Study Registration Dates

• First Submitted: April 13, 2022
• First Submitted That Met QC Criteria: May 4, 2022
• First Posted (Actual): May 9, 2022

Study Record Updates

• Last Update Posted (Actual): September 5, 2023
• Last Update Submitted That Met QC Criteria: September 1, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Osteoarthritis; Osteoarthritis, Knee
• Other Study ID Numbers: AAMT20231

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No