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Treatment Study of Steroid Injection and Physical Therapy for Acute Lateral Epicondylitis

Primary Purpose

Tennis Elbow, Epicondylitis, Lateral Humeral

Status
Completed
Phase
Phase 4
Locations
Norway
Study Type
Interventional
Intervention
triamcinolone
Placebo
Lidocaine
Physiotherapy
Naproxen
Sponsored by
University of Oslo
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Tennis Elbow focused on measuring Randomised, Placebo-controlled, double blind, Intervention study, Primary health care

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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

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:

    • 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.

Sites / Locations

  • Grålum legesenter

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Placebo Comparator

Active Comparator

Arm Label

1

2

3

Arm Description

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

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

Control group: wait-and-see treatment Naprosyn entero 500 mg bid for 14 days

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.

Full Information

First Posted
January 20, 2009
Last Updated
November 11, 2021
Sponsor
University of Oslo
Collaborators
Allmennmedisinsk forskningsfond, Norway
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1. Study Identification

Unique Protocol Identification Number
NCT00826462
Brief Title
Treatment Study of Steroid Injection and Physical Therapy for Acute Lateral Epicondylitis
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
Study Type
Interventional

2. Study Status

Record Verification Date
November 2021
Overall Recruitment Status
Completed
Study Start Date
March 2009 (undefined)
Primary Completion Date
June 2013 (Actual)
Study Completion Date
June 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Oslo
Collaborators
Allmennmedisinsk forskningsfond, Norway

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tennis Elbow, Epicondylitis, Lateral Humeral
Keywords
Randomised, Placebo-controlled, double blind, Intervention study, Primary health care

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Factorial Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
177 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
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
Arm Title
2
Arm Type
Placebo Comparator
Arm Description
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
Arm Title
3
Arm Type
Active Comparator
Arm Description
Control group: wait-and-see treatment Naprosyn entero 500 mg bid for 14 days
Intervention Type
Drug
Intervention Name(s)
triamcinolone
Other Intervention Name(s)
Kenacort - T (triamcinolone), Xylocaine (lidocaine)
Intervention Description
Injection with triamcinolone 10 mg at start and at 3 weeks
Intervention Type
Drug
Intervention Name(s)
Placebo
Other Intervention Name(s)
Sodium chloride
Intervention Description
Injection with sodium chloride at start and at 3 weeks
Intervention Type
Drug
Intervention Name(s)
Lidocaine
Other Intervention Name(s)
Xylocaine
Intervention Description
10 mg of lidocaine at start and at 3 weeks
Intervention Type
Other
Intervention Name(s)
Physiotherapy
Other Intervention Name(s)
Physical therapy
Intervention Description
12 treatments with deep friction massage, Mill's manipulation, soft tissue treatment and home exercises
Intervention Type
Drug
Intervention Name(s)
Naproxen
Other Intervention Name(s)
Naprosyn entero
Intervention Description
Naproxen 500 mg bid for 14 days
Primary Outcome Measure Information:
Title
Treatment Success - Event Rates in Each Group
Description
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.
Time Frame
6 - 52 weeks
Secondary Outcome Measure Information:
Title
Pain as Recorded by the Study Doctors on a Visual Analog Scale (VAS Scale)
Description
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.
Time Frame
6 weeks
Title
Pain as Recorded by the Study Doctors on a 100 mm VAS-scale (Visual Analog Scale).
Description
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.
Time Frame
12 weeks
Title
Pain as Recorded by the Study Doctors on a 100 mm VAS-scale (Visual Analog Scale).
Description
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.
Time Frame
26 weeks
Title
Pain as Recorded by the Study Doctors on a 100 mm VAS-scale
Description
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.
Time Frame
52 weeks
Title
Pain-free Grip Strength Ratio
Description
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.
Time Frame
6 weeks
Title
Pain-free Grip Strength Ratio
Description
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.
Time Frame
12 weeks
Title
Pain-free Grip Strength Ratio
Description
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.
Time Frame
26 weeks
Title
Pain-free Grip Strength Ratio
Description
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.
Time Frame
52 weeks
Title
Maximum Grip Strength Ratio
Description
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.
Time Frame
6 weeks
Title
Maximum Grip Strength Ratio
Description
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.
Time Frame
12 weeks
Title
Maximum Grip Strength Ratio
Description
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.
Time Frame
26 weeks
Title
Maximum Grip Strength Ratio
Description
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.
Time Frame
52 weeks
Title
Affected Function on 100 mm VAS-scale as Recorded by the Study Doctors
Description
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.
Time Frame
6 weeks
Title
Affected Function on 100 mm VAS-scale as Recorded by the Study Doctors
Description
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.
Time Frame
12 weeks
Title
Affected Function on 100 mm VAS-scale as Recorded by the Study Doctors
Description
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.
Time Frame
26 weeks
Title
Affected Function on a 100 mm VAS-scale as Recorded by the Study Doctors
Description
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.
Time Frame
52 weeks
Title
Overall Complaint on 100 mm VAS-scale as Recorded by the Study Doctors
Description
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.
Time Frame
6 weeks
Title
Overall Complaint on 100 mm VAS-scale as Recorded by the Study Doctors
Description
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.
Time Frame
12 weeks
Title
Overall Complaint on 100 mm VAS-scale as Recorded by the Study Doctors
Description
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.
Time Frame
26 weeks
Title
Overall Complaint on 100 mm VAS-scale as Recorded by the Study Doctors
Description
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.
Time Frame
52 weeks
Title
Pain Free Function Index of Everyday Activities
Description
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.
Time Frame
6 weeks
Title
Pain Free Function Index of Everyday Activities
Description
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.
Time Frame
12 weeks
Title
Pain Free Function Index of Everyday Activities
Description
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.
Time Frame
26 weeks
Title
Pain Free Function Index of Everyday Activities
Description
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.
Time Frame
52 weeks
Title
No Pain on Three Point Likert Scale on Dorsiflexion of Wrist
Description
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.
Time Frame
6 weeks
Title
No Pain on Three Point Likert Scale on Dorsiflexion of Wrist
Description
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.
Time Frame
12 weeks
Title
No Pain on Three Point Likert Scale on Dorsiflexion of Wrist
Description
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.
Time Frame
26 weeks
Title
No Pain on Three Point Likert Scale on Dorsiflexion of Wrist
Description
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.
Time Frame
52 weeks
Title
No Pain on Three Point Likert Scale on Isometric Extension of Third Finger
Description
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.
Time Frame
6 weeks
Title
No Pain on Three Point Likert Scale on Isometric Extension of Third Finger
Description
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.
Time Frame
12 weeks
Title
No Pain on Three Point Likert Scale on Isometric Extension of Third Finger
Description
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.
Time Frame
26 weeks
Title
No Pain on Three Point Likert Scale on Isometric Extension of Third Finger
Description
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.
Time Frame
52 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 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: 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Morten Lindbaek, Ph. D.
Organizational Affiliation
University of Oslo
Official's Role
Study Chair
Facility Information:
Facility Name
Grålum legesenter
City
Sarpsborg
ZIP/Postal Code
1712
Country
Norway

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
25989985
Citation
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.
Results Reference
result
PubMed Identifier
31421668
Citation
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.
Results Reference
derived
PubMed Identifier
19961603
Citation
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.
Results Reference
derived

Learn more about this trial

Treatment Study of Steroid Injection and Physical Therapy for Acute Lateral Epicondylitis

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