The Effect of Phonophoresis in Subacromial Impingement Syndrome.

Subacromial Impingement Syndrome Clinical Trial

Official title:

Phonophoresis Therapy in Subacromial Impingement Syndrome: Comparing of Pulsed Mode Ultrasound Phonophoresis and Continuous Mode Ultrasound Phonophoresis.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04676919
• Other study ID #: 72/1185
• Status: Completed
• Phase: N/A
• Start date: April 1, 2019
• Est. completion date: January 30, 2021

Study information

• Verified date: July 2021
• Source: Cukurova University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 88
• Est. completion date: January 30, 2021
• Est. primary completion date: January 15, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Rotator Cuff Injuries
• Shoulder Impingement Syndrome
• Subacromial Impingement Syndrome
• Syndrome

Intervention

Device:
• phonophoresis therapy with pulsed mode ultrasound
phonophoresis therapy with pulsed mode ultrasound, five days a week for three weeks
• phonophoresis therapy with continuous mode ultrasound
phonophoresis therapy with pulsed mode ultrasound, five days a week for three weeks
• sham ultrasound
sham ultrasound therapy, five days a week for three weeks

Locations

Country	Name	City	State
Turkey	Volkan deniz	Ankara

Sponsors (1)

Lead Sponsor	Collaborator
Cukurova University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Visual Analog Scale	The visual analog scale (VAS) is a pain rating scale first used by Hayes and Patterson in 1921. Scores are based on self-reported measures of symptoms that are recorded with a single handwritten mark placed at one point along the length of a 10-cm line that represents a continuum between the two ends of the scale-"no pain" on the left end (0 cm) of the scale and the "worst pain" on the right end of the scale (10 cm).	Baseline, Change from baseline pain scores at three weeks, Change from baseline pain scores at three months
Primary	The Shortened version of Disability of the Arm, Shoulder, and Hand	Disability of the Arm, Shoulder, and Hand (DASH) was designed to describe disability experienced by patients with any musculoskeletal condition of the upper extremity and to monitor change in symptoms and upper limb function over time. The DASH questionnaire has been validated in patients with upper extremity musculoskeletal disorders such as rheumatoid arthritis and shoulder impingement syndrome. The Quick-DASH is a shortened version of the DASH	Baseline, Change from baseline shoulder pain and function scores at three weeks, Change from baseline shoulder pain and function at three months
Secondary	Nottingham Health Profile	Nottingham Health Profile (NHP) evaluates emotional, social, and physical health problems perceived by the patient. It consists of six parts: pain (8 items), emotional reactions (9 items), sleep (5 items), social isolation (5 items), physical mobility (8 items), and energy level (3 items). Higher scores correspond to poorer perceived health status.	Baseline, Change from baseline quality of life scores at three weeks, Change from baseline quality of life scores at three months