Periosteal Electrical Dry Needling for Knee Osteoarthritis

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

586 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-03-01

Study Completion Date

2024-05-01

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.

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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.

Conditions

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Knee Osteoarthritis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Periosteal electrical dry needling followed by no maintenance treatments

Group Type EXPERIMENTAL

periosteal electrical dry needling with no maintenance treatments

Intervention Type OTHER

periosteal electrical dry needling

Periosteal electrical dry needling followed by maintenance treatments every other month

Group Type ACTIVE_COMPARATOR

periosteal electrical dry needling with maintenance treatments every other month

Intervention Type OTHER

periosteal electrical dry needling with maintenance treatments every other month

Periosteal electrical dry needling followed by monthly maintenance treatments

Group Type ACTIVE_COMPARATOR

periosteal electrical dry needling with monthly maintenance treatments

Intervention Type OTHER

periosteal electrical dry needling with monthly maintenance treatments

Interventions

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periosteal electrical dry needling with no maintenance treatments

periosteal electrical dry needling

Intervention Type OTHER

periosteal electrical dry needling with maintenance treatments every other month

Intervention Type OTHER

periosteal electrical dry needling with monthly maintenance treatments

Intervention Type OTHER

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No