Plantar Fasciitis Randomized Clinical Control Trial

Not Applicable

Recruiting

• Conditions: Plantar Fascitis
• Interventions: Procedure: Local Steroid Injection into the plantar heel; Procedure: Ultrasound Guided Injection; Procedure: Anatomical Guided injection

• Registration Number: NCT03231150
• Lead Sponsor: University of Pennsylvania

Brief 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. 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 Timeline

• Study Start: 2017-03-28
• Study First Submitted: 2017-07-21
• Study First Submitted QC: 2017-07-24
• Study First Posted: 2017-07-27
• Status Verified: 2024-04
• Last Update Submitted: 2024-04-30
• Last Update Posted: 2024-05-01
• Primary Completion: 2025-01-31
• Study Completion: 2025-01-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 62

Inclusion Criteria

• 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.

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Exclusion Criteria

• 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
• 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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Ultrasound Guided Injection	Local Steroid Injection into the plantar heel	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.
Ultrasound Guided Injection	Ultrasound Guided Injection	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.
Anatomical injection	Anatomical Guided injection	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.
Anatomical injection	Local Steroid Injection into the plantar heel	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.

Primary Outcome Measures

Name	Time	Method
Change in VAS pain score at post injection periods with use of USGI	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	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

Secondary Outcome Measures

Name	Time	Method
Observation of normal plantar fascia after treatment as measured by ultrasound (US)	Baseline to 12 month follow up
Foot-related quality of life outcomes as measured with use of the FFI	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	Baseline to 3 months, 6 month, 9 month, and 12 month follow up

Trial Locations

Locations (1)

Penn Presbyterian Medical Center; 🇺🇸 Philadelphia, Pennsylvania, United States