Back to resultsDry Needling Versus Conventional Physical Therapy in Patients With Knee Osteoarthritis
Primary Purpose
Knee Osteoarthritis
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Dry Needling, Conventional PT
Conventional PT
Sponsored by
About this trial
This is an interventional treatment trial for Knee Osteoarthritis
Eligibility Criteria
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.
Sites / Locations
- Alabama Physical Therapy & Acupuncture
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Dry Needling, Conventional PT
Conventional PT
Arm Description
Outcomes
Primary Outcome Measures
Change in Knee Pain Intensity (NPRS)
Change in Knee Osteoarthritis Index (Pain)
5 Questions each worth 0-4 points with a maximum score of 20 points possible
Change in Knee Osteoarthritis Index (Stiffness)
2 Questions each worth 0-4 points with a maximum score of 8 points possible
Change in Knee Osteoarthritis Index (Physical Function)
17 Questions each worth 0-4 points with a maximum score of 68 points possible
Change in Knee Osteoarthritis Index (Total)
24 Questions each worth 0-4 points with a maximum score of 96 points possible
Secondary Outcome Measures
Change in Global Rating of Change Score (GROC)
Change in Medicine Intake (Frequency of medication intake)
Frequency of medication intake (narcotics and over-the-counter) for knee pain
Full Information
NCT ID
NCT02373631
First Posted
February 10, 2015
Last Updated
May 22, 2017
Sponsor
Alabama Physical Therapy & Acupuncture
Collaborators
Universidad Rey Juan Carlos
1. Study Identification
Unique Protocol Identification Number
NCT02373631
Brief Title
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
2. Study Status
Record Verification Date
May 2017
Overall Recruitment Status
Completed
Study Start Date
February 2015 (undefined)
Primary Completion Date
May 19, 2017 (Actual)
Study Completion Date
May 19, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Alabama Physical Therapy & Acupuncture
Collaborators
Universidad Rey Juan Carlos
4. Oversight
Data Monitoring Committee
No
5. Study Description
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)
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Knee Osteoarthritis
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
105 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Dry Needling, Conventional PT
Arm Type
Experimental
Arm Title
Conventional PT
Arm Type
Active Comparator
Intervention Type
Other
Intervention Name(s)
Dry Needling, Conventional PT
Intervention Description
Dry needling to the knee and conventional physical therapy (stretching, ROM, strengthening), 1-2 treatments per week X6 weeks (up to 10 sessions total)
Intervention Type
Other
Intervention Name(s)
Conventional PT
Intervention Description
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 Measure Information:
Title
Change in Knee Pain Intensity (NPRS)
Time Frame
Baseline, 2 Weeks, 6 Weeks, 3 Months
Title
Change in Knee Osteoarthritis Index (Pain)
Description
5 Questions each worth 0-4 points with a maximum score of 20 points possible
Time Frame
Baseline, 2 Weeks, 6 Weeks, 3 Months
Title
Change in Knee Osteoarthritis Index (Stiffness)
Description
2 Questions each worth 0-4 points with a maximum score of 8 points possible
Time Frame
Baseline, 2 Weeks, 6 Weeks, 3 Months
Title
Change in Knee Osteoarthritis Index (Physical Function)
Description
17 Questions each worth 0-4 points with a maximum score of 68 points possible
Time Frame
Baseline, 2 Weeks, 6 Weeks, 3 Months
Title
Change in Knee Osteoarthritis Index (Total)
Description
24 Questions each worth 0-4 points with a maximum score of 96 points possible
Time Frame
Baseline, 2 Weeks, 6 Weeks, 3 Months
Secondary Outcome Measure Information:
Title
Change in Global Rating of Change Score (GROC)
Time Frame
2 Weeks, 6 Weeks, 3 Months
Title
Change in Medicine Intake (Frequency of medication intake)
Description
Frequency of medication intake (narcotics and over-the-counter) for knee pain
Time Frame
Baseline, 3 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
James Dunning, DPT FAAOMPT
Organizational Affiliation
American Academy of Manipulative Therapy
Official's Role
Principal Investigator
Facility Information:
Facility Name
Alabama Physical Therapy & Acupuncture
City
Montgomery
State/Province
Alabama
ZIP/Postal Code
36117
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
29864043
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.
Results Reference
derived
Learn more about this trial
Dry Needling Versus Conventional Physical Therapy in Patients With Knee Osteoarthritis
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