Dry Needling Versus Conventional Physical Therapy in Patients With Plantar Fasciitis

Plantar Fasciitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02373618
• Other study ID #: AAMT0002
• Status: Completed
• Phase: N/A
• First received: February 10, 2015
• Last updated: May 22, 2017
• Start date: December 2015
• Est. completion date: May 17, 2017

Study information

• Verified date: July 2016
• 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 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.

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)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 108
• Est. completion date: May 17, 2017
• Est. primary completion date: May 17, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Fasciitis
• Fasciitis, Plantar
• Plantar Fasciitis

Intervention

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.
• Conventional PT
Conventional physical therapy includes ultrasound, strengthening, cryotherapy, and manual therapy up to 8 sessions over 4 weeks.

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 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
Primary	Change in First Step Pain in the Morning (NPRS)		Baseline, 1 week, 4 weeks, 3 months
Primary	Change in Activity Pain (NPRS)	Average pain level during standing and walking.	Baseline, 1 week, 4 weeks, 3 months
Primary	Change in Pain Intensity (NPRS)		Baseline, 1 week, 4 weeks, 3 months
Primary	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
Primary	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
Primary	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
Primary	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	Change in Global Rating of Change Score		1 week, 4 weeks, 3 months
Secondary	Change in Medicine Intake (Frequency of pain medication)	Frequency of pain medication, including over-the-counter or narcotics for plantar fasciitis	Baseline, 3 months