Phase 4
N=177
Treatment Study of Steroid Injection and Physical Therapy for Acute Lateral Epicondylitis
Tennis Elbow · Epicondylitis, Lateral Humeral
Bottom Line
View on ClinicalTrials.gov: NCT00826462 ↗Enrolled (actual)
177
Serious AEs
0.0%
Results posted
Jan 2022
Primary outcome: Primary: Treatment Success - Event Rates in Each Group — 15; 24; 59; 48 percentage of participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- triamcinolone (Drug); Placebo (Drug); Lidocaine (Drug); Physiotherapy (Other); Naproxen (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of Oslo
- Primary completion
- Jun 2013
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Treatment Success - Event Rates in Each Group |
15; 24; 59; 48; 45; 42 | — |
| SECONDARY Pain as Recorded by the Study Doctors on a Visual Analog Scale (VAS Scale) |
29; 45; 44 | — |
| SECONDARY Pain as Recorded by the Study Doctors on a 100 mm VAS-scale (Visual Analog Scale). |
38; 21; 19 | — |
| SECONDARY Pain as Recorded by the Study Doctors on a 100 mm VAS-scale (Visual Analog Scale). |
38; 21; 19 | — |
| SECONDARY Pain as Recorded by the Study Doctors on a 100 mm VAS-scale |
19; 9; 13 | — |
| SECONDARY Pain-free Grip Strength Ratio |
100; 90; 91 | — |
| SECONDARY Pain-free Grip Strength Ratio |
100; 90; 91 | — |
| SECONDARY Pain-free Grip Strength Ratio |
100; 90; 91 | — |
| SECONDARY Pain-free Grip Strength Ratio |
100; 90; 91 | — |
| SECONDARY Maximum Grip Strength Ratio |
96; 102; 104 | — |
| SECONDARY Maximum Grip Strength Ratio |
96; 102; 104 | — |
| SECONDARY Maximum Grip Strength Ratio |
96; 102; 104 | — |
| SECONDARY Maximum Grip Strength Ratio |
96; 102; 104 | — |
| SECONDARY Affected Function on 100 mm VAS-scale as Recorded by the Study Doctors |
28; 17; 16 | — |
| SECONDARY Affected Function on 100 mm VAS-scale as Recorded by the Study Doctors |
28; 17; 16 | — |
| SECONDARY Affected Function on 100 mm VAS-scale as Recorded by the Study Doctors |
28; 17; 16 | — |
| SECONDARY Affected Function on a 100 mm VAS-scale as Recorded by the Study Doctors |
16; 9; 10 | — |
| SECONDARY Overall Complaint on 100 mm VAS-scale as Recorded by the Study Doctors |
20; 9; 12 | — |
| SECONDARY Overall Complaint on 100 mm VAS-scale as Recorded by the Study Doctors |
20; 9; 12 | — |
| SECONDARY Overall Complaint on 100 mm VAS-scale as Recorded by the Study Doctors |
20; 9; 12 | — |
| SECONDARY Overall Complaint on 100 mm VAS-scale as Recorded by the Study Doctors |
20; 9; 12 | — |
| SECONDARY Pain Free Function Index of Everyday Activities |
1.64; 1.03; 1.40 | — |
| SECONDARY Pain Free Function Index of Everyday Activities |
1.64; 1.03; 1.40 | — |
| SECONDARY Pain Free Function Index of Everyday Activities |
1.64; 1.03; 1.40 | — |
| SECONDARY Pain Free Function Index of Everyday Activities |
1.64; 1.03; 1.40 | — |
| SECONDARY No Pain on Three Point Likert Scale on Dorsiflexion of Wrist |
36; 60; 50 | — |
| SECONDARY No Pain on Three Point Likert Scale on Dorsiflexion of Wrist |
36; 60; 50 | — |
| SECONDARY No Pain on Three Point Likert Scale on Dorsiflexion of Wrist |
36; 60; 50 | — |
| SECONDARY No Pain on Three Point Likert Scale on Dorsiflexion of Wrist |
36; 60; 50 | — |
| SECONDARY No Pain on Three Point Likert Scale on Isometric Extension of Third Finger |
53; 76; 63 | — |
| SECONDARY No Pain on Three Point Likert Scale on Isometric Extension of Third Finger |
53; 76; 63 | — |
| SECONDARY No Pain on Three Point Likert Scale on Isometric Extension of Third Finger |
53; 76; 63 | — |
| SECONDARY No Pain on Three Point Likert Scale on Isometric Extension of Third Finger |
53; 76; 63 | — |
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?
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.
Data sourced from ClinicalTrials.gov (NCT00826462). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.