NCT06289400

Brief Summary

The purpose of this study is to examine the effect of magnetic field application used in the treatment of patellofemoral pain.

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 Mar 2024

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

First Submitted

Initial submission to the registry

February 26, 2024

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 1, 2024

Completed
Same day until next milestone

Study Start

First participant enrolled

March 1, 2024

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2024

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 24, 2024

Completed
Last Updated

December 4, 2024

Status Verified

February 1, 2024

Enrollment Period

4 months

First QC Date

February 26, 2024

Last Update Submit

December 2, 2024

Conditions

Keywords

Pain, Knee, Magnetic field, Physiotherapy

Outcome Measures

Primary Outcomes (4)

  • Visual Analogue Scale (VAS)

    A Visual Analogue Scale (VAS) is one of the pain rating scales.Scores are recorded by making a handwritten mark on a 10-cm line that represents a continuum between "no pain" and "worst pain.

    The evaluation will be applied at the beginning of the treatment program.

  • 36-Item Short Form Survey (SF-36)

    The SF-36 is a 36-item self-report measure of health-related quality of life. It has eight subscales measuring different domains of health-related quality of life: physical functioning (PF), role-physical (RP), bodily pain (BP), general health (GH), vitality (VT), social functioning (SF), role-emotional (RE), and mental health (MH).

    The evaluation will be applied at the beginning of the treatment program.

  • Manual Muscle Test

    Manual muscle testing is based on the physiotherapist manually applying resistance to the muscle or muscle group to be evaluated.

    The evaluation will be applied at the beginning of the treatment program.

  • The Lower Extremity Functional Scale (LEFS)

    The Lower Extremity Functional Scale (LEFS) is a questionnaire containing 20 questions about a person's ability to perform everyday tasks. The LEFS can be used by clinicians as a measure of patients' initial function, ongoing progress and outcome, as well as to set functional goals.

    The evaluation will be applied at the beginning of the treatment program.

Study Arms (2)

Study Group

EXPERIMENTAL

Conventional treatment+ Magnetic field application

Device: Magnetic field applicationOther: Conventional treatment

Control Group

ACTIVE COMPARATOR

Conventional treatment

Other: Conventional treatment

Interventions

The applicator (Size: 15x15 cm) has placed 1-3 cm above the skin surface at the painful area. During the treatment, treatment has applied with ready-made protocols included in the device.

Study Group

Within the scope of conventional treatment, hotpack application, transcutaneous electrical stimulation (TENS), interferential current and ultrasound treatment modalities will be applied. In addition, strengthening exercises will be applied to the muscles around the hip and knee and stretching exercises will be applied to the short muscle groups.

Control GroupStudy Group

Eligibility Criteria

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

You may qualify if:

  • Having been diagnosed with patellofemoral pain syndrome by an orthopedic physician
  • Volunteering to participate in the study
  • Having pain for more than eight weeks
  • Patients who did not undergo surgery

You may not qualify if:

  • Patients diagnosed with rheumatological disease
  • Patients who have previously had steroid injections in the knee area
  • Patients with entrapment neuropathy and deformity in the lower extremity
  • Patients who are pregnant
  • Patients suffering from scoliosis,
  • Patients who use non-steroidal anti-inflammatory and antidepressant regularly for any reason

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

KTO Karatay University

Konya, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Pain

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Osman Karaca, PhD

    KTO Karatay University

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 26, 2024

First Posted

March 1, 2024

Study Start

March 1, 2024

Primary Completion

June 30, 2024

Study Completion

October 24, 2024

Last Updated

December 4, 2024

Record last verified: 2024-02

Locations