Periosteal Electrical Dry Needling for Knee Osteoarthritis

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Knee Osteoarthritis

Intervention / Treatment
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* 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


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Periosteal electrical dry needling followed by no maintenance treatments<br>Periosteal electrical dry needling followed by no maintenance treatments | Other: periosteal electrical dry needling with no maintenance treatments<br>* periosteal electrical dry needling<br>|
| Active Comparator: Periosteal electrical dry needling followed by maintenance treatments every other month<br>Periosteal electrical dry needling followed by maintenance treatments every other month | Other: periosteal electrical dry needling with maintenance treatments every other month<br>* periosteal electrical dry needling with maintenance treatments every other month<br>|
| Active Comparator: Periosteal electrical dry needling followed by monthly maintenance treatments<br>Periosteal electrical dry needling followed by monthly maintenance treatments | Other: periosteal electrical dry needling with monthly maintenance treatments<br>* periosteal electrical dry needling with monthly maintenance treatments<br>|

What is the study measuring?
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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 |