Plantar FasciitisNCT02373618
Dry Needling Versus Conventional Physical Therapy in Patients With Plantar Fasciitis
A study testing DN and conventional PT and Conventional PT in people with Plantar Fasciitis, run by Alabama Physical Therapy & Acupuncture at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Plantar Fasciitis
- What is being tested?
- DN and conventional PT and Conventional PT
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 108 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2015to 17 May 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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
Show all 11Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Alabama Physical Therapy & Acupuncture
Montgomery, Alabama, 36117
About this study
Official title: Dry Needling Versus Conventional Physical Therapy in Patients With Plantar Fasciitis: a Multi-center Randomized Clinical Trial
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.
Read the 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)
- Conditions
- Plantar Fasciitis
- Being tested
- DN and conventional PT, Conventional PT
- Medical subject headings
- Fasciitis, Plantar
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DN and conventional PTOther
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 PTOther
Conventional physical therapy includes ultrasound, strengthening, cryotherapy, and manual therapy up to 8 sessions over 4 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Experimental: DN and Conventional PT | Experimental | Not described Receives: Other: DN and conventional PT |
| Active Comparator: Conventional PT | Active comparator | Not described Receives: Other: Conventional PT |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Baseline, 1 week, 4 weeks, 3 months
Change in First Step Pain in the Morning (NPRS)
Measured: Baseline, 1 week, 4 weeks, 3 months
Change in Activity Pain (NPRS)
Average pain level during standing and walking.
Measured: Baseline, 1 week, 4 weeks, 3 months
Change in Pain Intensity (NPRS)
Measured: 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.
Measured: 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
Measured: 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
Measured: 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
Measured: Baseline, 1 week, 4 weeks, 3 months
Secondary outcomes (2)
Change in Global Rating of Change Score
Measured: 1 week, 4 weeks, 3 months
Change in Medicine Intake (Frequency of pain medication)
Frequency of pain medication, including over-the-counter or narcotics for plantar fasciitis
Measured: Baseline, 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2015 (estimated)
- Study startDec 2015
- Primary completion17 May 2017
- Study completion17 May 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Plantar FasciitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 108 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Alabama Physical Therapy & Acupuncture
- Sponsor type
- University, hospital or other
- Collaborators
- Universidad Rey Juan Carlos
- Responsible party
- Principal investigator, James Dunning, DPT, MSc, FAAOMPT, Alabama Physical Therapy & Acupuncture
- Investigators
- James Dunning, DPT FAAOMPT, Principal investigator, American Academy of Manipulative Therapy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02373618
- Sponsor's protocol ID
- AAMT0002
- Status last verified
- Jul 2016
- First submitted
- 10 Feb 2015
- Last updated
- 23 May 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dry Needling Versus Conventional Physical Therapy in Patients With Plantar Fasciitis: a Multi-center Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT02373618
- Acronym / sponsor ID
- AAMT0002
- Conditions
- Plantar Fasciitis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 108 participants (estimated)
- Lead sponsor
- Alabama Physical Therapy & AcupunctureUniversity, hospital or other
- Collaborators
- Universidad Rey Juan Carlos
- Study start
- Dec 2015
- Primary completion
- 17 May 2017 (actual)
- Study completion
- 17 May 2017 (actual)
- First posted
- 27 Feb 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental: DN and Conventional PT | Experimental | Other: DN and conventional PT |
| Active Comparator: Conventional PT | Active comparator | Other: Conventional PT |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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:
- Plantar heel pain greater than or equal to 2/10 (NPRS 0-10 Scale)
Key exclusion criteria (11 listed)
- 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:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DN and conventional PTDry 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. | Other | Experimental: DN and Conventional PT |
| Conventional PTConventional physical therapy includes ultrasound, strengthening, cryotherapy, and manual therapy up to 8 sessions over 4 weeks. | Other | Active Comparator: Conventional PT |
Primary outcome
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
Change in First Step Pain in the Morning (NPRS)
Time frame: Baseline, 1 week, 4 weeks, 3 months
Change in Activity Pain (NPRS)
Time frame: Baseline, 1 week, 4 weeks, 3 months
Average pain level during standing and walking.
Change in Pain Intensity (NPRS)
Time frame: Baseline, 1 week, 4 weeks, 3 months
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.
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
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
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
2 secondary outcomes
Change in Global Rating of Change Score
Time frame: 1 week, 4 weeks, 3 months
Change in Medicine Intake (Frequency of pain medication)
Time frame: Baseline, 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 May 2017.
Related trials for Plantar Fasciitis
Not yet recruiting
Efficacy of TECAR Therapy in Plantar Fasciitis
Plantar Fasciitis
Active, not recruiting
Active Release Technique vs. Dynamic Soft Tissue Mobilization for Plantar Pain
Plantar Fascitis
Not yet recruiting
Hip Muscle Strengthening and Calf Myofascial Release in Females With Chronic Plantar Fasciitis
Chronic Planter Fascitis
Recruiting
F-18 Sodium Fluoride PET/CT-Guided Pain Palliation in Chronic Plantar Fasciitis: A Comparative Study of ¹⁷⁷Lutetium-Corticosteroid-Local Anaesthetic Injection vs Corticosteroid-Local Anaesthetic Injection
Plantar Fascitis, Chronic Heel Pain
Not yet recruiting
Radial vs Focused Shockwave Therapy for Plantar Fasciitis
Plantar Fasciitis, Chronic
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
James Dunning, DPT FAAOMPT principal investigator
American Academy of Manipulative Therapy
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing DN and conventional PT and Conventional PT in people with Plantar Fasciitis, run by Alabama Physical Therapy & Acupuncture at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 May 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Lower Extremity Functional Scale (time frame: Baseline, 1 week, 4 weeks, 3 months). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 May 2017.