NCT07789886

Brief Summary

This study aimed to compare the efficacy of physiotherapy alone (PTA), Kinesiotaping (KT) combined with physiotherapy (KTPT), and wrist rest splint combined with physiotherapy (PTWJRS) treatments for the treatment of LE

Trial Health

87
On Track

Trial Health Score

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

Enrollment
45

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Nov 2020

Shorter than P25 for not_applicable

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 20, 2020

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 10, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 10, 2021

Completed
5.4 years until next milestone

First Submitted

Initial submission to the registry

August 13, 2026

Completed
14 days until next milestone

First Posted

Study publicly available on registry

August 27, 2026

Completed
Last Updated

August 27, 2026

Status Verified

August 1, 2026

Enrollment Period

4 months

First QC Date

August 13, 2026

Last Update Submit

August 24, 2026

Conditions

Keywords

PhysiotherapyKinesiotapingWrist Rest SplintTennis ElbowLateral Epicondylitis

Outcome Measures

Primary Outcomes (2)

  • Change in Pain Intensity (VAS)

    Pain intensity was evaluated using the Visual Analogue Scale (VAS). The scale ranges from a minimum of 0 to a maximum of 10. Higher scores indicate greater pain severity, representing a worse clinical outcome.

    Baseline and at the end of the 15-session treatment program (approximately 3 weeks)

  • Change in Grip Strength Measured by Hand Dynamometer

    Painless and maximum grip strengths were evaluated using a hand dynamometer. The measurements are recorded in kilograms (kg). Higher values indicate greater grip strength, representing better physical function and a better clinical outcome.

    Baseline and at the end of the 15-session treatment program (approximately 3 weeks)

Secondary Outcomes (2)

  • Change in Patient-Rated Tennis Elbow Evaluation (PRTEE) Score

    Baseline and at the end of the 15-session treatment program (approximately 3 weeks)

  • Change in QuickDASH (Quick Disabilities of the Arm, Shoulder, and Hand) Score

    Baseline and at the end of the 15-session treatment program (approximately 3 weeks)

Study Arms (3)

Physiotherapy Alone (PTA)

ACTIVE COMPARATOR

Patients received only physiotherapy for a total of 15 sessions.

Other: Physiotherapy Program

Physiotherapy with Kinesiotaping (PTKT)

EXPERIMENTAL

Patients received the standard 15-session physiotherapy program and additional kinesiotaping for 5 days a week for 3 weeks.

Other: Physiotherapy ProgramDevice: Kinesiotaping (KT)

Physiotherapy with Wrist Splint (PTWJS)

EXPERIMENTAL

Patients received the standard 15-session physiotherapy program and a wrist joint rest splinting program.

Other: Physiotherapy ProgramDevice: Wrist Joint Rest Splint

Interventions

A 15-session program (5 days a week) consisting of ultrasound (1.5 W/cm2, 1 MHz for 3 min), TENS (15 min), cold pack (15 min), eccentric strengthening exercises for wrist extensors, and deep friction massage (5 min).

Physiotherapy Alone (PTA)Physiotherapy with Kinesiotaping (PTKT)Physiotherapy with Wrist Splint (PTWJS)

Applied at the end of each PT session using forearm muscle inhibition and fascia correction techniques. Tapes remained on the elbow for approximately 345 hours in total.

Physiotherapy with Kinesiotaping (PTKT)

Used 6-8 hours a day during the 15-session program. Fixed at a 5° to 10° extension to reduce loading stress.

Physiotherapy with Wrist Splint (PTWJS)

Eligibility Criteria

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

You may qualify if:

  • Patients applying with complaints of elbow pain lasting more than 3 months.
  • Diagnosed with lateral epicondylitis based on tenderness/pain on the lateral humeral epicondyle region.
  • Pain aggravated by passive stretching of the wrist extensors (Mill's test) or resisted extension of the middle finger (Maudley's test).
  • Pain, limited active ROM at the wrist joint, and hand grip weakness.

You may not qualify if:

  • Inflammatory/infectious joint disease, cubital tunnel syndrome, carpal tunnel syndrome, shoulder/hand/wrist pathologies.
  • Radiculopathy, fibromyalgia, psychiatric/neurological disease, history of malignancy.
  • Cervical trauma, surgery, or upper extremity trauma.
  • Adhesive tape allergy.
  • Received corticosteroid injections for LE within the previous 3 months or PT for the elbow within the previous 6 months.
  • Used oral or topical NSAIDs or received other treatments for LE in the previous 3 months or during the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Istanbul Medipol University Pendik Hospital

Istanbul, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Tennis Elbow

Condition Hierarchy (Ancestors)

Elbow TendinopathyTendinopathyMuscular DiseasesMusculoskeletal DiseasesElbow InjuriesArm InjuriesWounds and InjuriesTendon Injuries

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
To minimize detection bias, the researcher responsible for recording and evaluating the pre-treatment and post-treatment clinical assessments was blinded to the patients' group assignments.
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Asst. Prof. Dr.

Study Record Dates

First Submitted

August 13, 2026

First Posted

August 27, 2026

Study Start

November 20, 2020

Primary Completion

March 10, 2021

Study Completion

March 10, 2021

Last Updated

August 27, 2026

Record last verified: 2026-08

Data Sharing

IPD Sharing
Will not share

Locations