CompletedPhase 2ACTRN12612000993897

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

Randomised clinical trial to evaluate the effect of prolotherapy (Prt) injections and physiotherapy consisting of Mulligan's MWM and exercise (P/E) used singly and in combination, on pain and function in patients with lateral epicondylalgia (Tennis Elbow).


Sponsor

Griffith University

Enrollment

120 participants

Start Date

Oct 15, 2012

Study Type

Interventional

Conditions

Summary

This project aims to find an effective treatment that provides value for money and is acceptable to patients for the management of moderate-to-severe lateral epicondylalgia, a common, disabling and costly condition.


Eligibility

Sex: Both males and femalesMin Age: 18 YearssMax Age: 60 Yearss

Inclusion Criteria1

  • 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 Criteria1

  • 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.

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Interventions

Group 1- Physiotherapy and Therapeutic Exercise: a multimodal program comprising education, manual therapy and therapeutic exercise, and a home exercise program. Four, 30 minute physiotherapy sessions

Group 1- Physiotherapy and Therapeutic Exercise: a multimodal program comprising education, manual therapy and therapeutic exercise, and a home exercise program. Four, 30 minute physiotherapy sessions will be provided by a qualified physiotherapist over a 4-week period. Specific manual therapy techniques known as Mobilisation with Movement (MWM) will be applied. In addition, three main groups of exercises will be pragmatically prescribed: (a) Sensorimotor retraining of gripping and forearm movements and posture correction will be commenced early in the physiotherapy intervention; (b) progressive resistance exercise for the wrist extensors will be prescribed based on identified strength deficits in LE; (c) exercises geared towards general arm strengthening. Physiotherapists will prescribe exercises based on the participant's capabilities at any given session to allow for optimal exercise volume and load setting without exacerbating pain. The overriding rule for all exercise is that pain should not be provoked during or after exercise, including avoidance of delayed onset muscle soreness. Exercises will be performed in a slow manner with sufficient rest between sets to allow recovery, and correct form and posture emphasised throughout. Supervision of the home program at the commencement of every session and monitoring of exercise diaries by the treating practitioners will be used to facilitate program adherence and emphasise the importance of the exercise and self-treatment program. Group 2- Prolotherapy injection - the injection solution contains 20% glucose and 0.4% lignocaine. Injection sites will be determined by palpation for tenderness over the lateral epicondyle, the supracondylar ridge, the radial head, the common extensor insertion and the lateral collateral and annular ligaments. Each tender area will receive 0.5 to 1.0 ml using a peppering technique with a 25 gauge needle to a total of 2.0 ml. Injections will be given by a Musculoskeletal Medicine practitioner and will be repeated at 4, 8 and 12 weeks after the initial injections, giving a total of 4 treatments, each lasting approximately 30 minutes. Group 3- Combination of 1) Physiotherapy and Therapeutic Exercise and 2) Prolotherapy injection.


Locations(1)

QLD, Australia

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ACTRN12612000993897