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| Name | Class |
|---|---|
| Allmennmedisinsk forskningsfond, Norway | UNKNOWN |
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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?
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
|
| 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 |
|
| 3 | Active Comparator | Control group: wait-and-see treatment Naprosyn entero 500 mg bid for 14 days |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| triamcinolone | Drug | Injection with triamcinolone 10 mg at start and at 3 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 6 - 52 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 6 weeks |
| Pain as Recorded by the Study Doctors on a 100 mm VAS-scale (Visual Analog Scale). |
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Inclusion Criteria:
Exclusion Criteria:
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)
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:
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.
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| Name | Affiliation | Role |
|---|---|---|
| Morten Lindbaek, Ph. D. | University of Oslo | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Grålum legesenter | Sarpsborg | 1712 | Norway |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25989985 | Result | 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. | |
| 31421668 |
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| ID | Title | Description |
|---|---|---|
| FG000 | Corticosteroid Injection in Combination With Physical Therapy | 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 triamcinolone: Injection with triamcinolone 10 mg at start and at 3 weeks Lidocaine: 10 mg of lidocaine at start and at 3 weeks Physiotherapy: 12 treatments with deep friction massage, Mill's manipulation, soft tissue treatment and home exercises Naproxen: Naproxen 500 mg bid for 14 days |
| FG001 | Placebo Injection in Combination With Physical Therapy | 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 Placebo: Injection with sodium chloride at start and at 3 weeks Lidocaine: 10 mg of lidocaine at start and at 3 weeks Physiotherapy: 12 treatments with deep friction massage, Mill's manipulation, soft tissue treatment and home exercises Naproxen: Naproxen 500 mg bid for 14 days |
| FG002 | Control Group: Wait-and-see Treatment | Control group: wait-and-see treatment Naprosyn entero 500 mg bid for 14 days Naproxen: Naproxen 500 mg bid for 14 days |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Corticosteroid Injection in Combination With Physical Therapy | 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 triamcinolone: Injection with triamcinolone 10 mg at start and at 3 weeks Lidocaine: 10 mg of lidocaine at start and at 3 weeks Physiotherapy: 12 treatments with deep friction massage, Mill's manipulation, soft tissue treatment and home exercises Naproxen: Naproxen 500 mg bid for 14 days |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Our study was performed on an intention to treat basis. The number of participants in each included arm therefore was subsequently kept as the denominator at each follow - up regardless of any drop outs. | Posted | Number | 99% Confidence Interval | percentage of participants | 6 - 52 weeks |
|
1 year
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Corticosteroid Injection in Combination With Physical Therapy | 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 triamcinolone: Injection with triamcinolone 10 mg at start and at 3 weeks Lidocaine: 10 mg of lidocaine at start and at 3 weeks Physiotherapy: 12 treatments with deep friction massage, Mill's manipulation, soft tissue treatment and home exercises Naproxen: Naproxen 500 mg bid for 14 days |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Increased pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
Strict inclusion criteria limit generalizability.The patients were not blinded to physiotherapy.Home exercises not logged.Only one physiotherapist.No individual adjustment of treatment. .We did not look specifically at recurrence rates.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Professor Morten Lindbaek | University of Oslo | +47-22850646 | morten.lindbak@medisin.uio.no |
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| ID | Term |
|---|---|
| D013716 | Tennis Elbow |
| ID | Term |
|---|---|
| D000070639 | Elbow Tendinopathy |
| D052256 | Tendinopathy |
| D009135 | Muscular Diseases |
| D009140 | Musculoskeletal Diseases |
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| ID | Term |
|---|---|
| D014221 | Triamcinolone |
| D008012 | Lidocaine |
| D012965 | Sodium Chloride |
| D026741 | Physical Therapy Modalities |
| D009288 | Naproxen |
| ID | Term |
|---|---|
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
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| Placebo | Drug | Injection with sodium chloride at start and at 3 weeks |
|
|
| Lidocaine | Drug | 10 mg of lidocaine at start and at 3 weeks |
|
|
| Physiotherapy | Other | 12 treatments with deep friction massage, Mill's manipulation, soft tissue treatment and home exercises |
|
|
| Naproxen | Drug | Naproxen 500 mg bid for 14 days |
|
|
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. |
| 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 52 weeks |
| Holmedal 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. |
| 19961603 | Derived | Olaussen 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. |
| BG001 | Placebo Injection in Combination With Physical Therapy | 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 Placebo: Injection with sodium chloride at start and at 3 weeks Lidocaine: 10 mg of lidocaine at start and at 3 weeks Physiotherapy: 12 treatments with deep friction massage, Mill's manipulation, soft tissue treatment and home exercises Naproxen: Naproxen 500 mg bid for 14 days |
| BG002 | Control Group: Wait-and-see Treatment | Control group: wait-and-see treatment Naprosyn entero 500 mg bid for 14 days Naproxen: Naproxen 500 mg bid for 14 days |
| BG003 | Total | Total of all reporting groups |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
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 Placebo: Injection with sodium chloride at start and at 3 weeks Lidocaine: 10 mg of lidocaine at start and at 3 weeks Physiotherapy: 12 treatments with deep friction massage, Mill's manipulation, soft tissue treatment and home exercises Naproxen: Naproxen 500 mg bid for 14 days |
| OG002 | Corticosteroid Injection in Combination With Physical Therapy | 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 triamcinolone: Injection with triamcinolone 10 mg at start and at 3 weeks Lidocaine: 10 mg of lidocaine at start and at 3 weeks Physiotherapy: 12 treatments with deep friction massage, Mill's manipulation, soft tissue treatment and home exercises Naproxen: Naproxen 500 mg bid for 14 days |
|
|
| Secondary | 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. | Our study was performed on an intention to treat basis. The number of participants in each included arm therefore was subsequently kept as the denominator at each follow - up regardless of any drop outs. | Posted | Mean | Standard Deviation | mm | 6 weeks |
|
|
|
| Secondary | 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. | Our study was performed on an intention to treat basis. The number of participants in each included arm therefore was subsequently kept as the denominator at each follow - up regardless of any drop outs. | Posted | Mean | Standard Deviation | mm | 12 weeks |
|
|
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| Secondary | 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. | Our study was performed on an intention to treat basis. The number of participants in each included arm therefore was subsequently kept as the denominator at each follow - up regardless of any drop outs. | Posted | Mean | Standard Deviation | mm | 26 weeks |
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|
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| Secondary | 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. | Our study was performed on an intention to treat basis. The number of participants in each included arm therefore was subsequently kept as the denominator at each follow - up regardless of any drop outs. | Posted | Mean | Standard Deviation | mm | 52 weeks |
|
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| Secondary | 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. | Our study was performed on an intention to treat basis. The number of participants in each included arm therefore was subsequently kept as the denominator at each follow - up regardless of any drop outs. | Posted | Mean | Standard Deviation | Ratio x 100 | 6 weeks |
|
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| Secondary | 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. | Our study was performed on an intention to treat basis. The number of participants in each included arm therefore was subsequently kept as the denominator at each follow - up regardless of any drop outs. | Posted | Mean | Standard Deviation | Ratio x 100 | 12 weeks |
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| Secondary | 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. | Our study was performed on an intention to treat basis. The number of participants in each included arm therefore was subsequently kept as the denominator at each follow - up regardless of any drop outs. | Posted | Mean | Standard Deviation | Ratio x 100 | 26 weeks |
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| Secondary | 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. | Our study was performed on an intention to treat basis. The number of participants in each included arm therefore was subsequently kept as the denominator at each follow - up regardless of any drop outs. | Posted | Mean | Standard Deviation | Ratio x 100 | 52 weeks |
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| Secondary | 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. | Our study was performed on an intention to treat basis. The number of participants in each included arm therefore was subsequently kept as the denominator at each follow - up regardless of any drop outs. | Posted | Mean | Standard Deviation | Ratio x 100 | 6 weeks |
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| Secondary | 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. | Our study was performed on an intention to treat basis. The number of participants in each included arm therefore was subsequently kept as the denominator at each follow - up regardless of any drop outs. | Posted | Mean | Standard Deviation | Ratio x 100 | 12 weeks |
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| Secondary | 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. | Our study was performed on an intention to treat basis. The number of participants in each included arm therefore was subsequently kept as the denominator at each follow - up regardless of any drop outs. | Posted | Mean | Standard Deviation | Ratio x 100 | 26 weeks |
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| Secondary | 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. | Our study was performed on an intention to treat basis. The number of participants in each included arm therefore was subsequently kept as the denominator at each follow - up regardless of any drop outs. | Posted | Mean | Standard Deviation | Ratio x 100 | 52 weeks |
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| Secondary | 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. | Our study was performed on an intention to treat basis. The number of participants in each included arm therefore was subsequently kept as the denominator at each follow - up regardless of any drop outs. | Posted | Mean | Standard Deviation | mm | 6 weeks |
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| Secondary | 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. | Our study was performed on an intention to treat basis. The number of participants in each included arm therefore was subsequently kept as the denominator at each follow - up regardless of any drop outs. | Posted | Mean | Standard Deviation | mm | 12 weeks |
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| Secondary | 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. | Our study was performed on an intention to treat basis. The number of participants in each included arm therefore was subsequently kept as the denominator at each follow - up regardless of any drop outs. | Posted | Mean | Standard Deviation | mm | 26 weeks |
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| Secondary | 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. | Our study was performed on an intention to treat basis. The number of participants in each included arm therefore was subsequently kept as the denominator at each follow - up regardless of any drop outs. | Posted | Mean | Standard Deviation | mm | 52 weeks |
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| Secondary | 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. | Our study was performed on an intention to treat basis. The number of participants in each included arm therefore was subsequently kept as the denominator at each follow - up regardless of any drop outs. | Posted | Mean | Standard Deviation | mm | 6 weeks |
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| Secondary | 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. | Our study was performed on an intention to treat basis. The number of participants in each included arm therefore was subsequently kept as the denominator at each follow - up regardless of any drop outs. | Posted | Mean | Standard Deviation | mm | 12 weeks |
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| Secondary | 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. | Our study was performed on an intention to treat basis. The number of participants in each included arm therefore was subsequently kept as the denominator at each follow - up regardless of any drop outs. | Posted | Mean | Standard Deviation | mm | 26 weeks |
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| Secondary | 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. | Our study was performed on an intention to treat basis. The number of participants in each included arm therefore was subsequently kept as the denominator at each follow - up regardless of any drop outs. | Posted | Mean | Standard Deviation | mm | 52 weeks |
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| Secondary | 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. | Our study was performed on an intention to treat basis. The number of participants in each included arm therefore was subsequently kept as the denominator at each follow - up regardless of any drop outs. | Posted | Mean | Standard Deviation | score on a scale | 6 weeks |
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| Secondary | 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. | Our study was performed on an intention to treat basis. The number of participants in each included arm therefore was subsequently kept as the denominator at each follow - up regardless of any drop outs. | Posted | Mean | Standard Deviation | score on a scale | 12 weeks |
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| Secondary | 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. | Our study was performed on an intention to treat basis. The number of participants in each included arm therefore was subsequently kept as the denominator at each follow - up regardless of any drop outs. | Posted | Mean | Standard Deviation | score on a scale | 26 weeks |
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| Secondary | 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. | Our study was performed on an intention to treat basis. The number of participants in each included arm therefore was subsequently kept as the denominator at each follow - up regardless of any drop outs. | Posted | Mean | Standard Deviation | score on a scale | 52 weeks |
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| Secondary | 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. | Our study was performed on an intention to treat basis. The number of participants in each included arm therefore was subsequently kept as the denominator at each follow - up regardless of any drop outs. | Posted | Number | 99% Confidence Interval | percentage of participants | 6 weeks |
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| Secondary | 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. | Our study was performed on an intention to treat basis. The number of participants in each included arm therefore was subsequently kept as the denominator at each follow - up regardless of any drop outs. | Posted | Number | 99% Confidence Interval | percentage of patients | 12 weeks |
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| Secondary | 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. | Our study was performed on an intention to treat basis. The number of participants in each included arm therefore was subsequently kept as the denominator at each follow - up regardless of any drop outs. | Posted | Number | 99% Confidence Interval | percentage of patients | 26 weeks |
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| Secondary | 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. | Our study was performed on an intention to treat basis. The number of participants in each included arm therefore was subsequently kept as the denominator at each follow - up regardless of any drop outs. | Posted | Number | 99% Confidence Interval | percentage of patients | 52 weeks |
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| Secondary | 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. | Our study was performed on an intention to treat basis. The number of participants in each included arm therefore was subsequently kept as the denominator at each follow - up regardless of any drop outs. | Posted | Number | 99% Confidence Interval | percentage of patients | 6 weeks |
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| Secondary | 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. | Our study was performed on an intention to treat basis. The number of participants in each included arm therefore was subsequently kept as the denominator at each follow - up regardless of any drop outs. | Posted | Number | 99% Confidence Interval | percentage of patients | 12 weeks |
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| Secondary | 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. | Our study was performed on an intention to treat basis. The number of participants in each included arm therefore was subsequently kept as the denominator at each follow - up regardless of any drop outs. | Posted | Number | 99% Confidence Interval | percentage of patients | 26 weeks |
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| Secondary | 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. | Our study was performed on an intention to treat basis. The number of participants in each included arm therefore was subsequently kept as the denominator at each follow - up regardless of any drop outs. | Posted | Number | 99% Confidence Interval | percentage of patients | 52 weeks |
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| 0 |
| 59 |
| 6 |
| 59 |
| EG001 | Placebo Injection in Combination With Physical Therapy | 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 Placebo: Injection with sodium chloride at start and at 3 weeks Lidocaine: 10 mg of lidocaine at start and at 3 weeks Physiotherapy: 12 treatments with deep friction massage, Mill's manipulation, soft tissue treatment and home exercises Naproxen: Naproxen 500 mg bid for 14 days | 0 | 58 | 5 | 58 |
| EG002 | Control Group: Wait-and-see Treatment | Control group: wait-and-see treatment Naprosyn entero 500 mg bid for 14 days Naproxen: Naproxen 500 mg bid for 14 days | 0 | 60 | 10 | 60 |
| GI side effects | Gastrointestinal disorders | Systematic Assessment |
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| Skin atrophy | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
Not provided
Not provided
Not provided
| D000092464 |
| Elbow Injuries |
| D001134 | Arm Injuries |
| D014947 | Wounds and Injuries |
| D013708 | Tendon Injuries |
| D011083 |
| Polycyclic Compounds |
| D013259 | Steroids, Fluorinated |
| D000083 | Acetanilides |
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 | Aniline Compounds |
| D000588 | Amines |
| D002712 | Chlorides |
| D006851 | Hydrochloric Acid |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017670 | Sodium Compounds |
| D013812 | Therapeutics |
| D012046 | Rehabilitation |
| D009280 | Naphthaleneacetic Acids |
| D009281 | Naphthalenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| <0.01 |
| Other |