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PRP Versus Saline in Lateral Epicondylitis

NCT ID: NCT05125705

Last Updated: 2021-11-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2/PHASE3

Total Enrollment

70 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-11-30

Study Completion Date

2022-11-30

Brief Summary

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Lateral epicondylitis (LE), also known as tennis elbow, has an estimated prevalence in the general population of 1% to 3%, peaking at age 45 years to 54 years and affect both men and women equally. A randomised controlled trial published in The Lancet showed that 83% of the patients suffering from LE of more than 6 weeks duration on wait-and-see policy recovered only after 1 year without any therapeutic interventions. The costs associated with LE is substantial as patients not only incur hefty healthcare costs but also lose their productivity owing to their long recovery period.

Currently, there is a paucity of evidence worldwide for the efficacy of PRP injections compared to control in LE. This randomised controlled trial aims to compare the efficacy of PRP versus placebo (saline) injections in adults with LE.

Detailed Description

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The pathogenesis of LE was initially believed to be a generalised inflammatory process. However, in 1979, the pathology was better understood as invading immature fibroblasts disorganizing the normal collagen architecture of the elbow, associated with immature vascular responses to cellular repair. There is a variety of treatment modalities available for LE, varying from watchful waiting without any therapeutic interventions, pharmaceutical methods such as prescribing non-steroidal anti-inflammatory drugs, physiotherapy such as encouraging bracing and exercise, injections, and surgical modalities once non-surgical options fail.

For many years, injection with glucocorticoids has remained the mainstay of treatment. However, several studies have proven that the effects of corticosteroid injections do not seem to last in the long-term, amongst which a trial published in The Lancet showed that long-term differences at 52 weeks between injections and physiotherapy was significantly in favour of physiotherapy. Recently, many studies worldwide have demonstrated that platelet-rich-plasma (PRP) stimulates cartilage repair by actively secreting growth factors which activate cell proliferation and differentiation thereby promoting tissue regeneration. It has been postulated that PRP stimulates repair mechanisms within tendons and hence promote tendon healing.

However, there is a paucity of evidence worldwide for the efficacy of PRP injections compared to control in LE. Currently, PRP treatment is not formally recognized as a treatment modality for LE in Singapore, with the accepted indications for PRP treatment being limited to non-surgical treatment of acute muscle and ligamentous injuries, and the biological augmentation of acute Achilles tendon repairs.

This randomised controlled trial aims to compare the efficacy of PRP versus placebo (saline) injections in adults with LE.

Conditions

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Lateral Epicondylitis, Unspecified Elbow

Keywords

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platelet rich plasma saline randomised controlled trial

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors
Both the patients and the outcome assessor will be blinded in this trial.

Study Groups

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Platelet rich plasma injection

Patients will be treated with a single PRP injection, where 8 mL of whole blood will be collected and 2.5 mL of PRP will be given to the patient. Routine physiotherapy regimens will be implemented, similar to placebo arm.

Group Type EXPERIMENTAL

Platelet rich plasma injection

Intervention Type BIOLOGICAL

The PRP is prepared by RegenLab's RegenKit-THT, in accordance with operating instructions supplied with the kit. The device allows automated blood collection (8 mL) and blood component separation in closed circuit. After centrifugation at room temperature for 9 minutes at centrifugal force of 1500g, the RegenTHT tube is then inverted several times before re-suspension, allowing 4mL of PRP to be obtained for each tube. 2.5mL will be injected into patients

Saline injection

Patients will be treated with 2.5 mL saline 0.9%. Routine physiotherapy regimens will be implemented, similar to intervention arm.

Group Type PLACEBO_COMPARATOR

Saline injection

Intervention Type OTHER

Saline injection

Interventions

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Platelet rich plasma injection

The PRP is prepared by RegenLab's RegenKit-THT, in accordance with operating instructions supplied with the kit. The device allows automated blood collection (8 mL) and blood component separation in closed circuit. After centrifugation at room temperature for 9 minutes at centrifugal force of 1500g, the RegenTHT tube is then inverted several times before re-suspension, allowing 4mL of PRP to be obtained for each tube. 2.5mL will be injected into patients

Intervention Type BIOLOGICAL

Saline injection

Saline injection

Intervention Type OTHER

Other Intervention Names

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PRP

Eligibility Criteria

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Inclusion Criteria

* Patients of age \>21 years old
* History of chronic pain on the lateral side of the elbow and pain on lateral epicondyle on direct palpation and resisted dorsiflexion of the wrist for more than 3 months
* Ability of patients to provide informed consent

Exclusion Criteria

* Previous tennis elbow surgery to affected elbow
* Previous corticosteroid injections to affected elbow
* Concurrent complementary and alternative medicine (CAM) treatments e.g. acupuncture
* Inflammatory diseases / infection / fracture / trauma
* Neck pain on ipsilateral side
* Chronic pain syndromes
* Malignancies
* Pregnant or lactating females
* Consistent use of NSAIDs within 48 hours of procedure
* Systemic use of corticosteroids within 2 weeks
* History of anemia, any blood disorders, hypothyroidism
Minimum Eligible Age

21 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Singapore General Hospital

OTHER

Sponsor Role lead

Responsible Party

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Kenon Chua Ser

Orthopaedic Surgery Registrar

Responsibility Role PRINCIPAL_INVESTIGATOR

Central Contacts

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Kenon Chua

Role: CONTACT

Phone: +65 6222 3322

Email: [email protected]

Other Identifiers

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CIRB1

Identifier Type: -

Identifier Source: org_study_id