Overuse Related Shoulder ProblemsNCT03476395
Sport Specific Adaptions in Female Volleyball Players
An observational study of Overuse Related Shoulder Problems, run by Zurich University of Applied Sciences at 1 site in Switzerland.
Trial summary
The shoulder joint is the second most affected body part of all overuse injuries in overhead athletes. Due to the repetitive throwing motion overhead athletes show the following characteristic adaptations of their dominant shoulder: Loss of internal rotation (IR) and gain of external rotation (ER), reduced muscle… Read more about this study
- Who is it for?
- Ages 16 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Overuse Related Shoulder Problems
- What is being tested?
- shoulder range of motion in IR/ER, strength of the IR/ER muscles and Scapular Dyskinesis Test. Core endurance test.
- How many people
- 60 participants
- Where
- 1 siteSwitzerland
- Study dates
- 1 Sep 2017to 18 Mar 2018
- Phase
- Observational
- 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 16 years and older
- Women only
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: female volleyball players from the German part of Switzerland
Who may be able to join
- female
- being member of a Nat. League B/Nat. League A Volleyball Team in season 2017/2018
- minimum age 16 years
- sufficient understanding/speaking of the German language
- signed informed consent
Who cannot join
- having had any surgery at the shoulder joint of the dominant or non- dominant side within last six month
- having had any self reported trauma at the shoulder joint of the dominant or non-dominant side, which limits training or match participation of more than 50%
- limitation of more than 50% in training or match participation caused by a surgery or trauma at the core or lower extremity
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of Sport Specific Adaptations and Risk Factors at the Shoulder Joint and Core Stability Among Female Volleyball Players With and Without Overuse Related Shoulder Symptoms
The shoulder joint is the second most affected body part of all overuse injuries in overhead athletes. Due to the repetitive throwing motion overhead athletes show the following characteristic adaptations of their dominant shoulder: Loss of internal rotation (IR) and gain of external rotation (ER), reduced muscle strength of the shoulder external rotators and scapular dyskinesis. On the one hand these adaptations are normal and necessary for a powerful throwing performance. On the other hand the amount of adaptation seems to play a crucial role in developing overuse symptoms and therefore becoming a risk factor. Most previous studies investigating throwing specific adaptations and risk factors focused on overhead sports like baseball, handball or tennis, whereas similar research in volleyball is still insufficient. Therefore the aim of this study is to evaluate if sport specific adaptations are present in female volleyball players and if yes, if there is a difference of the extent of these adaptations in volleyball players with overuse symptoms and players without.
Read the detailed description
Background The shoulder joint is the second most affected body part of all overuse injuries in overhead athletes.Prevalence of a history of shoulder problems related to overuse in volleyball players was reported to be approximately 60%. Typical overuse symptoms like pain seriously limit progress in performance and the individual career options of volleyball players.
Due to the repetitive throwing motion overhead athletes show the following characteristic adaptations of their dominant (Ds), compared to the non-dominant (NDs) shoulder: 1) Loss of internal rotation (IR) and gain of external rotation (ER), by preserving the total rotational motion (TROM). 2) Reduced muscle strength of the shoulder external rotators (ER). 3) Scapular dyskinesis. On the one hand these adaptations are normal and necessary for a powerful throwing performance. On the other hand the amount of adaptation seems to play a crucial role in developing overuse symptoms and therefore becoming a risk factor; e.g. loss of IR, also known as glenohumeral internal rotation deficit (GIRD) of more than 20° side difference, and a loss of TROM of the Ds, were defined as risk factors in baseball players. Moreover decreased muscle strength of ER (OR: 0.71 per 10N decrease) in the Ds as well as obvious scapular dyskinesis were associated with increased risk of overuse related shoulder symptoms (ORSS). Nevertheless there are still overhead athletes showing these adaptations or risk factors without being symptomatic.
Recently, several authors underlined the importance of core stability related to the kinetic chain during an overhead throwing task. It is hypothesised that symptomatic athletes may overload the shoulder girdle through altered biomechanics in an effort to compensate for insufficient power generated by the core musculature. The most reliable measurements to asses core stability components are core endurance tests.
Most previous studies investigating throwing specific adaptations and risk factors focused on overhead sports like baseball, handball or tennis, whereas similar research in volleyball is still insufficient. Moreover, no one ever investigated core endurance and its possible association with (ORSS) in volleyball players.
Objective The first aim is, to evaluate if sport specific adaptations such as IR ROM deficit, gain of ER ROM, ER strength deficit, alterations in TROM and scapular dyskinesis are present in female volleyball players and if yes, if there is a difference of the extent of these adaptations in volleyball players with ORSS and players without.
The second aim is, to evaluate if there is a difference in core endurance in volleyball players with ORSS and players without and if there is a correlation of core endurance and shoulder related risk factors such as ER strength deficit and scapular dyskinesis?
- Conditions
- Overuse Related Shoulder Problems
- Being tested
- shoulder range of motion in IR/ER, strength of the IR/ER muscles and Scapular Dyskinesis Test. Core endurance test.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
shoulder range of motion in IR/ER, strength of the IR/ER muscles and Scapular Dyskinesis Test. Core endurance test.Other
Passive shoulder range of motion using a digital application Clinometer. Isometric strength of the shoulder IR/ER using a HHD measured. Scapular Dyskinesis Test uses a visual scoring system. Core Endurance is teste by measuring the time (s).
What is being measured
The primary outcome is the main question the study is designed to answer.
isometric strength of shoulder internal and extern rotators
Isometric strength is measured in Newton (N) using a digital handheld dynamometer (HHD; Model 01165, Lafayette Instrument Company, USA). The participants are placed in supine with their shoulder in 0° abduction (ABD) a small towel roll is used to maintain the humerus in a neutral position and their elbow flexed to 90°. The forearm is fixed to the core using a fixation band. The HHD is placed on the dorsal or ventral aspect of the forearm for ER and IR, directly proximal to wrist joint line. Players are asked to perform all strength measures twice with a rest of 30 sec. between the two attempts. The mean of the two attempts is recorded.
Measured: 2017
passive glenohumeral range of motion in internal and external rotation
Glenohumeral ROM is measured in degrees (°) on both sides using a digital application Clinometer (Plaincode Software Solutions, Peter Breitling, Stephanskirchen Germany, version 4.5 (1511062) on iOS). Participants are placed supine, the shoulder positioned in 90° of abduction, a small towel roll is used to maintain the position of the humerus in neutral and their elbow is flexed to 90°. A splint is fastened around the forearm, to attach the smartphone. The assessor palpates the coracoid process with the thumb and the spine of the scapula with the fingers to control for scapular movement. The shoulder is passively moved to the end of ROM (EOR) into IR and ER. EOR of IR and ER is defined at the point at which the scapula is moving. The mean of two trials for IR and ER is used for data analysis.
Measured: 2017
scapular dyskinesis
Scapular control is evaluated using the scapular dyskinesis test (SDT). In standing position players held two dumbbells each in one hand. Players are instructed to bilaterally elevate their arms overhead as far as possible to a 3-second count with thumbs positioned upwards and then lower to a 3-second count. Five repetitions are performed while they are visually observed from posterior. The final rating classifies scapula control as normal, subtle abnormal or obvious abnormal.
Measured: 2017
Secondary outcomes (1)
core stability
Core stability is assessed using core endurance tests in seconds (s). Tests are performed in a sit up position in 60° Flexion and in side plank position on both sides. Players are instructed to hold their back and hip to the upright position for as long as possible. The test terminates, when the player is not able to hold the position anymore.
Measured: 2017
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Mar 2018
- Study start1 Sep 2017
- Primary completion30 Nov 2017
- Study completion18 Mar 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (12)Papers the sponsor has linked to this study.
- Other trials for Overuse Related Shoulder ProblemsStudies 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
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zurich University of Applied Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lydia Bucher, Zurich University of Applied Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03476395
- Sponsor's protocol ID
- 2017-00762
- Other IDs
- 2017
- Status last verified
- Mar 2018
- First submitted
- 21 Dec 2017
- Last updated
- 26 Mar 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Clarsen B, Bahr R, Heymans MW, Engedahl M, Midtsundstad G, Rosenlund L, Thorsen G, Myklebust G. The prevalence and impact of overuse injuries in five Norwegian sports: Application of a new surveillance method. Scand J Med Sci Sports. 2015 Jun;25(3):323-30. doi: 10.1111/sms.12223. Epub 2014 Mar 30.
PubMed 24684525Ruotolo C, Price E, Panchal A. Loss of total arc of motion in collegiate baseball players. J Shoulder Elbow Surg. 2006 Jan-Feb;15(1):67-71. doi: 10.1016/j.jse.2005.05.006.
PubMed 16414471Burkhart SS, Morgan CD, Kibler WB. The disabled throwing shoulder: spectrum of pathology Part I: pathoanatomy and biomechanics. Arthroscopy. 2003 Apr;19(4):404-20. doi: 10.1053/jars.2003.50128.
PubMed 12671624Borsa PA, Laudner KG, Sauers EL. Mobility and stability adaptations in the shoulder of the overhead athlete: a theoretical and evidence-based perspective. Sports Med. 2008;38(1):17-36. doi: 10.2165/00007256-200838010-00003.
PubMed 18081365Burkhart SS, Morgan CD, Kibler WB. The disabled throwing shoulder: spectrum of pathology Part III: The SICK scapula, scapular dyskinesis, the kinetic chain, and rehabilitation. Arthroscopy. 2003 Jul-Aug;19(6):641-61. doi: 10.1016/s0749-8063(03)00389-x. No abstract available.
PubMed 12861203Wilk KE, Arrigo CA, Hooks TR, Andrews JR. Rehabilitation of the Overhead Throwing Athlete: There Is More to It Than Just External Rotation/Internal Rotation Strengthening. PM R. 2016 Mar;8(3 Suppl):S78-90. doi: 10.1016/j.pmrj.2015.12.005.
PubMed 26972270Cools AM, Johansson FR, Borms D, Maenhout A. Prevention of shoulder injuries in overhead athletes: a science-based approach. Braz J Phys Ther. 2015 Sep-Oct;19(5):331-9. doi: 10.1590/bjpt-rbf.2014.0109. Epub 2015 Sep 1.
PubMed 26537804Kibler WB, Press J, Sciascia A. The role of core stability in athletic function. Sports Med. 2006;36(3):189-98. doi: 10.2165/00007256-200636030-00001.
PubMed 16526831Reeser JC, Fleisig GS, Bolt B, Ruan M. Upper limb biomechanics during the volleyball serve and spike. Sports Health. 2010 Sep;2(5):368-74. doi: 10.1177/1941738110374624.
PubMed 23015961Evans K, Refshauge KM, Adams R. Trunk muscle endurance tests: reliability, and gender differences in athletes. J Sci Med Sport. 2007 Dec;10(6):447-55. doi: 10.1016/j.jsams.2006.09.003. Epub 2006 Dec 1.
PubMed 17141568Myklebust G, Hasslan L, Bahr R, Steffen K. High prevalence of shoulder pain among elite Norwegian female handball players. Scand J Med Sci Sports. 2013 Jun;23(3):288-94. doi: 10.1111/j.1600-0838.2011.01398.x. Epub 2011 Nov 11.
PubMed 22092886Seminati E, Minetti AE. Overuse in volleyball training/practice: A review on shoulder and spine-related injuries. Eur J Sport Sci. 2013;13(6):732-43. doi: 10.1080/17461391.2013.773090. Epub 2013 Mar 5.
PubMed 24251752
Study at a glance
From the registry record, last updated by the sponsor on 26 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Sport Specific Adaptations and Risk Factors at the Shoulder Joint and Core Stability Among Female Volleyball Players With and Without Overuse Related Shoulder Symptoms
- ClinicalTrials.gov ID
- NCT03476395
- Acronym / sponsor ID
- 2017-00762
- Conditions
- Overuse Related Shoulder Problems
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Zurich University of Applied SciencesUniversity, hospital or other
- Study start
- 1 Sep 2017 (actual)
- Primary completion
- 30 Nov 2017 (actual)
- Study completion
- 18 Mar 2018 (actual)
- First posted
- 26 Mar 2018 (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 shoulder joint is the second most affected body part of all overuse injuries in overhead athletes. Due to the repetitive throwing motion overhead athletes show the following characteristic adaptations of their dominant shoulder: Loss of internal rotation (IR) and gain of external rotation (ER), reduced muscle strength of the shoulder external rotators and scapular dyskinesis. On the one hand these adaptations are normal and necessary for a powerful throwing performance. On the other hand the amount of adaptation seems to play a crucial role in developing overuse symptoms and therefore becoming a risk factor. Most previous studies investigating throwing specific adaptations and risk factors focused on overhead sports like baseball, handball or tennis, whereas similar research in volleyball is still insufficient. Therefore the aim of this study is to evaluate if sport specific adaptations are present in female volleyball players and if yes, if there is a difference of the extent of these adaptations in volleyball players with overuse symptoms and players without.
Detailed description
Background The shoulder joint is the second most affected body part of all overuse injuries in overhead athletes.Prevalence of a history of shoulder problems related to overuse in volleyball players was reported to be approximately 60%. Typical overuse symptoms like pain seriously limit progress in performance and the individual career options of volleyball players.
Due to the repetitive throwing motion overhead athletes show the following characteristic adaptations of their dominant (Ds), compared to the non-dominant (NDs) shoulder: 1) Loss of internal rotation (IR) and gain of external rotation (ER), by preserving the total rotational motion (TROM). 2) Reduced muscle strength of the shoulder external rotators (ER). 3) Scapular dyskinesis. On the one hand these adaptations are normal and necessary for a powerful throwing performance. On the other hand the amount of adaptation seems to play a crucial role in developing overuse symptoms and therefore becoming a risk factor; e.g. loss of IR, also known as glenohumeral internal rotation deficit (GIRD) of more than 20° side difference, and a loss of TROM of the Ds, were defined as risk factors in baseball players. Moreover decreased muscle strength of ER (OR: 0.71 per 10N decrease) in the Ds as well as obvious scapular dyskinesis were associated with increased risk of overuse related shoulder symptoms (ORSS). Nevertheless there are still overhead athletes showing these adaptations or risk factors without being symptomatic.
Recently, several authors underlined the importance of core stability related to the kinetic chain during an overhead throwing task. It is hypothesised that symptomatic athletes may overload the shoulder girdle through altered biomechanics in an effort to compensate for insufficient power generated by the core musculature. The most reliable measurements to asses core stability components are core endurance tests.
Most previous studies investigating throwing specific adaptations and risk factors focused on overhead sports like baseball, handball or tennis, whereas similar research in volleyball is still insufficient. Moreover, no one ever investigated core endurance and its possible association with (ORSS) in volleyball players.
Objective The first aim is, to evaluate if sport specific adaptations such as IR ROM deficit, gain of ER ROM, ER strength deficit, alterations in TROM and scapular dyskinesis are present in female volleyball players and if yes, if there is a difference of the extent of these adaptations in volleyball players with ORSS and players without.
The second aim is, to evaluate if there is a difference in core endurance in volleyball players with ORSS and players without and if there is a correlation of core endurance and shoulder related risk factors such as ER strength deficit and scapular dyskinesis?
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 16 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- female volleyball players from the German part of Switzerland
Key inclusion criteria (5 listed)
- female
- being member of a Nat. League B/Nat. League A Volleyball Team in season 2017/2018
- minimum age 16 years
- sufficient understanding/speaking of the German language
- signed informed consent
Key exclusion criteria (3 listed)
- having had any surgery at the shoulder joint of the dominant or non- dominant side within last six month
- having had any self reported trauma at the shoulder joint of the dominant or non-dominant side, which limits training or match participation of more than 50%
- limitation of more than 50% in training or match participation caused by a surgery or trauma at the core or lower extremity
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 |
|---|---|---|
| shoulder range of motion in IR/ER, strength of the IR/ER muscles and Scapular Dyskinesis Test. Core endurance test.Passive shoulder range of motion using a digital application Clinometer. Isometric strength of the shoulder IR/ER using a HHD measured. Scapular Dyskinesis Test uses a visual scoring system. Core Endurance is teste by measuring the time (s). | Other | – |
Primary outcome
isometric strength of shoulder internal and extern rotators
Time frame: 2017
Isometric strength is measured in Newton (N) using a digital handheld dynamometer (HHD; Model 01165, Lafayette Instrument Company, USA). The participants are placed in supine with their shoulder in 0° abduction (ABD) a small towel roll is used to maintain the humerus in a neutral position and their elbow flexed to 90°. The forearm is fixed to the core using a fixation band. The HHD is placed on the dorsal or ventral aspect of the forearm for ER and IR, directly proximal to wrist joint line. Players are asked to perform all strength measures twice with a rest of 30 sec. between the two attempts. The mean of the two attempts is recorded.
passive glenohumeral range of motion in internal and external rotation
Time frame: 2017
Glenohumeral ROM is measured in degrees (°) on both sides using a digital application Clinometer (Plaincode Software Solutions, Peter Breitling, Stephanskirchen Germany, version 4.5 (1511062) on iOS). Participants are placed supine, the shoulder positioned in 90° of abduction, a small towel roll is used to maintain the position of the humerus in neutral and their elbow is flexed to 90°. A splint is fastened around the forearm, to attach the smartphone. The assessor palpates the coracoid process with the thumb and the spine of the scapula with the fingers to control for scapular movement. The shoulder is passively moved to the end of ROM (EOR) into IR and ER. EOR of IR and ER is defined at the point at which the scapula is moving. The mean of two trials for IR and ER is used for data analysis.
scapular dyskinesis
Time frame: 2017
Scapular control is evaluated using the scapular dyskinesis test (SDT). In standing position players held two dumbbells each in one hand. Players are instructed to bilaterally elevate their arms overhead as far as possible to a 3-second count with thumbs positioned upwards and then lower to a 3-second count. Five repetitions are performed while they are visually observed from posterior. The final rating classifies scapula control as normal, subtle abnormal or obvious abnormal.
1 secondary outcome
core stability
Time frame: 2017
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 26 Mar 2018.
- Background: PubMed 24684525Clarsen B, Bahr R, Heymans MW, Engedahl M, Midtsundstad G, Rosenlund L, Thorsen G, Myklebust G. The prevalence and impact of overuse injuries in five Norwegian sports: Application of a new surveillance method. Scand J Med Sci Sports. 2015 Jun;25(3):323-30. doi: 10.1111/sms.12223. Epub 2014 Mar 30.
- Background: PubMed 16414471Ruotolo C, Price E, Panchal A. Loss of total arc of motion in collegiate baseball players. J Shoulder Elbow Surg. 2006 Jan-Feb;15(1):67-71. doi: 10.1016/j.jse.2005.05.006.
- Background: PubMed 12671624Burkhart SS, Morgan CD, Kibler WB. The disabled throwing shoulder: spectrum of pathology Part I: pathoanatomy and biomechanics. Arthroscopy. 2003 Apr;19(4):404-20. doi: 10.1053/jars.2003.50128.
- Background: PubMed 18081365Borsa PA, Laudner KG, Sauers EL. Mobility and stability adaptations in the shoulder of the overhead athlete: a theoretical and evidence-based perspective. Sports Med. 2008;38(1):17-36. doi: 10.2165/00007256-200838010-00003.
- Background: PubMed 12861203Burkhart SS, Morgan CD, Kibler WB. The disabled throwing shoulder: spectrum of pathology Part III: The SICK scapula, scapular dyskinesis, the kinetic chain, and rehabilitation. Arthroscopy. 2003 Jul-Aug;19(6):641-61. doi: 10.1016/s0749-8063(03)00389-x. No abstract available.
- Background: PubMed 26972270Wilk KE, Arrigo CA, Hooks TR, Andrews JR. Rehabilitation of the Overhead Throwing Athlete: There Is More to It Than Just External Rotation/Internal Rotation Strengthening. PM R. 2016 Mar;8(3 Suppl):S78-90. doi: 10.1016/j.pmrj.2015.12.005.
- Background: PubMed 26537804Cools AM, Johansson FR, Borms D, Maenhout A. Prevention of shoulder injuries in overhead athletes: a science-based approach. Braz J Phys Ther. 2015 Sep-Oct;19(5):331-9. doi: 10.1590/bjpt-rbf.2014.0109. Epub 2015 Sep 1.
- Background: PubMed 16526831Kibler WB, Press J, Sciascia A. The role of core stability in athletic function. Sports Med. 2006;36(3):189-98. doi: 10.2165/00007256-200636030-00001.
- Background: PubMed 23015961Reeser JC, Fleisig GS, Bolt B, Ruan M. Upper limb biomechanics during the volleyball serve and spike. Sports Health. 2010 Sep;2(5):368-74. doi: 10.1177/1941738110374624.
- Background: PubMed 17141568Evans K, Refshauge KM, Adams R. Trunk muscle endurance tests: reliability, and gender differences in athletes. J Sci Med Sport. 2007 Dec;10(6):447-55. doi: 10.1016/j.jsams.2006.09.003. Epub 2006 Dec 1.
- Background: PubMed 22092886Myklebust G, Hasslan L, Bahr R, Steffen K. High prevalence of shoulder pain among elite Norwegian female handball players. Scand J Med Sci Sports. 2013 Jun;23(3):288-94. doi: 10.1111/j.1600-0838.2011.01398.x. Epub 2011 Nov 11.
- Background: PubMed 24251752Seminati E, Minetti AE. Overuse in volleyball training/practice: A review on shoulder and spine-related injuries. Eur J Sport Sci. 2013;13(6):732-43. doi: 10.1080/17461391.2013.773090. Epub 2013 Mar 5.
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?
An observational study of Overuse Related Shoulder Problems, run by Zurich University of Applied Sciences at 1 site in Switzerland.
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 5 inclusion and 3 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 26 Mar 2018. 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 Switzerland. 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?
isometric strength of shoulder internal and extern rotators (time frame: 2017). 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?
On the ClinicalTrials.gov record for NCT03476395, which also lists 12 linked publications.
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 26 Mar 2018.