Dry Needling Versus Conventional Physical Therapy in Patients With Knee Osteoarthritis

Dry Needling Versus Conventional Physical Therapy in Patients With Knee Osteoarthritis: a Multi-center Randomized Clinical Trial

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.

Study Overview

• Status: Completed
• Conditions: Knee Osteoarthritis
• Intervention / Treatment: Other: Dry Needling, Conventional PT; Other: Conventional PT

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)

• Study Type: Interventional
• Enrollment (Anticipated): 105
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Alabama
    • Montgomery, Alabama, United States, 36117
      • Alabama Physical Therapy & Acupuncture

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Dry Needling, Conventional PT	Other: Dry Needling, Conventional PT; Dry needling to the knee and conventional physical therapy (stretching, ROM, strengthening), 1-2 treatments per week X6 weeks (up to 10 sessions total)
Active Comparator: Conventional PT	Other: Conventional PT; Conventional physical therapy to include knee stretching, range of motion, and strengthening exercises,1-2 treatments per week X6 weeks (up to 10 sessions total)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Knee Pain Intensity (NPRS)		Baseline, 2 Weeks, 6 Weeks, 3 Months
Change in Knee Osteoarthritis Index (Pain)	5 Questions each worth 0-4 points with a maximum score of 20 points possible	Baseline, 2 Weeks, 6 Weeks, 3 Months
Change in Knee Osteoarthritis Index (Stiffness)	2 Questions each worth 0-4 points with a maximum score of 8 points possible	Baseline, 2 Weeks, 6 Weeks, 3 Months
Change in Knee Osteoarthritis Index (Physical Function)	17 Questions each worth 0-4 points with a maximum score of 68 points possible	Baseline, 2 Weeks, 6 Weeks, 3 Months
Change in Knee Osteoarthritis Index (Total)	24 Questions each worth 0-4 points with a maximum score of 96 points possible	Baseline, 2 Weeks, 6 Weeks, 3 Months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Global Rating of Change Score (GROC)		2 Weeks, 6 Weeks, 3 Months
Change in Medicine Intake (Frequency of medication intake)	Frequency of medication intake (narcotics and over-the-counter) for knee pain	Baseline, 3 months

Collaborators and Investigators

• Sponsor: Alabama Physical Therapy & Acupuncture
• Collaborators: Universidad Rey Juan Carlos
• Investigators: Principal Investigator: James Dunning, DPT FAAOMPT, American Academy of Manipulative Therapy

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: February 1, 2015
• Primary Completion (Actual): May 19, 2017
• Study Completion (Actual): May 19, 2017

Study Registration Dates

• First Submitted: February 10, 2015
• First Submitted That Met QC Criteria: February 23, 2015
• First Posted (Estimate): February 27, 2015

Study Record Updates

• Last Update Posted (Actual): May 23, 2017
• Last Update Submitted That Met QC Criteria: May 22, 2017
• Last Verified: May 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Osteoarthritis; Osteoarthritis, Knee
• Other Study ID Numbers: AAMT0003