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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2012 by University of Oslo.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborator:
Allmennmedisinsk forskningsfond, Norway
Information provided by:
University of Oslo
ClinicalTrials.gov Identifier:
NCT00826462
First received: January 20, 2009
Last updated: June 22, 2012
Last verified: June 2012
  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

Resource links provided by NLM:


Further study details as provided by University of Oslo:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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:
  • Kenacort - T (triamcinolone)
  • Xylocaine (lidocaine)
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
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
    • 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00826462

Locations
Norway
Grålum legesenter
Sarpsborg, Norway, 1712
Sponsors and Collaborators
University of Oslo
Allmennmedisinsk forskningsfond, Norway
Investigators
Study Chair: Morten Lindbaek, Ph. D. University of Oslo
  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
Arm Injuries
Musculoskeletal Diseases
Wounds and Injuries
Lidocaine
Triamcinolone
Triamcinolone Acetonide
Triamcinolone diacetate
Triamcinolone hexacetonide
Anesthetics
Anesthetics, Local
Anti-Arrhythmia Agents
Anti-Inflammatory Agents
Cardiovascular Agents
Central Nervous System Agents
Central Nervous System Depressants
Enzyme Inhibitors
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Immunologic Factors
Immunosuppressive Agents
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Sensory System Agents
Sodium Channel Blockers
Therapeutic Uses

ClinicalTrials.gov processed this record on November 24, 2014