Tennis ElbowNCT04187287
Comparison of Two Different Treatment Effects on Individuals With Chronic Lateral Epicondylitis
A study testing Radial Extracorporeal Shock Wave Therapy and Deep Friction Massage in people with Tennis Elbow and Lateral Epicondylitis, run by Eastern Mediterranean University at 1 site in Cyprus.
Trial summary
The aim of this study is to compare the effects of Radial Extracorporeal Shockwave Therapy (rESWT) treatment and Deep Friction Massage (DFM) treatment on pain, functionality, grip strength (GS), edema, range of motion (ROM) of the elbow and quality of life in individuals with chronic lateral epicondylitis (CLE). Read more about this study
- Who is it for?
- Ages 20 to 66 yearsHealthy volunteers can take part
- Conditions the study is for
- Tennis Elbow, Lateral Epicondylitis, Tendinopathy
- What is being tested?
- Radial Extracorporeal Shock Wave Therapy and Deep Friction Massage
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteCyprus
- Study dates
- 9 Dec 2019to 31 Jan 2020
- 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 20 to 66 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Individuals with pain on the lateral epicondyle or proximal musculotendinous area of the forearm extensor muscles for at least 3 months,
- Individuals with a positive Thomsen Test ,
- Individuals who have not received physical therapy for lateral epicondylitis,
- Individuals with a positive Maudsley Test will be included.
Who cannot join
- Individuals who have received any physical therapy,
- Individuals with reflected pain due to cervical and shoulder pathologies,
- Individuals with elbow osteoarthritis,
- Individuals with previous elbow fractures or elbow joint operations,
- Individuals with a history of systemic inflammatory disease,
- Individuals with osteoporosis,
- Individuals with cardiovascular problems will not be included in the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of Effects of Radial Extracorporeal Shock Wave Therapy and Deep Friction Massage on Individuals With Chronic Lateral Epicondylitis
The aim of this study is to compare the effects of Radial Extracorporeal Shockwave Therapy (rESWT) treatment and Deep Friction Massage (DFM) treatment on pain, functionality, grip strength (GS), edema, range of motion (ROM) of the elbow and quality of life in individuals with chronic lateral epicondylitis (CLE).
36 individuals diagnosed with CLE will be randomly divided into two equal groups. rESWT treatment will be applied to Group 1 and DFM treatment to Group 2. Visual analogue scale will be used to assess pain severity, functionality with Patient-Rated Elbow Evaluation Turkish version (PRTEE-T), GS with digital dynamometer, ROM of the elbow joint with goniometer, edema with environmental measurement, and quality of life with Short Form 36 (SF-36).
- Conditions
- Tennis Elbow, Lateral Epicondylitis, Tendinopathy
- Being tested
- Radial Extracorporeal Shock Wave Therapy, Deep Friction Massage
- Medical subject headings
- Tennis Elbow, Tendinopathy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Radial Extracorporeal Shock Wave TherapyOther
Radial Extracorporeal Shock Wave Therapy will given for 3 weeks, 1 days in a week. moreover 10-12 minutes cold pack will apply for every session
Deep Friction MassageOther
Deep Friction Massage will given for 3 weeks, 3 days in a week. Massage duration will be 10-15 min. for each session. Moreover 10-12 minutes cold pack will apply for every session. Also Mill's manipulation technique will applied once a week during 3 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Radial Extracorporeal Shock Wave Therapy | Active comparator | Radial Extracorporeal Shock Wave Therapy will be given for 3 weeks, 1 days in a week. Moreover 10-12 minutes cold pack will apply for every session. Receives: Other: Radial Extracorporeal Shock Wave Therapy |
| Deep Friction Massage | Active comparator | Deep Friction Massage treatment will be given for 3 weeks, 3 days in a week. Massage duration will be 10-15 min. for each session. Moreover 10-12 minutes cold pack will apply for every session. Also Mill's manipulation technique will applied once a week during 3 weeks. Receives: Other: Deep Friction Massage |
What is being measured
The primary outcome is the main question the study is designed to answer.
Elbow and Forearm Pain
will assessed using by visual analog scale
Measured: Change from Baseline elbow and forearm pain at 3 weeks
Secondary outcomes (5)
Functionality
will assessed using by Patient-Rated Tennis Elbow Evaluation Questionnaire
Measured: Change from baseline functionality at 3 weeks
Grip Strength
will assessed using by hand grip
Measured: Change from baseline grip strength at 3 weeks
Change in the level of elbow and forearm edema
Elbow and forearm circumference area will be measured by using a tape measure.
Measured: Change from baseline edema at 3 weeks
Range of motion of elbow joint
will evaluated using by goniometer
Measured: Change from baseline range of motion at 3 weeks
Change in the level of quality of life
will evaluated using by short form 36
Measured: Change from baseline quality of life level at 3 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2019
- Study start9 Dec 2019
- Primary completion22 Jan 2020
- Study completion31 Jan 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tennis ElbowStudies of the same condition, open and under way.
- 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
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eastern Mediterranean University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Berkiye Kırmızıgil, Eastern Mediterranean University
- Investigators
- Ozge Gokalp, Asst. Prof, Study director, Eastern Mediterranean University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04187287
- Sponsor's protocol ID
- 2017/48-01
- Status last verified
- Jan 2020
- First submitted
- 29 Nov 2019
- Last updated
- 5 Feb 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Effects of Radial Extracorporeal Shock Wave Therapy and Deep Friction Massage on Individuals With Chronic Lateral Epicondylitis
- ClinicalTrials.gov ID
- NCT04187287
- Acronym / sponsor ID
- 2017/48-01
- Conditions
- Tennis Elbow, Lateral Epicondylitis, Tendinopathy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Eastern Mediterranean UniversityUniversity, hospital or other
- Study start
- 9 Dec 2019 (actual)
- Primary completion
- 22 Jan 2020 (actual)
- Study completion
- 31 Jan 2020 (actual)
- First posted
- 5 Dec 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.
The aim of this study is to compare the effects of Radial Extracorporeal Shockwave Therapy (rESWT) treatment and Deep Friction Massage (DFM) treatment on pain, functionality, grip strength (GS), edema, range of motion (ROM) of the elbow and quality of life in individuals with chronic lateral epicondylitis (CLE).
36 individuals diagnosed with CLE will be randomly divided into two equal groups. rESWT treatment will be applied to Group 1 and DFM treatment to Group 2. Visual analogue scale will be used to assess pain severity, functionality with Patient-Rated Elbow Evaluation Turkish version (PRTEE-T), GS with digital dynamometer, ROM of the elbow joint with goniometer, edema with environmental measurement, and quality of life with Short Form 36 (SF-36).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Radial Extracorporeal Shock Wave Therapy | Active comparator | Other: Radial Extracorporeal Shock Wave TherapyRadial Extracorporeal Shock Wave Therapy will be given for 3 weeks, 1 days in a week. Moreover 10-12 minutes cold pack will apply for every session. |
| Deep Friction Massage | Active comparator | Other: Deep Friction MassageDeep Friction Massage treatment will be given for 3 weeks, 3 days in a week. Massage duration will be 10-15 min. for each session. Moreover 10-12 minutes cold pack will apply for every session. Also Mill's manipulation technique will applied once a week during 3 weeks. |
Who may qualify
- Ages
- 20 to 66 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Individuals with pain on the lateral epicondyle or proximal musculotendinous area of the forearm extensor muscles for at least 3 months,
- Individuals with a positive Thomsen Test ,
- Individuals with a positive Maudsley Test will be included.
Key exclusion criteria (7 listed)
- Individuals who have received any physical therapy,
- Individuals with reflected pain due to cervical and shoulder pathologies,
- Individuals with elbow osteoarthritis,
- Individuals with previous elbow fractures or elbow joint operations,
- Individuals with a history of systemic inflammatory disease,
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 |
|---|---|---|
| Radial Extracorporeal Shock Wave TherapyRadial Extracorporeal Shock Wave Therapy will given for 3 weeks, 1 days in a week. moreover 10-12 minutes cold pack will apply for every session | Other | Radial Extracorporeal Shock Wave Therapy |
| Deep Friction MassageDeep Friction Massage will given for 3 weeks, 3 days in a week. Massage duration will be 10-15 min. for each session. Moreover 10-12 minutes cold pack will apply for every session. Also Mill's manipulation technique will applied once a week during 3 weeks. | Other | Deep Friction Massage |
Primary outcome
Elbow and Forearm Pain
Time frame: Change from Baseline elbow and forearm pain at 3 weeks
will assessed using by visual analog scale
5 secondary outcomes
Functionality
Time frame: Change from baseline functionality at 3 weeks
Grip Strength
Time frame: Change from baseline grip strength at 3 weeks
Change in the level of elbow and forearm edema
Time frame: Change from baseline edema at 3 weeks
Range of motion of elbow joint
Time frame: Change from baseline range of motion at 3 weeks
Change in the level of quality of life
Time frame: Change from baseline quality of life level at 3 weeks
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 5 Feb 2020.
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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.
Ozge Gokalp, Asst. Prof study director
Eastern Mediterranean University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Radial Extracorporeal Shock Wave Therapy and Deep Friction Massage in people with Tennis Elbow and Lateral Epicondylitis, run by Eastern Mediterranean University at 1 site in Cyprus.
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 7 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 5 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Cyprus. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Elbow and Forearm Pain (time frame: Change from Baseline elbow and forearm pain at 3 weeks). 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 5 Feb 2020.