search
Back to results

The Effect of Phonophoresis in Subacromial Impingement Syndrome.

Primary Purpose

Subacromial Impingement Syndrome

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
phonophoresis therapy with pulsed mode ultrasound
phonophoresis therapy with continuous mode ultrasound
sham ultrasound
Sponsored by
Cukurova University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Subacromial Impingement Syndrome focused on measuring subacromial pain, ultrasound therapy, phonophoresis

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Volkan deniz

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Sham Comparator

Arm Label

pulsed mode phonophoresis group

continuous mode phonophoresis group

sham group

Arm Description

Phonophoresis therapy with pulsed mode ultrasound.

Phonophoresis therapy with continuous mode ultrasound.

Sham ultrasound

Outcomes

Primary Outcome Measures

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).
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

Secondary Outcome Measures

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.

Full Information

First Posted
December 18, 2020
Last Updated
July 27, 2021
Sponsor
Cukurova University
search

1. Study Identification

Unique Protocol Identification Number
NCT04676919
Brief Title
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

2. Study Status

Record Verification Date
July 2021
Overall Recruitment Status
Completed
Study Start Date
April 1, 2019 (Actual)
Primary Completion Date
January 15, 2021 (Actual)
Study Completion Date
January 30, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cukurova University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Subacromial Impingement Syndrome
Keywords
subacromial pain, ultrasound therapy, phonophoresis

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Masking Description
sham
Allocation
Randomized
Enrollment
88 (Actual)

8. Arms, Groups, and Interventions

Arm Title
pulsed mode phonophoresis group
Arm Type
Experimental
Arm Description
Phonophoresis therapy with pulsed mode ultrasound.
Arm Title
continuous mode phonophoresis group
Arm Type
Experimental
Arm Description
Phonophoresis therapy with continuous mode ultrasound.
Arm Title
sham group
Arm Type
Sham Comparator
Arm Description
Sham ultrasound
Intervention Type
Device
Intervention Name(s)
phonophoresis therapy with pulsed mode ultrasound
Intervention Description
phonophoresis therapy with pulsed mode ultrasound, five days a week for three weeks
Intervention Type
Device
Intervention Name(s)
phonophoresis therapy with continuous mode ultrasound
Intervention Description
phonophoresis therapy with pulsed mode ultrasound, five days a week for three weeks
Intervention Type
Device
Intervention Name(s)
sham ultrasound
Intervention Description
sham ultrasound therapy, five days a week for three weeks
Primary Outcome Measure Information:
Title
Visual Analog Scale
Description
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).
Time Frame
Baseline, Change from baseline pain scores at three weeks, Change from baseline pain scores at three months
Title
The Shortened version of Disability of the Arm, Shoulder, and Hand
Description
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
Time Frame
Baseline, Change from baseline shoulder pain and function scores at three weeks, Change from baseline shoulder pain and function at three months
Secondary Outcome Measure Information:
Title
Nottingham Health Profile
Description
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.
Time Frame
Baseline, Change from baseline quality of life scores at three weeks, Change from baseline quality of life scores at three months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bayram Kelle, Assoc. Prof.
Organizational Affiliation
Cukurova University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Volkan deniz
City
Ankara
ZIP/Postal Code
06560
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

The Effect of Phonophoresis in Subacromial Impingement Syndrome.

We'll reach out to this number within 24 hrs