Shoulder Impingement SyndromeNCT02670174
Influence of Kinetic Chain Training on the Treatment Outcome of Overhead Athletes With Impingement
A study testing Traditional training, Separate kinetic chain training and Integrated kinetic chain training in people with Shoulder Impingement Syndrome, run by University Ghent at 1 site in Belgium.
Trial summary
A randomized controlled trial will be conducted to examine the effectiveness of a traditional home exercise program versus 2 kinetic chain home exercise programs on treatment outcome of overhead athletes with shoulder impingement syndrome. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Shoulder Impingement Syndrome
- What is being tested?
- Traditional training, Separate kinetic chain training and Integrated kinetic chain training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 38 participants
- Where
- 1 siteBelgium
- Study dates
- Sep 2015to Jun 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
- Symptoms of shoulder impingement on the dominant side for at least 3 months and at least 3 of the following tests are considered positive
- Jobe
- Hawkins
- Neer
- Painful arc during elevation
- Pain or lack of force production with isometric external rotation
Show all 11Show fewer
- Apprehension test
- Relocation test
- Performing overhead sports at least 3 hours/week
- Shoulder pain interferes with sports activities
- They have not had treatment for this shoulder pain
Who cannot join
- History of shoulder dislocation or subluxation
- History of orthopedic surgery
- No complaints of pain or dysfunction in the upper limb (except impingement related complaints in the dominant shoulder), lower limb or spine at the last 6 months
- Currently taking nonsteroidal anti-inflammatory medication
- Received a steroid injection in the past 12 months
- Participating in another study
- Known systemic diseases
- Known structural diseases
Trial locations and contacts
1 site in 1 country.
Belgium1 site
Vakgroep REVAKI (Ghent University - Ghent University hospital)
Ghent, 9000
About this study
Official title: Influence of Kinetic Chain Training on the Treatment Outcome of Overhead Athletes With Shoulder Impingement Syndrome
A randomized controlled trial will be conducted to examine the effectiveness of a traditional home exercise program versus 2 kinetic chain home exercise programs on treatment outcome of overhead athletes with shoulder impingement syndrome. Primary outcome measures are reduction of pain and disability, and improvement in functionality and sports performance. Secondary outcome measures are strength, mobility, flexibility and functional performance.
Read the detailed description
Participant are randomly assigned in 3 home exercise groups.
- The traditional program: consists of solely strengthening the rotator cuff muscles and scapular muscles (e.g. external rotation)
- Separate kinetic chain program: same exercises as the first group but they also receive an exercise program to separately train the core and lower body. (e.g. external rotation separately and squat separately)
- Integrated kinetic chain program: same exercises as the first group but all exercises are performed while simultaneously activating the kinetic chain. (e.g. external rotation while squatting).
- Conditions
- Shoulder Impingement Syndrome
- Being tested
- Traditional training, Separate kinetic chain training, Integrated kinetic chain training
- Keywords
- Shoulder impingement syndrome, Overhead athletes, Kinetic chain, Exercise treatment
- 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.
Traditional trainingOther
Separate kinetic chain trainingOther
Integrated kinetic chain trainingOther
| Study group | Role | What they receive |
|---|---|---|
| Traditional training | Active comparator | A home exercise program consisting of rotator cuff and scapular muscle training will be performed during 6 weeks (4 sessions/week). To monitor progress and control load progression, a physical therapist will visit the subject every week. Receives: Other: Traditional training |
| Separate kinetic chain training | Experimental | A home exercise program consisting of traditional training exercises as well as separate exercises focusing on core and lower limb training will be performed during 6 weeks (4 sessions/week). To monitor progress and control load progression, a physical therapist will visit the subject every week. Receives: Other: Separate kinetic chain training |
| Integrated kinetic chain training | Experimental | A home exercise program consisting of traditional training exercises while integrating core and lower limb training will be performed during 6 weeks (4 sessions/week). To monitor progress and control load progression, a physical therapist will visit the subject every week. Receives: Other: Integrated kinetic chain training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in Shoulder Pain And Disability Index (SPADI) score
Patients will fill in the SPADI questionnaire to evaluate shoulder pain and function. The SPADI is a valid, reliable and frequently used questionnaire for shoulder pain patients consisting of 13 items divided in 2 subscales: pain (5 items) and disability (8 items). Each item was scored on a 10-point numeric rating scale. Total and subscale scores were summed and transformed to a score out of 100 (%) were a higher score indicates a higher level of pain and/or disability
Measured: At baseline and within one week after the 6-weeks training program
Changes in Western Ontario Shoulder Stability index (WOSI) score
The WOSI is a patient-evaluated disease-specific quality of life scoring questionnaire that has been developed for shoulder instability patients. This 21-item questionnaire consists of 4 subscales: physical symptoms (10 items), sport/recreation/work (4 items), lifestyle (4 items), and emotions (3 items). Each item was scored on a 100-mm visual analogue scale. Total and subscale scores were summed and transformed to a score out of 100 (%) where a higher score indicates more limitations in shoulder related quality of life
Measured: At baseline and within one week after the 6-weeks training program
Subjective perception of shoulder improvement
A Global Rating of Change (GROC) scale was used to quantify patient-perceived improvement of overall shoulder function after 6 weeks treatment as "improved", "unchanged" or "worse". In case they improved or got worse, the amount of change was reflected on a 5-point scale: very little change, little change, some change, a large change, a very large change. An "unchanged" condition scored 0, "improved" between 1 and 5, and "worse" between -1 and -5 points.
amount of change was scored on a 5-point scale (very little change, little change, some change, a large change, a very large change)
Measured: 6-weeks training program
Secondary outcomes (6)
Changes in shoulder muscle isokinetic strength (Biodex system 4)
Isokinetic strength of shoulder internal and external rotators will be measured bilateral with the Biodex device (Biodex system 4, Biodex Medical Systems, Inc., Shirley, New York, USA). For further analysis, concentric peak torque (PT) (rotation) or peak force (PF) (protraction-retraction) values were normalized to body weight (BW). A higher value represents more strength and thus a better outcome.
Measured: at baseline and within one week after the 6-weeks training program
Changes in shoulder scapular isokinetic strength
Isokinetic strength of scapular protraction and retraction muscles will be measured bilateral with the Biodex device (Biodex system 4, Biodex Medical Systems, Inc., Shirley, New York, USA). For further analysis, concentric peak torque (PT) (rotation) or peak force (PF) (protraction-retraction) values were normalized to body weight (BW). A higher value represents more strength and thus a better outcome.
Measured: at baseline and within one week after the 6-weeks training program
Changes in scapular dyskinesis
Scapular dyskinesis will be measured by observing the scapular movement during active elevation. For both sides (left and right), scapular dyskinesis was evaluated as being present or not. In case dyskinesis was present, the amount of dyskinesis is scored as subtle or prominent.
Measured: at baseline and within one week after the 6-weeks training program
Changes in functional tests for the upper limb measured with the Y Balance Test
The YBT-UQ is a commonly used upper extremity functional test to assess closed kinetic chain function of the stance arm while performing an open kinetic chain movement in the reaching arm. Under standardized verbal encouragement, patients stand in a three point plank position while using the free arm to push a reach indicator box as far as possible in 3 reach directions i.e. medial, inferolateral and superolateral.The average of the 3 test trials for each limb and each direction was normalized for upper limb length. Additionally, a normalized composite score per side was calculated by averaging the mean normalized test scores in the 3 reach directions. A higher scores indicates a better outcome.
Measured: at baseline and within one week after the 6-weeks training program
Return To Play (RTP)
Is it possible to return to play after 6 weeks intervention or not? In addition, following question was asked: on a scale of 0 to 100%, what is the extent to which the injured shoulder has reached the shoulder function before the injury occurred?
Measured: up to one week after the 6-weeks training program
Changes in functional tests for the upper limb measured with the Seated Medicine Ball Throw
The SMBT is an open kinetic chain functional screening test to assess bilateral upper body power and strength. The subjects were instructed to sit on the floor with the head, shoulder and back against the wall while holding a 2kg medicine ball with both arms.Participants had to throw the medicine ball forward, in a straight line and as far as possible with head, shoulders and back maintaining full wall contact. For further analysis, the mean distance of 4 test trials was calculated. A higher scores indicates a better outcome.
Measured: at baseline and within one week after the 6-weeks training program
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Feb 2016 (estimated)
- Study startSep 2015
- Primary completionJun 2018
- Study completionJun 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Shoulder Impingement SyndromeStudies of the same condition, open and under way.
- More trials run by University GhentThe 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
- Model description
- Subjects are randomly assigned in 3 parallel intervention groups. They cannot participate in 2 or more intervention groups.
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Ghent
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ann Cools, PT, PhD, Principal investigator, University Ghent
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02670174
- Sponsor's protocol ID
- 2015/0816
- Status last verified
- Dec 2023
- First submitted
- 29 Sep 2015
- Last updated
- 18 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence of Kinetic Chain Training on the Treatment Outcome of Overhead Athletes With Shoulder Impingement Syndrome
- ClinicalTrials.gov ID
- NCT02670174
- Acronym / sponsor ID
- 2015/0816
- Conditions
- Shoulder Impingement Syndrome
- Keywords
- Shoulder impingement syndrome, Overhead athletes, Kinetic chain, Exercise treatment
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 38 participants (actual)
- Lead sponsor
- University GhentUniversity, hospital or other
- Study start
- Sep 2015
- Primary completion
- Jun 2018 (actual)
- Study completion
- Jun 2018 (actual)
- First posted
- 1 Feb 2016 (estimated)
- 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.
A randomized controlled trial will be conducted to examine the effectiveness of a traditional home exercise program versus 2 kinetic chain home exercise programs on treatment outcome of overhead athletes with shoulder impingement syndrome. Primary outcome measures are reduction of pain and disability, and improvement in functionality and sports performance. Secondary outcome measures are strength, mobility, flexibility and functional performance.
Detailed description
Participant are randomly assigned in 3 home exercise groups.
- The traditional program: consists of solely strengthening the rotator cuff muscles and scapular muscles (e.g. external rotation)
- Separate kinetic chain program: same exercises as the first group but they also receive an exercise program to separately train the core and lower body. (e.g. external rotation separately and squat separately)
- Integrated kinetic chain program: same exercises as the first group but all exercises are performed while simultaneously activating the kinetic chain. (e.g. external rotation while squatting).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 3
- Model description
- Subjects are randomly assigned in 3 parallel intervention groups. They cannot participate in 2 or more intervention groups.
| Arm | Type | Receives |
|---|---|---|
| Traditional training | Active comparator | Other: Traditional trainingA home exercise program consisting of rotator cuff and scapular muscle training will be performed during 6 weeks (4 sessions/week). To monitor progress and control load progression, a physical therapist will visit the subject every week. |
| Separate kinetic chain training | Experimental | Other: Separate kinetic chain trainingA home exercise program consisting of traditional training exercises as well as separate exercises focusing on core and lower limb training will be performed during 6 weeks (4 sessions/week). To monitor progress and control load progression, a physical therapist will visit the subject every week. |
| Integrated kinetic chain training | Experimental | Other: Integrated kinetic chain trainingA home exercise program consisting of traditional training exercises while integrating core and lower limb training will be performed during 6 weeks (4 sessions/week). To monitor progress and control load progression, a physical therapist will visit the subject every week. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (11 listed)
- Symptoms of shoulder impingement on the dominant side for at least 3 months and at least 3 of the following tests are considered positive
- Performing overhead sports at least 3 hours/week
- Shoulder pain interferes with sports activities
- They have not had treatment for this shoulder pain
Key exclusion criteria (8 listed)
- History of shoulder dislocation or subluxation
- History of orthopedic surgery
- No complaints of pain or dysfunction in the upper limb (except impingement related complaints in the dominant shoulder), lower limb or spine at the last 6 months
- Currently taking nonsteroidal anti-inflammatory medication
- Received a steroid injection in the past 12 months
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 |
|---|---|---|
| Traditional training | Other | Traditional training |
| Separate kinetic chain training | Other | Separate kinetic chain training |
| Integrated kinetic chain training | Other | Integrated kinetic chain training |
Primary outcome
Changes in Shoulder Pain And Disability Index (SPADI) score
Time frame: At baseline and within one week after the 6-weeks training program
Patients will fill in the SPADI questionnaire to evaluate shoulder pain and function. The SPADI is a valid, reliable and frequently used questionnaire for shoulder pain patients consisting of 13 items divided in 2 subscales: pain (5 items) and disability (8 items). Each item was scored on a 10-point numeric rating scale. Total and subscale scores were summed and transformed to a score out of 100 (%) were a higher score indicates a higher level of pain and/or disability
Changes in Western Ontario Shoulder Stability index (WOSI) score
Time frame: At baseline and within one week after the 6-weeks training program
The WOSI is a patient-evaluated disease-specific quality of life scoring questionnaire that has been developed for shoulder instability patients. This 21-item questionnaire consists of 4 subscales: physical symptoms (10 items), sport/recreation/work (4 items), lifestyle (4 items), and emotions (3 items). Each item was scored on a 100-mm visual analogue scale. Total and subscale scores were summed and transformed to a score out of 100 (%) where a higher score indicates more limitations in shoulder related quality of life
Subjective perception of shoulder improvement
Time frame: 6-weeks training program
A Global Rating of Change (GROC) scale was used to quantify patient-perceived improvement of overall shoulder function after 6 weeks treatment as "improved", "unchanged" or "worse". In case they improved or got worse, the amount of change was reflected on a 5-point scale: very little change, little change, some change, a large change, a very large change. An "unchanged" condition scored 0, "improved" between 1 and 5, and "worse" between -1 and -5 points. amount of change was scored on a 5-point scale (very little change, little change, some change, a large change, a very large change)
6 secondary outcomes
Changes in shoulder muscle isokinetic strength (Biodex system 4)
Time frame: at baseline and within one week after the 6-weeks training program
Changes in shoulder scapular isokinetic strength
Time frame: at baseline and within one week after the 6-weeks training program
Changes in scapular dyskinesis
Time frame: at baseline and within one week after the 6-weeks training program
Changes in functional tests for the upper limb measured with the Y Balance Test
Time frame: at baseline and within one week after the 6-weeks training program
Return To Play (RTP)
Time frame: up to one week after the 6-weeks training program
Changes in functional tests for the upper limb measured with the Seated Medicine Ball Throw
Time frame: at baseline and within one week after the 6-weeks training program
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 18 Dec 2023.
- Individual participant dataSharing planned: No
Related trials for Shoulder Impingement Syndrome
Not yet recruiting
TECAR With Shoulder Chronic Shoulder Impingement Syndrome
Shoulder Impingement Syndrome
Recruiting
Device-Assisted Balance Training for People With Shoulder Impingement
Shoulder
Not yet recruiting
"Effectiveness of a Telerehabilitation Program Versus a Conventional Rehabilitation Program in Patients With Subacromial Pain"
Subacromial Impingement Syndrome
Active, not recruitingObservational study
Natural History of Shoulder Pathology in Manual Wheelchair Users
Paraplegia, Spinal Cord Injuries
Not yet recruiting
Spencer vs Positional Release Techniques for Chronic Subacromial Impingement
Chronic Subacromial Impingement Syndrome
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.
Ann Cools, PT, PhD principal investigator
University Ghent
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Traditional training, Separate kinetic chain training and Integrated kinetic chain training in people with Shoulder Impingement Syndrome, run by University Ghent at 1 site in Belgium.
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 11 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 18 Dec 2023. 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 Belgium. 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?
Changes in Shoulder Pain And Disability Index (SPADI) score (time frame: At baseline and within one week after the 6-weeks training program). The study lists 3 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 18 Dec 2023.