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Dry Needling Versus Conventional Physical Therapy in Patients With Plantar Fasciitis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02373618
Recruitment Status : Completed
First Posted : February 27, 2015
Last Update Posted : May 23, 2017
Sponsor:
Collaborator:
Universidad Rey Juan Carlos
Information provided by (Responsible Party):
James Dunning, DPT, MSc, FAAOMPT, Alabama Physical Therapy & Acupuncture

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)

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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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Health Checkup

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.




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



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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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02373618


Locations
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United States, Alabama
Alabama Physical Therapy & Acupuncture
Montgomery, Alabama, United States, 36117
Sponsors and Collaborators
Alabama Physical Therapy & Acupuncture
Universidad Rey Juan Carlos
Investigators
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Principal Investigator: James Dunning, DPT FAAOMPT American Academy of Manipulative Therapy
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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    Key Record Dates
Last Update Posted: May 23, 2017
Last Verified: July 2016
Additional relevant MeSH terms:
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Fasciitis
Fasciitis, Plantar
Musculoskeletal Diseases
Foot Diseases