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

NCT ID: NCT00826462

Last Updated: 2022-01-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 177 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-03-31
• Study Completion Date: 2013-06-30

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.

Conditions

Tennis Elbow; Epicondylitis, Lateral Humeral

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: FACTORIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

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

Group Type: EXPERIMENTAL

triamcinolone

Intervention Type: DRUG

Injection with triamcinolone 10 mg at start and at 3 weeks

Lidocaine

Intervention Type: DRUG

10 mg of lidocaine at start and at 3 weeks

Physiotherapy

Intervention Type: OTHER

12 treatments with deep friction massage, Mill's manipulation, soft tissue treatment and home exercises

Naproxen

Intervention Type: DRUG

Naproxen 500 mg bid for 14 days

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

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Injection with sodium chloride at start and at 3 weeks

Lidocaine

Intervention Type: DRUG

10 mg of lidocaine at start and at 3 weeks

Physiotherapy

Intervention Type: OTHER

12 treatments with deep friction massage, Mill's manipulation, soft tissue treatment and home exercises

Naproxen

Intervention Type: DRUG

Naproxen 500 mg bid for 14 days

3

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

Group Type: ACTIVE_COMPARATOR

Naproxen

Intervention Type: DRUG

Naproxen 500 mg bid for 14 days

Interventions

triamcinolone

Injection with triamcinolone 10 mg at start and at 3 weeks

Intervention Type: DRUG

Placebo

Injection with sodium chloride at start and at 3 weeks

Intervention Type: DRUG

Lidocaine

10 mg of lidocaine at start and at 3 weeks

Intervention Type: DRUG

Physiotherapy

12 treatments with deep friction massage, Mill's manipulation, soft tissue treatment and home exercises

Intervention Type: OTHER

Naproxen

Naproxen 500 mg bid for 14 days

Intervention Type: DRUG

Other Intervention Names

Kenacort - T (triamcinolone); Xylocaine (lidocaine); Sodium chloride; Xylocaine; Physical therapy; Naprosyn entero

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Allmennmedisinsk forskningsfond, Norway

UNKNOWN

Sponsor Role: collaborator

University of Oslo

OTHER

Sponsor Role: lead

Responsible Party

Morten Lindbaek

Professor Dr.med

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Morten Lindbaek, Ph. D.

Role: STUDY_CHAIR

University of Oslo

Locations

Grålum legesenter

Sarpsborg, , Norway

Countries

Norway

References

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.

Reference Type: RESULT

PMID: 25989985 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 31421668 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 19961603 (View on PubMed)

Other Identifiers

2006-002283-26

Identifier Type: -

Identifier Source: org_study_id