Periosteal Electrical Dry Needling for Knee Osteoarthritis

Knee Osteoarthritis Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05365061
• Other study ID #: AAMT20231
• Status: Recruiting
• Phase: N/A
• Start date: March 1, 2021
• Est. completion date: March 1, 2024

Study information

• Verified date: September 2023
• Source: Alabama Physical Therapy & Acupuncture
• Contact: James Dunning, PhD DPT
• Phone: 801-707-9056
• Email: jamesdunning[@]hotmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: March 1, 2024
• Est. primary completion date: March 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Knee Osteoarthritis
• Osteoarthritis
• Osteoarthritis, Knee

Intervention

Other:
• periosteal electrical dry needling with no maintenance treatments
periosteal electrical dry needling
• periosteal electrical dry needling with maintenance treatments every other month
periosteal electrical dry needling with maintenance treatments every other month
• periosteal electrical dry needling with monthly maintenance treatments
periosteal electrical dry needling with monthly maintenance treatments

Locations

Country	Name	City	State
United States	Team Rehabilitation	Chamblee	Georgia

Sponsors (2)

Lead Sponsor	Collaborator
Alabama Physical Therapy & Acupuncture	Universidad Rey Juan Carlos

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	Change in knee pain	Average Numeric Pain Rating Score. Higher score means greater pain	baseline, 6 weeks, 14 weeks, 22 weeks, 30 weeks
Secondary	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
Secondary	Change in Medication Intake (Frequency of medication intake during last time period)	Frequency of medication intake during last time period	baseline, 30 weeks