Clinical trial NCT04676919: The Effect of Phonophoresis in Subacromial Impingement Syndrome.
Official title: Phonophoresis Therapy in Subacromial Impingement Syndrome: Comparing of Pulsed Mode Ultrasound Phonophoresis and Continuous Mode Ultrasound Phonophoresis.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Subacromial Impingement Syndrome
Keywords: subacromial pain
ultrasound therapy
phonophoresis
Lead sponsor: Cukurova University
Sponsor class: OTHER
First posted: 2020-12-21
Enrollment: 88
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Visual Analog Scale
timeFrame: Baseline, Change from baseline pain scores at three weeks, Change from baseline pain scores at three months
measure: The Shortened version of Disability of the Arm, Shoulder, and Hand
timeFrame: Baseline, Change from baseline shoulder pain and function scores at three weeks, Change from baseline shoulder pain and function at three months
Secondary outcomes:
measure: Nottingham Health Profile
timeFrame: Baseline, Change from baseline quality of life scores at three weeks, Change from baseline quality of life scores at three months
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Volkan deniz
Study officials:
affiliation: Cukurova University
name: Bayram Kelle, Assoc. Prof.
role: PRINCIPAL_INVESTIGATOR
References: