NCT06094361

Brief Summary

The aim of this study was to compare the effects of iontophoresis and phonophoresis applications added to conventional treatment on pain, range of motion, disability, and functional status in the shoulder region in patients with subacromial impingement syndrome.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
43

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jun 2015

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2015

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2015

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2016

Completed
7.5 years until next milestone

First Submitted

Initial submission to the registry

October 16, 2023

Completed
7 days until next milestone

First Posted

Study publicly available on registry

October 23, 2023

Completed
Last Updated

October 23, 2023

Status Verified

October 1, 2023

Enrollment Period

5 months

First QC Date

October 16, 2023

Last Update Submit

October 18, 2023

Conditions

Keywords

IontophoresisPhonophoresisPainDisability

Outcome Measures

Primary Outcomes (2)

  • Visual Analog Scale

    This scale assess the pain of the patients. The scale is scored from 0-10, with 0 indicating no pain and 10 indicating intolerable pain.

    At the baseline

  • Visual Analog Scale

    This scale assess the pain of the patients. The scale is scored from 0-10, with 0 indicating no pain and 10 indicating intolerable pain.

    Immediately after 10 physiotherapy sessions on consecutive days

Secondary Outcomes (7)

  • Sociodemographic Data Form

    At the baseline

  • Range of Motion

    At the baseline

  • Range of Motion

    Immediately after 10 physiotherapy sessions on consecutive days

  • Shoulder Disability Questionnaire

    At the baseline

  • Shoulder Disability Questionnaire

    Immediately after 10 physiotherapy sessions on consecutive days

  • +2 more secondary outcomes

Study Arms (2)

IONTOPHORESIS

EXPERIMENTAL

The group that received 75 mg diclofenac sodium with Chattanooga Physio device.

Procedure: Iontophoresis InterventionProcedure: Conventional Therapy

PHONOPHORESIS

EXPERIMENTAL

It is a treatment performed by applying 75 mg of 1% diclofenac sodium gel to the intervention area with the Chattanooga ultrasound device.

Procedure: PhonophoresisProcedure: Conventional Therapy

Interventions

Iontophoresis was applied with a Chattanooga Physio (DJO Global, Herentals, Belgium) brand device. The galvanic current mode was selected for the intervention. Intervention area was cleaned to prevent irritation and active electrode pad (cathode-5 cm2) was immersed in 75 mg diclofenac sodium solution. The current intensity of the application for 10 minutes was 0.1-0.2 mA/cm2.

IONTOPHORESIS
PhonophoresisPROCEDURE

Phonophoresis was performed with a Chattanooga brand ultrasound device (Chattanooga, Intelect Legend Ultrasound, TN, USA). 75 mg gel containing 1% diclofenac sodium was applied to the shoulder area. The ultrasound was conducted continuously for 6 minutes with frequency of 1 MHz and an intensity of 1.5 watts/cm2.

PHONOPHORESIS

All groups received a treatment program consisting of hot pack, Transcutaneous Electrical Nerve Stimulation and Shoulder girdle exercises for 30 minutes.

IONTOPHORESISPHONOPHORESIS

Eligibility Criteria

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

You may qualify if:

  • Patients diagnosed with Stage I-II SIS
  • The ages between 18 and 65 years

You may not qualify if:

  • Having underwent shoulder surgery,
  • Participated in a shoulder-related treatment program within the previous six months,
  • Failed to adhere to the treatment program by 70% or more

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Marmara University

Istanbul, 34083, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Shoulder Impingement SyndromePain

Interventions

Phonophoresis

Condition Hierarchy (Ancestors)

Joint DiseasesMusculoskeletal DiseasesShoulder InjuriesWounds and InjuriesNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Drug Administration RoutesDrug TherapyTherapeutics

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: There were two separate groups in the study. The first group received iontophoresis and the other group received phonophoresis. The effects on treatment outcomes were compared.
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Research Assisstant

Study Record Dates

First Submitted

October 16, 2023

First Posted

October 23, 2023

Study Start

June 1, 2015

Primary Completion

November 1, 2015

Study Completion

April 1, 2016

Last Updated

October 23, 2023

Record last verified: 2023-10

Data Sharing

IPD Sharing
Will not share

Locations