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CompletedNCT03834090Updated Feb 7, 2019

Effectiveness of Radial Extracorporeal Shock Wave Therapy and Supervised Exercises in Lateral Epicondylitis

An interventional study of rESWT and Supervised exercises in Lateral Epicondylitis, sponsored by Istanbul University. Completed. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-02-07.

Sponsored by Istanbul University · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 3 years 11 months after the study started (first participant enrolled Feb 2015, registered Feb 2019).
Phase
Not applicable
Study type
Interventional
Enrollment
41
Allocation
Randomized
Ages
18 Years and older
Sex
All
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Study summary

No consensus has yet been built on the treatment of lateral epicondylitis (LE) due to the lack of evidence. Although conflicting results are present, radial extracorporeal shock wave therapy (rESWT) has increasingly been used in the treatment of tendinopathy

Read the detailed description

ESWT and exercise have beneficial effects on the management of tendinopathies owing to their various mechanisms that showed therapeutic efficacy. Owing to its positive outcomes, extracorporeal shock wave therapy (ESWT) has recently been used in the treatment of musculoskeletal system diseases such as plantar fasciitis, Achilles tendinopathy, calcific rotator cuff tendinopathies, and patellar tendinopathy

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Conditions studied

  • Lateral Epicondylitis

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03

In context

Tennis Elbow

284 studies on the registry are indexed under Tennis Elbow; 60 are open to participants now.

This study's enrollment of 41 is below the median of 50 across 253 interventional studies indexed under Tennis Elbow.

Browse Tennis Elbow studies →

Lead sponsor

Istanbul University is the lead sponsor of 496 studies on the registry; 79 are open to participants now.

Of its 5 completed or terminated interventional studies of FDA-regulated products, 1 (20%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • The diagnosis of LE was made in the clinical examination, and the diagnosis was confirmed with the Southampton Diagnostic Criteria of "the presence of epicondyle pain, and epicondyle pain and tenderness on resisted extension of the wrist.
  • Patients with symptoms lasting longer than 3 months
  • with average pain in the previous week detected as 3 or above on a 10-cm visual analogue scale (VAS)
  • who were aged over 18 years

Exclusion criteria

Exclusion Criteria:

  • pain in the proximal part of the affected extremity (e.g. shoulder pain, neck pain)
  • abnormal neurogenic symptoms (e.g. radicular pain, numbness) on the affected extremity
  • presence of posterior interosseous nerve entrapment
  • congenital or acquired upper extremity deformities that might affect grip strength
  • systemic musculoskeletal system or neurologic disorders
  • systemic rheumatologic disease or systemic infection
  • presence of malignancy, coagulation disorders, and anticoagulant use
  • inserted cardiac pacemaker
  • history of surgical treatment on the elbow of the affected extremity
  • pregnancy.
  • patients who were administered other treatments such as physical therapy or steroid injections in the last 3 months
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Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Investigator, Outcomes assessor)
Enrollment
41 participants (actual)

Study arms

  • Experimental
    rESWT

    the group receiving rESWT

    Device: rESWT

  • Active comparator
    supervised exercises

    the group receiving supervised exercises

    Other: Supervised exercises

Interventions

  • DevicerESWT

    rESWT was administered once per week for 3 weeks using a ShockMaster 500 device with 1.8 bar pneumatic pressure, 10 Hz frequency, with 2000 pulses.

  • OtherSupervised exercises

    A program including post-isometric relaxation, and progressive resistance exercise (eccentric wrist extension) on the wrist extensors

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What researchers measure

Primary outcomes

  1. Change Patient-rated Tennis Elbow Evaluation score

    The Patient-rated Tennis Elbow Evaluation is a specific questionnaire designed for the evaluation of the disease-specific pain and function/disability in LE. The scores were calculated separately and as the total PRTEE score, where 0 represented the best score, and 100 represented the worst score. The PRTEE consists of a pain scale with 5 items questioning pain during rest and specific activities (0 represents 'no pain' and 10 represents 'the highest pain'), and a function/disability scale with 10 items evaluating difficulties experienced during specific and daily activities (0 represents 'no difficulty' and 10 represents 'the highest difficulty)

    Time frame: Change from Baseline at 1 month and 3 months after treatment.

Secondary outcomes

  1. Change Visual Analogue Scale score

    The self-evaluation of pain severity during rest and activity in the previous week was calculated using a 10-cm VAS scale

    Time frame: Change from Baseline at 1 month and 3 months after treatment.

  2. Change Roles and Maudsley Score

    The Roles and Maudsley score was used to evaluate pain and activity limitation as classified in four categories: 1 point = excellent, "no pain, complete movement, and complete activity;" 2 points = good, "discomfort from time to time, complete movement, and complete activity;" 3 points = fair, "discomfort after long-duration activity;" and 4 points = poor, "pain that restricts activity".

    Time frame: Change from Baseline at 1 month and 3 months after treatment.

  3. Change Grip Strength score

    Grip strength of the affected upper extremity was calculated using a Hydraulic Hand Dynamometer

    Time frame: Change from Baseline at 1 month and 3 months after treatment.

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Study locations

No study locations are listed for this record.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 7, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT03834090
Lead sponsor
Istanbul University
Responsible party
MUSTAFA CORUM (Principal Investigator, Istanbul University) — Principal investigator
First posted
Feb 7, 2019
Start date
Feb 20, 2015
Primary completion
Aug 15, 2015
Completion
Jan 15, 2016
Last update
Feb 7, 2019

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Feb 2019. You cannot join it, but the record below documents what was studied.

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