Conservative Treatment in Lateral Epicondylitis

Prospective Comparison of Conservative Treatment Methods in Patients With Lateral Epicondylitis

Conservative treatments follow the vast majority of treatments in lateral epicondylitis. In this research, we aimed to elucidate the treatment outcomes of patients via epicondylitis bandage, wrist dorsiflexion splint, and kinesio tape groups by sequential randomization and to compare treatment outcomes.

Study Overview

• Status: Completed
• Conditions: Lateral Epicondylitis
• Intervention / Treatment: Device: Epicondylitis bandage; Device: Wrist dorsiflexion splint; Device: Kinesio tape

• Study Type: Interventional
• Enrollment (Actual): 54
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Nilüfer
    • Bursa, Nilüfer, Turkey, 16059
      • Bursa Uludag University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Patients who were ≥18 years of age, and had no history of elbow surgery.
• Participants should have pain and sensitivity, with symptom duration less than 12 weeks.
• Patients with a positive result in one of the provocation tests (Maudsley's Test-resisted middle finger extension extensor carpi radialis test), resisted wrist extension, or passive stretching of the wrist extensors (Mill's Test) were included.

Exclusion Criteria:

• Patients under 18 years of age,
• patients who did not consent to participate in the study,
• those who had previous surgery on the elbow,
• presence of cervical spondylosis and radiculopathy,
• presence of endocrine disease,
• presence of autoimmune disease,
• presence of concomitant entrapment neuropathy or polyneuropathy,
• pregnancy,
• presence of systemic inflammatory disease,
• presence of acute trauma,
• presence of deformity in the upper extremity,
• presence of metabolic disease,
• presence of elbow arthritis,
• presence of allergy to kinesio tape and orthoses,
• having received treatment for lateral epicondylitis in the past (exercise, injection, NSAIDs).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Lateral Epicondylitis (treatment with epicondylitis bandage); Patients with diagnosis of lateral epicondylitis.	Device: Epicondylitis bandage; A conservative treatment method of lateral epicondylitis.
Experimental: Lateral Epicondylitis (treatment with wrist dorsiflexion orthesis); Patients with diagnosis of lateral epicondylitis.	Device: Wrist dorsiflexion splint; A conservative treatment method of lateral epicondylitis.
Experimental: Lateral Epicondylitis (treatment with kinesio tape); Patients with diagnosis of lateral epicondylitis.	Device: Kinesio tape; A conservative treatment method of lateral epicondylitis

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Visual analog score	Minimum value: 0 Maximum value: 10 Minimum is better.	Baseline
Visual analog score	Minimum value: 0 Maximum value:10 Minimum is better.	At sixth weeks.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Disabilities of the Arm, Shoulder Score	Minimum value:0 Maximum value:100 Minimum is better	Baseline
Disabilities of the Arm, Shoulder Score	Minimum value:0 Maximum value:100 Minimum is better	At sixth weeks.

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient-Rated Tennis Elbow Evaluation Score	Minimum value:0 Maximum value:10 Minimum is better.	Baseline
Patient-Rated Tennis Elbow Evaluation Score	Minimum value:0 Maximum value:10 Minimum is better.	At sixth weeks.
hand grip strength	Minimum value: 0 Maximum value: 100 Maximum is better.	Baseline
hand grip strength	Minimum value: 0 Maximum value: 100 Maximum is better.	At sixth weeks.

Collaborators and Investigators

• Sponsor: Uludag University

Study record dates

Study Major Dates

• Study Start (Actual): December 15, 2020
• Primary Completion (Actual): December 15, 2021
• Study Completion (Actual): May 15, 2022

Study Registration Dates

• First Submitted: December 8, 2024
• First Submitted That Met QC Criteria: December 8, 2024
• First Posted (Estimated): December 12, 2024

Study Record Updates

• Last Update Posted (Estimated): December 12, 2024
• Last Update Submitted That Met QC Criteria: December 8, 2024
• Last Verified: December 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Elbow Tendinopathy; Elbow Injuries; Musculoskeletal Diseases; Muscular Diseases; Wounds and Injuries; Tendon Injuries; Arm Injuries; Tendinopathy; Tennis Elbow
• Other Study ID Numbers: IEAH-YB-2020-01

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No