Treatment Study of Steroid Injection and Physical Therapy for Acute Lateral Epicondylitis
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Purpose
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?
| Condition | Intervention | Phase |
|---|---|---|
|
Tennis Elbow Epicondylitis, Lateral Humeral |
Drug: triamcinolone Drug: Placebo Drug: Lidocaine Other: Physiotherapy Drug: Naproxen |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Factorial Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| 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 patient's evaluation of improvement [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
- The patient's evaluation of improvement [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
- The patient's evaluation of improvement [ Time Frame: 26 weeks ] [ Designated as safety issue: No ]
- The patient's evaluation of improvement [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]
- Pain, function and severity of main complaint as recorded by the study doctors [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
- The patient's satisfaction with the treatment [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
- Time off work [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
- Pain, function and severity of main complaint as recorded by the study doctors [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
- Pain, function and severity of main complaint as recorded by the study doctors [ Time Frame: 26 weeks ] [ Designated as safety issue: No ]
- Pain, function and severity of main complaint as recorded by the study doctors [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]
- The patient's satisfaction with the treatment [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
- The patient's satisfaction with the treatment [ Time Frame: 26 weeks ] [ Designated as safety issue: No ]
- The patient's satisfaction with the treatment [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]
- Time off work [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
- Time off work [ Time Frame: 26 weeks ] [ Designated as safety issue: No ]
- Time off work [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 174 |
| Study Start Date: | March 2009 |
| Estimated Study Completion Date: | June 2013 |
| Estimated Primary Completion Date: | June 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: 1
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 |
Drug: triamcinolone
Injection with triamcinolone 10 mg at start and at 3 weeks
Other Names:
Drug: Lidocaine
10 mg of lidocaine at start and at 3 weeks
Other Name: Xylocaine
Other: Physiotherapy
12 treatments with deep friction massage, Mill's manipulation, soft tissue treatment and home exercises
Other Name: Physical therapy
Drug: Naproxen
Naproxen 500 mg bid for 14 days
Other Name: Naprosyn entero
|
|
Placebo Comparator: 2
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 |
Drug: Placebo
Injection with sodium chloride at start and at 3 weeks
Other Name: Sodium chloride
Drug: Lidocaine
10 mg of lidocaine at start and at 3 weeks
Other Name: Xylocaine
Other: Physiotherapy
12 treatments with deep friction massage, Mill's manipulation, soft tissue treatment and home exercises
Other Name: Physical therapy
Drug: Naproxen
Naproxen 500 mg bid for 14 days
Other Name: Naprosyn entero
|
|
No Intervention: 3
Control group: wait-and-see treatment Naprosyn entero 500 mg bid for 14 days
|
Drug: Naproxen
Naproxen 500 mg bid for 14 days
Other Name: Naprosyn entero
|
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 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.
Eligibility| Ages Eligible for Study: | 18 Years to 70 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
- SLE
- 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.
Contacts and Locations More Information
Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Department of General Practice and Community Medicine, University of Oslo |
| ClinicalTrials.gov Identifier: | NCT00826462 History of Changes |
| Other Study ID Numbers: | 2006-002283-26 |
| Study First Received: | January 20, 2009 |
| Last Updated: | June 22, 2012 |
| Health Authority: | Norway: Norwegian Medicines Agency |
Keywords provided by University of Oslo:
|
Randomised Placebo-controlled double blind Intervention study Primary health care |
Additional relevant MeSH terms:
|
Tennis Elbow Musculoskeletal Diseases Arm Injuries Wounds and Injuries Naproxen Triamcinolone hexacetonide Triamcinolone Triamcinolone Acetonide Triamcinolone diacetate Lidocaine Anti-Inflammatory Agents, Non-Steroidal Analgesics, Non-Narcotic Analgesics Sensory System Agents Peripheral Nervous System Agents |
Physiological Effects of Drugs Pharmacologic Actions Anti-Inflammatory Agents Therapeutic Uses Antirheumatic Agents Gout Suppressants Cyclooxygenase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Central Nervous System Agents Anesthetics, Local Anesthetics Central Nervous System Depressants Anti-Arrhythmia Agents Cardiovascular Agents |
ClinicalTrials.gov processed this record on May 23, 2013