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Lateral EpicondylitisNCT06189521

Lateral Epicondylitis Extracorporeal Shock Wave Therapy, Ultrasound Iontophoresis

A study testing Extracorporeal shock wave group, ultrasound group and dexamethasone iontophoresis group in people with Lateral Epicondylitis, run by Pınar Özge Başaran at 1 site in Turkey (Türkiye).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Lateral epicondylitis (LE) is one of the most common causes of non-traumatic elbow pain, which develops as a result of repetitive stresses due to overuse of the forearm muscles, and is also called tennis elbow.Conservative treatment options include electrotherapy, exercises, extracorporeal shock wave therapy (ESWT)… Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Lateral Epicondylitis
What is being tested?
Extracorporeal shock wave group, ultrasound group and dexamethasone iontophoresis group
Could I receive a placebo?
No, everyone receives an active treatment
How many people
78 participants
Where
1 siteTurkey (Türkiye)
Study dates
14 Jun 2023to 1 Dec 2023
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 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patients who had pain at the lateral epicondyle at least for four weeks,
  • detection of sensitivity by palpation on the lateral epicondyle and
  • having positivity in at least two of the special tests (Cozen test, Maudsley test and Mills test) were included in the study

Who cannot join

  • Physical therapy, ESWT or local injections for lateral epicondylitis within the last 3 months,
  • the presence of cervical radiculopathy, carpal tunnel syndrome, other neuropathic diseases, neurologic diseases, medial epicondylitis, systemic inflammatory diseases, --
  • tenderness or swelling at the ipsilateral extremity and
  • patients with fibromyalgia have been excluded.

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site
  • Hitit University

    Çorum, 19040

Other trials in Turkey (Türkiye)

About this study

Official title: Comparison of Extracorporeal Shock Wave Therapy, Ultrasound and Dexamethasone Iontophoresis in Patients With Lateral Epicondylitis

Lateral epicondylitis (LE) is one of the most common causes of non-traumatic elbow pain, which develops as a result of repetitive stresses due to overuse of the forearm muscles, and is also called tennis elbow.Conservative treatment options include electrotherapy, exercises, extracorporeal shock wave therapy (ESWT), steroid injections, platelet rich plasma, hyaluronic acid injections. As our knowledge this is the first study comparing the three different treatment modalities ESWT, Us and Iontophoresis on lateral epicondylitis The aim of our study; to evaluate the efficacy of ESWT, ultrasound and iontophoresis treatments in terms of pain, grip strength, functionality and quality of life in patients with lateral epicondylitis and to determine the superiority of the treatments against each other.

Read the detailed description

This is a prospective randomized single blind clinical study. A total of 78 patients age between 18-65 who were diagnosed with lateral epicondylitis between June 2023 and December 2023 were included in our study. The study was approved by the University Ethics Committee (2023-77) and written informed consent was obtained from all the patients. The study was carried out in accordance with the principles of the Declaration of Helsinki.

Patients who had pain at the lateral epicondyle at least for four weeks, detection of sensitivity by palpation on the lateral epicondyle and having positivity in at least two of the special tests (Cozen test, Maudsley test and Mills test) were included in the study. Physical therapy, ESWT or local injections for lateral epicondylitis within the last 3 months, the presence of cervical radiculopathy, carpal tunnel syndrome, other neuropathic diseases, neurologic diseases, medial epicondylitis, systemic inflammatory diseases, tenderness or swelling at the ipsilateral extremity and fibromyalgia have been excluded.

Patients were randomized into three groups by a physiotherapist with sealed envelopes. The researchers were blinded to the patient's groups. The same physiotherapy program was applied to all groups. The physiotherapy program consisted of hot packs and transcutaneus electrical nerve stimulation (TENS) for 10 minutes and stretching and eccentric strengthening exercises were given to all groups. All exercises were done under the supervision of the same physiotherapist.

In addition to the ten-day of physiotherapy program, in the first group one day for a week a total of 3 sessions of ESWT was applied at 1.8 bar, 10.0 Hz, 2000 beats (Elmed Vibrolith Ortho).

In the second group, ten days of ultrasound applied at 1.5 watt/cm2, continuous mode to the painful area for 5 minutes, 5 days a week for two weeks (Chattanooga Intelect Advanced).

In the third group ten days of dexamethasone iontophoresis therapy was applied. 10 days for 10 minutes. 0,1% dexamethasone ophthalmic pomade was applied to the anodal electrode and placed on the lateral epicondyle and 0.1-0.2 milliampere/cm2 galvanic current was applied in each session (ES-522; ITO Physiotherapy and Rehabilitation).

Evaluations were conducted at before treatment and one month after treatment in all groups by the same researchers who were blind in treatment groups.

The clinical and demographic data of the patients were recorded. Numerical Rating Scale (NRS) was used for the pain assessment. The NRS is a subjective measure in which individuals rate their pain on an eleven-point numerical scale. The scale is composed of 0 (no pain at all) to 10 (worst imaginable pain). It has been shown that a composite scoring system including best, worse, and current level of pain over the last 24 hours was sufficient to pick up changes in pain intensity with maximal reliability(Jensen et al 1999).

The hand grip strength (HGS) was measured with a Jamar hydraulic hand dynamometer (Saehan, SH5001)) in kilograms. This instrument has a closed hydraulic system that measures the amount of grip strength produced by an isometric contraction applied to the handles and the grip strength of the hand is registered in kilograms Hand and pinch strength were measured by hydraulic pinch gauge (Saehan, SH5005) This instrument has also a closed hydraulic system that measures the amount of grip strength produced by an isometric contraction applied to the handles and the pinc strength of the hand is registered in kilograms Upper extremity disability levels were assessed with Quick Disabilities of the Arm, Shoulder and Hand (QuickDASH). The Quick-DASH is an 11-item that measures upper extremity activity limitation and symptoms . Items were scored from 1: indicating no functional limitation and no symptoms, to 5: indicating functional inability and extreme symptoms. The totalscore was computed by transforming the mean items score to a scale from 0 to 100, where 0 indicates the best upper extremity function and no symptoms. Turkish version of the test was evaluated.

Quality of life was measured by notthingham health profile (NHP). Scale, 6 dimensions, total It consists of 38 items. Sub-dimensions: Energy (3 items), pain (8 items), emotional status (9 items), sleep (5 items),social isolation (5 items) and physical activity (8 items). Its range is 0-100is scored. As the score increases health status gets worse. The validity and reliability of the Turkish version of the test was evaluated.

In the study power analysis performed by examining the related studies in the literature and the sample size required to obtain a significant result was calculated as totally 76 patients, 26 patients in each group (G-Power v3.1.9.7). All data were analysed using the Windows 15.0 Statistical Package for Social Sciences (SPSS Inc., Chicago, IL, USA). Fisher Exact and Chi-square tests were used to determine the differences between proportions or relationships between categorical variables. Paired Sample T-test was used to compare measurements at multiple different times in the same individuals. The Student's t-test was used when the data were normally distributed, the Wilcoxon signed rank test was used for intragroup comparisons and the Mann Whitney U test was used for intergroup comparisons when the data were not normally distributed.

Being tested
Extracorporeal shock wave group, ultrasound group, dexamethasone iontophoresis group
Medical subject headings
Tennis Elbow

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Extracorporeal shock wave groupOther

    In addition to the ten-day of physiotherapy program, in the first group one day for a week a total of 3 sessions of ESWT was applied at 1.8 bar, 10.0 Hz, 2000 beats (Elmed Vibrolith Ortho).

  • ultrasound groupOther

    In addition to the ten-day of physiotherapy program,In the second group, ten days of ultrasound applied at 1.5 watt/cm2 continuous mode to the painful area for 5 minutes, 5 days a week for two weeks (Chattanooga Intelect Advanced).

  • dexamethasone iontophoresis groupOther

    In addition to the ten-day of physiotherapy program, In the third group ten days of dexamethasone iontophoresis therapy was applied. 10 days for 10 minutes. 0,1% dexamethasone ophthalmic pomade was applied to the anodal electrode and placed on the lateral epicondyle and 0.1-0.2 milliampere/cm2 galvanic current was applied in each session (ES-522; ITO Physiotherapy and Rehabilitation).

Study groups in NCT06189521
Study groupRoleWhat they receive
Extracorporeal shock wave groupActive comparatorPatients were randomized into three groups by a physiotherapist with sealed envelopes. The researchers were blinded to the patient's groups. The same physiotherapy program was applied to all groups. The physiotherapy program consisted of hot packs and TENS for 10 minutes and stretching and eccentric strengthening exercises were given to all groups. All exercises were done under the supervision of the same physiotherapist. In addition to the ten-day of physiotherapy program, in the first group one day for a week a total of 3 sessions of ESWT was applied at 1.8 bar, 10.0 Hz, 2000 beats (Elmed Vibrolith Ortho).
Receives: Other: Extracorporeal shock wave group
ultrasound groupActive comparatorIn addition to the ten-day of physiotherapy program, in the second group, ten days of ultrasound applied at 1.5 watt/cm2, continuous mode to the painful area for 5 minutes, 5 days a week for two weeks (Chattanooga Intelect Advanced).
Receives: Other: ultrasound group
dexamethasone iontophoresis groupActive comparatorIn addition to the ten-day of physiotherapy program, in the third group ten days of dexamethasone iontophoresis therapy was applied. 10 days for 10 minutes. 0,1% dexamethasone ophthalmic pomade was applied to the anodal electrode and placed on the lateral epicondyle and 0.1-0.2 milliampere/cm2 galvanic current was applied in each session (ES-522; ITO Physiotherapy and Rehabilitation).
Receives: Other: dexamethasone iontophoresis group

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Evaluate the efficacy of ESWT, ultrasound and iontophoresis treatments in term of pain

    Investigators aimed to evaluate the efficacy of ESWT, ultrasound and iontophoresis treatments in terms of pain, grip strength, functionality and quality of life in patients with lateral epicondylitis.

    Numerical Rating Scale (NRS) was used for the pain assessment The NRS is a subjective measure in which individuals rate their pain on an eleven-point numerical scale. The scale is composed of 0 (no pain at all) to 10 (worst imaginable pain).

    Measured: 6 months from June 2023 to December 2023

  2. Evaluate the efficacy of ESWT, ultrasound and iontophoresis treatments in terms of disability

    Upper extremity disability levels were assessed with Quick Disabilities of the Arm, Shoulder and Hand questionnaire The Quick-DASH is an 11-item that measures upper extremity activity limitation and symptoms . Items were scored from 1: indicating no functional limitation and no symptoms, to 5: indicating functional inability and extreme symptoms. The tota lscore was computed by transforming the mean items score to a scale from 0 to 100, where 0 indicates the best upper extremity function and no symptoms. Turkish version of the test was evaluated.

    Quality of life was measured by notthingham health profile (NHP) questionaireQuality of life was measured by notthingham health profile (NHP). Scale, 6 dimensions, total It consists of 38 items. Sub-dimensions: Energy (3 items), pain (8 items), emotional status (9 items), sleep (5 items),social isolation (5 items) and physical activity (8 items). Its range is 0-100is scored. As the score increases health status gets worse.

    Measured: 6 months from June 2023 to December 2023

Secondary outcomes (1)
  1. Evaluate the efficacy of ESWT, ultrasound and iontophoresis treatments in terms of strength

    Investigators aimed to evaluate the efficacy of ESWT, ultrasound and iontophoresis treatments in terms of grip strength, The hand grip strength (HGS) was measured with a Jamar hydraulic hand dynamometer .This instrument has a closed hydraulic system that measures the amount of grip strength produced by an isometric contraction applied to the handles and the grip strength of the hand is registered in kilograms.

    Hand and pinch strength were measured by hydraulic pinch gauge.This instrument has also a closed hydraulic system that measures the amount of grip strength produced by an isometric contraction applied to the handles and the pinc strength of the hand is registered in kilograms.

    Measured: 6 months from June 2023 to December 2023

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 Jan 2024
  2. Study start14 Jun 2023
  3. Primary completion1 Dec 2023
  4. Study completion1 Dec 2023

Resources

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
Single group
Model description
This single-blind prospective randomized study. Patients were randomized into three groups by a physiotherapist with sealed envelopes. The researchers were blinded to the patient's groups.
Masking
Triple blind
Who is masked
Participant, Care provider, Investigator
Enrolment
78 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06189521
Sponsor's protocol ID
2023-77
Status last verified
Dec 2023
First submitted
9 Dec 2023
Last updated
3 Jan 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Extracorporeal shock wave group, ultrasound group and dexamethasone iontophoresis group in people with Lateral Epicondylitis, run by Pınar Özge Başaran at 1 site in Turkey (Türkiye).

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 3 inclusion and 4 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 3 Jan 2024. 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 Turkey (Türkiye). 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?

Evaluate the efficacy of ESWT, ultrasound and iontophoresis treatments in term of pain (time frame: 6 months from June 2023 to December 2023). The study lists 2 primary outcomes in all. 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 3 Jan 2024.

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