Prolotherapy for the Treatment of Chronic Lateral Epicondylitis

Status Completed

Clinical Trial Summary

Lateral epicondylitis (LE), or tennis elbow, is a common and often disabling condition affecting young and middle-aged adults-most commonly manual workers and recreational athletes. It results in significant pain and disability, limiting work productivity and an individual's ability to participate in and enjoy recreational activities. Like many other chronic musculoskeletal conditions LE often shows an incomplete response to acute treatments, leading to chronic pain and disability. Prolotherapy (PrT) involves the injection of an irritant or proliferant solution into tendons, ligaments, and joints to treat chronic musculoskeletal pain. We will be conducting a 3-group randomized, blinded trial to determine the safety and efficacy of PrT injections in the treatment of chronic LE. Additionally, we will seek to determine to what extent any beneficial effect of PrT is derived from deep needle placement vs. a specific effect of the injectate. The specific aims for this study are: 1) to determine if PrT is a safe, well-tolerated, and effective treatment for individuals with chronic LE; and 2) to determine whether the deep needle placement alone is responsible for the therapeutic effect, independent of injectate. In order to accomplish these aims, we will measure indicators of pain and disability using self-rating scales, questionnaires and physical measures. Subjects will be stratified prior to randomization on two factors: 1) unilateral vs. bilateral LE; and 2) treatment with steroids within the prior 6 months. If effective, subjects receiving PrT will show greater reduction of pain and functional impairment compared with the other two groups. This research will guide future studies on prolotherapy by determining what may be the best control condition. Additionally, further studies may explore the mechanism responsible for any beneficial effect.

Clinical Trial Description

Same ;

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT00674622
Study type	Interventional
Source	University of Pittsburgh
Contact
Status	Completed
Phase	Phase 2/Phase 3
Start date	September 2007
Completion date	October 2011

View Details

See also
Status	Clinical Trial	Phase
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Completed	`NCT06206109` - The Effect of Tendon Tears on Lateral Epicondylitis
Completed	`NCT06301152` - Lateral Epicondylitis Treatment High Intensive Laser Therapy and Extracorporeal Shock Wave Therapy	N/A
Not yet recruiting	`NCT04382144` - Levobupivacaine Versus Liposomal Bupivacaine (Exparel®) for Treatment of Pain and Disability in Lateral Epicondylitis	Phase 4
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Recruiting	`NCT05648032` - PLT and Steroid in Lateral Epicondylopathy and Supraspinatus Calcific Tendinopathy	Phase 3
Completed	`NCT06300749` - Effectiveness of Chiropractic Cervical Manipulation in Lateral Epicondylitis	N/A
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Completed	`NCT06087081` - Mills Manipulation and Mulligan PRP Affect Pain, Grip Strength and Function on Lateral Epicondylitis	N/A
Completed	`NCT05602571` - The Effectiveness of the Combination of PRP and ESWT in Lateral Epicondylitis	N/A
Completed	`NCT05566418` - Immediate and Longterm Effects of Mulligan Mobilization With and Without Myofascial Release on Pain,Grip Strength and Function in Patients With Lateral Epicondylitis	N/A
Not yet recruiting	`NCT03279796` - Treatment of Tendon Disease Using Autologous Adipose-derived Mesenchymal Stem Cells	Phase 2
Completed	`NCT04687943` - Comparison of PELOID Therapy and Kinesio Tape Effectiveness in Patients With Lateral Epicondylitis
Recruiting	`NCT05947968` - Scapular PNF Versus Shoulder Strengthening Exercises in Patients With Lateral Epicondylitis.	N/A
Active, not recruiting	`NCT06438328` - Effectiveness of Scapular Muscle Training in Improving Grip Strength Among Lateral Epicondylitis Patients	N/A
Completed	`NCT06317545` - Effects of Nerchal Exercises on Lateral Epicondylitis.	N/A
Completed	`NCT05070559` - Active Release Technique and Graston Technique in Patients With Lateral Epicondylitis	N/A
Completed	`NCT03433716` - Neuromodulation in Lateral Elbow Pain	N/A

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.