Clinical trial NCT02373618: Dry Needling Versus Conventional Physical Therapy in Patients With Plantar Fasciitis
Official title: Dry Needling Versus Conventional Physical Therapy in Patients With Plantar Fasciitis: a Multi-center Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Plantar Fasciitis
Lead sponsor: Alabama Physical Therapy & Acupuncture
Sponsor class: OTHER
Collaborators: name: Universidad Rey Juan Carlos
First posted: 2015-02-27
Enrollment: 108
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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)

Eligibility criteria: 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

Primary outcomes:
measure: Change in Lower Extremity Functional Scale
timeFrame: Baseline, 1 week, 4 weeks, 3 months
measure: Change in First Step Pain in the Morning (NPRS)
timeFrame: Baseline, 1 week, 4 weeks, 3 months
measure: Change in Activity Pain (NPRS)
timeFrame: Baseline, 1 week, 4 weeks, 3 months
measure: Change in Pain Intensity (NPRS)
timeFrame: Baseline, 1 week, 4 weeks, 3 months
measure: Change in Foot Functional Index Pain
timeFrame: Baseline, 1 week, 4 weeks, 3 months
measure: Change in Foot Functional Index Disability
timeFrame: Baseline, 1 week, 4 weeks, 3 months
measure: Change in Foot Functional Index Activity Limitation
timeFrame: Baseline, 1 week, 4 weeks, 3 months
measure: Change in Foot Functional Index Total
timeFrame: Baseline, 1 week, 4 weeks, 3 months
Secondary outcomes:
measure: Change in Global Rating of Change Score
timeFrame: 1 week, 4 weeks, 3 months
measure: Change in Medicine Intake (Frequency of pain medication)
timeFrame: Baseline, 3 months
Other outcomes:
Locations:
city: Montgomery
country: United States
facility: Alabama Physical Therapy & Acupuncture
state: Alabama
Study officials:
affiliation: American Academy of Manipulative Therapy
name: James Dunning, DPT FAAOMPT
role: PRINCIPAL_INVESTIGATOR
References: