Clinical trial NCT02373631: Dry Needling Versus Conventional Physical Therapy in Patients With Knee Osteoarthritis
Official title: Dry Needling Versus Conventional Physical Therapy in Patients With Knee Osteoarthritis: a Multi-center Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Knee Osteoarthritis
Lead sponsor: Alabama Physical Therapy & Acupuncture
Sponsor class: OTHER
Collaborators: name: Universidad Rey Juan Carlos
First posted: 2015-02-27
Enrollment: 105
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this research is to compare the effectiveness of conventional physical therapy (manual physical therapy, exercise, range of motion, and stretching) versus conventional physical therapy combined with dry needling in patients with knee osteoarthritis (OA). Physical therapists commonly use conventional physical therapy techniques and dry needling to treat knee OA, and this study is attempting to find out if the addition of dry needling to conventional physical therapy has an equal, greater, or lesser effect than conventional physical therapy alone.

Detailed description: Patients with knee OA will be randomized to receive 1-2 treatments per week for 6 weeks (up to 10 sessions total) of either: (1) Dry Needling and conventional physical therapy or the (2) Conventional physical therapy (manual physical therapy, exercise, range of motion and stretching)

Eligibility criteria: Inclusion Criteria:

1. Report of knee pain of at least 2/10 per NPRS (0---10 scale) for \>3 months
2. Report of at least 3 of the following per Altman et al. (1986)

   * 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:

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 previous surgery to the knee
3. History of physical therapy, massage therapy, chiropractic treatment, or injections for knee pain in the last 4 weeks
4. History of a surgical procedure on either lower extremity in last 6 months
5. 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
6. Involvement in litigation or worker's compensation regarding knee pain.
7. Any condition that might contraindicate the use of electro-needling
8. The patient is pregnant.

Primary outcomes:
measure: Change in Knee Pain Intensity (NPRS)
timeFrame: Baseline, 2 Weeks, 6 Weeks, 3 Months
measure: Change in Knee Osteoarthritis Index (Pain)
timeFrame: Baseline, 2 Weeks, 6 Weeks, 3 Months
measure: Change in Knee Osteoarthritis Index (Stiffness)
timeFrame: Baseline, 2 Weeks, 6 Weeks, 3 Months
measure: Change in Knee Osteoarthritis Index (Physical Function)
timeFrame: Baseline, 2 Weeks, 6 Weeks, 3 Months
measure: Change in Knee Osteoarthritis Index (Total)
timeFrame: Baseline, 2 Weeks, 6 Weeks, 3 Months
Secondary outcomes:
measure: Change in Global Rating of Change Score (GROC)
timeFrame: 2 Weeks, 6 Weeks, 3 Months
measure: Change in Medicine Intake (Frequency of medication intake)
timeFrame: Baseline, 3 months
Other outcomes:
Locations:
city: Montgomery
country: United States
facility: Alabama Physical Therapy & Acupuncture
state: Alabama
Study officials:
affiliation: American Academy of Manipulative Therapy
name: James Dunning, DPT FAAOMPT
role: PRINCIPAL_INVESTIGATOR
References:
citation: Dunning J, Butts R, Young I, Mourad F, Galante V, Bliton P, Tanner M, Fernandez-de-Las-Penas C. Periosteal Electrical Dry Needling as an Adjunct to Exercise and Manual Therapy for Knee Osteoarthritis: A Multicenter Randomized Clinical Trial. Clin J Pain. 2018 Dec;34(12):1149-1158. doi: 10.1097/AJP.0000000000000634.