Effects of Prolotherapy Injections and an Exercise Program Used Singly and In Combination for Refractory Tennis Elbow.

Phase 1

Completed

• Conditions: ateral epicondylalgia (Tennis Elbow); Lateral epicondylalgia (Tennis Elbow); Physical Medicine / Rehabilitation - Other physical medicine / rehabilitation; Musculoskeletal - Other muscular and skeletal disorders

• Registration Number: ACTRN12612000993897
• Lead Sponsor: Griffith University

Brief Summary

ABSTRACT Objective: Lateral epicondylalgia (LE, tennis elbow) is a common, debilitating and often treatment-resistant condition. Two treatments thought to address the pathology of LE are hypertonic glucose plus lignocaine injections (prolotherapy) and a physical therapist guided manual therapy/exercise program (PT). This trial aimed to compare the short- and long-term clinical effectiveness, cost effectiveness, and safety of prolotherapy used singly and in combination with PT. Design: Single-blinded randomized clinical trial. Methods: 120 participants with LE of at least six weeks’ duration were randomly assigned to prolotherapy (4 sessions, monthly intervals), PT (weekly for 4 sessions) or combined (prolotherapy+PT). Patient-Rated Tennis Elbow Evaluation (PRTEE) and participant global impression of change scores were assessed by blinded evaluators at baseline, 6, 12, 26 and 52 weeks. Success rate was defined as the percentage of participants indicating elbow condition was either 'much improved' or 'completely recovered.’ Analysis was by intention-to-treat. Results: 88% completed the 12-month assessment. At 52 weeks, there were substantial, significant improvements compared with baseline status for all outcomes and groups, but no significant differences between groups. The PT group exhibited greater reductions in PRTEE at 6 and 12 weeks than the prolotherapy group. Duration of illness of less than 6 months predicted success rate, regardless of treatment. Conclusions: Pain and function measures improved substantially in all groups, more quickly in the PT group than prolotherapy group. The addition of prolotherapy to PT did not influence the rate of recovery.

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2012-09-17
• Study Completion: 2015-07-06
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

Unilateral lateral elbow pain over the lateral epicondyle of at least 6 weeks duration which is aggravated by gripping, resisted wrist/finger extension and palpation, reduced pain-free grip force, as well as a minimum pain severity of 30 on a 0-100 mm visual analogue scale.

Exclusion Criteria

Current pregnancy or breast feeding; presence of peripheral nerve involvement or cervical radiculopathy; systemic disorders including diabetes, rheumatoid arthritis or bleeding disorders; concomitant neck or other arm pain preventing usual work or recreation or necessitated treatment within the last 3 months; evidence of other primary sources of lateral elbow pain including osteoarthritis; sensory disturbance in the affected hand; history of upper limb dislocations, fractures or tendon ruptures within the preceding 10 years; allergy to corn, maize, or seafood; history of corticosteroid injection to the affected elbow within the previous 3 months; history of elbow surgery, malignancy or any medical condition which may contraindicate any of the study treatments; or unresolved litigation.

Study & Design

• Study Type: Interventional
• Study Design: Not specified