Tennis ElbowPhase 3NCT00110318
Trial of Physiotherapy and Corticosteroid Injections in Lateral Epicondylalgia
A Phase 3 study testing Manual therapy and therapeutic exercise and Corticosteroid injections in people with Tennis Elbow and Musculoskeletal Diseases, run by The University of Queensland at 1 site in Australia.
Trial summary
This randomised controlled trial will evaluate the role of manual therapy and therapeutic exercise and corticosteroid injections in the treatment of lateral epicondylalgia (tennis elbow). Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Tennis Elbow, Musculoskeletal Diseases
- What is being tested?
- Manual therapy and therapeutic exercise and Corticosteroid injections
- Type of treatment
- Injection or infusion, Surgery or procedure
- How many people
- 198 participants
- Where
- 1 siteAustralia
- Study dates
- Mar 2002to Sep 2006
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Elbow pain for at least 6 weeks and satisfy the widely accepted diagnostic criteria of lateral epicondylalgia
- Diagnostic criteria are pain over the lateral humeral epicondyle that is provoked by gripping activities
- Reduced grip strength and increased sensitivity to manual palpation over the lateral epicondyle
- 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.
Who cannot join
- In the preceding 6 months, had consulted a health care practitioner for neck or arm pain or injury, other than lateral epicondylalgia, which has prevented participation in usual work or recreational activities
- Had treatment with physiotherapy or corticosteroid injections for lateral epicondylalgia in the preceding 6 months
- Upper limb fractures
- Diseases of the bone, muscle and nervous systems that preclude treatment by any of the treatments being evaluated in the project.
Trial locations and contacts
1 site in 1 country.
Australia1 site
Musculoskeletal Pain & Injury Research Unit, Division of Physiotherapy, The University of Queensland
Brisbane, Queensland, 4072
About this study
Official title: A Pragmatic, Randomised Controlled Trial of Physiotherapy and Corticosteroid Injections in Lateral Epicondylalgia
This randomised controlled trial will evaluate the role of manual therapy and therapeutic exercise and corticosteroid injections in the treatment of lateral epicondylalgia (tennis elbow).
Read the detailed description
Musculoskeletal conditions account for the third leading cause of health systems expenditure in Australia. Lateral epicondylalgia (tennis elbow) is a painful musculoskeletal condition that is often treated in primary care. Seven out of every 1000 patients seeing their general medical practitioner do so for this condition, though most are not tennis related. On average 10-30% of sufferers take 12 weeks of absenteeism from work and the condition may last 6-48 months.
Two popular treatment options that are commonly prescribed for the management of lateral epicondylalgia are manual therapy/therapeutic exercise and corticosteroid injections. To date there is little evidence that supports manual therapy/therapeutic exercise. This lack of evidence is largely due to the small number of studies of physiotherapy treatments, most of which are of poor quality. The small number of studies of manual therapy contrasts with the larger number of studies of corticosteroid injections, which show that corticosteroid injections are beneficial in the short term (3-6 weeks), but they are associated with significantly greater recurrence rates and offer no advantage in the long term (12 months). The efficacy of a manual therapy and therapeutic exercise programme compared to that of corticosteroid injections is unknown at this stage.
This randomised controlled trial will evaluate the role of manual therapy and therapeutic exercise in the treatment of lateral epicondylalgia. The factors associated with success or failure of these common treatment options for lateral epicondylalgia will also be examined. A tangible outcome of this project will be the development of clinical guidelines for the most effective method of treating lateral epicondylalgia.
- Conditions
- Tennis Elbow, Musculoskeletal Diseases
- Being tested
- Manual therapy and therapeutic exercise, Corticosteroid injections
- Keywords
- Tennis Elbow, Physical Therapy Techniques, Evidence-Based Medicine, Primary Health Care
- Medical subject headings
- Tennis Elbow, Musculoskeletal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Manual therapy and therapeutic exerciseProcedure or surgery
Corticosteroid injectionsProcedure or surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
General improvement
Assessors assessment of severity
Pain free grip strength
Secondary outcomes (10)
Global perceived effect score
Pain Visual Analogue Scale
Function Visual Analogue Scale
Impact on occupational and recreational activities
Stratford pain free function questionnaire
Patient rated evaluation questionnaire
Pressure pain threshold
Maximum grip strength
Pain visual analogue scale with gripping
Tests of motor control (reaction time, speed, accuracy, coordination)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2005 (estimated)
- Study startMar 2002
- Primary completionSep 2006
- Study completionSep 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Tennis ElbowStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Enrolment
- 198 participants
Sponsor and investigators
- Lead sponsor
- The University of Queensland
- Sponsor type
- University, hospital or other
- Collaborators
- National Health and Medical Research Council, Australia
- Responsible party
- Principal investigator, Dr Bill Vicenzino, The University of Queensland
- Investigators
- Dr Bill Vicenzino, PhD, Principal investigator, The University of Queensland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00110318
- Sponsor's protocol ID
- H/355/PHYSIO/01/NHMRC
- Other IDs
- NHMRC#252710
- Status last verified
- Dec 2013
- First submitted
- 5 May 2005
- Last updated
- 11 Dec 2013
- Results posted
- No
Publications
Assendelft WJ, Hay EM, Adshead R, Bouter LM. Corticosteroid injections for lateral epicondylitis: a systematic overview. Br J Gen Pract. 1996 Apr;46(405):209-16.
PubMed 8703521Mathers C, Penm R. Health systems costs of injury, poisoning and musculskeletal disorders in Australia 1993-94. Australian Institute of Health and Welfare (Health and Welfare Expenditure Series no. 6): Canberra. p 77, 1999.
Labelle H, Guibert R, Joncas J, Newman N, Fallaha M, Rivard CH. Lack of scientific evidence for the treatment of lateral epicondylitis of the elbow. An attempted meta-analysis. J Bone Joint Surg Br. 1992 Sep;74(5):646-51. doi: 10.1302/0301-620X.74B5.1388172.
PubMed 1388172Hay EM, Paterson SM, Lewis M, Hosie G, Croft P. Pragmatic randomised controlled trial of local corticosteroid injection and naproxen for treatment of lateral epicondylitis of elbow in primary care. BMJ. 1999 Oct 9;319(7215):964-8. doi: 10.1136/bmj.319.7215.964.
PubMed 10514160
Study at a glance
From the registry record, last updated by the sponsor on 11 Dec 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pragmatic, Randomised Controlled Trial of Physiotherapy and Corticosteroid Injections in Lateral Epicondylalgia
- ClinicalTrials.gov ID
- NCT00110318
- Acronym / sponsor ID
- H/355/PHYSIO/01/NHMRC
- Conditions
- Tennis Elbow, Musculoskeletal Diseases
- Keywords
- Tennis Elbow, Physical Therapy Techniques, Evidence-Based Medicine, Primary Health Care
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 198 participants
- Lead sponsor
- The University of QueenslandUniversity, hospital or other
- Collaborators
- National Health and Medical Research Council, Australia
- Study start
- Mar 2002
- Primary completion
- Sep 2006 (actual)
- Study completion
- Sep 2006 (actual)
- First posted
- 6 May 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This randomised controlled trial will evaluate the role of manual therapy and therapeutic exercise and corticosteroid injections in the treatment of lateral epicondylalgia (tennis elbow).
Detailed description
Musculoskeletal conditions account for the third leading cause of health systems expenditure in Australia. Lateral epicondylalgia (tennis elbow) is a painful musculoskeletal condition that is often treated in primary care. Seven out of every 1000 patients seeing their general medical practitioner do so for this condition, though most are not tennis related. On average 10-30% of sufferers take 12 weeks of absenteeism from work and the condition may last 6-48 months.
Two popular treatment options that are commonly prescribed for the management of lateral epicondylalgia are manual therapy/therapeutic exercise and corticosteroid injections. To date there is little evidence that supports manual therapy/therapeutic exercise. This lack of evidence is largely due to the small number of studies of physiotherapy treatments, most of which are of poor quality. The small number of studies of manual therapy contrasts with the larger number of studies of corticosteroid injections, which show that corticosteroid injections are beneficial in the short term (3-6 weeks), but they are associated with significantly greater recurrence rates and offer no advantage in the long term (12 months). The efficacy of a manual therapy and therapeutic exercise programme compared to that of corticosteroid injections is unknown at this stage.
This randomised controlled trial will evaluate the role of manual therapy and therapeutic exercise in the treatment of lateral epicondylalgia. The factors associated with success or failure of these common treatment options for lateral epicondylalgia will also be examined. A tangible outcome of this project will be the development of clinical guidelines for the most effective method of treating lateral epicondylalgia.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Elbow pain for at least 6 weeks and satisfy the widely accepted diagnostic criteria of lateral epicondylalgia
- Diagnostic criteria are pain over the lateral humeral epicondyle that is provoked by gripping activities
- Reduced grip strength and increased sensitivity to manual palpation over the lateral epicondyle
- 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.
Key exclusion criteria (4 listed)
- In the preceding 6 months, had consulted a health care practitioner for neck or arm pain or injury, other than lateral epicondylalgia, which has prevented participation in usual work or recreational activities
- Had treatment with physiotherapy or corticosteroid injections for lateral epicondylalgia in the preceding 6 months
- Upper limb fractures
- Diseases of the bone, muscle and nervous systems that preclude treatment by any of the treatments being evaluated in the project.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Manual therapy and therapeutic exercise | Procedure or surgery | – |
| Corticosteroid injections | Procedure or surgery | – |
Primary outcome
General improvement
Assessors assessment of severity
Pain free grip strength
10 secondary outcomes
Global perceived effect score
Pain Visual Analogue Scale
Function Visual Analogue Scale
Impact on occupational and recreational activities
Stratford pain free function questionnaire
Patient rated evaluation questionnaire
Pressure pain threshold
Maximum grip strength
Pain visual analogue scale with gripping
Tests of motor control (reaction time, speed, accuracy, coordination)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Dec 2013.
- Background: PubMed 8703521Assendelft WJ, Hay EM, Adshead R, Bouter LM. Corticosteroid injections for lateral epicondylitis: a systematic overview. Br J Gen Pract. 1996 Apr;46(405):209-16.
- BackgroundMathers C, Penm R. Health systems costs of injury, poisoning and musculskeletal disorders in Australia 1993-94. Australian Institute of Health and Welfare (Health and Welfare Expenditure Series no. 6): Canberra. p 77, 1999.
- Background: PubMed 1388172Labelle H, Guibert R, Joncas J, Newman N, Fallaha M, Rivard CH. Lack of scientific evidence for the treatment of lateral epicondylitis of the elbow. An attempted meta-analysis. J Bone Joint Surg Br. 1992 Sep;74(5):646-51. doi: 10.1302/0301-620X.74B5.1388172.
- Background: PubMed 10514160Hay EM, Paterson SM, Lewis M, Hosie G, Croft P. Pragmatic randomised controlled trial of local corticosteroid injection and naproxen for treatment of lateral epicondylitis of elbow in primary care. BMJ. 1999 Oct 9;319(7215):964-8. doi: 10.1136/bmj.319.7215.964.
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Comparing Surgical and Nonsurgical Outcomes of Tennis Elbow
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dr Bill Vicenzino, PhD principal investigator
The University of Queensland
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Manual therapy and therapeutic exercise and Corticosteroid injections in people with Tennis Elbow and Musculoskeletal Diseases, run by The University of Queensland at 1 site in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Dec 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
General improvement. The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00110318, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Dec 2013.