Clinical trial NCT00826462: 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
Overall status: COMPLETED
Phase: PHASE4
Conditions: Tennis Elbow
Epicondylitis, Lateral Humeral
Keywords: Randomised
Placebo-controlled
double blind
Intervention study
Primary health care
Lead sponsor: University of Oslo
Sponsor class: OTHER
Collaborators: name: Allmennmedisinsk forskningsfond, Norway
First posted: 2009-01-22
Enrollment: 177
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Treatment Success - Event Rates in Each Group
timeFrame: 6 - 52 weeks
Secondary outcomes:
measure: Pain as Recorded by the Study Doctors on a Visual Analog Scale (VAS Scale)
timeFrame: 6 weeks
measure: Pain as Recorded by the Study Doctors on a 100 mm VAS-scale (Visual Analog Scale).
timeFrame: 12 weeks
measure: Pain as Recorded by the Study Doctors on a 100 mm VAS-scale (Visual Analog Scale).
timeFrame: 26 weeks
measure: Pain as Recorded by the Study Doctors on a 100 mm VAS-scale
timeFrame: 52 weeks
measure: Pain-free Grip Strength Ratio
timeFrame: 6 weeks
measure: Pain-free Grip Strength Ratio
timeFrame: 12 weeks
measure: Pain-free Grip Strength Ratio
timeFrame: 26 weeks
measure: Pain-free Grip Strength Ratio
timeFrame: 52 weeks
measure: Maximum Grip Strength Ratio
timeFrame: 6 weeks
measure: Maximum Grip Strength Ratio
timeFrame: 12 weeks
measure: Maximum Grip Strength Ratio
timeFrame: 26 weeks
measure: Maximum Grip Strength Ratio
timeFrame: 52 weeks
measure: Affected Function on 100 mm VAS-scale as Recorded by the Study Doctors
timeFrame: 6 weeks
measure: Affected Function on 100 mm VAS-scale as Recorded by the Study Doctors
timeFrame: 12 weeks
measure: Affected Function on 100 mm VAS-scale as Recorded by the Study Doctors
timeFrame: 26 weeks
measure: Affected Function on a 100 mm VAS-scale as Recorded by the Study Doctors
timeFrame: 52 weeks
measure: Overall Complaint on 100 mm VAS-scale as Recorded by the Study Doctors
timeFrame: 6 weeks
measure: Overall Complaint on 100 mm VAS-scale as Recorded by the Study Doctors
timeFrame: 12 weeks
measure: Overall Complaint on 100 mm VAS-scale as Recorded by the Study Doctors
timeFrame: 26 weeks
measure: Overall Complaint on 100 mm VAS-scale as Recorded by the Study Doctors
timeFrame: 52 weeks
measure: Pain Free Function Index of Everyday Activities
timeFrame: 6 weeks
measure: Pain Free Function Index of Everyday Activities
timeFrame: 12 weeks
measure: Pain Free Function Index of Everyday Activities
timeFrame: 26 weeks
measure: Pain Free Function Index of Everyday Activities
timeFrame: 52 weeks
measure: No Pain on Three Point Likert Scale on Dorsiflexion of Wrist
timeFrame: 6 weeks
measure: No Pain on Three Point Likert Scale on Dorsiflexion of Wrist
timeFrame: 12 weeks
measure: No Pain on Three Point Likert Scale on Dorsiflexion of Wrist
timeFrame: 26 weeks
measure: No Pain on Three Point Likert Scale on Dorsiflexion of Wrist
timeFrame: 52 weeks
measure: No Pain on Three Point Likert Scale on Isometric Extension of Third Finger
timeFrame: 6 weeks
measure: No Pain on Three Point Likert Scale on Isometric Extension of Third Finger
timeFrame: 12 weeks
measure: No Pain on Three Point Likert Scale on Isometric Extension of Third Finger
timeFrame: 26 weeks
measure: No Pain on Three Point Likert Scale on Isometric Extension of Third Finger
timeFrame: 52 weeks
Other outcomes:
Locations:
city: Sarpsborg
country: Norway
facility: Grålum legesenter
Study officials:
affiliation: University of Oslo
name: Morten Lindbaek, Ph. D.
role: STUDY_CHAIR
References:
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.
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.
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.