Lateral EpicondylitisNCT03834090
Effectiveness of Radial Extracorporeal Shock Wave Therapy and Supervised Exercises in Lateral Epicondylitis
A study testing rESWT and Supervised exercises in people with Lateral Epicondylitis, run by Istanbul University.
Trial 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 more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lateral Epicondylitis
- What is being tested?
- rESWT and Supervised exercises
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 41 participants
- Where
- No sites listed yet
- Study dates
- 20 Feb 2015to 15 Jan 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 11Show fewer
- 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
About this study
Official title: Comparison of the Effectiveness of Radial Extracorporeal Shock Wave Therapy and Supervised Exercises in the Treatment of Lateral Epicondylitis: A Randomized Controlled Trial
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
- Conditions
- Lateral Epicondylitis
- Being tested
- rESWT, Supervised exercises
- Medical subject headings
- Tennis Elbow
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
rESWTDevice
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.
Supervised exercisesOther
A program including post-isometric relaxation, and progressive resistance exercise (eccentric wrist extension) on the wrist extensors
| Study group | Role | What they receive |
|---|---|---|
| rESWT | Experimental | the group receiving rESWT Receives: Device: rESWT |
| supervised exercises | Active comparator | the group receiving supervised exercises Receives: Other: Supervised exercises |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: Change from Baseline at 1 month and 3 months after treatment.
Secondary outcomes (3)
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
Measured: Change from Baseline at 1 month and 3 months after treatment.
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".
Measured: Change from Baseline at 1 month and 3 months after treatment.
Change Grip Strength score
Grip strength of the affected upper extremity was calculated using a Hydraulic Hand Dynamometer
Measured: Change from Baseline at 1 month and 3 months after treatment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Feb 2019
- Study start20 Feb 2015
- Primary completion15 Aug 2015
- Study completion15 Jan 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lateral EpicondylitisStudies of the same condition, open and under way.
- More trials run by Istanbul UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 41 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istanbul University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, MUSTAFA CORUM, Istanbul University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03834090
- Sponsor's protocol ID
- 2015/369
- Status last verified
- Feb 2019
- First submitted
- 5 Feb 2019
- Last updated
- 7 Feb 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Effectiveness of Radial Extracorporeal Shock Wave Therapy and Supervised Exercises in the Treatment of Lateral Epicondylitis: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03834090
- Acronym / sponsor ID
- 2015/369
- Conditions
- Lateral Epicondylitis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 41 participants (actual)
- Lead sponsor
- Istanbul UniversityUniversity, hospital or other
- Study start
- 20 Feb 2015 (actual)
- Primary completion
- 15 Aug 2015 (actual)
- Study completion
- 15 Jan 2016 (actual)
- First posted
- 7 Feb 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| rESWT | Experimental | Device: rESWTthe group receiving rESWT |
| supervised exercises | Active comparator | Other: Supervised exercisesthe group receiving supervised exercises |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| rESWTrESWT 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. | Device | rESWT |
| Supervised exercisesA program including post-isometric relaxation, and progressive resistance exercise (eccentric wrist extension) on the wrist extensors | Other | supervised exercises |
Primary outcome
Change Patient-rated Tennis Elbow Evaluation score
Time frame: Change from Baseline at 1 month and 3 months after treatment.
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)
3 secondary outcomes
Change Visual Analogue Scale score
Time frame: Change from Baseline at 1 month and 3 months after treatment.
Change Roles and Maudsley Score
Time frame: Change from Baseline at 1 month and 3 months after treatment.
Change Grip Strength score
Time frame: Change from Baseline at 1 month and 3 months after treatment.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Feb 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing rESWT and Supervised exercises in people with Lateral Epicondylitis, run by Istanbul University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change Patient-rated Tennis Elbow Evaluation score (time frame: Change from Baseline at 1 month and 3 months after treatment.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Feb 2019.