Planter Fasciitis
Conditions
Keywords
Planter fasciitis, Prolotherapy, Platelet Rich Plasma
Brief summary
This randomized controlled trial evaluates the comparative effectiveness of platelet-rich plasma (PRP) therapy and prolotherapy in patients with plantar fasciitis. Both interventions are commonly used regenerative injection therapies intended to improve pain and functional outcomes in patients who do not respond adequately to conventional conservative treatments. Participants diagnosed with plantar fasciitis will be randomly assigned to receive either PRP injection or prolotherapy. The results of this study aim to identify the more effective injection therapy for improving clinical outcomes in patients with plantar fasciitis
Detailed description
Plantar fasciitis is a common musculoskeletal disorder characterized by chronic heel pain resulting from degeneration and microtears of the plantar fascia at its calcaneal insertion. It frequently affects individuals who perform prolonged standing, repetitive walking, or high-impact activities. The condition may lead to persistent discomfort, functional limitation, and reduced quality of life. Initial management typically includes conservative measures such as rest, stretching exercises, orthotic devices, physiotherapy, and pharmacological pain management. Although many patients respond to these treatments, a subset of patients continues to experience chronic symptoms requiring additional therapeutic options. Regenerative injection therapies have emerged as alternative treatments for chronic plantar fasciitis. Platelet-rich plasma therapy involves preparing a concentrated platelet suspension from autologous blood and injecting it into the affected region. The platelets release multiple growth factors that may stimulate tissue regeneration, promote collagen synthesis, and enhance healing of the damaged plantar fascia. Prolotherapy is another injection-based therapy that uses an irritant solution, most commonly hypertonic dextrose, injected at the site of ligament or tendon attachment. The solution induces a controlled inflammatory response that stimulates fibroblast proliferation and connective tissue repair, which may strengthen the affected structures. Despite the increasing use of PRP therapy and prolotherapy, the comparative effectiveness of these treatments remains uncertain. Evidence comparing the two techniques is limited, and determining their relative benefits may assist clinicians in selecting the most appropriate treatment for patients with persistent plantar fasciitis. This study is designed as a randomized controlled trial in which eligible participants will be allocated to either PRP therapy or prolotherapy. Clinical outcomes will be assessed during follow-up to determine the effectiveness of each intervention in reducing pain and improving functional status. The findings of this trial may provide evidence to guide treatment decisions for patients with plantar fasciitis who do not respond to conventional conservative management.
Interventions
PROCEDUREplatelet-rich plasma injection
autologous platelet-rich plasma prepared from the participant's blood and injected into the plantar fascia under aseptic conditions.
PROCEDUREProlotherapy with 25% Dextrose
Injection of hypertonic dextrose solution into the plantar fascia at the site of maximal tenderness to stimulate tissue healing.
Sponsors
Bangladesh Medical University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 64 Years
Healthy volunteers
No
Inclusion criteria
* Patient with plantar fasciitis not responding to conservative therapy.
Exclusion criteria
* Patients with uncontrolled diabetes, haematological disorders, hepatitis B or C, HIV, clinical signs of acute inflammation, or septicaemia. * Those receiving local steroid injections within one month. * Those receiving non-steroidal anti-inflammatory medications within 72 hours. * Platelet levels 25% below the normal level. * Patient who had acute ankle or foot trauma, a diagnosis of calcaneal fracture, or stress fracture.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pain intensity measured by the Visual Analog Scale (VAS) | Baseline, 2 weeks, 4 weeks, 3 months, 6 months | Pain intensity will be measured using the Visual Analog Scale (VAS). The Visual Analog Scale is a validated measure of pain intensity consisting of a 10-cm line ranging from 0 to 10, where 0 represents no pain, and 10 represents the worst imaginable pain. Higher scores indicate greater pain intensity. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Foot function assessed using the Foot Function Index (FFI) | Baseline, 2 weeks, 4 weeks, 3 months, 6 months | Evaluation of functional limitation and disability related to plantar fasciitis. The total score ranges from 0 to 100, where 0 represents no pain or disability, and 100 represents the worst possible pain and functional limitation. Higher scores indicate worse foot function and greater disability. |
| Patient satisfaction score by 5-point Likert Scale | 2 weeks, 4 weeks, 3 months, 6 months | Patient satisfaction will be assessed using a 5-point Likert Satisfaction Scale. The scale ranges from 1 to 5, where 1 represents very dissatisfied, 2 represents dissatisfied, 3 represents neutral, 4 represents satisfied, and 5 represents very satisfied. Higher scores indicate greater patient satisfaction with the treatment. |
| Plantar fascial thickness measured by ultrasound | Baseline, 2 weeks, 4 weeks, 3 months, 6 months | Plantar fascial thickness will be measured using diagnostic ultrasound. Plantar fascia thickness will be measured in millimeters (mm) at the point of maximal thickness near the calcaneal insertion using musculoskeletal ultrasound. Increased plantar fascia thickness is associated with greater disease severity, and a reduction in thickness over time indicates improvement. |
Countries
Bangladesh
Contacts
CONTACTKazi Mahzabin Arin, MD
CONTACTAKM Akhtaruzzaman, MD
STUDY_DIRECTORAKM Akhtaruzzaman, MD
Bangladesh Medical University
Outcome results
None listed