Subacromial Impingement SyndromeNCT03186287
Effectiveness of Eccentric and Concentric Strength Training in Patients With Subacromial Impingement Syndrome
A study testing Eccentric training, Concentric training and Standard physiotherapy in people with Subacromial Impingement Syndrome, run by Dokuz Eylul University at 1 site in Turkey (Türkiye).
Trial summary
The purpose of this study is to investigate and compare the effects of eccentric and concentric strength training on pain, strength, joint position sense and function in patients with subacromial impingement syndrome. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Subacromial Impingement Syndrome
- What is being tested?
- Eccentric training, Concentric training and Standard physiotherapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 21 Sep 2017to 16 Mar 2020
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of subacromial impingement syndrome
- Complaints associated with subacromial impingement syndrome for at least 3 months
- No extra pain with 90 degree abduction-90 degree external rotation position of the shoulder
- Ability to complete the entire study procedure
Who cannot join
- Severe pain; shoulder pain is > 7/10
- History of upper extremity fracture
- History of shoulder, cervical and thoracic surgery
- Having shoulder instability or frozen shoulder diagnosis
- History of shoulder injuries, trauma and / or shoulder symptoms requiring treatment during the last 1 year (except than subacromial impingement syndrome)
- Full-thickness rotator cuff tear
Show all 9Show fewer
- Systemic musculoskeletal disease
- Neck and shoulder pain with cervical spine movement
- Chest deformity or scoliosis diagnosis
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Dokuz Eylul University, School of Physical Therapy and Rehabilitation
Izmir, Balçova, 35340
About this study
Official title: Effectiveness of Eccentric and Concentric Strength Training in Patients With Subacromial Impingement Syndrome: A Randomized Controlled Trial
The purpose of this study is to investigate and compare the effects of eccentric and concentric strength training on pain, strength, joint position sense and function in patients with subacromial impingement syndrome.
- Conditions
- Subacromial Impingement Syndrome
- Being tested
- Eccentric training, Concentric training, Standard physiotherapy
- 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.
Eccentric trainingOther
Eccentric phase of resistive shoulder exercises will be performed three sets of 15 repetitions once a day for 12 weeks using therabands. Participants will be supervised by the physiotherapist 3 days a week for the first 6 weeks, 2 days a week for the next 3 weeks and 1 day a week for the last 3 weeks.
Concentric trainingOther
Concentric phase of resistive shoulder exercises will be performed three sets of 15 repetitions once a day for 12 weeks using therabands. Participants will be supervised by the physiotherapist 3 days a week for the first 6 weeks, 2 days a week for the next 3 weeks and 1 day a week for the last 3 weeks.
Standard physiotherapyOther
The participants will receive standard physiotherapy. The standard physiotherapy exercises will be supervised by the physiotherapist, same as intervention exercises.
| Study group | Role | What they receive |
|---|---|---|
| Eccentric training group | Experimental | The participants in this group will actively perform eccentric phase of resistive shoulder exercises. Additionally they will receive standard physiotherapy. Receives: Other: Eccentric training; Other: Standard physiotherapy |
| Concentric training group | Experimental | The participants in this group will actively perform concentric phase of resistive shoulder exercises. Additionally they will receive standard physiotherapy. Receives: Other: Concentric training; Other: Standard physiotherapy |
| Control group | Active comparator | The participants in this group will receive only standard physiotherapy. Receives: Other: Standard physiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Shoulder Function
Change of Constant Murley Score
Measured: Baseline, 12 weeks and 24 weeks
Secondary outcomes (5)
Pain intensity
Change of visual analog scale score in activity and rest
Measured: Baseline, 12 weeks and 24 weeks
Upper extremity function
Change of disabilities of the arm, shoulder, and hand (DASH) score
Measured: Baseline, 12 weeks and 24 weeks
Isometric strength
Change of shoulder abduction and external rotation isometric strength (in kg, with hand held dynamometer)
Measured: Baseline, 12 weeks and 24 weeks
Eccentric strength
Change of shoulder abduction and external rotation eccentric strength (in kg, with hand held dynamometer)
Measured: Baseline, 12 weeks and 24 weeks
Joint position sense
Change of shoulder joint repositioning angle errors (with bubble inclinometer)
Measured: Baseline, 12 weeks and 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jun 2017
- Study start21 Sep 2017
- Primary completion16 Mar 2020
- Study completion16 Mar 2020
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.
- 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
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dokuz Eylul University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Damla Karabay, Izmir Katip Celebi University
- Investigators
- Damla KARABAY, MSc, Principal investigator, Izmir Katip Celebi UniversitySevgi Sevi YESILYAPRAK, PhD, Study director, Dokuz Eylul UniversityMehmet ERDURAN, MD, Study director, Dokuz Eylul UniversityCem OZCAN, MD, Study director, Izmır Katip Celebi University Atatürk Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03186287
- Sponsor's protocol ID
- 2837-GOA
- Status last verified
- Apr 2020
- First submitted
- 9 Jun 2017
- Last updated
- 17 Apr 2020
- 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 17 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Eccentric and Concentric Strength Training in Patients With Subacromial Impingement Syndrome: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03186287
- Acronym / sponsor ID
- 2837-GOA
- Conditions
- Subacromial Impingement Syndrome
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Dokuz Eylul UniversityUniversity, hospital or other
- Study start
- 21 Sep 2017 (actual)
- Primary completion
- 16 Mar 2020 (actual)
- Study completion
- 16 Mar 2020 (actual)
- First posted
- 14 Jun 2017 (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.
The purpose of this study is to investigate and compare the effects of eccentric and concentric strength training on pain, strength, joint position sense and function in patients with subacromial impingement syndrome.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Eccentric training group | Experimental | Other: Eccentric training, Other: Standard physiotherapyThe participants in this group will actively perform eccentric phase of resistive shoulder exercises. Additionally they will receive standard physiotherapy. |
| Concentric training group | Experimental | Other: Concentric training, Other: Standard physiotherapyThe participants in this group will actively perform concentric phase of resistive shoulder exercises. Additionally they will receive standard physiotherapy. |
| Control group | Active comparator | Other: Standard physiotherapyThe participants in this group will receive only standard physiotherapy. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Diagnosis of subacromial impingement syndrome
- Complaints associated with subacromial impingement syndrome for at least 3 months
- No extra pain with 90 degree abduction-90 degree external rotation position of the shoulder
- Ability to complete the entire study procedure
Key exclusion criteria (9 listed)
- Severe pain; shoulder pain is > 7/10
- History of upper extremity fracture
- History of shoulder, cervical and thoracic surgery
- Having shoulder instability or frozen shoulder diagnosis
- History of shoulder injuries, trauma and / or shoulder symptoms requiring treatment during the last 1 year (except than subacromial impingement syndrome)
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 |
|---|---|---|
| Eccentric trainingEccentric phase of resistive shoulder exercises will be performed three sets of 15 repetitions once a day for 12 weeks using therabands. Participants will be supervised by the physiotherapist 3 days a week for the first 6 weeks, 2 days a week for the next 3 weeks and 1 day a week for the last 3 weeks. | Other | Eccentric training group |
| Concentric trainingConcentric phase of resistive shoulder exercises will be performed three sets of 15 repetitions once a day for 12 weeks using therabands. Participants will be supervised by the physiotherapist 3 days a week for the first 6 weeks, 2 days a week for the next 3 weeks and 1 day a week for the last 3 weeks. | Other | Concentric training group |
| Standard physiotherapyThe participants will receive standard physiotherapy. The standard physiotherapy exercises will be supervised by the physiotherapist, same as intervention exercises. | Other | Concentric training group, Control group, Eccentric training group |
Primary outcome
Shoulder Function
Time frame: Baseline, 12 weeks and 24 weeks
Change of Constant Murley Score
5 secondary outcomes
Pain intensity
Time frame: Baseline, 12 weeks and 24 weeks
Upper extremity function
Time frame: Baseline, 12 weeks and 24 weeks
Isometric strength
Time frame: Baseline, 12 weeks and 24 weeks
Eccentric strength
Time frame: Baseline, 12 weeks and 24 weeks
Joint position sense
Time frame: Baseline, 12 weeks and 24 weeks
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 17 Apr 2020.
- 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.
Damla KARABAY, MSc principal investigator
Izmir Katip Celebi University
Sevgi Sevi YESILYAPRAK, PhD study director
Dokuz Eylul University
Mehmet ERDURAN, MD study director
Dokuz Eylul 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 Eccentric training, Concentric training and Standard physiotherapy in people with Subacromial Impingement Syndrome, run by Dokuz Eylul 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 4 inclusion and 9 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 17 Apr 2020. 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 Function (time frame: Baseline, 12 weeks and 24 weeks). 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 17 Apr 2020.