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Optimisating corticosteroid injection for lateral epicondylalgia with the addition of physiotherapy: A randomised control trial with placebo comparison.

The efficacy of combining physiotherapy and corticosteroid injection in the treatment of tennis elbow: a randomised control trial

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12609000051246
Acronym
PINTe
Enrollment
132
Registered
2009-01-22
Start date
2008-08-01
Completion date
Unknown
Last updated
2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

A recent systematic review has identified an urgent need to study the long-term effects of corticosteroid injection, especially the possible deleterious ones. We have recently completed a high quality RCT with long term follow up that found poor long-term effects and very high recurrence rates following corticosteroid injection;which clearly highlights the problem to be addressed by this project. The solution to the problem, which we propose to test, is the addition to the injection treatment of a specific physiotherapy program that we have recently shown to have merit for this purpose. As well as evaluating the impact on clinical efficacy and recurrence rates of adding physiotherapy to injection we will also evaluate the economic value of adding the two treatments. In addition the project will help provide insight into the role of medication and non-medication injection related factors (eg placebo) in treatment of tennis elbow. The hypotheses to be tested in this study are: I Addition of physiotherapy to an injection when compared to injection alone will: (a) improve long term efficacy, and (b) reduce the recurrence rate. II The benefits gained by adding physiotherapy to injection outweighs the cost associated with injection alone. III The combined corticosteroid and local anaesthetic medication are superior to that of saline.

Interventions

All participants in the study will be warned that pain-provoking activities should be avoided, especially if the provoked pain persists for longer than several minutes. They will also be advised that complete rest is extremely detrimental to musculoskeletal disorders and that activity that does not create pain in the elbow should be encouraged. There will be four groups: (a) corticosteroid injection only, (b) corticosteroid injection plus physiotherapy, (c) saline injection, and (d) saline inje

All participants in the study will be warned that pain-provoking activities should be avoided, especially if the provoked pain persists for longer than several minutes. They will also be advised that complete rest is extremely detrimental to musculoskeletal disorders and that activity that does not create pain in the elbow should be encouraged. There will be four groups: (a) corticosteroid injection only, (b) corticosteroid injection plus physiotherapy, (c) saline injection, and (d) saline injection and physiotherapy. The corticosteroid injection and physiotherapy are described here and saline below in the comparator condition. Corticosteroid injection: This involves the placement of the corticosteroid injection into the most-tender palpable point(s) of the lateral elbow in the region of the lateral humeral epicondyle. The single injection consists of a 1 ml quantity of 1% lignocaine with 10mg of triaminolone acetonide in 1 ml. Participants will be advised to gradually return to normal activities and not to aggressively pursue return of normal activities even if they were pain free. Prior to the injection the practitioner will perform a routine clinical examination as would be regarded best clinical practice. The protocol has been previously followed in Bisset et al (2006, BMJ 333(7575): 939-41). Physiotherapy: Physiotherapy will be as recently evaluated by Bisset et al (2006, BMJ 333(7575): 939-41), which consists of specific elbow manipulation know as mobilisation with movement and a customized therapeutic exercise program (Vicenzino 2003 Manual Therapy 8(2): 66-79) under the guidance of a physiotherapist over 8 thirty minute sessions in 8 weeks (Vicenzino and Bisset 2007, EBM 12: 37-8). Participants are required to perform a home program of exercises and self manipulation twice daily, each session lasting approximately 20 minutes for the duration of the study. The program will be taught by the therapist and progressed at the physiotherapy treatment sessions, as per a standardised protocol, which is based on the status of the condition and its response to the previously prescribed exercise and self manipulation. Program adherence will be facilitated by attendance at the regular therapist sessions, as well as the provision of exercise equipment (e.g., elasticised resistance exercise band(s)) and an exercise booklet. Timing of measures: The injection will be performed within 10 days of randomisation. Participants receiving physiotherapy will commence their first session prior to injection and second session one week following injection, with the remaining 6 sessions completed by 8 weeks post randomisation. Hence participants receiving injection alone will complete their treatment with 10 days, while those receiving injection with physiotherapy will complete treatment by 8 weeks.

Sponsors

Professor Bill Vicenzino
Lead SponsorIndividual

Study design

Allocation
Randomised controlled trial
Intervention model
Factorial
Primary purpose
Treatment
Masking
Blinded (masking used)

Eligibility

Sex/Gender
All
Age
18 Years to 70 Years
Healthy volunteers
No

Inclusion criteria

Lateral elbow pain of greater than 6 weeks duration and satisfying widely accepted diagnostic criteria for tennis elbow: (a) pain over the lateral humeral epicondylar region, (b) pain that is provoked by gripping activities, (c) reduced grip strength, and (d) increased sensitivity to manual palpation over the lateral epicondylar region. Reproduction of pain with stretching of the forearm extensor muscles or with specific resisted static contraction of extensor carpi radialis brevis is also usually present.

Exclusion criteria

i. Bilateral elbow symptoms ii. Received an injection for lateral epicondylalgia (LE) within the preceding 6 months iii. Received a course of physiotherapy, acupuncture or massage for their LE, within the preceding 3 months iv. Concomitant neck or arm pain, other than LE, that has prevented participation in usual work or recreational activities or necessitated treatment within the last 6 months. v. Evidence of other primary sources of lateral elbow pain including: pain over the radiohumeral joint; exacerbation of elbow pain with neck movements or manual examination; or sensory disturbance in the affected hand vi. History of other specific elbow pathology including: fractures within the preceding 10years; surgery; malignancy or inflammatory or arthritic disorder vii. Any medical condition which may contraindicate injection or exercise prescription viii. Pregnant or breastfeeding

Outcome results

None listed

Source: ANZCTR · Data processed: Apr 2, 2026