Which Treatment Works Best for Chronic Heel Pain? Comparing PRP with Nerve Block, PRP Alone, and Steroid Injections

Not yet recruiting

Conditions: Diseases of the skin and subcutaneous tissue,

Registration Number: CTRI/2025/05/087247

Lead Sponsor: AIIMS Rishikesh

Brief Summary: This single center prospective pilot randomized controlled trial investigates the comparative efficacy of three interventional modalities for the management of chronic plantar fasciitis: ultrasound guided platelet rich plasma PRP injections into the plantar fascia, PRP injections combined with ultrasound guided Baxters nerve block targeting the first branch of the lateral plantar nerve, and ultrasound guided corticosteroid methylprednisolone injections with lignocaine. A total of 45 adult patients aged 18 years and above with clinically diagnosed and ultrasonographically confirmed plantar fasciitis with fascia thickness greater than 4 mm refractory to conservative therapy will be randomized equally into three parallel groups. All participants will continue to receive standardized conservative management. The primary endpoints include changes in pain intensity measured using the Numeric Rating Scale NRS and plantar fascia thickness assessed via high resolution ultrasonography at baseline, 6 weeks, and 12 weeks. Secondary endpoints include functional outcomes assessed by the Foot and Ankle Disability Index FADI, patient satisfaction measured via a structured questionnaire at 12 weeks, and documentation of any adverse events. Statistical analysis will involve repeated measures ANOVA, t tests, or nonparametric equivalents with significance set at p less than 005. The primary aim is to determine whether combining Baxters nerve block with PRP provides superior analgesic and functional benefits compared to PRP alone or corticosteroid injections.

Detailed Description: Not available

Recruitment & Eligibility

Status: Not Yet Recruiting

Sex: All

Target Recruitment: 45

Inclusion Criteria

1.Age greater than or equal to 18 years, either sex.
2.Clinical diagnosis of plantar fasciitis for at least 3 months, plus ultrasound confirmed thickening of the plantar fascia ( greater than 4 mm at the insertion).
3.Pain score (NRS) greater than or equal 5/10 at baseline.
4.Failure of conservative treatments (NSAIDs, exercises, orthotics, etc.) for at least 6 weeks.
5.Willingness to provide written informed consent and comply with follow-up visits.

Exclusion Criteria

Previous foot or ankle surgery within the last 6 months.
Systemic diseases or conditions that may impair healing (e.g., uncontrolled diabetes, significant peripheral vascular disease, rheumatoid arthritis, autoimmune disorders).
Coagulopathies or ongoing use of anticoagulants that contraindicate injection therapy.
Pregnant or breastfeeding women.
Neurological conditions affecting foot sensation (e.g., peripheral neuropathy) or pain perception.
Any contraindication to local anesthetics or PRP (e.g., local infection, severe anemia, platelet dysfunction).

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Plantar fascia thickness measurement using Ultrasound	baseline, 6 weeks,and 12 weeks post-treatment.
Reduction in heel pain, measured using Numeric Rating Scale .	baseline, 6 weeks,and 12 weeks post-treatment.

Secondary Outcome Measures

Name	Time	Method
Functional Improvement: Assessed through the Foot and Ankle Disability	Index (FADI)
Patient Satisfaction: Measured through a patient satisfaction questionnaire	baseline, 6 weeks,and 12 weeks post-treatment.

Trial Locations

Locations (1): AIl India Institute of Medical Science
🇮🇳
Dehradun, UTTARANCHAL, India
AIl India Institute of Medical Science
🇮🇳Dehradun, UTTARANCHAL, India
Dr Ajit Kumar
Principal investigator
9910789377
ajit.anaes@aiimsrishikesh.edu.in