Combined Isotonic Exercise in the Treatment of Lateral Epicondylitis

NCT ID: NCT07170839

Last Updated: 2025-09-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-01-20

Study Completion Date

2025-05-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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).

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Lateral Epicondylitis (Tennis Elbow)

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

ESWT Application

A total of 5 sessions of ESWT were applied to all 3 groups, once a week for 5 weeks.

Group Type EXPERIMENTAL

ESWT Aplication

Intervention Type OTHER

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 Treatment Protocol

Patients 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.

Group Type EXPERIMENTAL

ECCENTRIC EXERCISE

Intervention Type OTHER

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 Exercise

Patients in the combined isotonic exercise group underwent an eccentric-concentric exercise protocol combined with wrist isometric exercises 3 days a week for 5 weeks.

Group Type EXPERIMENTAL

COMBINED ISOTONIC EXERCISE

Intervention Type OTHER

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.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

ESWT Aplication

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.

Intervention Type OTHER

ECCENTRIC EXERCISE

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

Intervention Type OTHER

COMBINED ISOTONIC EXERCISE

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.

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* 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

Exclusion Criteria

* 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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Inonu University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

BÜŞRA CANDİRİ

assistant professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

İnönü Üniversitesi

Malatya, , Turkey (Türkiye)

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Turkey (Türkiye)

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type BACKGROUND
PMID: 27833925 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 32299691 (View on PubMed)

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

Reference Type RESULT

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

2024/103

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.