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NCT01668953 · ClinicalTrials.gov registry record · NA

Comparison of Platelet Rich Plasma and Alternative Therapies for the Treatment of Tennis Elbow (Lateral Epicondylitis)

A NA study, sponsored by McMaster University.

Terminated
Registry status
NA
Development phase
100
Enrollment target

NCT01668953: Clinical Trial NA study, sponsored by McMaster University.

NCT01668953 is a NA study that was terminated before completion, run by McMaster University. The registered enrollment target is 100 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (93% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT01668953, a NA study, was terminated before completion, sponsored by McMaster University.

TERMINATED
Registry status
NA
Development phase
100 participants
Enrollment target

Study Summary

"Tennis elbow" is the most common cause of lateral elbow pain, generally caused by either work or sports related repetitive strain. In this condition, a tendon along the outside of the elbow becomes inflamed leading to pain, especially with flexing and extending the elbow. Many treatments have been attempted, including physiotherapy and steroids, with little success. One treatment which has been very effective is the injection of the patients own blood (taken from their other non-affected arm) into their abnormal tendon. The blood recruits the patients own healing factors and heals the damaged tendon. As platelets are thought to be largely responsible, injection of concentrated platelets, extracted from the patient's blood (platelet rich plasma) is a newer, but expensive, technique. At this point, it is unclear whether whole blood, concentrated platelets, or simply passing a ultrasound-guided needle through the abnormal tendon as a means to stimulate tissue healing (tendon fenestration) is the better treatment. The objective of this trial is to compare platelet rich plasma, whole blood, dry needle tendon fenestration, and sham injection (with physical therapy) to identify the best and most cost-effective therapy for this debilitating condition.

Primary Outcome

Pain reduction will be measured using the Visual Analog Scale (VAS), a subjective scale in which the patient rates their pain on a scale from 0 to 10 (0, no pain, 10, maximum possible pain).

Interventions

  • OTHER Sham Injection
  • OTHER Platelet Rich Plasma (PRP) Injection
  • OTHER Whole Blood Injection
  • OTHER Dry Needle Fenestration

Trial Details

FieldValue
Enrollment Target 100 participants
Start Date 2012-08
Est. Completion 2023-04
Phase NA
McMaster University

31 total trials

Why NCT01668953 stopped before completion

NCT01668953 is an interventional study that assigns participants to a tested intervention. The registered 100 participants enrollment target is mid-sized for trials with a published cap, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (93% lower).

The record links to 0 conditions, and to 4 interventions - of which Sham Injection is the first listed.

NCT01668953 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT01668953 about?

NCT01668953 is a clinical study titled "Comparison of Platelet Rich Plasma and Alternative Therapies for the Treatment of Tennis Elbow (Lateral Epicondylitis)". "Tennis elbow" is the most common cause of lateral elbow pain, generally caused by either work or sports related repetitive strain. In this condition, a tendon along the outside of the elbow becomes inflamed leading to pain, especially with flexing and extending the elbow. Many treatments have been...

What is the current status of trial NCT01668953?

This trial is currently terminated. It is a NA study. The enrollment target is 100 participants. The study started on 2012-08. Estimated completion is 2023-04.

What interventions are being tested in trial NCT01668953?

The interventions under investigation include: Sham Injection (OTHER), Platelet Rich Plasma (PRP) Injection (OTHER), Whole Blood Injection (OTHER), Dry Needle Fenestration (OTHER).

Who is sponsoring clinical trial NCT01668953?

This trial is sponsored by McMaster University, which has 31 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT01668953's enrollment target sits among peer trials

100 840th of 2000 higher than 1,081 of 2,000 other NA trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT01668953, the US trial registry maintained by the National Library of Medicine. NCT01668953 (mid enrollment · none site footprint · terminated) retrieved and formatted by PlainTrial, see methodology.