Dry Needling Versus Conventional Physical Therapy in Patients With Plantar Fasciitis

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

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.

Study Overview

• Status: Completed
• Conditions: Plantar Fasciitis
• Intervention / Treatment: Other: DN and conventional PT; Other: Conventional PT

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)

• Study Type: Interventional
• Enrollment (Anticipated): 108
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Alabama
    • Montgomery, Alabama, United States, 36117
      • Alabama Physical Therapy & Acupuncture

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Report of at least 3 months of heel pain
2. Patient has not had physical therapy, massage therapy, chiropractic treatment, or injections for plantar heel pain in the least 4 weeks.

3. 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
4. Plantar heel pain greater than or equal to 2/10 (NPRS 0-10 Scale)

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 tibia, fibula, ankle joint, or foot.
3. History of arthrosis or arthritis of the ankle and/or foot.
4. History of significant ankle and/or foot instability.

5. 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
6. Involvement in litigation or worker's compensation regarding their foot pain.
7. Any condition that might contraindicate the use of electro---needling
8. The patient is pregnant

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Experimental: DN and Conventional PT	Other: DN and conventional PT; 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.
Active Comparator: Active Comparator: Conventional PT	Other: Conventional PT; Conventional physical therapy includes ultrasound, strengthening, cryotherapy, and manual therapy up to 8 sessions over 4 weeks.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Alabama Physical Therapy & Acupuncture
• Collaborators: Universidad Rey Juan Carlos
• Investigators: Principal Investigator: James Dunning, DPT FAAOMPT, American Academy of Manipulative Therapy

Study record dates

Study Major Dates

• Study Start: December 1, 2015
• Primary Completion (Actual): May 17, 2017
• Study Completion (Actual): May 17, 2017

Study Registration Dates

• First Submitted: February 10, 2015
• First Submitted That Met QC Criteria: February 23, 2015
• First Posted (Estimate): February 27, 2015

Study Record Updates

• Last Update Posted (Actual): May 23, 2017
• Last Update Submitted That Met QC Criteria: May 22, 2017
• Last Verified: July 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Foot Diseases; Musculoskeletal Diseases; Fasciitis; Fasciitis, Plantar
• Other Study ID Numbers: AAMT0002