Clinical trial NCT05365061: Periosteal Electrical Dry Needling for Knee Osteoarthritis
Official title: Periosteal Electrical Dry Needling With no Maintenance Treatments vs. Maintenance Treatments Every Other Month vs. Maintenance Treatments Once Per Month for Knee Osteoarthritis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Knee Osteoarthritis
Lead sponsor: Alabama Physical Therapy & Acupuncture
Sponsor class: OTHER
Collaborators: name: Universidad Rey Juan Carlos
First posted: 2022-05-09
Enrollment: 586
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Change in WOMAC Knee Osteoarthritis Index (Total Score)
timeFrame: baseline, 6 weeks, 14 weeks, 22 weeks, 30 weeks
Secondary outcomes:
measure: Change in WOMAC Knee Osteoarthritis Index (Pain)
timeFrame: baseline, 6 weeks, 14 weeks, 22 weeks, 30 weeks
measure: Change in WOMAC Knee Osteoarthritis Index (Stiffness)
timeFrame: baseline, 6 weeks, 14 weeks, 22 weeks, 30 weeks
measure: Change in WOMAC Knee Osteoarthritis Index (Physical Function)
timeFrame: baseline, 6 weeks, 14 weeks, 22 weeks, 30 weeks
measure: Change in knee pain
timeFrame: baseline, 6 weeks, 14 weeks, 22 weeks, 30 weeks
measure: Change in GROC (Global Rating of Change score)
timeFrame: 6 weeks, 14 weeks, 22 weeks, 30 weeks
measure: Change in Medication Intake (Frequency of medication intake during last time period)
timeFrame: baseline, 30 weeks
Other outcomes:
Locations:
city: Chamblee
country: United States
facility: Team Rehabilitation
state: Georgia
Study officials:
affiliation: American Academy of Manipulative Therapy
name: James Dunning, PhD DPT
role: PRINCIPAL_INVESTIGATOR
References: