The Effect of Phonophoresis in Subacromial Impingement Syndrome.

NCT ID: NCT04676919

Last Updated: 2021-07-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

88 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-04-01

Study Completion Date

2021-01-30

Brief Summary

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Subacromial impingement syndrome (SIS) is a dysfunction caused by an impingement of the rotator cuff tendon between the head of the humerus and the acromion as a result of changes in the subacromial space. The patients' symptoms, such as pain, limited joint mobility and reduced strength, may lead to a diagnosis of SIS. The conservative treatment of individuals with SIS is includes analgesics and non-steroidal anti-inflammatory drugs (NSAIDs), steroid injections and physiotherapy. Ultrasound therapy is one of the common physiotherapy applications for SIS, but its effectiveness is controversial. Phonophoresis is a combination of ultrasound therapy and medical therapy. In phonophoresis, a medicine in gel form is used as a transmitter with ultrasound instead of the aquatic conductor gel. It was hypothesized that ultrasound waves favoring the penetration of an anti-inflammatory drug would lead to an improved response to the treatment of SIS. However, the effectiveness of ultrasound modes (pulsed or continuous) can be used in phonophoresis is debatable. The purpose of this study is to determine the effect of ultrasound therapy, pulsed mode ultrasound and continuous mode ultrasound phonophoresis in patients with SIS.

Detailed Description

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Conditions

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Subacromial Impingement Syndrome

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants
sham

Study Groups

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pulsed mode phonophoresis group

Phonophoresis therapy with pulsed mode ultrasound.

Group Type EXPERIMENTAL

phonophoresis therapy with pulsed mode ultrasound

Intervention Type DEVICE

phonophoresis therapy with pulsed mode ultrasound, five days a week for three weeks

continuous mode phonophoresis group

Phonophoresis therapy with continuous mode ultrasound.

Group Type EXPERIMENTAL

phonophoresis therapy with continuous mode ultrasound

Intervention Type DEVICE

phonophoresis therapy with pulsed mode ultrasound, five days a week for three weeks

sham group

Sham ultrasound

Group Type SHAM_COMPARATOR

sham ultrasound

Intervention Type DEVICE

sham ultrasound therapy, five days a week for three weeks

Interventions

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phonophoresis therapy with pulsed mode ultrasound

phonophoresis therapy with pulsed mode ultrasound, five days a week for three weeks

Intervention Type DEVICE

phonophoresis therapy with continuous mode ultrasound

phonophoresis therapy with pulsed mode ultrasound, five days a week for three weeks

Intervention Type DEVICE

sham ultrasound

sham ultrasound therapy, five days a week for three weeks

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* to be diagnosed as shoulder impingement syndrome,
* shoulder pain for at least one month,
* VAS score over 40mm.

Exclusion Criteria

* grade III supraspinatus tendon injury,
* major shoulder trauma,
* diabetes mellitus,
* hipotiroidizm,
* adhesive capsulitis,
* cardiac pacemaker
* physical therapy or local injection to the shoulder at last six month
* serious cervical pathologies.
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Cukurova University

OTHER

Sponsor Role lead

Responsible Party

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Volkan Deniz, PT

MSc

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Bayram Kelle, Assoc. Prof.

Role: PRINCIPAL_INVESTIGATOR

Cukurova University

Locations

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Volkan deniz

Ankara, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

Other Identifiers

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72/1185

Identifier Type: -

Identifier Source: org_study_id

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