Subacromial Impingement SyndromeNCT04676919
The Effect of Phonophoresis in Subacromial Impingement Syndrome.
A study testing phonophoresis therapy with pulsed mode ultrasound and phonophoresis therapy with continuous mode ultrasound in people with Subacromial Impingement Syndrome, run by Cukurova University at 1 site in Turkey (Türkiye).
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Subacromial Impingement Syndrome
- What is being tested?
- phonophoresis therapy with pulsed mode ultrasound and phonophoresis therapy with continuous mode ultrasound
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 88 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Apr 2019to 30 Jan 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- to be diagnosed as shoulder impingement syndrome,
- shoulder pain for at least one month,
- VAS score over 40mm.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Subacromial Impingement Syndrome
- Being tested
- phonophoresis therapy with pulsed mode ultrasound, phonophoresis therapy with continuous mode ultrasound, sham ultrasound
- Keywords
- subacromial pain, ultrasound therapy, phonophoresis
- Medical subject headings
- Shoulder Impingement Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
phonophoresis therapy with pulsed mode ultrasoundDevice
phonophoresis therapy with pulsed mode ultrasound, five days a week for three weeks
phonophoresis therapy with continuous mode ultrasoundDevice
phonophoresis therapy with pulsed mode ultrasound, five days a week for three weeks
sham ultrasoundDevice
sham ultrasound therapy, five days a week for three weeks
| Study group | Role | What they receive |
|---|---|---|
| pulsed mode phonophoresis group | Experimental | Phonophoresis therapy with pulsed mode ultrasound. Receives: Device: phonophoresis therapy with pulsed mode ultrasound |
| continuous mode phonophoresis group | Experimental | Phonophoresis therapy with continuous mode ultrasound. Receives: Device: phonophoresis therapy with continuous mode ultrasound |
| sham group | Sham comparator | Sham ultrasound Receives: Device: sham ultrasound |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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
Measured: 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
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.
Measured: Baseline, Change from baseline quality of life scores at three weeks, Change from baseline quality of life scores at three months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Dec 2020
- Study start1 Apr 2019
- Primary completion15 Jan 2021
- Study completion30 Jan 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Subacromial Impingement SyndromeStudies of the same condition, open and under way.
- More trials run by Cukurova UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 88 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cukurova University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Volkan Deniz, PT, Cukurova University
- Investigators
- Bayram Kelle, Assoc. Prof., Principal investigator, Cukurova University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04676919
- Sponsor's protocol ID
- 72/1185
- Status last verified
- Jul 2021
- First submitted
- 18 Dec 2020
- Last updated
- 28 Jul 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phonophoresis Therapy in Subacromial Impingement Syndrome: Comparing of Pulsed Mode Ultrasound Phonophoresis and Continuous Mode Ultrasound Phonophoresis.
- ClinicalTrials.gov ID
- NCT04676919
- Acronym / sponsor ID
- 72/1185
- Conditions
- Subacromial Impingement Syndrome
- Keywords
- subacromial pain, ultrasound therapy, phonophoresis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 88 participants (actual)
- Lead sponsor
- Cukurova UniversityUniversity, hospital or other
- Study start
- 1 Apr 2019 (actual)
- Primary completion
- 15 Jan 2021 (actual)
- Study completion
- 30 Jan 2021 (actual)
- First posted
- 21 Dec 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| pulsed mode phonophoresis group | Experimental | Device: phonophoresis therapy with pulsed mode ultrasoundPhonophoresis therapy with pulsed mode ultrasound. |
| continuous mode phonophoresis group | Experimental | Device: phonophoresis therapy with continuous mode ultrasoundPhonophoresis therapy with continuous mode ultrasound. |
| sham group | Sham comparator | Device: sham ultrasoundSham ultrasound |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- to be diagnosed as shoulder impingement syndrome,
- shoulder pain for at least one month,
- VAS score over 40mm.
Key exclusion criteria (8 listed)
- grade III supraspinatus tendon injury,
- major shoulder trauma,
- diabetes mellitus,
- hipotiroidizm,
- adhesive capsulitis,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| phonophoresis therapy with pulsed mode ultrasoundphonophoresis therapy with pulsed mode ultrasound, five days a week for three weeks | Device | pulsed mode phonophoresis group |
| phonophoresis therapy with continuous mode ultrasoundphonophoresis therapy with pulsed mode ultrasound, five days a week for three weeks | Device | continuous mode phonophoresis group |
| sham ultrasoundsham ultrasound therapy, five days a week for three weeks | Device | sham group |
Primary outcome
Visual Analog Scale
Time frame: Baseline, Change from baseline pain scores at three weeks, Change from baseline pain scores at three months
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
Time frame: Baseline, Change from baseline shoulder pain and function scores at three weeks, Change from baseline shoulder pain and function at three months
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
1 secondary outcome
Nottingham Health Profile
Time frame: Baseline, Change from baseline quality of life scores at three weeks, Change from baseline quality of life scores at three months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jul 2021.
- Individual participant dataSharing planned: No
Related trials for Subacromial Impingement Syndrome
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TECAR With Shoulder Chronic Shoulder Impingement Syndrome
Shoulder Impingement Syndrome
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Device-Assisted Balance Training for People With Shoulder Impingement
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"Effectiveness of a Telerehabilitation Program Versus a Conventional Rehabilitation Program in Patients With Subacromial Pain"
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Natural History of Shoulder Pathology in Manual Wheelchair Users
Paraplegia, Spinal Cord Injuries
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Spencer vs Positional Release Techniques for Chronic Subacromial Impingement
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bayram Kelle, Assoc. Prof. principal investigator
Cukurova University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing phonophoresis therapy with pulsed mode ultrasound and phonophoresis therapy with continuous mode ultrasound in people with Subacromial Impingement Syndrome, run by Cukurova University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual Analog Scale (time frame: Baseline, Change from baseline pain scores at three weeks, Change from baseline pain scores at three months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jul 2021.