The Effect of Phonophoresis in Subacromial Impingement Syndrome.

NCT04676919 | Completed

• 1 other identifier: 72/1185
• Study Type: interventional
• Target: 88
• Locations: 1 country
• Sites: 1

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.

Conditions

Subacromial Impingement Syndrome

Keywords

subacromial pain; ultrasound therapy; phonophoresis

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (1)

• Nottingham Health Profile

  Baseline, Change from baseline quality of life scores at three weeks, Change from baseline quality of life scores at three months

Study Arms (3)

pulsed mode phonophoresis group

EXPERIMENTAL

Phonophoresis therapy with pulsed mode ultrasound.

Device: phonophoresis therapy with pulsed mode ultrasound

continuous mode phonophoresis group

EXPERIMENTAL

Phonophoresis therapy with continuous mode ultrasound.

Device: phonophoresis therapy with continuous mode ultrasound

sham group

SHAM COMPARATOR

Sham ultrasound

Device: sham ultrasound

Interventions

phonophoresis therapy with pulsed mode ultrasound DEVICE

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

pulsed mode phonophoresis group

phonophoresis therapy with continuous mode ultrasound DEVICE

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

continuous mode phonophoresis group

sham ultrasound DEVICE

sham ultrasound therapy, five days a week for three weeks

sham group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Cukurova University: lead

Study Sites (1)

Volkan deniz

Ankara, 06560, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Shoulder Impingement Syndrome

Interventions

Phonophoresis

Condition Hierarchy (Ancestors)

Joint Diseases; Musculoskeletal Diseases; Shoulder Injuries; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Drug Administration Routes; Drug Therapy; Therapeutics

Study Officials

• Bayram Kelle, Assoc. Prof.

  Cukurova University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: sham
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MSc

Study Record Dates

• First Submitted: December 18, 2020
• First Posted: December 21, 2020
• Study Start: April 1, 2019
• Primary Completion: January 15, 2021
• Study Completion: January 30, 2021
• Last Updated: July 28, 2021

Record last verified: 2021-07

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)