Periosteal Electrical Dry Needling for Knee Osteoarthritis

Not Applicable

Completed

• Conditions: Knee Osteoarthritis
• Interventions: Other: periosteal electrical dry needling with monthly maintenance treatments; Other: periosteal electrical dry needling with no maintenance treatments; Other: periosteal electrical dry needling with maintenance treatments every other month

• Registration Number: NCT05365061
• Lead Sponsor: Alabama Physical Therapy & Acupuncture

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.

Study Timeline

• Study Start: 2021-03-01
• Study First Submitted: 2022-04-13
• Study First Submitted QC: 2022-05-04
• Study First Posted: 2022-05-09
• Primary Completion: 2024-05-01
• Study Completion: 2024-05-01
• Status Verified: 2024-06
• Last Update Submitted: 2024-06-11
• Last Update Posted: 2024-06-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 586

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Periosteal electrical dry needling followed by monthly maintenance treatments	periosteal electrical dry needling with monthly maintenance treatments	Periosteal electrical dry needling followed by monthly maintenance treatments
Periosteal electrical dry needling followed by no maintenance treatments	periosteal electrical dry needling with no maintenance treatments	Periosteal electrical dry needling followed by no maintenance treatments
Periosteal electrical dry needling followed by maintenance treatments every other month	periosteal electrical dry needling with maintenance treatments every other month	Periosteal electrical dry needling followed by maintenance treatments every other month

Primary Outcome Measures

Name	Time	Method
Change in WOMAC Knee Osteoarthritis Index (Total Score)	baseline, 6 weeks, 14 weeks, 22 weeks, 30 weeks	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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Team Rehabilitation; 🇺🇸 Chamblee, Georgia, United States