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Completed

NCT Number: NCT02373618

Dry Needling Versus Conventional Physical Therapy in Patients With Plantar Fasciitis

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Alabama Physical Therapy & Acupuncture

Montgomery, Alabama, 36117, United States

About this study

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)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Report of at least 3 months of heel pain
  • Patient has not had physical therapy, massage therapy, chiropractic treatment, or injections for plantar heel pain in the least 4 weeks.
  • 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
  • Plantar heel pain greater than or equal to 2/10 (NPRS 0-10 Scale)

Exclusion criteria

  • 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.
  • History of previous surgery to the tibia, fibula, ankle joint, or foot.
  • History of arthrosis or arthritis of the ankle and/or foot.
  • History of significant ankle and/or foot instability.
  • 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
  • Involvement in litigation or worker's compensation regarding their foot pain.
  • Any condition that might contraindicate the use of electro---needling
  • The patient is pregnant

Treatment and study plan

DN and conventional PT

Other

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

Other

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

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Alabama Physical Therapy & Acupuncture

Other

Collaborators

  • Universidad Rey Juan Carlos

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2017
Study completion
2017
First posted
Feb 27, 2015
Registry last updated
May 23, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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