Dry Needling Versus Conventional Physical Therapy in Patients With Plantar Fasciitis

NCT02373618 | Completed

• 1 other identifier: AAMT0002
• Study Type: interventional
• Target: 108
• Locations: 1 country
• Sites: 1

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.

Conditions

Plantar Fasciitis

Outcome Measures

Primary Outcomes (8)

• 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

• Change in First Step Pain in the Morning (NPRS)

  Baseline, 1 week, 4 weeks, 3 months

• Change in Activity Pain (NPRS)

  Average pain level during standing and walking.

  Baseline, 1 week, 4 weeks, 3 months

• Change in Pain Intensity (NPRS)

  Baseline, 1 week, 4 weeks, 3 months

• 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

• 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

• 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

• 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 Outcomes (2)

• Change in Global Rating of Change Score

  1 week, 4 weeks, 3 months

• Change in Medicine Intake (Frequency of pain medication)

  Baseline, 3 months

Study Arms (2)

Experimental: DN and Conventional PT

EXPERIMENTAL

Other: DN and conventional PT

Active Comparator: Conventional PT

ACTIVE COMPARATOR

Other: Conventional PT

Interventions

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.

Experimental: DN and Conventional PT

Conventional PT OTHER

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

Active Comparator: Conventional PT

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Alabama Physical Therapy & Acupuncture: lead
• Universidad Rey Juan Carlos: collaborator

Study Sites (1)

Alabama Physical Therapy & Acupuncture

Montgomery, Alabama, 36117, United States

Location

MeSH Terms

Conditions

Fasciitis, Plantar

Condition Hierarchy (Ancestors)

Fasciitis; Musculoskeletal Diseases; Foot Diseases

Study Officials

• James Dunning, DPT FAAOMPT

  American Academy of Manipulative Therapy

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: DPT FAAOMPT

Study Record Dates

• First Submitted: February 10, 2015
• First Posted: February 27, 2015
• Study Start: December 1, 2015
• Primary Completion: May 17, 2017
• Study Completion: May 17, 2017
• Last Updated: May 23, 2017

Record last verified: 2016-07

Locations

US (1)