Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12609000051246
Ethics application status
Approved
Date submitted
25/11/2008
Date registered
22/01/2009
Date last updated
2/03/2012
Type of registration
Retrospectively registered

Titles & IDs
Public title
Optimisating corticosteroid injection for lateral epicondylalgia with the addition of physiotherapy: A randomised control trial with placebo comparison.
Scientific title
The efficacy of combining physiotherapy and corticosteroid injection in the treatment of tennis elbow: a randomised control trial
Universal Trial Number (UTN)
Trial acronym
PINTe
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Tennis Elbow 2574 0
Lateral Epicondylalgia 2575 0
Condition category
Condition code
Musculoskeletal 2684 2684 0 0
Other muscular and skeletal disorders
Physical Medicine / Rehabilitation 2685 2685 0 0
Physiotherapy

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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.
Intervention code [1] 2310 0
Rehabilitation
Intervention code [2] 2311 0
Treatment: Drugs
Comparator / control treatment
A placebo injection comprising 0.5ml of isotonic saline (0.9%) will be injected in a similar manner to the corticosteroid injection. The syringe will be drawn up and injected such that the patient is unable to view its contents and standardised advice will be provided as per the corticosteroid injection advice outlined above. As the therapeutically active constituent of the corticosteroid injection is unknown, it could be argued that it is ethically responsible from a community healthcare perspective to include such an injection arm in a high quality randomised clinical trial.
Control group
Placebo

Outcomes
Primary outcome [1] 3587 0
General improvement (6-point scale: completely recovered, much improved, improved, no change, worse, much worse)
Timepoint [1] 3587 0
4, 8, 12, 26 and 52 weeks
Primary outcome [2] 3588 0
Pain-free Grip Force
Timepoint [2] 3588 0
0, 4, 8, 12, 26 and 52 weeks
Secondary outcome [1] 6010 0
Patient-rated tennis elbow evaluation questionnaire (PRTEE)
Timepoint [1] 6010 0
0, 4, 8, 12, 26 and 52 weeks
Secondary outcome [2] 6011 0
Severity of resting pain and worst pain and functional capacity measured on an 10cm pain visual analogue scale
Timepoint [2] 6011 0
0, 4, 8, 12, 26 and 52 weeks
Secondary outcome [3] 8554 0
Pressure Pain Threshold will be measured using a Somedic algometer with 1cm2 probe size applied at a rate of 40kPa/s immediately anterior to the lateral epicondyle. The end point of this test is when the participant willl press a button when the sensation of pressure changes to one of pressure and pain. Triplicate measures will be performed.
Timepoint [3] 8554 0
0, 4, 8, 12, 26 and 52 weeks
Secondary outcome [4] 8555 0
Thermal (heat and cold) Pain Threshold will be measured using a Somedic Thermotest system which will adjust the temperature of the probe applied to the lateral epicondyle region at a rate of 1-2degrees/second. The end point of this test is when the participant first notes the sensation of pain by pressing a button.
Timepoint [4] 8555 0
0 weeks only
Secondary outcome [5] 8556 0
Tampa Scale of Kinesiophobia (TSK): will be administered at baseline to assess the degree of kinesiophobia, also known as fear of movement or (re)injury.
Timepoint [5] 8556 0
0 weeks only
Secondary outcome [6] 8557 0
Hospital Anxiety and Depression Scale (HADS)
Timepoint [6] 8557 0
0 weeks only
Secondary outcome [7] 8558 0
Elbow Flexion and Extension Isometric Strength will be measured in standing with the elbow positioned in 90 degrees flexion and neutral shoulder and forearm pronation/supination. A dynamometer attached to a frame will allow measurement of force applied at the wrist during either flexion or extension (in kilograms). Participants will be instructed to maintain upright position (no formal fixation of posture will occur). As gripping is pain provoking in participants with lateral epicondylalgia, participants will be instructed to avoid making a fist during the test.
Timepoint [7] 8558 0
0 and 12 weeks
Secondary outcome [8] 8559 0
European Quality of Life Measurement (EuroQol)
Timepoint [8] 8559 0
0, 4, 8, 12, 26 and 52 weeks
Secondary outcome [9] 8560 0
Costs will be measured from a societal perspective by a standardised telephone interview requesting information about expenses incurred over the preceding month. Data will include including a) direct health care costs, such as visits to doctors, therapists, investigations and prescribed medication; b) direct non-health care costs, such as costs of over-the-counter medication, hours of paid and unpaid household help, transportation and other out-of-pocket expenses; c) indirect costs, such as absence from work, housekeeping and other daily activities.
Timepoint [9] 8560 0
Participants will be contacted every three months, totaling four interviews over the 12 month period. The first interview will be randomly allocated by computerised number generation to either 1,2 or 3 months following randomisation and subsequent interviews conducted at three monthly intervals.
Secondary outcome [10] 8561 0
Contingent valuation will be performed at baseline using a willingness to pay questionnaire and structured interview to elicit a participants' monetary valuation of a healthcare intervention, standardised by use of a hypothetical scenario. Starting bids will be randomised according to a computerised number generation to minimise bias.
Timepoint [10] 8561 0
0 weeks only

Eligibility
Key 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.
Minimum age
18 Years
Maximum age
70 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Concealed allocation by a computerised randomisation schedule developed by a central trial unit (Queensland Clinical Trial Centre).
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computer generated randomisation schedule with stratification by baseline pain severity on Visual Analogue Scale.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Factorial
Other design features
A 2x2 factorial design will be used, such that the two main effects of injection and physiotherapy are combined to constitute four treatment groups.
Phase
Phase 4
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/08/2008
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
132
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment postcode(s) [1] 497 0
4000 - 4170

Funding & Sponsors
Funding source category [1] 4189 0
Government body
Name [1] 4189 0
National Health and Medical Research Council
Country [1] 4189 0
Australia
Primary sponsor type
Individual
Name
Professor Bill Vicenzino
Address
Therapies building 84A
Therapies Rd
University of Queensland
St Lucia QLD 4072
Country
Australia
Secondary sponsor category [1] 3763 0
Individual
Name [1] 3763 0
Dr Leanne Bisset
Address [1] 3763 0
School of Physiotherapy and Exercise Science
Griffith University
Gold Coast Campus
QLD 4222
Country [1] 3763 0
Australia
Other collaborator category [1] 485 0
Individual
Name [1] 485 0
Professor Peter Brooks
Address [1] 485 0
Executive Dean of Faculty of Health Sciences
The University of Queensland
St Lucia QLD 4072
Country [1] 485 0
Australia
Other collaborator category [2] 486 0
Individual
Name [2] 486 0
Associate Prof Luke Connelly
Address [2] 486 0
School of Medicine, Conrod Building, The University of Queensland
St Lucia QLD 4072
Country [2] 486 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 6244 0
Medical Research Ethics Committee
Ethics committee address [1] 6244 0
The Office of Research and Postgraduate Studies
Cumbrae-Stewart Bldg (72)
THE UNIVERSITY OF QUEENSLAND
St Lucia QLD 4072
Ethics committee country [1] 6244 0
Australia
Date submitted for ethics approval [1] 6244 0
04/07/2008
Approval date [1] 6244 0
11/07/2008
Ethics approval number [1] 6244 0
2007001703

Summary
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.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 28207 0
Address 28207 0
Country 28207 0
Phone 28207 0
Fax 28207 0
Email 28207 0
Contact person for public queries
Name 11364 0
Professor Bill Vicenzino
Address 11364 0
Therapies building 84A
Therapies Rd
University of Queensland
St Lucia
QLD 4072
Country 11364 0
Australia
Phone 11364 0
+617 3365 2275
Fax 11364 0
+617 3365 1622
Email 11364 0
[email protected]
Contact person for scientific queries
Name 2292 0
Professor Bill Vicenzino
Address 2292 0
Therapies building 84A
Therapies Rd
University of Queensland
St Lucia QLD 4072
Country 2292 0
Australia
Phone 2292 0
+617 3365 2275
Fax 2292 0
+617 3365 1622
Email 2292 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
Dimensions AIElbow flexor and extensor muscle weakness in lateral epicondylalgia2011https://doi.org/10.1136/bjsm.2011.083949
N.B. These documents automatically identified may not have been verified by the study sponsor.