Subacromial Impingement SyndromeNCT04057170
Manual Therapy Versus Conventional Rehabilitation Protocol on Subacromial Pain Syndrome
A study testing accelerated protocol and mulligan method in people with Subacromial Impingement Syndrome, run by Cukurova University at 1 site in Turkey (Türkiye).
Trial summary
This study compares the periodic effects of Accelerated rehabilitation protocol (ARP) and Mulligan mobilization with mowement method (MWM) in subacromial pain syndrome patients rehabilitation. Half of the participants will receive ARP, while the other half will receive MWM. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Subacromial Impingement Syndrome
- What is being tested?
- accelerated protocol and mulligan method
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Mar 2018to 30 Nov 2018
- 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 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- to be in the 18-60 age range, to be cooperative during evaluation and treatment and to accept to participate in the study
Who cannot join
- the presence of adhesive capsulitis, surgical indication or shoulder surgery, cervicothoracic problems (such as stenosis and disc herniation) diagnosed as neurological or inflammatory joint diseases
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of the Effects of Mulligan Mobilization With Movement Method and Accelerated Rehabilitation Protocol on Shoulder Pain and Functions in Subacromial Pain Syndrome: A Randomized Single Blind Trial
This study compares the periodic effects of Accelerated rehabilitation protocol (ARP) and Mulligan mobilization with mowement method (MWM) in subacromial pain syndrome patients rehabilitation. Half of the participants will receive ARP, while the other half will receive MWM.
- Conditions
- Subacromial Impingement Syndrome
- Being tested
- accelerated protocol and mulligan method
- Keywords
- shoulder pain
- Medical subject headings
- Shoulder Impingement Syndrome, Shoulder Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
accelerated protocol and mulligan methodOther
manual therapy technic
| Study group | Role | What they receive |
|---|---|---|
| mulligan method | Experimental | Mulligan mobilization with mowement method every three days for six weeks Receives: Other: accelerated protocol and mulligan method |
| accelerated protocol | Experimental | accelerated rehabilitation protocol every three days for six weeks Receives: Other: accelerated protocol and mulligan method |
What is being measured
The primary outcome is the main question the study is designed to answer.
Shoulder Pain and Disability Index
It consists of 13 questions in two sections as 5 pain questions and 8 disability questions. Both sections are scored with VAS. The total score range is between 0-130 and it is calculated with the percentage score. Pain and disability are inversely proportional with the percentage score
Measured: two weeks
Visual Analogue Scale
to record pain intensity during rest and active shoulder movements. The patient is asked to mark the point corresponding to the pain (0 no pain and 10 maximal pain) on 10 cm horizontal line. The distance between the marked point and the beginning is recorded as a pain score
Measured: two weeks
Active Range of Motion measurement
Conventional goniometer with 1° increments is used to determine shoulder limitations due to pain in patients
Measured: two weeks
Subacromial Interval Measurement
Subacromial interval measurement was performed via anterior-posterior shoulder radiography
Measured: six weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2019
- Study start1 Mar 2018
- Primary completion1 Oct 2018
- Study completion30 Nov 2018
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
- Outcomes assessor
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cukurova University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Volkan Deniz, PT, Cukurova University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04057170
- Sponsor's protocol ID
- 0
- Status last verified
- Aug 2019
- First submitted
- 13 Aug 2019
- Last updated
- 15 Aug 2019
- Results posted
- No
- Data monitoring committee
- Yes
- 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 15 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Effects of Mulligan Mobilization With Movement Method and Accelerated Rehabilitation Protocol on Shoulder Pain and Functions in Subacromial Pain Syndrome: A Randomized Single Blind Trial
- ClinicalTrials.gov ID
- NCT04057170
- Acronym / sponsor ID
- 0
- Conditions
- Subacromial Impingement Syndrome
- Keywords
- shoulder pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Cukurova UniversityUniversity, hospital or other
- Study start
- 1 Mar 2018 (actual)
- Primary completion
- 1 Oct 2018 (actual)
- Study completion
- 30 Nov 2018 (actual)
- First posted
- 15 Aug 2019 (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.
This study compares the periodic effects of Accelerated rehabilitation protocol (ARP) and Mulligan mobilization with mowement method (MWM) in subacromial pain syndrome patients rehabilitation. Half of the participants will receive ARP, while the other half will receive MWM.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| mulligan method | Experimental | Other: accelerated protocol and mulligan methodMulligan mobilization with mowement method every three days for six weeks |
| accelerated protocol | Experimental | Other: accelerated protocol and mulligan methodaccelerated rehabilitation protocol every three days for six weeks |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- to be in the 18-60 age range, to be cooperative during evaluation and treatment and to accept to participate in the study
Key exclusion criteria (1 listed)
- the presence of adhesive capsulitis, surgical indication or shoulder surgery, cervicothoracic problems (such as stenosis and disc herniation) diagnosed as neurological or inflammatory joint diseases
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 |
|---|---|---|
| accelerated protocol and mulligan methodmanual therapy technic | Other | accelerated protocol, mulligan method |
Primary outcome
Shoulder Pain and Disability Index
Time frame: two weeks
It consists of 13 questions in two sections as 5 pain questions and 8 disability questions. Both sections are scored with VAS. The total score range is between 0-130 and it is calculated with the percentage score. Pain and disability are inversely proportional with the percentage score
Visual Analogue Scale
Time frame: two weeks
to record pain intensity during rest and active shoulder movements. The patient is asked to mark the point corresponding to the pain (0 no pain and 10 maximal pain) on 10 cm horizontal line. The distance between the marked point and the beginning is recorded as a pain score
Active Range of Motion measurement
Time frame: two weeks
Conventional goniometer with 1° increments is used to determine shoulder limitations due to pain in patients
Subacromial Interval Measurement
Time frame: six weeks
Subacromial interval measurement was performed via anterior-posterior shoulder radiography
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 15 Aug 2019.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing accelerated protocol and mulligan method 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 1 inclusion and 1 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 15 Aug 2019. 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. 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?
Shoulder Pain and Disability Index (time frame: two weeks). The study lists 4 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 15 Aug 2019.