Back to resultsDry Needling Versus Conventional Physical Therapy in Patients With Plantar Fasciitis
Primary Purpose
Plantar Fasciitis
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
DN and conventional PT
Conventional PT
Sponsored by
About this trial
This is an interventional treatment trial for Plantar Fasciitis
Eligibility Criteria
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
Sites / Locations
- Alabama Physical Therapy & Acupuncture
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Experimental: DN and Conventional PT
Active Comparator: Conventional PT
Arm Description
Outcomes
Primary Outcome Measures
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
Change in First Step Pain in the Morning (NPRS)
Change in Activity Pain (NPRS)
Average pain level during standing and walking.
Change in Pain Intensity (NPRS)
Change in Foot Functional Index Pain
5 questions each worth 0-10 points with maximum score of 50 points possible.
Change in Foot Functional Index Disability
9 questions each worth 0-10 points with maximum score of 90 points possible
Change in Foot Functional Index Activity Limitation
3 questions each worth 0-10 points with maximum score of 30 points possible
Change in Foot Functional Index Total
3 questions each worth 0-10 points with maximum score of 30 points possible
Secondary Outcome Measures
Change in Global Rating of Change Score
Change in Medicine Intake (Frequency of pain medication)
Frequency of pain medication, including over-the-counter or narcotics for plantar fasciitis
Full Information
NCT ID
NCT02373618
First Posted
February 10, 2015
Last Updated
May 22, 2017
Sponsor
Alabama Physical Therapy & Acupuncture
Collaborators
Universidad Rey Juan Carlos
1. Study Identification
Unique Protocol Identification Number
NCT02373618
Brief Title
Dry Needling Versus Conventional Physical Therapy in Patients With Plantar Fasciitis
Official Title
Dry Needling Versus Conventional Physical Therapy in Patients With Plantar Fasciitis: a Multi-center Randomized Clinical Trial
Study Type
Interventional
2. Study Status
Record Verification Date
July 2016
Overall Recruitment Status
Completed
Study Start Date
December 2015 (undefined)
Primary Completion Date
May 17, 2017 (Actual)
Study Completion Date
May 17, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Alabama Physical Therapy & Acupuncture
Collaborators
Universidad Rey Juan Carlos
4. Oversight
Data Monitoring Committee
No
5. 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.
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)
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Plantar Fasciitis
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
108 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Experimental: DN and Conventional PT
Arm Type
Experimental
Arm Title
Active Comparator: Conventional PT
Arm Type
Active Comparator
Intervention Type
Other
Intervention Name(s)
DN and conventional PT
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Conventional PT
Intervention Description
Conventional physical therapy includes ultrasound, strengthening, cryotherapy, and manual therapy up to 8 sessions over 4 weeks.
Primary Outcome Measure Information:
Title
Change in Lower Extremity Functional Scale
Description
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
Time Frame
Baseline, 1 week, 4 weeks, 3 months
Title
Change in First Step Pain in the Morning (NPRS)
Time Frame
Baseline, 1 week, 4 weeks, 3 months
Title
Change in Activity Pain (NPRS)
Description
Average pain level during standing and walking.
Time Frame
Baseline, 1 week, 4 weeks, 3 months
Title
Change in Pain Intensity (NPRS)
Time Frame
Baseline, 1 week, 4 weeks, 3 months
Title
Change in Foot Functional Index Pain
Description
5 questions each worth 0-10 points with maximum score of 50 points possible.
Time Frame
Baseline, 1 week, 4 weeks, 3 months
Title
Change in Foot Functional Index Disability
Description
9 questions each worth 0-10 points with maximum score of 90 points possible
Time Frame
Baseline, 1 week, 4 weeks, 3 months
Title
Change in Foot Functional Index Activity Limitation
Description
3 questions each worth 0-10 points with maximum score of 30 points possible
Time Frame
Baseline, 1 week, 4 weeks, 3 months
Title
Change in Foot Functional Index Total
Description
3 questions each worth 0-10 points with maximum score of 30 points possible
Time Frame
Baseline, 1 week, 4 weeks, 3 months
Secondary Outcome Measure Information:
Title
Change in Global Rating of Change Score
Time Frame
1 week, 4 weeks, 3 months
Title
Change in Medicine Intake (Frequency of pain medication)
Description
Frequency of pain medication, including over-the-counter or narcotics for plantar fasciitis
Time Frame
Baseline, 3 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
James Dunning, DPT FAAOMPT
Organizational Affiliation
American Academy of Manipulative Therapy
Official's Role
Principal Investigator
Facility Information:
Facility Name
Alabama Physical Therapy & Acupuncture
City
Montgomery
State/Province
Alabama
ZIP/Postal Code
36117
Country
United States
12. IPD Sharing Statement
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Dry Needling Versus Conventional Physical Therapy in Patients With Plantar Fasciitis
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