The Effect of Phonophoresis in Subacromial Impingement Syndrome.

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

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.

Study Overview

• Status: Completed
• Conditions: Subacromial Impingement Syndrome
• Intervention / Treatment: Device: phonophoresis therapy with pulsed mode ultrasound; Device: phonophoresis therapy with continuous mode ultrasound; Device: sham ultrasound

• Study Type: Interventional
• Enrollment (Actual): 88
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Ankara, Turkey, 06560
    • Volkan Deniz

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: pulsed mode phonophoresis group; Phonophoresis therapy with pulsed mode ultrasound.	Device: phonophoresis therapy with pulsed mode ultrasound; phonophoresis therapy with pulsed mode ultrasound, five days a week for three weeks
Experimental: continuous mode phonophoresis group; Phonophoresis therapy with continuous mode ultrasound.	Device: phonophoresis therapy with continuous mode ultrasound; phonophoresis therapy with pulsed mode ultrasound, five days a week for three weeks
Sham Comparator: sham group; Sham ultrasound	Device: sham ultrasound; sham ultrasound therapy, five days a week for three weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Cukurova University
• Investigators: Principal Investigator: Bayram Kelle, Assoc. Prof., Çukurova university

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2019
• Primary Completion (Actual): January 15, 2021
• Study Completion (Actual): January 30, 2021

Study Registration Dates

• First Submitted: December 18, 2020
• First Submitted That Met QC Criteria: December 18, 2020
• First Posted (Actual): December 21, 2020

Study Record Updates

• Last Update Posted (Actual): July 28, 2021
• Last Update Submitted That Met QC Criteria: July 27, 2021
• Last Verified: July 1, 2021

More Information

Terms related to this study

• Keywords: phonophoresis; ultrasound therapy; subacromial pain
• Additional Relevant MeSH Terms: Pathologic Processes; Wounds and Injuries; Disease; Joint Diseases; Musculoskeletal Diseases; Rupture; Shoulder Injuries; Tendon Injuries; Syndrome; Rotator Cuff Injuries; Shoulder Impingement Syndrome
• Other Study ID Numbers: 72/1185

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No