Plantar FascitisPF-RCTNCT03231150
Plantar Fasciitis Randomized Clinical Control Trial
A study testing Local Steroid Injection into the plantar heel, Ultrasound Guided Injection and Anatomical Guided injection in people with Plantar Fascitis, run by University of Pennsylvania at 1 site in United States.
Trial summary
The primary aim of this clinical experiment is to compare, in terms of pain relief measured using the 10-cm visual analog scale (VAS) pain score (5-7), the clinical results of ultrasound-guided injection (USGI) versus anatomic topography-guided injection (ATGI) of corticosteroid for the treatment of proximal PF. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Plantar Fascitis
- What is being tested?
- Local Steroid Injection into the plantar heel, Ultrasound Guided Injection and Anatomical Guided injection
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 62 participants
- Where
- 1 siteUnited States
- Study dates
- 28 Mar 2017to 31 Oct 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Pain on palpation along the proximal plantar fascia with or without radiographic evidence of a plantar calcaneal bone spur
- ≥18 years of age
- Male or non-pregnant female of any ethnicity or race
- Active, former or non smoker
- With or without peripheral vascular disease without lower extremity intermittent claudication or rest pain
- With or without diabetes mellitus without polyneuropathy
- With or without collagen vascular disease without lower extremity wound formation.
Who cannot join
- Known drug or alcohol dependence
- Chronic pain syndrome or lumbosacral radiculitis
- Neurological condition that requires the use of analgesic medications or anti-seizure or neuroleptic medications
- Peripheral vascular disease that results in rest pain or intermittent claudication or venous stasis ulceration
- Calcaneal stress fracture or show evidence of a foreign body or tumor of the affected heel as viewed radiographically
- Pregnant females
Show all 10Show fewer
- Known allergy to any of the components of the injection therapy
- Previously suffered a rupture or surgery of the plantar fascia within the 5 years preceding participation in the investigation
- Existing or prior osteomyelitis of the involved calcaneus
- Unable to consent to participation in clinical research or currently be involved in another clinical investigation.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Penn Presbyterian Medical Center
Philadelphia, Pennsylvania, 19104
Donald S Malay, DPM, 484-844-0755, malaydsm@gmail.com
Brittany Winfield, DPM
About this study
Official title: Randomized Clinical Study to Evaluate Ultrasound Guided Injection Therapy Versus Topographic Injection Therapy for Plantar Fasciitis
The primary aim of this clinical experiment is to compare, in terms of pain relief measured using the 10-cm visual analog scale (VAS) pain score (5-7), the clinical results of ultrasound-guided injection (USGI) versus anatomic topography-guided injection (ATGI) of corticosteroid for the treatment of proximal PF. Secondary aims will be to compare foot-related quality of life, as measured using the Foot Function Index (FFI)and the Bristol Foot Score (BFS), between the injection groups, and also to compare the pre-injection to late-term post-injection thickness of the plantar fascia as measured in the nested USGI group.
Read the detailed description
Clinically, proximal PF causes plantar heel pain, which may extend into the proximal portion of the plantar longitudinal arch. Typically, the pain is most notable upon initial weight bearing ambulation (post-static dyskinesia, PSD), such as the first step in the morning or following a period of non-weight bearing or rest. This can be attributed to walking on hard surfaces or barefoot, prolonged weight bearing activity, inadequate stretching and use of poor footwear, as well as increased amounts of walking. Standard treatment of PF includes the use of foot orthotics, both pre-fabricated and custom molded, physical therapy and myotendinous stretching, splinting or strapping the foot, nonsteroidal anti-inflammatory drugs, ice, and corticosteroid injections. Ultrasonography (US) can be useful for examining the plantar fascia, which typically measures between 2 mm to 4 mm in thickness, and findings indicative of PF include diffuse hypoechogenicity at the calcaneal attachment of the plantar fascia, loss of definition between the plantar fascia and the surrounding soft tissues, peri-insertion edema, and thickness over 4.5 mm. Local infiltration of corticosteroids has been used to treat PF since the 1950s. Despite this being a well established treatment, there are still unexamined features of this form of intervention, including the method of injection, type of steroid used, concurrent use of localanesthetic agents, concurrent use of orthoses and/or supportive arch strapping, concurrent physical therapy, and the use of ultrasonographic guidance of the corticosteroid injection. The primary aim of this clinical experiment is to compare, in terms of pain relief measured using the 10-cm visual analog scale (VAS) pain score (5-7), the clinical results of ultrasound-guided injection (USGI) versus anatomic topography-guided injection (ATGI) of corticosteroid for the treatment of proximal PF. Secondary aims will be to compare foot-related quality of life, as measured using the Foot Function Index (FFI)and the Bristol Foot Score (BFS), between the injection groups, and also to compare the pre-injection to late-term post-injection thickness of the plantar fascia as measured in the nested USGI group.
- Conditions
- Plantar Fascitis
- Being tested
- Local Steroid Injection into the plantar heel, Ultrasound Guided Injection, Anatomical Guided injection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Local Steroid Injection into the plantar heelProcedure or surgery
Injections consisting of 0.5 ml 0.25% bupivacaine plain, 0.5 ml dexamethasone phosphate, and 0.5 ml triamcinolone acetonide 40 mg/ml.
Ultrasound Guided InjectionProcedure or surgery
Execution of the USGI will employ an actual diagnostic US machine (Voluson E8 Expert, General Electric Company, Boston, MA) and a plantarmedial approach
Anatomical Guided injectionProcedure or surgery
Execution of the ATGI will employ a sham diagnostic US machine and a plantarmedial approach.
| Study group | Role | What they receive |
|---|---|---|
| Anatomical injection | Active comparator | Once patient has been randomized, if placed in the anatomically-guided injection group, the medial band of the plantar fascia origin on the calcaneus will be palpated and marked approximately. In the clinical setting, a sham ultrasound machine will be utilized to "locate" the plantar fascia keeping the patient blinded to the treatment modality. The area will then be prepped with alcohol to the medial heel and utilizing a medial approach, an injection of 0.5 cc 0.5% bupivacaine, 0.5 cc dexamethasone and 0.25 cc triamcinolone acetamide 40 mg/mL will be administered into the area surrounding the plantar fascia. The area will then be cleaned will alcohol and dressed with a small elastic bandage. Receives: Procedure: Local Steroid Injection into the plantar heel; Procedure: Anatomical Guided injection |
| Ultrasound Guided Injection | Experimental | Once patient has been randomized, if placed in the USGI group, the patient will be scheduled for an ultrasound therapy in the radiology department at Penn Presbyterian Medical Center. In this setting, the patient will be informed that in order to keep them blinded, that all patients must have either injection performed in the radiology department and that the ultrasound machine utilized will either be on or off during the injection keeping the patient blinded to the treatment modality. The area will then be prepped with alcohol to the medial heel and utilizing a medial approach, an injection of 0.5 cc 0.5% bupivacaine, 0.5 cc dexamethasone and 0.25 cc triamcinolone acetamide 40 mg/mL will be administered into the area surrounding the plantar fascia. The area will then be cleaned will alcohol and dressed with a small elastic bandage. Receives: Procedure: Local Steroid Injection into the plantar heel; Procedure: Ultrasound Guided Injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in VAS pain score at post injection periods with use of USGI
with the primary efficacy endpoint being the 3-month post injection pain score
Measured: Baseline to 3 months, 6 month, 9 month, and 12 month follow up
Change in VAS pain score at post injection periods with use of ATGI
with the primary efficacy endpoint being the 3-month post injection pain score
Measured: Baseline to 3 months, 6 month, 9 month, and 12 month follow up
Secondary outcomes (3)
Observation of normal plantar fascia after treatment as measured by ultrasound (US)
Measured: Baseline to 12 month follow up
Foot-related quality of life outcomes as measured with use of the FFI
Measured: Baseline to 3 months, 6 month, 9 month, and 12 month follow up
Foot-related quality of life outcomes as measured with use of the BFS
Measured: Baseline to 3 months, 6 month, 9 month, and 12 month follow up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2017
- Study start28 Mar 2017
- Primary completion15 Jun 2026 (estimated)
- Study completion31 Oct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (13)Papers the sponsor has linked to this study.
- Other trials for Plantar FascitisStudies of the same condition, open and under way.
- More trials run by University of PennsylvaniaThe sponsor's other registered studies.
- 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
- Single group
- Model description
- This investigation will be chronologically divided into four stages that will commence after procurement of institutional review board (IRB) approval and funding, namely: 1) screening and enrollment, 2) random treatment allocation and treatment, 3) data collection and analysis, and 4) presentation and publication. We anticipate that it will take approximately 23.5 months to execute the clinical experiment and to prepare the report for publication.
- Masking
- Double blind
- Who is masked
- Care provider, Investigator
- Enrolment
- 62 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Pennsylvania
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Donald S Malay, DPM, Principal investigator, Penn Presbyterian Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03231150
- Sponsor's protocol ID
- PPMC-04
- Acronym
- PF-RCT
- Status last verified
- Oct 2025
- First submitted
- 21 Jul 2017
- Last updated
- 10 Oct 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Ang TW. The effectiveness of corticosteroid injection in the treatment of plantar fasciitis. Singapore Med J. 2015 Aug;56(8):423-32. doi: 10.11622/smedj.2015118.
PubMed 26311907Weil L Jr, Glover JP, Weil LS Sr. A new minimally invasive technique for treating plantar fasciosis using bipolar radiofrequency: a prospective analysis. Foot Ankle Spec. 2008 Feb;1(1):13-8. doi: 10.1177/1938640007312318..
PubMed 19825686Young CC, Rutherford DS, Niedfeldt MW. Treatment of plantar fasciitis. Am Fam Physician. 2001 Feb 1;63(3):467-74, 477-8.
PubMed 11272297Buchbinder R. Clinical practice. Plantar fasciitis. N Engl J Med. 2004 May 20;350(21):2159-66. doi: 10.1056/NEJMcp032745. No abstract available.
PubMed 15152061Wessel J. The reliability and validity of pain threshold measurements in osteoarthritis of the knee. Scand J Rheumatol. 1995;24(4):238-42. doi: 10.3109/03009749509100881.
PubMed 7481589Lundeberg T, Lund I, Dahlin L, Borg E, Gustafsson C, Sandin L, Rosen A, Kowalski J, Eriksson SV. Reliability and responsiveness of three different pain assessments. J Rehabil Med. 2001 Nov;33(6):279-83. doi: 10.1080/165019701753236473.
PubMed 11766958Bijur PE, Silver W, Gallagher EJ. Reliability of the visual analog scale for measurement of acute pain. Acad Emerg Med. 2001 Dec;8(12):1153-7. doi: 10.1111/j.1553-2712.2001.tb01132.x.
PubMed 11733293Budiman-Mak E, Conrad KJ, Roach KE. The Foot Function Index: a measure of foot pain and disability. J Clin Epidemiol. 1991;44(6):561-70. doi: 10.1016/0895-4356(91)90220-4.
PubMed 2037861Barnett S, Campbell R, Harvey I. The Bristol Foot Score: developing a patient-based foot-health measure. J Am Podiatr Med Assoc. 2005 May-Jun;95(3):264-72. doi: 10.7547/0950264.
PubMed 15901814Tsai WC, Wang CL, Tang FT, Hsu TC, Hsu KH, Wong MK. Treatment of proximal plantar fasciitis with ultrasound-guided steroid injection. Arch Phys Med Rehabil. 2000 Oct;81(10):1416-21. doi: 10.1053/apmr.2000.9175.
PubMed 11030509Tsai WC, Hsu CC, Chen CP, Chen MJ, Yu TY, Chen YJ. Plantar fasciitis treated with local steroid injection: comparison between sonographic and palpation guidance. J Clin Ultrasound. 2006 Jan;34(1):12-6. doi: 10.1002/jcu.20177.
PubMed 16353228Chen CM, Chen JS, Tsai WC, Hsu HC, Chen KH, Lin CH. Effectiveness of device-assisted ultrasound-guided steroid injection for treating plantar fasciitis. Am J Phys Med Rehabil. 2013 Jul;92(7):597-605. doi: 10.1097/PHM.0b013e318278a831.
PubMed 23221670Li Z, Xia C, Yu A, Qi B. Ultrasound- versus palpation-guided injection of corticosteroid for plantar fasciitis: a meta-analysis. PLoS One. 2014 Mar 21;9(3):e92671. doi: 10.1371/journal.pone.0092671. eCollection 2014.
PubMed 24658102
Study at a glance
From the registry record, last updated by the sponsor on 10 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Clinical Study to Evaluate Ultrasound Guided Injection Therapy Versus Topographic Injection Therapy for Plantar Fasciitis
- ClinicalTrials.gov ID
- NCT03231150
- Acronym / sponsor ID
- PF-RCT / PPMC-04
- Conditions
- Plantar Fascitis
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 62 participants (estimated)
- Lead sponsor
- University of PennsylvaniaUniversity, hospital or other
- Study start
- 28 Mar 2017 (actual)
- Primary completion
- 15 Jun 2026 (estimated)
- Study completion
- 31 Oct 2026 (estimated)
- First posted
- 27 Jul 2017 (actual)
- 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 primary aim of this clinical experiment is to compare, in terms of pain relief measured using the 10-cm visual analog scale (VAS) pain score (5-7), the clinical results of ultrasound-guided injection (USGI) versus anatomic topography-guided injection (ATGI) of corticosteroid for the treatment of proximal PF. Secondary aims will be to compare foot-related quality of life, as measured using the Foot Function Index (FFI)and the Bristol Foot Score (BFS), between the injection groups, and also to compare the pre-injection to late-term post-injection thickness of the plantar fascia as measured in the nested USGI group.
Detailed description
Clinically, proximal PF causes plantar heel pain, which may extend into the proximal portion of the plantar longitudinal arch. Typically, the pain is most notable upon initial weight bearing ambulation (post-static dyskinesia, PSD), such as the first step in the morning or following a period of non-weight bearing or rest. This can be attributed to walking on hard surfaces or barefoot, prolonged weight bearing activity, inadequate stretching and use of poor footwear, as well as increased amounts of walking. Standard treatment of PF includes the use of foot orthotics, both pre-fabricated and custom molded, physical therapy and myotendinous stretching, splinting or strapping the foot, nonsteroidal anti-inflammatory drugs, ice, and corticosteroid injections. Ultrasonography (US) can be useful for examining the plantar fascia, which typically measures between 2 mm to 4 mm in thickness, and findings indicative of PF include diffuse hypoechogenicity at the calcaneal attachment of the plantar fascia, loss of definition between the plantar fascia and the surrounding soft tissues, peri-insertion edema, and thickness over 4.5 mm. Local infiltration of corticosteroids has been used to treat PF since the 1950s. Despite this being a well established treatment, there are still unexamined features of this form of intervention, including the method of injection, type of steroid used, concurrent use of localanesthetic agents, concurrent use of orthoses and/or supportive arch strapping, concurrent physical therapy, and the use of ultrasonographic guidance of the corticosteroid injection. The primary aim of this clinical experiment is to compare, in terms of pain relief measured using the 10-cm visual analog scale (VAS) pain score (5-7), the clinical results of ultrasound-guided injection (USGI) versus anatomic topography-guided injection (ATGI) of corticosteroid for the treatment of proximal PF. Secondary aims will be to compare foot-related quality of life, as measured using the Foot Function Index (FFI)and the Bristol Foot Score (BFS), between the injection groups, and also to compare the pre-injection to late-term post-injection thickness of the plantar fascia as measured in the nested USGI group.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind (care provider, investigator)
- Number of arms
- 2
- Model description
- This investigation will be chronologically divided into four stages that will commence after procurement of institutional review board (IRB) approval and funding, namely: 1) screening and enrollment, 2) random treatment allocation and treatment, 3) data collection and analysis, and 4) presentation and publication. We anticipate that it will take approximately 23.5 months to execute the clinical experiment and to prepare the report for publication.
| Arm | Type | Receives |
|---|---|---|
| Anatomical injection | Active comparator | Procedure: Local Steroid Injection into the plantar heel, Procedure: Anatomical Guided injectionOnce patient has been randomized, if placed in the anatomically-guided injection group, the medial band of the plantar fascia origin on the calcaneus will be palpated and marked approximately. In the clinical setting, a sham ultrasound machine will be utilized to "locate" the plantar fascia keeping the patient blinded to the treatment modality. The area will then be prepped with alcohol to the medial heel and utilizing a medial approach, an injection of 0.5 cc 0.5% bupivacaine, 0.5 cc dexamethasone and 0.25 cc triamcinolone acetamide 40 mg/mL will be administered into the area surrounding the plantar fascia. The area will then be cleaned will alcohol and dressed with a small elastic bandage. |
| Ultrasound Guided Injection | Experimental | Procedure: Local Steroid Injection into the plantar heel, Procedure: Ultrasound Guided InjectionOnce patient has been randomized, if placed in the USGI group, the patient will be scheduled for an ultrasound therapy in the radiology department at Penn Presbyterian Medical Center. In this setting, the patient will be informed that in order to keep them blinded, that all patients must have either injection performed in the radiology department and that the ultrasound machine utilized will either be on or off during the injection keeping the patient blinded to the treatment modality. The area will then be prepped with alcohol to the medial heel and utilizing a medial approach, an injection of 0.5 cc 0.5% bupivacaine, 0.5 cc dexamethasone and 0.25 cc triamcinolone acetamide 40 mg/mL will be administered into the area surrounding the plantar fascia. The area will then be cleaned will alcohol and dressed with a small elastic bandage. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Pain on palpation along the proximal plantar fascia with or without radiographic evidence of a plantar calcaneal bone spur
- ≥18 years of age
- Male or non-pregnant female of any ethnicity or race
- Active, former or non smoker
- With or without peripheral vascular disease without lower extremity intermittent claudication or rest pain
Key exclusion criteria (10 listed)
- Known drug or alcohol dependence
- Chronic pain syndrome or lumbosacral radiculitis
- Neurological condition that requires the use of analgesic medications or anti-seizure or neuroleptic medications
- Peripheral vascular disease that results in rest pain or intermittent claudication or venous stasis ulceration
- Calcaneal stress fracture or show evidence of a foreign body or tumor of the affected heel as viewed radiographically
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 |
|---|---|---|
| Local Steroid Injection into the plantar heelInjections consisting of 0.5 ml 0.25% bupivacaine plain, 0.5 ml dexamethasone phosphate, and 0.5 ml triamcinolone acetonide 40 mg/ml. | Procedure or surgery | Anatomical injection, Ultrasound Guided Injection |
| Ultrasound Guided InjectionExecution of the USGI will employ an actual diagnostic US machine (Voluson E8 Expert, General Electric Company, Boston, MA) and a plantarmedial approach | Procedure or surgery | Ultrasound Guided Injection |
| Anatomical Guided injectionExecution of the ATGI will employ a sham diagnostic US machine and a plantarmedial approach. | Procedure or surgery | Anatomical injection |
Primary outcome
Change in VAS pain score at post injection periods with use of USGI
Time frame: Baseline to 3 months, 6 month, 9 month, and 12 month follow up
with the primary efficacy endpoint being the 3-month post injection pain score
Change in VAS pain score at post injection periods with use of ATGI
Time frame: Baseline to 3 months, 6 month, 9 month, and 12 month follow up
with the primary efficacy endpoint being the 3-month post injection pain score
3 secondary outcomes
Observation of normal plantar fascia after treatment as measured by ultrasound (US)
Time frame: Baseline to 12 month follow up
Foot-related quality of life outcomes as measured with use of the FFI
Time frame: Baseline to 3 months, 6 month, 9 month, and 12 month follow up
Foot-related quality of life outcomes as measured with use of the BFS
Time frame: Baseline to 3 months, 6 month, 9 month, and 12 month follow up
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Oct 2025.
- Results publication: PubMed 26311907Ang TW. The effectiveness of corticosteroid injection in the treatment of plantar fasciitis. Singapore Med J. 2015 Aug;56(8):423-32. doi: 10.11622/smedj.2015118.
- Results publication: PubMed 19825686Weil L Jr, Glover JP, Weil LS Sr. A new minimally invasive technique for treating plantar fasciosis using bipolar radiofrequency: a prospective analysis. Foot Ankle Spec. 2008 Feb;1(1):13-8. doi: 10.1177/1938640007312318..
- Results publication: PubMed 11272297Young CC, Rutherford DS, Niedfeldt MW. Treatment of plantar fasciitis. Am Fam Physician. 2001 Feb 1;63(3):467-74, 477-8.
- Results publication: PubMed 15152061Buchbinder R. Clinical practice. Plantar fasciitis. N Engl J Med. 2004 May 20;350(21):2159-66. doi: 10.1056/NEJMcp032745. No abstract available.
- Results publication: PubMed 7481589Wessel J. The reliability and validity of pain threshold measurements in osteoarthritis of the knee. Scand J Rheumatol. 1995;24(4):238-42. doi: 10.3109/03009749509100881.
- Results publication: PubMed 11766958Lundeberg T, Lund I, Dahlin L, Borg E, Gustafsson C, Sandin L, Rosen A, Kowalski J, Eriksson SV. Reliability and responsiveness of three different pain assessments. J Rehabil Med. 2001 Nov;33(6):279-83. doi: 10.1080/165019701753236473.
- Results publication: PubMed 11733293Bijur PE, Silver W, Gallagher EJ. Reliability of the visual analog scale for measurement of acute pain. Acad Emerg Med. 2001 Dec;8(12):1153-7. doi: 10.1111/j.1553-2712.2001.tb01132.x.
- Results publication: PubMed 2037861Budiman-Mak E, Conrad KJ, Roach KE. The Foot Function Index: a measure of foot pain and disability. J Clin Epidemiol. 1991;44(6):561-70. doi: 10.1016/0895-4356(91)90220-4.
- Results publication: PubMed 15901814Barnett S, Campbell R, Harvey I. The Bristol Foot Score: developing a patient-based foot-health measure. J Am Podiatr Med Assoc. 2005 May-Jun;95(3):264-72. doi: 10.7547/0950264.
- Results publication: PubMed 11030509Tsai WC, Wang CL, Tang FT, Hsu TC, Hsu KH, Wong MK. Treatment of proximal plantar fasciitis with ultrasound-guided steroid injection. Arch Phys Med Rehabil. 2000 Oct;81(10):1416-21. doi: 10.1053/apmr.2000.9175.
- Results publication: PubMed 16353228Tsai WC, Hsu CC, Chen CP, Chen MJ, Yu TY, Chen YJ. Plantar fasciitis treated with local steroid injection: comparison between sonographic and palpation guidance. J Clin Ultrasound. 2006 Jan;34(1):12-6. doi: 10.1002/jcu.20177.
- Results publication: PubMed 23221670Chen CM, Chen JS, Tsai WC, Hsu HC, Chen KH, Lin CH. Effectiveness of device-assisted ultrasound-guided steroid injection for treating plantar fasciitis. Am J Phys Med Rehabil. 2013 Jul;92(7):597-605. doi: 10.1097/PHM.0b013e318278a831.
- Individual participant dataSharing planned: No
Related trials for Plantar Fascitis
RecruitingObservational study
Tibial Nerve Size and Clinical Features in Chronic Plantar Fasciitis
Plantar Fasciitis, Chronic, Tibial Nerve
Recruiting
Video-Based Versus Physician-Led Exercise Training for Plantar Fasciitis
Plantar Fasciitis of Both Feet, Plantar Fascitis
Recruiting
Extracorporeal Shock Wave Therapy With or Without Kinesiotaping for Plantar Fasciitis
Plantar Fasciitis
Recruiting
Comparison of Transverse Friction Massage and Instrument- Assisted Soft-Tissue Mobilization in Plantar Fasciitis
Plantar Fasciitis
Active, not recruiting
Comparison of Platelet-Rich Plasma and Prolotherapy for Plantar Fasciitis
Planter Fasciitis
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.
Donald S Malay, DPM principal investigator
Penn Presbyterian Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Local Steroid Injection into the plantar heel, Ultrasound Guided Injection and Anatomical Guided injection in people with Plantar Fascitis, run by University of Pennsylvania 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 10 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: looking for participants now, as of the sponsor's last update on 10 Oct 2025. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Donald S Malay, DPM (4848440755, malaydsm@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in VAS pain score at post injection periods with use of USGI (time frame: Baseline to 3 months, 6 month, 9 month, and 12 month follow up). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03231150, which also lists 13 linked publications.
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 10 Oct 2025.