Tennis ElbowPhase 4NCT00826462
Treatment Study of Steroid Injection and Physical Therapy for Acute Lateral Epicondylitis
A Phase 4 study testing triamcinolone, Lidocaine and Physiotherapy in people with Tennis Elbow and Epicondylitis, Lateral Humeral, run by University of Oslo at 1 site in Norway.
Trial summary
The purpose of this study is to compare the clinical effect of physiotherapy alone or combined with corticosteroid injection in the initial treatment of lateral epicondylitis in a primary care setting. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Tennis Elbow, Epicondylitis, Lateral Humeral
- What is being tested?
- triamcinolone, Lidocaine and Physiotherapy
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 177 participants
- Where
- 1 siteNorway
- Study dates
- Mar 2009to Jun 2013
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18-70 years
- Pain from the lateral part of the elbow
- The pain increases on resisted dorsiflexion of the wrist with the elbow extended and the fingers flexed or the pain increases on resisted radial deviation of the wrist or the pain increases on resisted extension of the 3. finger
Who cannot join
- Duration of complaints less than 2 weeks or more than 3 months
- The tenderness is located within the muscle body itself in the proximal part of the short radial extensors muscle of the wrist (Cyriax type IV)9.
- Treatment within the last 12 months for the same condition with corticosteroid injection or physiotherapy
- Bilateral complaints
- Previous surgical treatment for lateral epicondylitis
- Deformities of the elbow (congenital or acquired)
Show all 25Show fewer
- Cervical radiculopathy or referred pain from neck or shoulder
- Previous fractures or tendon ruptures in the elbow
- Systemic musculoskeletal disease
- Previous allergic reactions to corticosteroids or lidocaine
- Contraindications to corticosteroids or NSAIDs:
- On-going or previous gastro-intestinal bleeding
- previous ulcer or dyspepsia, severe asthma
- on-going systemic infection
- local skin-infection
- recently vaccinated with live virus
- coagulopathies
- systemic lupus erythematodes
- severe liver- or kidney-disease
- heart failure
- diabetes
- use of warfarin or NSAIDS
- Pregnancy or breast-feeding
- Fertile females not on effective birth control
- Psycho-social or other reasons for not being able to participate throughout the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Physiotherapy Alone, in Combination With Corticosteroid Injection or Wait-and-see for Acute Lateral Epicondylitis in General Practice: a Randomised, Placebo-controlled Study With 12 Months Follow-up
The purpose of this study is to compare the clinical effect of physiotherapy alone or combined with corticosteroid injection in the initial treatment of lateral epicondylitis in a primary care setting.
To find the short and long term effect of physiotherapy with Mill's manipulation, deep friction massage and exercise therapy.
To ascertain wether the outcome is influenced by corticosteroid injection, which has been shown to be of benefit alone in the short term?
Read the detailed description
Much has been written about lateral epicondylitis/tennis elbow reflecting the existence of many treatments for the condition. However, there is no consensus as to which treatment gives the best results.
Based on the latest meta-studies and reviews from the Cochrane Library, one may conclude that there is evidence of a short-term effect of topical or per oral NSAIDs. The same is true for manipulation and exercise. Corticosteroid injection has also been shown to have short-term effect, but not beyond 6 weeks. Ultrasound has a possible short-term effect based on one meta-analysis. Extra corporeal shock wave therapy does not seem to be effective. The treatment with acupuncture, orthosis, surgery or long-term NSAIDs has no support in the literature, and it is impossible to draw any conclusions about the effects or absence thereof. In fact, there is scant support for any long-term treatment in the literature.
We have found two studies to be of special interest (see citations below). Both have been done in a primary care setting with one-year follow up. One study compares corticosteroid injection with physical therapy (ultrasound, manipulation and exercise) and a wait-and-see group. The other compares corticosteroid injection with naproxen orally and placebo-medication. Both conclude that corticosteroid injection is a safe and effective treatment as pain-relief during the first 6 weeks, and that the effect of this treatment is better than physical therapy, wait-and-see and naproxen orally within the same time-frame. Physical therapy in one study gives some, but not statistically significantly better long-term (one year) effect than wait-and-see treatment.
There seems to be some indication that corticosteroid injection is a good alternative for the first 6 weeks. We find there is a good reason to investigate the long-term effects of physical therapy. At the same time, it would be interesting to see whether the good initial response from corticosteroid injection may be extended if combined with physiotherapy.
This randomised, placebo-controlled study will be conducted in general practice in the town of Sarpsborg, Ostfold County, Norway including patient aged 18-70 years with pain of recent onset from the lateral part of the elbow. After a treatment-period of 6 weeks, the patient is followed for a total of 12 months.
Patients are recruited by interested general practitioners in the city of Sarpsborg and surroundings and remitted to two study-physicians who make the initial evaluation of inclusion- and exclusion criteria, as well as treatment, follow-up and outcome assessments during the whole study-period. The patients are treated by one of the two study-physicians in the 6-weeks treatment-period. From the 6. week, the patient sees the other physician, who is unaware of the allocated intervention, for further registration and assessment.
- Conditions
- Tennis Elbow, Epicondylitis, Lateral Humeral
- Being tested
- triamcinolone, Placebo, Lidocaine, Physiotherapy, Naproxen
- Keywords
- Randomised, Placebo-controlled, double blind, Intervention study, Primary health care
- Medical subject headings
- Tennis Elbow
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
triamcinoloneDrug
Also called Kenacort - T (triamcinolone), Xylocaine (lidocaine)
Injection with triamcinolone 10 mg at start and at 3 weeks
PlaceboDrug
Also called Sodium chloride
Injection with sodium chloride at start and at 3 weeks
LidocaineDrug
Also called Xylocaine
10 mg of lidocaine at start and at 3 weeks
PhysiotherapyOther
Also called Physical therapy
12 treatments with deep friction massage, Mill's manipulation, soft tissue treatment and home exercises
NaproxenDrug
Also called Naprosyn entero
Naproxen 500 mg bid for 14 days
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Corticosteroid injection in combination with physical therapy
Injection with triamcinolone 10 mg and 10 mg of lidocaine at start and at 3 weeks in combination with physiotherapy for 6 weeks (12 treatments with deep friction massage, Mill's manipulation, soft tissue treatment and home exercises) Naprosyn Entero 500 mg bid for 14 days Receives: Drug: triamcinolone; Drug: Lidocaine; Other: Physiotherapy; Drug: Naproxen |
| 2 | Placebo comparator | Placebo injection in combination with physical therapy
Injection with sodium chloride and 10 mg of lidocaine at start and at 3 weeks in combination with physiotherapy for 6 weeks (12 treatments with deep friction massage, Mill's manipulation, soft tissue treatment and home exercises) Naprosyn entero 500 mg bid for 14 days Receives: Drug: Placebo; Drug: Lidocaine; Other: Physiotherapy; Drug: Naproxen |
| 3 | Active comparator | Control group: wait-and-see treatment Naprosyn entero 500 mg bid for 14 days Receives: Drug: Naproxen |
What is being measured
The primary outcome is the main question the study is designed to answer.
Treatment Success - Event Rates in Each Group
Unadjusted event rates of treatment success, defined as participants rating themselves 'much improved' or 'completely recovered' on a six point scale. Percentage with 99% confidence interval.
Measured: 6 - 52 weeks
Secondary outcomes (32)
Pain as Recorded by the Study Doctors on a Visual Analog Scale (VAS Scale)
Pain in elbow as recorded by the study doctors on a 100 mm VAS-scale (Visual Analog Scale). The scale runs from 0 mm (no pain) to 100 mm (maximum pain), higher scores means worse outcome.
Measured: 6 weeks
Pain as Recorded by the Study Doctors on a 100 mm VAS-scale (Visual Analog Scale).
Pain in elbow as recorded by the study doctors on a 100 mm VAS-scale (Visual Analog Scale). The scale runs from 0 mm (no pain) to 100 mm (maximum pain), higher scores means worse outcome.
Measured: 12 weeks
Pain as Recorded by the Study Doctors on a 100 mm VAS-scale (Visual Analog Scale).
Pain in elbow as recorded by the study doctors on a 100 mm VAS-scale (Visual Analog Scale). The scale runs from 0 mm (no pain) to 100 mm (maximum pain), higher scores means worse outcome.
Measured: 26 weeks
Pain as Recorded by the Study Doctors on a 100 mm VAS-scale
Pain in elbow as recorded by the study doctors on a 100 mm VAS-scale (Visual Analog Scale). The scale runs from 0 mm (no pain) to 100 mm (maximum pain), higher scores means worse outcome.
Measured: 52 weeks
Pain-free Grip Strength Ratio
Pain free grip strength registered with hand held dynamometer . Mean of three measurements as ratio of affected to unaffected side.Strength registered in kg. A ratio closer to zero signifies that pain occurs at the application of a small force signifying a more severe condition. A ratio approaching 1 signifies a milder complaint.
Measured: 6 weeks
Pain-free Grip Strength Ratio
Pain free grip strength registered with hand held dynamometer 30 31. Mean of three measurements as ratio of affected to unaffected side. Strength registered in kg. A ratio closer to zero signifies that pain occurs at the application of a small force signifying a more severe condition. A ratio approaching 1 signifies a milder complaint.
Measured: 12 weeks
Pain-free Grip Strength Ratio
Pain free grip strength registered with hand held dynamometer 30 31. Mean of three measurements as ratio of affected to unaffected side.Strength registered in kg. A ratio closer to zero signifies that pain occurs at the application of a small force signifying a more severe condition. A ratio approaching 1 signifies a milder complaint.
Measured: 26 weeks
Pain-free Grip Strength Ratio
Pain free grip strength registered with hand held dynamometer 30 31. Mean of three measurements as ratio of affected to unaffected side.Strength registered in kg. A ratio closer to zero signifies that pain occurs at the application of a small force signifying a more severe condition. A ratio approaching 1 signifies a milder complaint.
Measured: 52 weeks
Maximum Grip Strength Ratio
Maximum grip strength registered with hand held dynamometer. Mean of three measurements as ratio of affected to unaffected side. Strength registered in kg. A ratio closer to zero signifies that pain hampers the application of grip force to a larger degree signifying a more severe condition. A ratio approaching 1 signifies a milder complaint where grip strength is not hampered by pain.
Measured: 6 weeks
Maximum Grip Strength Ratio
Maximum grip strength registered with hand held dynamometer. Mean of three measurements as ratio of affected to unaffected side. Strength registered in kg. A ratio closer to zero signifies that pain hampers the application of grip force to a larger degree signifying a more severe condition. A ratio approaching 1 signifies a milder complaint where grip strength is not hampered by pain.
Measured: 12 weeks
Maximum Grip Strength Ratio
Maximum grip strength registered with hand held dynamometer. Mean of three measurements as ratio of affected to unaffected side. Strength registered in kg. A ratio closer to zero signifies that pain hampers the application of grip force to a larger degree signifying a more severe condition. A ratio approaching 1 signifies a milder complaint where grip strength is not hampered by pain.
Measured: 26 weeks
Maximum Grip Strength Ratio
Maximum grip strength registered with hand held dynamometer. Mean of three measurements as ratio of affected to unaffected side.Strength registered in kg. A ratio closer to zero signifies that pain hampers the application of grip force to a larger degree signifying a more severe condition. A ratio approaching 1 signifies a milder complaint where grip strength is not hampered by pain.
Measured: 52 weeks
Affected Function on 100 mm VAS-scale as Recorded by the Study Doctors
To what extent is the use of the elbow affected registered on 100 mm VAS-scale. 0 mm represents use not affected. 100 mm signifies maximum affected function. Higher scores mean a worse outcome.
Measured: 6 weeks
Affected Function on 100 mm VAS-scale as Recorded by the Study Doctors
To what extent is the use of the elbow affected registered on 100 mm VAS-scale. 0 mm represents use not affected. 100 mm signifies maximum affected function. Higher scores mean a worse outcome.
Measured: 12 weeks
Affected Function on 100 mm VAS-scale as Recorded by the Study Doctors
To what extent is the use of the elbow affected registered on 100 mm VAS-scale. 0 mm represents use not affected. 100 mm signifies maximum affected function. Higher scores mean a worse outcome.
Measured: 26 weeks
Affected Function on a 100 mm VAS-scale as Recorded by the Study Doctors
To what extent is the use of the elbow affected registered on 100 mm VAS-scale. 0 mm represents use not affected. 100 mm signifies maximum affected function. Higher scores mean a worse outcome.
Measured: 52 weeks
Overall Complaint on 100 mm VAS-scale as Recorded by the Study Doctors
Overall complaint registered on VAS-scale as recorded by study doctors. 0 mm represents no overall complaint. 100 mm signifies maximum overall complaint. Higher scores mean a worse outcome.
Measured: 6 weeks
Overall Complaint on 100 mm VAS-scale as Recorded by the Study Doctors
Overall complaint registered on VAS-scale as recorded by study doctors. 0 mm represents no overall complaint. 100 mm signifies maximum overall complaint. Higher scores mean a worse outcome.
Measured: 12 weeks
Overall Complaint on 100 mm VAS-scale as Recorded by the Study Doctors
Overall complaint registered on VAS-scale as recorded by study doctors. 0 mm represents no overall complaint. 100 mm signifies maximum overall complaint. Higher scores mean a worse outcome.
Measured: 26 weeks
Overall Complaint on 100 mm VAS-scale as Recorded by the Study Doctors
Overall complaint registered on VAS-scale as recorded by study doctors. 0 mm represents no overall complaint. 100 mm signifies maximum overall complaint. Higher scores mean a worse outcome.
Measured: 52 weeks
Pain Free Function Index of Everyday Activities
Pain free function Index ( 0 - 8 ; 0: full function, 8 no function). Does the patient have pain on 8 every-day activities (dressing, eating, washing, household tasks, opening doors, carrying objects, with work, at sports). Recording a 0 on a complaint listed signifies full function, recording a 1 signifies no function. Thus the more activities with no function the higher score and the higher impairment.
Measured: 6 weeks
Pain Free Function Index of Everyday Activities
Pain free function Index ( 0 - 8 ; 0: full function, 8 no function). Does the patient have pain on 8 every-day activities (dressing, eating, washing, household tasks, opening doors, carrying objects, with work, at sports). Recording a 0 on a complaint listed signifies full function, recording a 1 signifies no function. Thus the more activities with no function the higher score and the higher impairment.
Measured: 12 weeks
Pain Free Function Index of Everyday Activities
Pain free function Index ( 0 - 8 ; 0: full function, 8 no function). Does the patient have pain on 8 every-day activities (dressing, eating, washing, household tasks, opening doors, carrying objects, with work, at sports). Recording a 0 on a complaint listed signifies full function, recording a 1 signifies no function. Thus the more activities with no function the higher score and the higher impairment.
Measured: 26 weeks
Pain Free Function Index of Everyday Activities
Pain free function Index ( 0 - 8 ; 0: full function, 8 no function). Does the patient have pain on 8 every-day activities (dressing, eating, washing, household tasks, opening doors, carrying objects, with work, at sports). Recording a 0 on a complaint listed signifies full function, recording a 1 signifies no function. Thus the more activities with no function the higher score and the higher impairment.
Measured: 52 weeks
No Pain on Three Point Likert Scale on Dorsiflexion of Wrist
Percentage of patients reporting "no pain" on dorsiflexion of wrist on a three-point Likert scale on dorsiflexion of wrist. Scale: No pain - some pain - definite pain.
Measured: 6 weeks
No Pain on Three Point Likert Scale on Dorsiflexion of Wrist
Percentage of patients reporting "no pain" on dorsiflexion of wrist on a three-point Likert scale on dorsiflexion of wrist. Scale: No pain - some pain - definite pain.
Measured: 12 weeks
No Pain on Three Point Likert Scale on Dorsiflexion of Wrist
Percentage of patients reporting "no pain" on dorsiflexion of wrist on a three-point Likert scale on dorsiflexion of wrist. Scale: No pain - some pain - definite pain.
Measured: 26 weeks
No Pain on Three Point Likert Scale on Dorsiflexion of Wrist
Percentage of patients reporting "no pain" on dorsiflexion of wrist on a three-point Likert scale on dorsiflexion of wrist. Scale: No pain - some pain - definite pain.
Measured: 52 weeks
No Pain on Three Point Likert Scale on Isometric Extension of Third Finger
Percentage of patients reporting "no pain" on isometric extension of third finger on a three-point Likert scale on dorsiflexion of wrist. Scale: No pain - some pain - definite pain.
Measured: 6 weeks
No Pain on Three Point Likert Scale on Isometric Extension of Third Finger
Percentage of patients reporting "no pain" on isometric extension of third finger on a three-point Likert scale on dorsiflexion of wrist. Scale: No pain - some pain - definite pain.
Measured: 12 weeks
No Pain on Three Point Likert Scale on Isometric Extension of Third Finger
Percentage of patients reporting "no pain" on isometric extension of third finger on a three-point Likert scale on dorsiflexion of wrist. Scale: No pain - some pain - definite pain.
Measured: 26 weeks
No Pain on Three Point Likert Scale on Isometric Extension of Third Finger
Percentage of patients reporting "no pain" on isometric extension of third finger on a three-point Likert scale on dorsiflexion of wrist. Scale: No pain - some pain - definite pain.
Measured: 52 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2009 (estimated)
- Study startMar 2009
- Primary completionJun 2013
- Study completionJun 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (3)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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 177 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Oslo
- Sponsor type
- University, hospital or other
- Collaborators
- Allmennmedisinsk forskningsfond, Norway
- Responsible party
- Principal investigator, Morten Lindbaek, University of Oslo
- Investigators
- Morten Lindbaek, Ph. D., Study chair, University of Oslo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00826462
- Sponsor's protocol ID
- 2006-002283-26
- Status last verified
- Nov 2021
- First submitted
- 20 Jan 2009
- Last updated
- 24 Jan 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Olaussen M, Holmedal O, Mdala I, Brage S, Lindbaek M. Corticosteroid or placebo injection combined with deep transverse friction massage, Mills manipulation, stretching and eccentric exercise for acute lateral epicondylitis: a randomised, controlled trial. BMC Musculoskelet Disord. 2015 May 20;16:122. doi: 10.1186/s12891-015-0582-6.
PubMed 25989985Holmedal O, Olaussen M, Mdala I, Natvig B, Lindbaek M. Predictors for outcome in acute lateral epicondylitis. BMC Musculoskelet Disord. 2019 Aug 17;20(1):375. doi: 10.1186/s12891-019-2758-y.
PubMed 31421668Olaussen M, Holmedal O, Lindbaek M, Brage S. Physiotherapy alone or in combination with corticosteroid injection for acute lateral epicondylitis in general practice: a protocol for a randomised, placebo-controlled study. BMC Musculoskelet Disord. 2009 Dec 4;10:152. doi: 10.1186/1471-2474-10-152.
PubMed 19961603
Study at a glance
From the registry record, last updated by the sponsor on 24 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Physiotherapy Alone, in Combination With Corticosteroid Injection or Wait-and-see for Acute Lateral Epicondylitis in General Practice: a Randomised, Placebo-controlled Study With 12 Months Follow-up
- ClinicalTrials.gov ID
- NCT00826462
- Acronym / sponsor ID
- 2006-002283-26
- Conditions
- Tennis Elbow, Epicondylitis, Lateral Humeral
- Keywords
- Randomised, Placebo-controlled, double blind, Intervention study, Primary health care
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 177 participants (actual)
- Lead sponsor
- University of OsloUniversity, hospital or other
- Collaborators
- Allmennmedisinsk forskningsfond, Norway
- Study start
- Mar 2009
- Primary completion
- Jun 2013 (actual)
- Study completion
- Jun 2013 (actual)
- First posted
- 22 Jan 2009 (estimated)
- Results
- Posted 24 Jan 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to compare the clinical effect of physiotherapy alone or combined with corticosteroid injection in the initial treatment of lateral epicondylitis in a primary care setting.
To find the short and long term effect of physiotherapy with Mill's manipulation, deep friction massage and exercise therapy.
To ascertain wether the outcome is influenced by corticosteroid injection, which has been shown to be of benefit alone in the short term?
Detailed description
Much has been written about lateral epicondylitis/tennis elbow reflecting the existence of many treatments for the condition. However, there is no consensus as to which treatment gives the best results.
Based on the latest meta-studies and reviews from the Cochrane Library, one may conclude that there is evidence of a short-term effect of topical or per oral NSAIDs. The same is true for manipulation and exercise. Corticosteroid injection has also been shown to have short-term effect, but not beyond 6 weeks. Ultrasound has a possible short-term effect based on one meta-analysis. Extra corporeal shock wave therapy does not seem to be effective. The treatment with acupuncture, orthosis, surgery or long-term NSAIDs has no support in the literature, and it is impossible to draw any conclusions about the effects or absence thereof. In fact, there is scant support for any long-term treatment in the literature.
We have found two studies to be of special interest (see citations below). Both have been done in a primary care setting with one-year follow up. One study compares corticosteroid injection with physical therapy (ultrasound, manipulation and exercise) and a wait-and-see group. The other compares corticosteroid injection with naproxen orally and placebo-medication. Both conclude that corticosteroid injection is a safe and effective treatment as pain-relief during the first 6 weeks, and that the effect of this treatment is better than physical therapy, wait-and-see and naproxen orally within the same time-frame. Physical therapy in one study gives some, but not statistically significantly better long-term (one year) effect than wait-and-see treatment.
There seems to be some indication that corticosteroid injection is a good alternative for the first 6 weeks. We find there is a good reason to investigate the long-term effects of physical therapy. At the same time, it would be interesting to see whether the good initial response from corticosteroid injection may be extended if combined with physiotherapy.
This randomised, placebo-controlled study will be conducted in general practice in the town of Sarpsborg, Ostfold County, Norway including patient aged 18-70 years with pain of recent onset from the lateral part of the elbow. After a treatment-period of 6 weeks, the patient is followed for a total of 12 months.
Patients are recruited by interested general practitioners in the city of Sarpsborg and surroundings and remitted to two study-physicians who make the initial evaluation of inclusion- and exclusion criteria, as well as treatment, follow-up and outcome assessments during the whole study-period. The patients are treated by one of the two study-physicians in the 6-weeks treatment-period. From the 6. week, the patient sees the other physician, who is unaware of the allocated intervention, for further registration and assessment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: triamcinolone, Drug: Lidocaine, Other: Physiotherapy, Drug: NaproxenCorticosteroid injection in combination with physical therapy Injection with triamcinolone 10 mg and 10 mg of lidocaine at start and at 3 weeks in combination with physiotherapy for 6 weeks (12 treatments with deep friction massage, Mill's manipulation, soft tissue treatment and home exercises) Naprosyn Entero 500 mg bid for 14 days |
| 2 | Placebo comparator | Drug: Placebo, Drug: Lidocaine, Other: Physiotherapy, Drug: NaproxenPlacebo injection in combination with physical therapy Injection with sodium chloride and 10 mg of lidocaine at start and at 3 weeks in combination with physiotherapy for 6 weeks (12 treatments with deep friction massage, Mill's manipulation, soft tissue treatment and home exercises) Naprosyn entero 500 mg bid for 14 days |
| 3 | Active comparator | Drug: NaproxenControl group: wait-and-see treatment Naprosyn entero 500 mg bid for 14 days |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age 18-70 years
- Pain from the lateral part of the elbow
- The pain increases on resisted dorsiflexion of the wrist with the elbow extended and the fingers flexed or the pain increases on resisted radial deviation of the wrist or the pain increases on resisted extension of the 3. finger
Key exclusion criteria (25 listed)
- Duration of complaints less than 2 weeks or more than 3 months
- The tenderness is located within the muscle body itself in the proximal part of the short radial extensors muscle of the wrist (Cyriax type IV)9.
- Treatment within the last 12 months for the same condition with corticosteroid injection or physiotherapy
- Bilateral complaints
- Previous surgical treatment for lateral epicondylitis
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 |
|---|---|---|
| triamcinoloneAlso: Kenacort - T (triamcinolone), Xylocaine (lidocaine)Injection with triamcinolone 10 mg at start and at 3 weeks | Drug | 1 |
| PlaceboAlso: Sodium chlorideInjection with sodium chloride at start and at 3 weeks | Drug | 2 |
| LidocaineAlso: Xylocaine10 mg of lidocaine at start and at 3 weeks | Drug | 1, 2 |
| PhysiotherapyAlso: Physical therapy12 treatments with deep friction massage, Mill's manipulation, soft tissue treatment and home exercises | Other | 1, 2 |
| NaproxenAlso: Naprosyn enteroNaproxen 500 mg bid for 14 days | Drug | 1, 2, 3 |
Primary outcome
Treatment Success - Event Rates in Each Group
Time frame: 6 - 52 weeks
Unadjusted event rates of treatment success, defined as participants rating themselves 'much improved' or 'completely recovered' on a six point scale. Percentage with 99% confidence interval.
32 secondary outcomes
Pain as Recorded by the Study Doctors on a Visual Analog Scale (VAS Scale)
Time frame: 6 weeks
Pain as Recorded by the Study Doctors on a 100 mm VAS-scale (Visual Analog Scale).
Time frame: 12 weeks
Pain as Recorded by the Study Doctors on a 100 mm VAS-scale (Visual Analog Scale).
Time frame: 26 weeks
Pain as Recorded by the Study Doctors on a 100 mm VAS-scale
Time frame: 52 weeks
Pain-free Grip Strength Ratio
Time frame: 6 weeks
Pain-free Grip Strength Ratio
Time frame: 12 weeks
Pain-free Grip Strength Ratio
Time frame: 26 weeks
Pain-free Grip Strength Ratio
Time frame: 52 weeks
Maximum Grip Strength Ratio
Time frame: 6 weeks
Maximum Grip Strength Ratio
Time frame: 12 weeks
Maximum Grip Strength Ratio
Time frame: 26 weeks
Maximum Grip Strength Ratio
Time frame: 52 weeks
Affected Function on 100 mm VAS-scale as Recorded by the Study Doctors
Time frame: 6 weeks
Affected Function on 100 mm VAS-scale as Recorded by the Study Doctors
Time frame: 12 weeks
Affected Function on 100 mm VAS-scale as Recorded by the Study Doctors
Time frame: 26 weeks
Affected Function on a 100 mm VAS-scale as Recorded by the Study Doctors
Time frame: 52 weeks
Overall Complaint on 100 mm VAS-scale as Recorded by the Study Doctors
Time frame: 6 weeks
Overall Complaint on 100 mm VAS-scale as Recorded by the Study Doctors
Time frame: 12 weeks
Overall Complaint on 100 mm VAS-scale as Recorded by the Study Doctors
Time frame: 26 weeks
Overall Complaint on 100 mm VAS-scale as Recorded by the Study Doctors
Time frame: 52 weeks
Pain Free Function Index of Everyday Activities
Time frame: 6 weeks
Pain Free Function Index of Everyday Activities
Time frame: 12 weeks
Pain Free Function Index of Everyday Activities
Time frame: 26 weeks
Pain Free Function Index of Everyday Activities
Time frame: 52 weeks
No Pain on Three Point Likert Scale on Dorsiflexion of Wrist
Time frame: 6 weeks
No Pain on Three Point Likert Scale on Dorsiflexion of Wrist
Time frame: 12 weeks
No Pain on Three Point Likert Scale on Dorsiflexion of Wrist
Time frame: 26 weeks
No Pain on Three Point Likert Scale on Dorsiflexion of Wrist
Time frame: 52 weeks
No Pain on Three Point Likert Scale on Isometric Extension of Third Finger
Time frame: 6 weeks
No Pain on Three Point Likert Scale on Isometric Extension of Third Finger
Time frame: 12 weeks
No Pain on Three Point Likert Scale on Isometric Extension of Third Finger
Time frame: 26 weeks
No Pain on Three Point Likert Scale on Isometric Extension of Third Finger
Time frame: 52 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jan 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 25989985Olaussen M, Holmedal O, Mdala I, Brage S, Lindbaek M. Corticosteroid or placebo injection combined with deep transverse friction massage, Mills manipulation, stretching and eccentric exercise for acute lateral epicondylitis: a randomised, controlled trial. BMC Musculoskelet Disord. 2015 May 20;16:122. doi: 10.1186/s12891-015-0582-6.
- Derived from this study: PubMed 31421668Holmedal O, Olaussen M, Mdala I, Natvig B, Lindbaek M. Predictors for outcome in acute lateral epicondylitis. BMC Musculoskelet Disord. 2019 Aug 17;20(1):375. doi: 10.1186/s12891-019-2758-y.
- Derived from this study: PubMed 19961603Olaussen M, Holmedal O, Lindbaek M, Brage S. Physiotherapy alone or in combination with corticosteroid injection for acute lateral epicondylitis in general practice: a protocol for a randomised, placebo-controlled study. BMC Musculoskelet Disord. 2009 Dec 4;10:152. doi: 10.1186/1471-2474-10-152.
- Individual participant dataSharing planned: No
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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.
Morten Lindbaek, Ph. D. study chair
University of Oslo
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing triamcinolone, Lidocaine and Physiotherapy in people with Tennis Elbow and Epicondylitis, Lateral Humeral, run by University of Oslo at 1 site in Norway.
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 3 inclusion and 25 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 24 Jan 2022. 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 Norway. 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. Some participants in this study may receive a placebo. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 24 Jan 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Treatment Success - Event Rates in Each Group (time frame: 6 - 52 weeks). 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 NCT00826462, which also lists 3 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 24 Jan 2022.