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

NCT00826462 | Completed Phase 4 Results

• 1 other identifier: 2006-002283-26
• Study Type: interventional
• Target: 177
• Locations: 1 country
• Sites: 1

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?

Conditions

Tennis Elbow; Epicondylitis, Lateral Humeral

Keywords

Randomised; Placebo-controlled; double blind; Intervention study; Primary health care

Outcome Measures

Primary Outcomes (1)

• Treatment Success - Event Rates in Each Group

  Unadjusted event rates of treatment success, defined as participants rating themselves 'much improved' or 'completely recovered' on a six point scale. Percentage with 99% confidence interval.

  6 - 52 weeks

Secondary Outcomes (32)

• Pain as Recorded by the Study Doctors on a Visual Analog Scale (VAS Scale)

  6 weeks

• Pain as Recorded by the Study Doctors on a 100 mm VAS-scale (Visual Analog Scale).

  12 weeks

• Pain as Recorded by the Study Doctors on a 100 mm VAS-scale (Visual Analog Scale).

  26 weeks

• Pain as Recorded by the Study Doctors on a 100 mm VAS-scale

  52 weeks

• Pain-free Grip Strength Ratio

  6 weeks

Study Arms (3)

1

EXPERIMENTAL

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; Drug: Lidocaine; Other: Physiotherapy; Drug: Naproxen

2

PLACEBO COMPARATOR

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; Drug: Lidocaine; Other: Physiotherapy; Drug: Naproxen

3

ACTIVE COMPARATOR

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

Drug: Naproxen

Interventions

triamcinolone DRUG

Injection with triamcinolone 10 mg at start and at 3 weeks

Also known as: Kenacort - T (triamcinolone), Xylocaine (lidocaine)

1

Placebo DRUG

Injection with sodium chloride at start and at 3 weeks

Also known as: Sodium chloride

2

Lidocaine DRUG

10 mg of lidocaine at start and at 3 weeks

Also known as: Xylocaine

1; 2

Physiotherapy OTHER

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

Also known as: Physical therapy

1; 2

Naproxen DRUG

Naproxen 500 mg bid for 14 days

Also known as: Naprosyn entero

1; 2; 3

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Oslo: lead
• Allmennmedisinsk forskningsfond, Norway: collaborator

Study Sites (1)

Grålum legesenter

Sarpsborg, 1712, Norway

Location

Related Publications (3)

• 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.

  PMID: 25989985 RESULT

• 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.

  PMID: 31421668 DERIVED

• 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.

  PMID: 19961603 DERIVED

MeSH Terms

Conditions

Tennis Elbow

Interventions

Triamcinolone; Lidocaine; Sodium Chloride; Physical Therapy Modalities; Naproxen

Condition Hierarchy (Ancestors)

Elbow Tendinopathy; Tendinopathy; Muscular Diseases; Musculoskeletal Diseases; Elbow Injuries; Arm Injuries; Wounds and Injuries; Tendon Injuries

Intervention Hierarchy (Ancestors)

Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated; Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds; Therapeutics; Rehabilitation; Naphthaleneacetic Acids; Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons

Limitations and Caveats

Strict inclusion criteria limit generalizability.The patients were not blinded to physiotherapy.Home exercises not logged.Only one physiotherapist.No individual adjustment of treatment. .We did not look specifically at recurrence rates.

Results Point of Contact

• Title: Professor Morten Lindbaek
• Organization: University of Oslo

morten.lindbak@medisin.uio.no

+47-22850646

Study Officials

• Morten Lindbaek, Ph. D.

  University of Oslo

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor Dr.med

Study Record Dates

• First Submitted: January 20, 2009
• First Posted: January 22, 2009
• Study Start: March 1, 2009
• Primary Completion: June 1, 2013
• Study Completion: June 1, 2013
• Last Updated: January 24, 2022
• Results First Posted: January 24, 2022

Record last verified: 2021-11

Data Sharing

• IPD Sharing: Will not share

Locations

NO (1)