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Lateral Epicondylitis (Tennis Elbow)NCT07170839

Combined Isotonic Exercise in the Treatment of Lateral Epicondylitis

A study testing ESWT Aplication, ECCENTRIC EXERCISE and COMBINED ISOTONIC EXERCISE in people with Lateral Epicondylitis (Tennis Elbow), run by Inonu 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

This study was designed to investigate the effectiveness of the combined isotonic exercise technique applied with extracorporeal shock waves in the treatment of lateral epicondylitis. Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Lateral Epicondylitis (Tennis Elbow)
What is being tested?
ESWT Aplication, ECCENTRIC EXERCISE and COMBINED ISOTONIC EXERCISE
Could I receive a placebo?
No, everyone receives an active treatment
How many people
40 participants
Where
1 siteTurkey (Türkiye)
Study dates
20 Jan 2025to 30 May 2025
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

  • Diagnosis of lateral epicondylitis
  • Having elbow pain lasting longer than 8 weeks
  • Diagnosis of unilateral lateral epicondylitis
  • Being a woman or man between the ages of 18 and 65
  • No other lesions in or around the elbow

Who cannot join

  • Cardiovascular, neurological, and neuromuscular diseases
  • Prior trauma to the elbow area and previous elbow treatment
  • Prior elbow surgery
  • Peripheral nerve entrapment
  • Corticosteroid injection within 6 months
  • Bilateral elbow pain

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site
  • İnönü Üniversitesi

    Malatya

Other trials in Turkey (Türkiye)

About this study

Official title: Comparison of Eccentric and Combined Isotonic Exercises Combined With Extracorporeal Shock Wave Therapy in the Treatment of Lateral Epicondylitis

This study was designed to investigate the effectiveness of the combined isotonic exercise technique applied with extracorporeal shock waves in the treatment of lateral epicondylitis.

Individuals aged 39-65 diagnosed with lateral epicondylitis were randomized using a sealed envelope method to one of the following groups: extracorporeal shock wave therapy, eccentric exercise and extracorporeal shock wave therapy, or combined isotonic exercise and extracorporeal shock wave therapy. Patients in the combined isotonic exercise and eccentric exercise groups were enrolled in a rehabilitation program under the supervision of a physiotherapist three days a week for five weeks. Extracorporeal shock wave therapy was also administered once a week for five weeks for all three groups. Pain intensity was assessed using the Visual Analog Scale, pressure pain threshold algometer, muscle strength using a hand-held dynamometer, grip strength using a digital hand-held dynamometer, and functionality using the Disabilities of the Arm, Shoulder, and Hand Questionnaire (DASH).

Being tested
ESWT Aplication, ECCENTRIC EXERCISE, COMBINED ISOTONIC EXERCISE
Keywords
Pain, Exercise, Treatment, Extracorporeal shock wave therapy, Rehabilitation
Medical subject headings
Tennis Elbow, Pain, Motor Activity

What participants receive

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

  • ESWT AplicationOther

    All three groups received a total of five ESWT sessions, once a week for five weeks. All ESWT sessions were administered by the same physiotherapist, and the patients were positioned with their elbows flexed to 90 degrees and supported. ESWT was applied to sensitive points on the lateral epicondyle using a shock wave dose of 2000 pulses/session, with an intensity of 1.6 bar, a frequency of 10 Hz, and 1.6 bar. No analgesics or local anesthetics were administered before, during, or after the treatment.

  • ECCENTRIC EXERCISEOther

    Patients in the eccentric exercise group underwent a protocol consisting of slow-progressive eccentric wrist extensor exercises combined with static stretching exercises three times a week for 5 weeks. Eccentric exercises were performed without any resistance to eliminate gravity in the first week, and the intensity of the resistance was gradually increased using yellow elastic resistance bands in weeks 2-3 and red elastic resistance bands in weeks 4-5. Eccentric exercises were performed with the elbow extended, the forearm pronated, the wrist extended, and hanging down from the support surface. Patients were asked to slowly bend the wrist downward, count to 30, and then return to the starting position. Eccentric contractions were then performed in the same manner, and so on. Patients were instructed to continue the exercise if mild pain occurred but to stop the exercise if the pain increased to the point of preventing movement. Once patients tolerated the exercise, the lo

  • COMBINED ISOTONIC EXERCISEOther

    Patients in the combined isotonic exercise group underwent an eccentric-concentric exercise protocol combined with wrist isometric exercises three days a week for 5 weeks. Similar to the eccentric training group, this group completed the training with resistance applied in the first week and elastic bands in subsequent weeks. In the first week, exercise training began with the patients' elbows in full extension, forearms in pronation, wrists in extension, and hanging from the support surface. Participants were asked to slowly bend their wrists for a count of 30, and the wrist extensors were eccentrically exercised. Immediately afterward, patients performed a concentric contraction while returning to the starting position (extension). Then, isometric contraction of the wrist extensors was maintained in the starting position for 30-45 seconds. Once the isometric contraction was achieved, concentric contraction continued, completing the exercise protocol.

Study groups in NCT07170839
Study groupRoleWhat they receive
ESWT ApplicationExperimentalA total of 5 sessions of ESWT were applied to all 3 groups, once a week for 5 weeks.
Receives: Other: ESWT Aplication
Eccentric Treatment ProtocolExperimentalPatients in the eccentric exercise group underwent a protocol consisting of slow-progressive eccentric exercise of the wrist extensors combined with static stretching exercise, 3 times a week for 5 weeks.
Receives: Other: ECCENTRIC EXERCISE
Combined Isotonic ExerciseExperimentalPatients in the combined isotonic exercise group underwent an eccentric-concentric exercise protocol combined with wrist isometric exercises 3 days a week for 5 weeks.
Receives: Other: COMBINED ISOTONIC EXERCISE

What is being measured

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

  1. Pain assessment

    To determine patients' pain levels, pain intensity at rest and during activity was measured using a Visual Analog Scale (VAS). A 10-centimeter (cm) horizontal line was used on this scale, grading from "0: no pain" to "10: unbearable pain." Patients were asked to rate their current pain within this range.

    Measured: Baseline

  2. Pain assessment

    To determine patients' pain levels, pain intensity at rest and during activity was measured using a Visual Analog Scale (VAS). A 10-centimeter (cm) horizontal line was used on this scale, grading from "0: no pain" to "10: unbearable pain." Patients were asked to rate their current pain within this range.

    Measured: 5 weeks

  3. Pressure Pain Assessment

    An algometer was used to measure the pressure pain threshold. The 1-cm tip of the device was placed perpendicular to the patient's arm, with the arm in 30 degrees of abduction and the elbow in 90 degrees of flexion, and the forearm and wrist supported. The patient was asked to report the first time the applied pressure produced pain. This value was recorded on an assessment form in kg/cm².

    Measured: Baseline

  4. Pressure Pain Assessment

    An algometer was used to measure the pressure pain threshold. The 1-cm tip of the device was placed perpendicular to the patient's arm, with the arm in 30 degrees of abduction and the elbow in 90 degrees of flexion, and the forearm and wrist supported. The patient was asked to report the first time the applied pressure produced pain. This value was recorded on an assessment form in kg/cm².

    Measured: 5 weeks

  5. Muscle Strength Assessment

    Wrist extensor and middle finger muscle strength were measured using a hand-held dynamometer (Lafayette Instrument®, Lafayette, UK). The device was placed on the lateral surface of the metacarpal bones while the forearm was resting on the support surface. Participants were asked to perform an isometric contraction against the device in the direction of wrist extension for 5 seconds. The measured values were recorded on an evaluation form. Middle finger extension strength was tested with both the forearm and hand resting on the support surface.

    Measured: Baseline

  6. Muscle Strength Assessment

    Wrist extensor and middle finger muscle strength were measured using a hand-held dynamometer (Lafayette Instrument®, Lafayette, UK). The device was placed on the lateral surface of the metacarpal bones while the forearm was resting on the support surface. Participants were asked to perform an isometric contraction against the device in the direction of wrist extension for 5 seconds. The measured values were recorded on an evaluation form. Middle finger extension strength was tested with both the forearm and hand resting on the support surface.

    Measured: 5 weeks

  7. Grip Strength Measurement

    A Baseline digital handheld dynamometer (300 LB / 135 KG®) was used to measure maximum grip strength in patients. For this measurement, patients were asked to sit upright in a chair. With the arm and shoulder in a neutral position, the elbow in 90-degree flexion, the forearm in neutral, the wrist in slight extension, and ulnar deviation, the patient was instructed to squeeze the dynamometer firmly. The measured value was recorded in kilograms (kg). Three repetitions were performed for the affected hand, with a 1-minute rest period between repetitions. Grip strength was objectively measured by averaging these three values.

    Measured: Baseline

  8. Grip Strength Measurement

    A Baseline digital handheld dynamometer (300 LB / 135 KG®) was used to measure maximum grip strength in patients. For this measurement, patients were asked to sit upright in a chair. With the arm and shoulder in a neutral position, the elbow in 90-degree flexion, the forearm in neutral, the wrist in slight extension, and ulnar deviation, the patient was instructed to squeeze the dynamometer firmly. The measured value was recorded in kilograms (kg). Three repetitions were performed for the affected hand, with a 1-minute rest period between repetitions. Grip strength was objectively measured by averaging these three values.

    Measured: 5 weeks

  9. Determining the Functionality Level

    The Disabilities of the Arm, Shoulder, and Hand Questionnaire (DASH), developed for use in upper extremity musculoskeletal disorders, was used to determine patients' functional levels and symptoms. This questionnaire consists of three sections and 30 questions. Twenty-one questions address difficulties experienced by patients related to activities, five address disease symptoms, and the remaining questions assess work, sleep, social function, and patient self-confidence.

    Measured: Baseline

  10. Determining the Functionality Level

    The Disabilities of the Arm, Shoulder, and Hand Questionnaire (DASH), developed for use in upper extremity musculoskeletal disorders, was used to determine patients' functional levels and symptoms. This questionnaire consists of three sections and 30 questions. Twenty-one questions address difficulties experienced by patients related to activities, five address disease symptoms, and the remaining questions assess work, sleep, social function, and patient self-confidence.

    Measured: 5 weeks

Timeline

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

  1. First posted12 Sep 2025
  2. Study start20 Jan 2025
  3. Primary completion20 May 2025
  4. Study completion30 May 2025

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
Participant
Enrolment
40 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07170839
Sponsor's protocol ID
2024/103
Status last verified
Sep 2025
First submitted
19 Aug 2025
Last updated
12 Sep 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Bhabra G, Wang A, Ebert JR, Edwards P, Zheng M, Zheng MH. Lateral Elbow Tendinopathy: Development of a Pathophysiology-Based Treatment Algorithm. Orthop J Sports Med. 2016 Nov 1;4(11):2325967116670635. doi: 10.1177/2325967116670635. eCollection 2016 Nov.

    PubMed 27833925
  • Wilps T, Kaufmann RA, Yamakawa S, Fowler JR. Elbow Biomechanics: Bony and Dynamic Stabilizers. J Hand Surg Am. 2020 Jun;45(6):528-535. doi: 10.1016/j.jhsa.2020.01.016. Epub 2020 Apr 13.

    PubMed 32299691
  • Marshall NR, Randell MR, Nicholls AJ. Elbow anatomy, biomechanics and clinical examination. Shoulder Elbow. 2024;16(2):81-88.

Questions about this trial

What is this clinical trial studying?

A study testing ESWT Aplication, ECCENTRIC EXERCISE and COMBINED ISOTONIC EXERCISE in people with Lateral Epicondylitis (Tennis Elbow), run by Inonu 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 5 inclusion and 6 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 12 Sep 2025. 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?

Pain assessment (time frame: Baseline). The study lists 10 primary outcomes in all. 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 NCT07170839, which also lists 3 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 12 Sep 2025.

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