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Completed

NCT Number: NCT02596659

Effectiveness of Radial Extracorporeal Shockwave Therapy on Tennis Elbow

Background:

Tennis elbow, also known as lateral epicondylitis, is the inflammatory status of insertion site of common extensor tendon to humerus. It is usually related to overuse of local muscle. Radial extracorporeal shock wave therapy (rESWT) is a non-invasive physical treatment. It applies shockwave energy to the lesion site, enhancing the growth of microvascularity, inducing tissue repair, and thus relieving the symptom.

The purpose of this study is to understand the therapeutic effect of rESWT to tennis elbow.

Material and Methods

* Subjects: 30 patients will be recruited from outpatient department of physical medicine and rehabilitation department. * Duration: 2013.09.01-2015.05.31 * Methods: The patients will be randomly divided into the experimental group and the control group through the draw, with 15 patients in each group. Patients in the experimental group receive rESWT plus routine rehabilitation program. Patients in the control group receive sham shockwave therapy plus routine rehabilitation program. * Assessment: Before the therapy starts, patients who match the inclusion criteria will be evaluated using tools mentioned below: * General data: age, sex, body height, body weight, affected side, medical history * Assess upper extremity function and symptom with Disabilities of the Arm, Shoulder and Hand Questionnaire (DASH) * Assess severity of pain with Visual Analogue Scale (VAS) * Assess grip strength with grip strength dynamometer * Measure the size of tear (if any) of common extensor tendon through ultrasonography, and assess the texture of common extensor tendon through real-time sonoelastography (RTS)

Patients will be followed up 6 weeks, 3months, and 6 months after therapy starts. They will be re-assessed of upper extremity function and symptom, severity of pain, grip strength, and presentation on ultrasonography and RTS.

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Key information

Conditions

Lateral Epicondylosis Arm Injuries Elbow Injuries Elbow Tendinopathy Lateral Epicondylitis Muscular Diseases Musculoskeletal Diseases Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms Tendinopathy Tendon Injuries Tennis Elbow Wounds and Injuries

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Physical Medicine and Rehabilitation, Kaohsiung Chang Gung Memorial Hospital

Kaohsiung City, 833, Taiwan

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Aged > 18 years old
  • Lateral elbow pain lasting > 3 months
  • Pain induced by direct compression on the lateral epicondyle or common extensor tendon, resistant wrist extension and pronation in the elbow extension position, or static stretching of common extensor tendon through the palmer flexion in wrist pronation and elbow extension position

Exclusion criteria

  • Generalized inflammatory arthritis (e.g., rheumatic arthritis)
  • Pain at the proximal part of involved arm (e.g., shoulder pain, neck pain)
  • Pain other than elbow pain at the involved arm
  • Abnormal neurogenic symptom over the involved arm (e.g., radicular pain, hands numbness, hemiplegia)
  • Wound or skin lesion at the elbow of the involved arm
  • Pregnancy
  • Severe local or systemic infection
  • Malignancy
  • Coagulopathy
  • Cardiac pacemaker
  • History of surgical treatment at the elbow of the involved arm
  • Non-steroid anti-inflammatory drug (NSAID) use orally or topically at the elbow of the involved arm in the past week
  • Local steroid injection at the elbow of the involved arm in the past 3 months
  • Oral steroid use in the past 6 weeks
  • Refusal to sign the informed consent
  • Impairment in self-expression (e.g., dementia, aphasia)
  • Inability/unwillingness to participate in all the measurements.

Treatment and study plan

Radial extracorporeal shock wave therapy (rESWT)

Procedure

Each participant in the experimental group received rESWT for 3 sessions, consisting of 2000 impulses for each session, and one session per week over 3 weeks (a total of 6000 shock waves were given). The pneumatic pressure was set at the maximum level tolerable for each patient. The frequency of pulses was set at 10 Hz.

sham shockwave therapy

Procedure

Sham shockwave therapy were given by the same physiatrist using the same machine as the experimental group, with the same rESWT protocol (3 sessions, 2000 impulses for each session, one session per week over 3 weeks) and the same frequency (10 Hz) of impulses, but the pneumatic pressure was set at 0.1 bar, with a similar sound to the regular rESWT but without actual energy conduction.

physical therapy

Procedure

The physical therapy program was performed 3 times a week over the same 3 weeks as rESWT, and consisted of 5 minutes of ultrasound diathermy, 15 minutes of transcutaneous electrical nerve stimulation (TENS), and 10 minutes of therapeutic exercise, including wrist common extensor stretching and self-massage.

Primary outcomes

  1. Changes in pain intensity

    Time frame: At baseline, 6 weeks, 12 weeks and 24 weeks

    Participants were asked to rate their present pain intensity, as caused by the tennis elbow, from 0-10 using the Visual Analogue Scale (VAS). If participants had bilateral tennis elbow, the side with the worse pain intensity was chosen for the assessment.

  2. Changes in grip strength

    Time frame: At baseline, 6 weeks, 12 weeks and 24 weeks

    Maximal grip strength of the involved arm was assessed using a grip strength dynamometer. Participants were asked to grip the dynamometer 3 times, at 15- second rest intervals, and the highest grip strength number was recorded.

  3. Changes in upper limb function

    Time frame: At baseline, 6 weeks, 12 weeks and 24 weeks

    Upper extremity disability and symptoms were assessed using the Taiwan version Disabilities of the Arm, Shoulder, and Hand (DASH) questionnaire.

  4. Changes in stiffness of common extensor tendon

    Time frame: At baseline, 6 weeks, 12 weeks and 24 weeks

    The changes in stiffness of common extensor tendon were assessed with sonoelastography. The images of sonoelastography were interpreted with the modified RTS scoring system and analyzed with color histogram.

Secondary outcomes

  1. Changes in size of tear within common extensor tendon

    Time frame: At baseline, 6 weeks, 12 weeks and 24 weeks

    On the 2-D image, the common extensor tendon was located. If there was tear within common extensor tendon, diameters in the 3-D dimension were measured and the size of the tear was calculated as a spheroid.

Sponsors and collaborators

Lead sponsor

Chang Gung Memorial Hospital

Other

Registry information

Important dates

Study start
2013
Primary completion
2015
Study completion
2015
First posted
Nov 4, 2015
Registry last updated
Nov 4, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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