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Dry Needling Versus Conventional Physical Therapy in Patients With Knee Osteoarthritis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02373631
Recruitment Status : Completed
First Posted : February 27, 2015
Last Update Posted : May 23, 2017
Sponsor:
Collaborator:
Universidad Rey Juan Carlos
Information provided by (Responsible Party):
James Dunning, DPT, MSc, FAAOMPT, Alabama Physical Therapy & Acupuncture

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.

Condition or disease Intervention/treatment Phase
Knee Osteoarthritis Other: Dry Needling, Conventional PT Other: Conventional PT Not Applicable

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)

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 105 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Dry Needling Versus Conventional Physical Therapy in Patients With Knee Osteoarthritis: a Multi-center Randomized Clinical Trial
Study Start Date : February 2015
Actual Primary Completion Date : May 19, 2017
Actual Study Completion Date : May 19, 2017

Resource links provided by the National Library of Medicine


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)




Primary Outcome Measures :
  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 Outcome Measures :
  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



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02373631


Locations
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United States, Alabama
Alabama Physical Therapy & Acupuncture
Montgomery, Alabama, United States, 36117
Sponsors and Collaborators
Alabama Physical Therapy & Acupuncture
Universidad Rey Juan Carlos
Investigators
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Principal Investigator: James Dunning, DPT FAAOMPT American Academy of Manipulative Therapy
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: James Dunning, DPT, MSc, FAAOMPT, DPT MSc FAAOMPT, Alabama Physical Therapy & Acupuncture
ClinicalTrials.gov Identifier: NCT02373631    
Other Study ID Numbers: AAMT0003
First Posted: February 27, 2015    Key Record Dates
Last Update Posted: May 23, 2017
Last Verified: May 2017
Additional relevant MeSH terms:
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Osteoarthritis
Osteoarthritis, Knee
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases