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Clinical Trials/CTRI/2024/03/063417
CTRI/2024/03/063417CompletedPhase 4

EFFICACY OF PLATELET RICH PLASMA INJECTION AS AN COMBINED MODALITY IN REDUCING PAIN AND IMPROVING FUNCTIONAL OUTCOME IN PLANTAR FASCIITIS - A RANDOMIZED CONTROL TRIAL

PONDICHERRY INSTITUTE OF MEDICAL SCIENCES1 site in 1 country50 target enrollmentStarted: March 15, 2024Last updated:

Trial Snapshot

Phase
Phase 4
Status
Completed
Enrollment
50
Locations
1
Primary Endpoint
foot and ankle ability measure scale

Study Overview

Brief Summary

successful treatment of plantar fasciitis usually requires a combination of treatment modalities, rather than administering only one treatment at a time there were no studies showing the efficacy of platelet-rich plasma as a safe and effective therapeutic adjuvant. we would be using  three parameters to assess the disease by radiological and functional outcomes in PFPS, FAAM, and ultrasonogram of the plantar fascia. Hence our study aimed at proving the efficacy of PRP as a combined modality treatment of plantar fasciitis.We hypothesize that Platelet-rich plasma local injection given along with standard conventional treatment reduces pain and improves functional outcomes better than standard conventional treatment alone among patients with plantar fasciitis

Study Design

Study Type
Interventional
Allocation
Computer generated randomization
Masking
Participant Blinded

Eligibility Criteria

Ages
18.00 Year(s) to 60.00 Year(s) (—)
Sex
All

Inclusion Criteria

  • •1.)Patients aged between 18 to 60 years.
  • •2.)Patients having complaints of heel pain for more than 3 months.
  • •3.)Tenderness on palpation at the proximal insertion of the plantar fascia.
  • •4.) Patients with positive windlass test.
  • •5.) Ultrasound plantar fascia thickness of more than 4mm.

Exclusion Criteria

  • •1.)Congenital defects of the foot 2.)Previous surgery of the foot.
  • •3.)Patient with a History of Trauma to the heel.
  • •4.)Pregnancy 5.)Patient on Anti-coagulant therapy 6.)Patient with the Bleeding disorder.
  • •7.)Presence of any Local infection.
  • •9.)History of Peripheral Vascular disease.

Outcomes

Primary Outcomes

foot and ankle ability measure scale

Time Frame: PFPS AND FAAM SCORE AT BASELINE,2 WEEKS ,4WEEKS,8 WEEKS AND 12 WEEKS | USG PLANTAR FASCIA THICKNESS AT BASELINE AND 12 WEEKS

ultrasound plantar fascia thickness

Time Frame: PFPS AND FAAM SCORE AT BASELINE,2 WEEKS ,4WEEKS,8 WEEKS AND 12 WEEKS | USG PLANTAR FASCIA THICKNESS AT BASELINE AND 12 WEEKS

Plantra dasciitis pain scale

Time Frame: PFPS AND FAAM SCORE AT BASELINE,2 WEEKS ,4WEEKS,8 WEEKS AND 12 WEEKS | USG PLANTAR FASCIA THICKNESS AT BASELINE AND 12 WEEKS

Secondary Outcomes

  • ultrasound plantar fascia thickness(ultrasound plantar fascia thickness at 3 months)

Investigators

Sponsor Class
Research institution and hospital

Study Sites (1)

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