Dry Needling Versus Conventional Physical Therapy in Patients With Plantar Fasciitis

Sponsor
Alabama Physical Therapy & Acupuncture (Other)
Overall Status
Completed
CT.gov ID
NCT02373618
Collaborator
Universidad Rey Juan Carlos (Other)
108
1
2
17.5
6.2

Study Details

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
  • Other: DN and conventional PT
  • Other: Conventional PT
N/A

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
Anticipated 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 :
Dec 1, 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 [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) [Baseline, 1 week, 4 weeks, 3 months]

  3. Change in Activity Pain (NPRS) [Baseline, 1 week, 4 weeks, 3 months]

    Average pain level during standing and walking.

  4. Change in Pain Intensity (NPRS) [Baseline, 1 week, 4 weeks, 3 months]

  5. Change in Foot Functional Index Pain [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 [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 [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 [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 [1 week, 4 weeks, 3 months]

  2. Change in Medicine Intake (Frequency of pain medication) [Baseline, 3 months]

    Frequency of pain medication, including over-the-counter or narcotics for plantar fasciitis

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

  1. 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

  1. Involvement in litigation or worker's compensation regarding their foot pain.

  2. Any condition that might contraindicate the use of electro---needling

  3. The patient is pregnant

Contacts and Locations

Locations

Site City State Country Postal Code
1 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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
James Dunning, DPT, MSc, FAAOMPT, DPT FAAOMPT, Alabama Physical Therapy & Acupuncture
ClinicalTrials.gov Identifier:
NCT02373618
Other Study ID Numbers:
  • AAMT0002
First Posted:
Feb 27, 2015
Last Update Posted:
May 23, 2017
Last Verified:
Jul 1, 2016
Additional relevant MeSH terms:

Study Results

No Results Posted as of May 23, 2017