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Completed

NCT Number: NCT02373631

Dry Needling Versus Conventional Physical Therapy in Patients With Knee Osteoarthritis

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Alabama Physical Therapy & Acupuncture

Montgomery, Alabama, 36117, United States

About this study

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)

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • 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)
  • 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 previous surgery to the knee
  • History of physical therapy, massage therapy, chiropractic treatment, or injections for knee pain in the last 4 weeks
  • History of a surgical procedure on either lower extremity in last 6 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 electro-needling
  • The patient is pregnant.

Treatment and study plan

Dry Needling, Conventional PT

Other

Dry needling to the knee and conventional physical therapy (stretching, ROM, strengthening), 1-2 treatments per week X6 weeks (up to 10 sessions total)

Conventional PT

Other

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)

Primary outcomes

  1. Change in Knee Pain Intensity (NPRS)

    Time frame: Baseline, 2 Weeks, 6 Weeks, 3 Months

  2. Change in Knee Osteoarthritis Index (Pain)

    Time frame: Baseline, 2 Weeks, 6 Weeks, 3 Months

    5 Questions each worth 0-4 points with a maximum score of 20 points possible

  3. Change in Knee Osteoarthritis Index (Stiffness)

    Time frame: Baseline, 2 Weeks, 6 Weeks, 3 Months

    2 Questions each worth 0-4 points with a maximum score of 8 points possible

  4. Change in Knee Osteoarthritis Index (Physical Function)

    Time frame: Baseline, 2 Weeks, 6 Weeks, 3 Months

    17 Questions each worth 0-4 points with a maximum score of 68 points possible

  5. Change in Knee Osteoarthritis Index (Total)

    Time frame: Baseline, 2 Weeks, 6 Weeks, 3 Months

    24 Questions each worth 0-4 points with a maximum score of 96 points possible

Secondary outcomes

  1. Change in Global Rating of Change Score (GROC)

    Time frame: 2 Weeks, 6 Weeks, 3 Months

  2. Change in Medicine Intake (Frequency of medication intake)

    Time frame: Baseline, 3 months

    Frequency of medication intake (narcotics and over-the-counter) for knee pain

Sponsors and collaborators

Lead sponsor

Alabama Physical Therapy & Acupuncture

Other

Collaborators

  • Universidad Rey Juan Carlos

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2017
Study completion
2017
First posted
Feb 27, 2015
Registry last updated
May 23, 2017

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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