Botulinum Toxin Versus Active Strength Training in the Treatment of Lateral Epicondylitis

NCT00930709 | Completed

• 2 other identifiers: EVO11222009-009837-14
• Study Type: interventional
• Target: 103
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to compare efficacy, feasibility and cost effectiveness of botulinum toxin type A injections to active nine weeks strength training and stretching program in the treatment of the chronic lateral epicondylitis. The main hypothesis is that the botulinum toxin type A injections may enable more rapid pain relief while strength training may provide better functional results and less relapses during the follow-up.

Conditions

Epicondylitis, Lateral Humeral; Tennis Elbow

Keywords

Botulinum Toxin Type A; Exercise; Randomized Controlled Trial; Muscle Stretching Exercises; Strength Training; Treatment Outcome

Outcome Measures

Primary Outcomes (2)

• Pain, 100 mm visual analogue scale, change from baseline

  0, 6, 13, 26, 39, 52 weeks

• Grip strength (pain free and maximal), hydraulic hand dynamometer, change from baseline

  0, 6, 13, 26, 39, 52 weeks

Secondary Outcomes (7)

• Experienced disability, 100 mm visual analogue scale, change from baseline

  0, 6, 13, 26, 39, 52 weeks

• Isometric wrist extension and flexion strength, digital hanging scale with rigid bench frame, change from baseline

  0, 6, 13, 26, 39, 52 weeks

• Treatment adverse effects

  0, 6, 13, 26, 39, 52 weeks

• Economic evaluation of interventions, direct and indirect costs

  0, 6, 13, 26, 39, 52 weeks

• Days in sick leave

  0, 6, 13, 26, 39, 52 weeks

Study Arms (2)

Active strength training and stretching

ACTIVE COMPARATOR

Active strength training and stretching

Behavioral: Active strength training and stretching

Botulinum toxin type A injections

ACTIVE COMPARATOR

Botulinum toxin type A injections

Drug: Botulinum toxin type A (Botox®, Allergan)

Interventions

Botulinum toxin type A (Botox®, Allergan) DRUG

Two injections of 10-60 units of botulinum toxin type A. Injections are administered with ENMG assisted technique at the baseline and after 13 weeks.

Also known as: Botox®, Allergan, NDC 0023-1145-01

Botulinum toxin type A injections

Active strength training and stretching BEHAVIORAL

Training duration 9 weeks, intensified every 3 weeks in supervision of physiotherapist. Training program includes progressive, slow, repetitive wrist and forearm stretching, eccentric muscle strengthening, occupational exercises and upper limb neural mobilization training.

Also known as: Eccentric strength training

Active strength training and stretching

Eligibility Criteria

• Age: 20 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• pain at the lateral side of the elbow over 3 months
• local tenderness on palpation over the lateral epicondyle
• positive Mill's sign
• lateral elbow pain progression on resisted wrist and/or middle finger extension
• involved in working life

You may not qualify if:

• bilateral symptoms or simultaneous medial epicondylitis
• verified or suspected cervical radiculopathy or affected limb neuropathy
• congenital or acquired deformities of the elbow
• previous surgery of the elbow
• infection, dislocation, tendon ruptures, or fractures in the area
• systemic musculoskeletal or neurological disorders, incl. rheumatic diseases and fibromyalgia
• allergy, antibodies or other contraindications for botulinum toxin
• severe depression, chronic pain syndrome or somatisation disorder
• ongoing retirement process
• pregnancy or breastfeeding
• current participation in other clinical trials

Sponsors & Collaborators

• Seinajoki Central Hospital: lead

Study Sites (1)

Department of Physical medicine and Rehabilitation, Seinäjoki Central Hospital

Seinäjoki, 60220, Finland

Location

Related Links

• Seinäjoki Central Hospital homepage

MeSH Terms

Conditions

Tennis Elbow; Motor Activity

Interventions

Botulinum Toxins, Type A

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Botulinum Toxins; Metalloendopeptidases; Endopeptidases; Peptide Hydrolases; Hydrolases; Enzymes; Enzymes and Coenzymes; Metalloproteases; Bacterial Proteins; Proteins; Amino Acids, Peptides, and Proteins; Bacterial Toxins; Toxins, Biological; Biological Factors

Study Officials

• Aki Vainionpää, M.D., Ph.D.

  Department of Physical Medicine and Rehabilitation, Seinäjoki Central Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Specialist in Physical Medicine and Rehabilitation

Study Record Dates

• First Submitted: June 29, 2009
• First Posted: June 30, 2009
• Study Start: March 1, 2009
• Primary Completion: December 1, 2014
• Study Completion: December 1, 2014
• Last Updated: December 31, 2014

Record last verified: 2014-12

Locations

FI (1)