NCT05840146

Brief Summary

Kinesiotaping is increasingly being used as a complement to musculoskeletal pain management. This study aimed to evaluate the immediate clinical efficacy of kinesiotaping on pain and pain-related symptoms of Legg-Calvé-Perthes Disease (LCPD).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2017

Longer than P75 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

September 25, 2017

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 6, 2020

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 11, 2021

Completed
2.2 years until next milestone

First Submitted

Initial submission to the registry

March 20, 2023

Completed
1 month until next milestone

First Posted

Study publicly available on registry

May 3, 2023

Completed
Last Updated

May 3, 2023

Status Verified

April 1, 2023

Enrollment Period

2.5 years

First QC Date

March 20, 2023

Last Update Submit

April 21, 2023

Conditions

Legg-Calve-Perthes Disease

Keywords

KinesiotapeTapingPediatric painHip jointPhysiotherapy

Outcome Measures

Primary Outcomes (1)

  • Immediate Clinical Efficacy on Activity Related Hip

    Horizontal 10 cm VAS (0, no pain; 10, the worst pain ever possible)

    The change between T1 (baseline) to T2 (thirty minutes later from the application)

Secondary Outcomes (4)

  • Immediate Clinical Efficacy on Hip Abduction ROM

    The change between T1 (baseline) to T2 (thirty minutes later from the application)

  • Immediate Clinical Efficacy on Functional Task Durations

    The change between T1 (baseline) to T2 (thirty minutes later from the application)

  • Immediate Clinical Efficacy on Balance test durations

    The change between T1 (baseline) to T2 (thirty minutes later from the application)

  • Immediate Clinical Efficacy on Gluteus medius muscle strength

    The change between T1 (baseline) to T2 (thirty minutes later from the application)

Study Arms (2)

Kinesiotaping group

EXPERIMENTAL

Kinesiotape was applied to the lateral side of the affected hip for gluteus medius muscle. Each patient was positioned lying down with the affected side up, and two I-strips were used.

Other: Kinesiotaping

Sham taping group

SHAM COMPARATOR

Sham tape was applied with a single I-strip without tension in tape or muscle stretch. After paper backing was completely removed, tape was essentially placed on the skin across the lateral side of the affected hip.

Other: Sham taping

Interventions

KinesiotapingOTHER

Two I-strips were used: 1. The first-third of one I-strip began at the posterior iliac crest, without tension as an anchor. Then the patient actively flexed and adducted the affected hip, thus, the middle-third of the tape was applied with approximately 50% tension. Then the hip was set in its original position and the last-third of the tape ended approximately greater trochanter without tension. 2. The first-third of the second I-strip was applied starting at the anterior iliac crest, without tension as an anchor. The patient actively extended and adducted the affected hip, thus, the middle-third of the tape was applied with approximately 50% tension. Then the hip was set in its original position and the last-third of the tape ended approximately greater trochanter without tension.

Kinesiotaping group
Sham tapingOTHER

A single I-strip without tension in tape or muscle stretch. After paper backing was completely removed, tape was essentially placed on the skin across the lateral side of the hip.

Sham taping group

Eligibility Criteria

Age5 Years - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Having received unilateral LCPD diagnosis,
  • Anterior hip pain minimum three points on 10-cm Visual Analog Scale (VAS) over the previous week,
  • Having the following symptoms; weakness of gluteus medius muscle and patient-reported complaints on function or balance

You may not qualify if:

  • Having a history of any other hip pathologies,
  • Having allergy to polyacrylate adhesive,
  • Having used analgesic medication within the previous three days.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Istanbul University-Cerrahpasa

Istanbul, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Legg-Calve-Perthes Disease

Condition Hierarchy (Ancestors)

Femur Head NecrosisOsteonecrosisBone DiseasesMusculoskeletal Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

March 20, 2023

First Posted

May 3, 2023

Study Start

September 25, 2017

Primary Completion

April 6, 2020

Study Completion

January 11, 2021

Last Updated

May 3, 2023

Record last verified: 2023-04

Locations

TU(1)