Dry Needling Versus Conventional Physical Therapy in Patients With Plantar Fasciitis

Study Overview
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Brief Summary
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The purpose of this research is to compare patient outcomes following treatment of plantar fasciitis with conventional physical therapy (stretching, strengthening, ultrasound, manual therapy, and cryotherapy) and conventional physical therapy plus dry needling. Physical therapists commonly use conventional physical therapy techniques and dry needling to treat plantar fasciitis, and this study is attempting to find out if the addition of dry needling to conventional physical therapy is more effective than conventional physical therapy alone.

Detailed Description
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Patients with plantar fasciitis will be randomly assigned to receive 1-2 treatments per week for 4 weeks of either: (1) Dry Needling and conventional physical therapy, or the (2) Conventional physical therapy (stretching, strengthening, ultrasound, manual therapy, and cryotherapy)

Official Title
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Dry Needling Versus Conventional Physical Therapy in Patients With Plantar Fasciitis: a Multi-center Randomized Clinical Trial

Conditions
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Plantar Fasciitis

Intervention / Treatment
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* Other: DN and conventional PT
* Other: Conventional PT


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Report of at least 3 months of heel pain Patient has not had physical therapy, massage therapy, chiropractic treatment, or injections for plantar heel pain in the least 4 weeks. Diagnosis of plantar heel pain with ALL of the following positive clinical signs: First---step pain upon weight bearing in the morning OR after sitting for a period of time Pain localized over the medial calcaneal tubercle Increased pain with extended walking OR standing >15 minutes Plantar heel pain greater than or equal to 2/10 (NPRS 0-10 Scale) 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 tibia, fibula, ankle joint, or foot. History of arthrosis or arthritis of the ankle and/or foot. History of significant ankle and/or foot instability. Two or more positive neurologic signs consistent with nerve root compression, including any two of the following: Muscle weakness involving a major lower extremity muscle group Diminished lower extremity patella or Achilles tendon reflexes Diminished / absent sensation in any lower extremity dermatome Involvement in litigation or worker's compensation regarding their foot pain. Any condition that might contraindicate the use of electro---needling The patient is pregnant

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Experimental: DN and Conventional PT<br> | Other: DN and conventional PT<br>* Dry needling to the foot and lower leg. Up to 8 sessions over 4 weeks. Also conventional PT including: ultrasound, stretching, strengthening, cryotherapy and manual therapy to the foot and lower leg.<br>|
| Active Comparator: Active Comparator: Conventional PT<br> | Other: Conventional PT<br>* Conventional physical therapy includes ultrasound, strengthening, cryotherapy, and manual therapy up to 8 sessions over 4 weeks.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Lower Extremity Functional Scale | 20 questions each worth 0-4 points with maximum score of 80 points possible. Do not convert to a 20 questions, each worth 0-4 points with maximum score of 80 points possible | Baseline, 1 week, 4 weeks, 3 months | 
| Change in First Step Pain in the Morning (NPRS) |  | Baseline, 1 week, 4 weeks, 3 months | 
| Change in Activity Pain (NPRS) | Average pain level during standing and walking. | Baseline, 1 week, 4 weeks, 3 months | 
| Change in Pain Intensity (NPRS) |  | Baseline, 1 week, 4 weeks, 3 months | 
| Change in Foot Functional Index Pain | 5 questions each worth 0-10 points with maximum score of 50 points possible. | Baseline, 1 week, 4 weeks, 3 months | 
| Change in Foot Functional Index Disability | 9 questions each worth 0-10 points with maximum score of 90 points possible | Baseline, 1 week, 4 weeks, 3 months | 
| Change in Foot Functional Index Activity Limitation | 3 questions each worth 0-10 points with maximum score of 30 points possible | Baseline, 1 week, 4 weeks, 3 months | 
| Change in Foot Functional Index Total | 3 questions each worth 0-10 points with maximum score of 30 points possible | Baseline, 1 week, 4 weeks, 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Global Rating of Change Score |  | 1 week, 4 weeks, 3 months | 
| Change in Medicine Intake (Frequency of pain medication) | Frequency of pain medication, including over-the-counter or narcotics for plantar fasciitis | Baseline, 3 months |