NCT06730789

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
54

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Dec 2020

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 15, 2020

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 15, 2021

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 15, 2022

Completed
2.6 years until next milestone

First Submitted

Initial submission to the registry

December 8, 2024

Completed
4 days until next milestone

First Posted

Study publicly available on registry

December 12, 2024

Completed
Last Updated

December 12, 2024

Status Verified

December 1, 2024

Enrollment Period

1 year

First QC Date

December 8, 2024

Last Update Submit

December 8, 2024

Conditions

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (2)

  • Disabilities of the Arm, Shoulder Score

    Baseline

  • Disabilities of the Arm, Shoulder Score

    At sixth weeks.

Other Outcomes (4)

  • Patient-Rated Tennis Elbow Evaluation Score

    Baseline

  • Patient-Rated Tennis Elbow Evaluation Score

    At sixth weeks.

  • hand grip strength

    Baseline

  • +1 more other outcomes

Study Arms (3)

Lateral Epicondylitis (treatment with epicondylitis bandage)

EXPERIMENTAL

Patients with diagnosis of lateral epicondylitis.

Device: Epicondylitis bandage

Lateral Epicondylitis (treatment with wrist dorsiflexion orthesis)

EXPERIMENTAL

Patients with diagnosis of lateral epicondylitis.

Device: Wrist dorsiflexion splint

Lateral Epicondylitis (treatment with kinesio tape)

EXPERIMENTAL

Patients with diagnosis of lateral epicondylitis.

Device: Kinesio tape

Interventions

A conservative treatment method of lateral epicondylitis.

Lateral Epicondylitis (treatment with epicondylitis bandage)

A conservative treatment method of lateral epicondylitis.

Lateral Epicondylitis (treatment with wrist dorsiflexion orthesis)

A conservative treatment method of lateral epicondylitis

Lateral Epicondylitis (treatment with kinesio tape)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Bursa Uludag University

Bursa, Nilüfer, 16059, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Tennis Elbow

Interventions

Athletic Tape

Condition Hierarchy (Ancestors)

Elbow TendinopathyTendinopathyMuscular DiseasesMusculoskeletal DiseasesElbow InjuriesArm InjuriesWounds and InjuriesTendon Injuries

Intervention Hierarchy (Ancestors)

BandagesEquipment and SuppliesOrthotic DevicesOrthopedic EquipmentSurgical Equipment

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, Orthopedics and Traumatolody Specialist

Study Record Dates

First Submitted

December 8, 2024

First Posted

December 12, 2024

Study Start

December 15, 2020

Primary Completion

December 15, 2021

Study Completion

May 15, 2022

Last Updated

December 12, 2024

Record last verified: 2024-12

Locations