Dry Needling Versus Conventional Physical Therapy in Patients With Plantar Fasciitis

• ClinicalTrials.gov Identifier: NCT02373618
• Recruitment Status: Completed
• First Posted: February 27, 2015
• Last Update Posted: May 23, 2017
• Sponsor: Alabama Physical Therapy & Acupuncture
• Collaborator: Universidad Rey Juan Carlos
• Information provided by (Responsible Party): James Dunning, DPT, MSc, FAAOMPT, Alabama Physical Therapy & Acupuncture

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Plantar Fasciitis	Other: DN and conventional PT; Other: Conventional PT	Not Applicable

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 Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 108 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Dry Needling Versus Conventional Physical Therapy in Patients With Plantar Fasciitis: a Multi-center Randomized Clinical Trial
• Study Start Date: December 2015
• Actual Primary Completion Date: May 17, 2017
• Actual Study Completion Date: May 17, 2017

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures :

1. 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
2. Change in First Step Pain in the Morning (NPRS) [ Time Frame: Baseline, 1 week, 4 weeks, 3 months ]
3. Change in Activity Pain (NPRS) [ Time Frame: Baseline, 1 week, 4 weeks, 3 months ]
   Average pain level during standing and walking.
4. Change in Pain Intensity (NPRS) [ Time Frame: Baseline, 1 week, 4 weeks, 3 months ]
5. 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.
6. 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
7. 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
8. 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

Secondary Outcome Measures :

1. Change in Global Rating of Change Score [ Time Frame: 1 week, 4 weeks, 3 months ]
2. Change in Medicine Intake (Frequency of pain medication) [ Time Frame: Baseline, 3 months ]
   Frequency of pain medication, including over-the-counter or narcotics for plantar fasciitis

Eligibility Criteria

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

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

Contacts and Locations

Locations

United States, Alabama

Alabama Physical Therapy & Acupuncture

Montgomery, Alabama, United States, 36117

Sponsors and Collaborators

Alabama Physical Therapy & Acupuncture

Universidad Rey Juan Carlos

Investigators

• Principal Investigator: James Dunning, DPT FAAOMPT; American Academy of Manipulative Therapy

More Information

• Responsible Party: James Dunning, DPT, MSc, FAAOMPT, DPT FAAOMPT, Alabama Physical Therapy & Acupuncture
• ClinicalTrials.gov Identifier: NCT02373618
• Other Study ID Numbers: AAMT0002
• First Posted: February 27, 2015
• Last Update Posted: May 23, 2017
• Last Verified: July 2016

Additional relevant MeSH terms:

Fasciitis; Fasciitis, Plantar; Musculoskeletal Diseases; Foot Diseases