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Lateral EpicondylitisNCT05334953

Efficacy of Extracorporeal Shock Wave Therapy, Ultrasound and Phonophoresis Treatments in Lateral Epicondylitis

A study testing ESWT, Phonophoresis and Ultrasound in people with Lateral Epicondylitis, run by Bezmialem Vakif University 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

The aim of this study; to determine the effectiveness of ESWT, ultrasound and phonophoresis treatments on pain, grip strength, functionality and quality of life in patients with lateral epicondylitis and to determine the superiority of the treatments to each other. Read more about this study

Who is it for?
Ages 18 to 65 yearsHealthy volunteers can take part
Conditions the study is for
Lateral Epicondylitis
What is being tested?
ESWT, Phonophoresis and Ultrasound
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
68 participants
Where
1 siteTurkey (Türkiye)
Study dates
1 Jun 2022to 6 Jan 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
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Aged between 18-65 years
  • Pain on the lateral side of the elbow for at least 4 weeks
  • Tenderness over the lateral epicondyle
  • Positive in at least two of the lateral epicondylitis spesific tests (Cozen test, Maudley test and Mills test)

Who cannot join

  • Be younger than 18
  • Having had ESWT treatment in the elbow area before
  • History of injection, surgery, physical therapy in the elbow area in the last 3 months
  • Previous elbow surgery
  • History of radius/ulna fracture
  • A history of cervical and shoulder problems
Show all 14Show fewer
  • having bilateral symptoms
  • concomitant medial epicondylitis
  • Malignancy
  • Pregnancy
  • Systemic rheumatologic disease or systemic infection
  • inserted cardiac pacemaker
  • presence of coagulation disorders
  • Cognitive disfunction

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site

  • Bezmialem Vakif university

    Istanbul

Other trials in Turkey (Türkiye)

About this study

Official title: Comparing the Efficacy of Extracorporeal Shock Wave Therapy, Ultrasound and Phonophoresis Treatments in Lateral Epicondylitis: A Randomized Controlled Trial

The aim of this study; to determine the effectiveness of ESWT, ultrasound and phonophoresis treatments on pain, grip strength, functionality and quality of life in patients with lateral epicondylitis and to determine the superiority of the treatments to each other.

Read the detailed description

Lateral epicondylitis is the most common cause of elbow lateral pain in adults. Pain that occurs in LE and radiates to the humerus and forearm is characteristic of this disease. The main complaints being pain and decreased grip strength, both of which may affect activities of daily living. The patient's complaints regress with rest,but but can increase again during daily activities such as grasping, repetitive hand movements, holding door handles, turning keys, lifting heavy loads. Diagnosis of lateral epicondylitis is largely based on clinical history and examination. Conservative treatment is the first line treatment. Generally, %90 of patients with LE benefit from conservative and medical treatment, and only a few need surgery. These treatment methods include many options such as activity modification, topical and oral NSAIDs, splinting, stretching and strengthening exercises, various injections, prolotherapy and electrotherapy modalities. Laser, TENS, ultrasound, phonophoresis, iontophoresis and ESWT are electrotherapeutic agents that can be used in therapy to relieve pain and promote healing. Research on physical treatments for LE has not yet proven superiority of one specific approach.

Although many studies have been done for ESWT, ultrasound and phonophoresis, there is not any study that compares these three modalities.In addition, there ara fewer studies about measuring the effect of these treatment methods which contain control groups. In this study, our aim is to investigate the efficacy of ESWT, ultrasound therapy and phonophoresis methods used in the treatment of LE and to compare the efficacy of these three treatments against each other and control group.

Being tested
ESWT, Phonophoresis, Ultrasound, Control group
Keywords
lateral epicondylitis, extracorporeal shock wave therapy, ultrasound, phonophoresis
Medical subject headings
Tennis Elbow

What participants receive

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

  • ESWTDevice

    Group 1 (n = 17) will be given two times a week, total 5 sessions of ESWT + home exercise program

    Other: Home Workout Program Patients will be given eccentric exercises and stretching exercises

  • PhonophoresisDevice

    Group 2 ( n=17) will be given five times a week total 10 sessions of diclofenac phonophoresis + home exercise program

    Other: Home Workout Program Patients will be given eccentric exercises and stretching exercises

  • UltrasoundDevice

    Group 3 (n=17) will be given five times a week total 10 sessions of ultrasound therapy+ home exercise program

    Other: Home Workout Program Patients will be given eccentric exercises and stretching exercises

  • Control groupOther

    Other: Home Workout Program Patients will be given eccentric exercises and stretching exercises

Study groups in NCT05334953
Study groupRoleWhat they receive
Experimental: ESWT(Extracorporeal Shock Wave Therapy)ExperimentalGroup 1 (n = 17) will be given two times a week, total 5 sessions of ESWT + home exercise program
Receives: Device: ESWT
PhonophoresisExperimentalGroup 2 ( n=17) will be given five times a week, total 10 sessions of diclofenac phonophoresis + home exercise program
Receives: Device: Phonophoresis
Ultrasound therapyExperimentalGroup 2 (n=17) will be given five times a week, total 10 sessions of ultrasound therapy+ home exercise program
Receives: Device: Ultrasound
Control goupOtherGroup 4 ( n=17) will be given home exercise program
Receives: Other: Control group

What is being measured

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

  1. Visual Analog Scale

    The self-evaluation of pain severity during rest, activity,night and with palpation was calculated using a 10-cm VAS scale

    Measured: Change from Baseline at 1 month after treatment.

Secondary outcomes (5)

  1. Patient-Rated Tennis Elbow Evaluation (PRTEE) scales

    The PRTEE is a 15-item questionnaire designed to measure forearm pain and disability in patients with lateral epicondylitis

    Measured: Change from Baseline at 1 month after treatment.

  2. Quick Disabilities of the Arm, Shoulder and Hand (QuickDASH) questionnaire score

    The Quick DASH is an 11-item measure of the magnitude of disability and symptoms specific to the upper extremity. The first 6 items measure the degree of difficulty in performing various physical activities because of a shoulder, arm, and hand problem, and the other 5 items related to quality of sleeping, social activities, and daily activities, and the intensity of pain and numbness

    Measured: Change from Baseline at 1 month after treatment.

  3. 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, 2 points = good, 3 points = fair and 4 points = poor.

    Measured: Change from Baseline at 1 month after treatment.

  4. Health Assessment Questionnaire (HAQ) score

    This is a self-reported questionnaire covering 20 items in eight domains related to measuring difficulty in performing activities of daily living: dressing, arising, eating, walking, hygiene, reach, grip, and common daily activities

    Measured: Change from Baseline at 1 month after treatment.

  5. Grip Strength score

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

    Measured: Change from Baseline at 1 month after treatment.

Timeline

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

  1. First posted19 Apr 2022
  2. Study start1 Jun 2022
  3. Primary completion15 Sep 2022
  4. Study completion6 Jan 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
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
68 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05334953
Sponsor's protocol ID
71306642-050.05.04
Status last verified
Jan 2023
First submitted
31 Mar 2022
Last updated
10 Jan 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Yalvac B, Mesci N, Geler Kulcu D, Yurdakul OV. Comparison of ultrasound and extracorporeal shock wave therapy in lateral epicondylosis. Acta Orthop Traumatol Turc. 2018 Sep;52(5):357-362. doi: 10.1016/j.aott.2018.06.004. Epub 2018 Jun 28.

    PubMed 30497658

  • Bayram K, Yesil H, Dogan E. Efficacy of extracorporeal shock wave therapy in the treatment of lateral epicondylitis. North Clin Istanb. 2014 Aug 3;1(1):33-38. doi: 10.14744/nci.2014.77487. eCollection 2014.

    PubMed 28058299

  • Stasinopoulos D, Johnson MI. Cyriax physiotherapy for tennis elbow/lateral epicondylitis. Br J Sports Med. 2004 Dec;38(6):675-7. doi: 10.1136/bjsm.2004.013573.

    PubMed 15562158

  • Weber C, Thai V, Neuheuser K, Groover K, Christ O. Efficacy of physical therapy for the treatment of lateral epicondylitis: a meta-analysis. BMC Musculoskelet Disord. 2015 Aug 25;16:223. doi: 10.1186/s12891-015-0665-4.

    PubMed 26303397

Questions about this trial

What is this clinical trial studying?

A study testing ESWT, Phonophoresis and Ultrasound in people with Lateral Epicondylitis, run by Bezmialem Vakif University 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 4 inclusion and 14 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 10 Jan 2023. 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?

Visual Analog Scale (time frame: Change from Baseline at 1 month after treatment.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05334953, which also lists 4 linked publications.

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 10 Jan 2023.

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