Dry Needling Versus Conventional Physical Therapy in Patients With Knee Osteoarthritis

Knee Osteoarthritis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02373631
• Other study ID #: AAMT0003
• Status: Completed
• Phase: N/A
• First received: February 10, 2015
• Last updated: May 22, 2017
• Start date: February 2015
• Est. completion date: May 19, 2017

Study information

• Verified date: May 2017
• Source: Alabama Physical Therapy & Acupuncture
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 105
• Est. completion date: May 19, 2017
• Est. primary completion date: May 19, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Knee Osteoarthritis
• Osteoarthritis
• Osteoarthritis, Knee

Intervention

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)
• 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)

Locations

Country	Name	City	State
United States	Alabama Physical Therapy & Acupuncture	Montgomery	Alabama

Sponsors (2)

Lead Sponsor	Collaborator
Alabama Physical Therapy & Acupuncture	Universidad Rey Juan Carlos

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Knee Pain Intensity (NPRS)		Baseline, 2 Weeks, 6 Weeks, 3 Months
Primary	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
Primary	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
Primary	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
Primary	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	Change in Global Rating of Change Score (GROC)		2 Weeks, 6 Weeks, 3 Months
Secondary	Change in Medicine Intake (Frequency of medication intake)	Frequency of medication intake (narcotics and over-the-counter) for knee pain	Baseline, 3 months