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Completed

NCT Number: NCT05365061

Periosteal Electrical Dry Needling for Knee Osteoarthritis

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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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Team Rehabilitation

Chamblee, Georgia, 30341, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

periosteal electrical dry needling with no maintenance treatments

Other

periosteal electrical dry needling

periosteal electrical dry needling with maintenance treatments every other month

Other

periosteal electrical dry needling with maintenance treatments every other month

periosteal electrical dry needling with monthly maintenance treatments

Other

periosteal electrical dry needling with monthly maintenance treatments

Primary outcomes

  1. Change in WOMAC Knee Osteoarthritis Index (Total Score)

    Time frame: 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 outcomes

  1. Change in WOMAC Knee Osteoarthritis Index (Pain)

    Time frame: 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.

  2. Change in WOMAC Knee Osteoarthritis Index (Stiffness)

    Time frame: 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.

  3. Change in WOMAC Knee Osteoarthritis Index (Physical Function)

    Time frame: 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.

  4. Change in knee pain

    Time frame: baseline, 6 weeks, 14 weeks, 22 weeks, 30 weeks

    Average Numeric Pain Rating Score. Higher score means greater pain

  5. Change in GROC (Global Rating of Change score)

    Time frame: 6 weeks, 14 weeks, 22 weeks, 30 weeks

    GROC (ranges from -7 to +7). Global Rating of Change score

  6. Change in Medication Intake (Frequency of medication intake during last time period)

    Time frame: baseline, 30 weeks

    Frequency of medication intake during last time period

Sponsors and collaborators

Lead sponsor

Alabama Physical Therapy & Acupuncture

Other

Collaborators

  • Universidad Rey Juan Carlos

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2024
Study completion
2024
First posted
May 9, 2022
Registry last updated
Jun 12, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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