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Clinical Trials/NCT02373618
NCT02373618
Completed
Not Applicable

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

Alabama Physical Therapy & Acupuncture1 site in 1 country108 target enrollmentDecember 2015

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Plantar Fasciitis
Sponsor
Alabama Physical Therapy & Acupuncture
Enrollment
108
Locations
1
Primary Endpoint
Change in Pain Intensity (NPRS)
Status
Completed
Last Updated
8 years ago

Overview

Brief Summary

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

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)

Registry
clinicaltrials.gov
Start Date
December 2015
End Date
May 17, 2017
Last Updated
8 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Alabama Physical Therapy & Acupuncture
Responsible Party
Principal Investigator
Principal Investigator

James Dunning, DPT, MSc, FAAOMPT

DPT FAAOMPT

Alabama Physical Therapy & Acupuncture

Eligibility Criteria

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

Outcomes

Primary Outcomes

Change in Pain Intensity (NPRS)

Time Frame: Baseline, 1 week, 4 weeks, 3 months

Change in First Step Pain in the Morning (NPRS)

Time Frame: Baseline, 1 week, 4 weeks, 3 months

Change in Activity Pain (NPRS)

Time Frame: Baseline, 1 week, 4 weeks, 3 months

Average pain level during standing and walking.

Change in Foot Functional Index Total

Time Frame: Baseline, 1 week, 4 weeks, 3 months

3 questions each worth 0-10 points with maximum score of 30 points possible

Change in Foot Functional Index Disability

Time Frame: Baseline, 1 week, 4 weeks, 3 months

9 questions each worth 0-10 points with maximum score of 90 points possible

Change in Lower Extremity Functional Scale

Time Frame: Baseline, 1 week, 4 weeks, 3 months

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

Change in Foot Functional Index Activity Limitation

Time Frame: Baseline, 1 week, 4 weeks, 3 months

3 questions each worth 0-10 points with maximum score of 30 points possible

Change in Foot Functional Index Pain

Time Frame: Baseline, 1 week, 4 weeks, 3 months

5 questions each worth 0-10 points with maximum score of 50 points possible.

Secondary Outcomes

  • Change in Medicine Intake (Frequency of pain medication)(Baseline, 3 months)
  • Change in Global Rating of Change Score(1 week, 4 weeks, 3 months)

Study Sites (1)

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