Shoulder Dislocation or SubluxationROTOFUNCNCT06261645
Rotofunc - Non-traumatic Shoulder Instability and Total Rotator Cuff Function
A study testing Early Physiotherapist selected active exercises and Delayed Physiotherapist selected active exercises in people with Shoulder Dislocation or Subluxation, run by Sahlgrenska University Hospital at 1 site in Sweden.
Trial summary
The goal of this clinical trial is to test the effect of a novel assessment and treatment strategy for young adults with severely disabling non-traumatic shoulder instability. The main question it aims to answer is if this treatment will substantially change the patients shoulder function to a more stable and… Read more about this study
- Who is it for?
- Ages 16 to 35 years
- Conditions the study is for
- Shoulder Dislocation or Subluxation
- What is being tested?
- Early Physiotherapist selected active exercises and Delayed Physiotherapist selected active exercises
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteSweden
- Study dates
- 1 May 2023to Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 to 35 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- young adults, non traumatic as well as non-controllable, positional, functional shoulder instability according to Moroder et al. demonstrating a lack of ≥ 20%, active, dynamic control compared with the total passive range of motion in shoulder rotation with or without previous shoulder stabilizing surgery
- Understanding the Swedish language well, in speaking, in reading and writing.
Who cannot join
- Other significant shoulder pathologies, patients diagnosed with severe systemic connective tissue, congenital anatomic abnormalities, or psychiatric diagnoses according to previous medical records
- <60% adherence to assigned exercises
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Emil Steen, BSc contact
Sweden1 site, 1 recruiting
- Recruiting
Sahlgrenska University Hospital/Mölndal, Physiotherapy Dpt
Gothenburg, Mölndal, SE 43180
Ingrid K Hultenheim Klintberg, PhD, ingrid.hultenheim-klintberg@vgregion.se
About this study
Official title: ROTOFUNC - a Randomized and Controlled Study to Evaluate the Effect of a Novel Assessment and Treatment Strategy for Patients With Non-traumatic Shoulder Instability
The goal of this clinical trial is to test the effect of a novel assessment and treatment strategy for young adults with severely disabling non-traumatic shoulder instability. The main question it aims to answer is if this treatment will substantially change the patients shoulder function to a more stable and controllable state and thereby give a higher quality of life. Participants failure in active shoulder muscle function will be assessed and exercises will be selected individually. Patients will be asked to perform the exercises twice per day. At clinical visits to a specialized physiotherapist the exercises will be upgraded to restore full dynamic stability throughout shoulder movement range. The active treatment period will be 4 months. Researchers will compare two groups. One group will start directly after a baseline assessment is fulfilled. The other group will receive the treatment with a delay of 4 months to evaluate if the selected exercises can substantially change the shoulder stability compared to no treatment, the natural course of the condition.
Read the detailed description
Impaired shoulder function and pain results in decreased quality-of-life, reduced working capacity and affect both society and individuals with high costs. Young adults with non-traumatic shoulder instability are one of the most difficult patient groups to treat. Surgery has previously been the treatment offered for these patients. Today, surgery is more and more questioned and physiotherapy and now active exercises are suggested to be the first - line of treatment.
A novel physiotherapy treatment strategy has been developed during the recent years.
The intervention is based on an entirely updated mode to assess and restore shoulder muscle function. The development has been initiated by new data from EMG- studies that has given a deepened understanding of the complex stabilizing muscle function of the shoulder. The hypothesis is that the main stabilizing muscles, the rotator cuff has by franc dislocations, subluxations and pain lost its rapidness, precision, and endurance to keep the humeral head stabilized and centered within the glenoid fossa.
The hypothesis is that with restored, full rotator cuff function, i. e. a rotator cuff able to perform its stabilizing role and the mover role into the extremes of the range of motion, where the fibers act from their most shortened to their most lengthened positions and during concentric as well as eccentric muscle action, will regain the sense of shoulder stability, pain-free shoulder function and higher quality-of-life.
The purpose of this study is to evaluate the effect of this new active exercise-based intervention in patients with non-traumatic shoulder instability.
Methods: A total of 100 patients randomly be allocated into two different groups, Early start and Delayed start. Both groups will receive the same 16-week physiotherapy supervised exercise program, however the latter group with a delay of four months.
The primary outcome is assessment of neuromuscular control during active rotation movements documented with video. The range of motion is measured, and sway and steadiness are graded. The secondary outcomes include: 1) active and passive range of motion; 2) shoulder pain at rest using an 11-graded numeric rating scale; 3) Pain during motion, and 4) Apprehension during motion using Patient Specific Functional Scale; 5) Quality-of-life will be assessed using Western Ontario Shoulder Instability Index (WOSI) Patients will be assessed by one of two independent investigators at baseline (second baseline if Delayed Start), 6 weeks, 4 and 12 months. At 4 and 12 months also Patient's Satisfaction of being treated with the novel strategy will be assessed.
The statistical analysis will assess change over time and differences between groups using ANOVA and Tukey's PostHoc-test as well as Kruskal- Wallis and Mann-Whitney-U test with the significant level was set at 0.05.
- Conditions
- Shoulder Dislocation or Subluxation
- Being tested
- Early Physiotherapist selected active exercises, Delayed Physiotherapist selected active exercises
- Keywords
- physiotherapy, muscle control, non-surgical
- Medical subject headings
- Shoulder Dislocation, Joint Dislocations
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Early Physiotherapist selected active exercisesOther
Exercises to restore total rotator cuff function selected and progressed according to patients performance. Performance is assessed by the physiotherapist regarding available range of motion, comfort during as well as pain-free performance.
Education on shoulder muscles functional anatomy and on effect of pain on muscle performance
Delayed Physiotherapist selected active exercisesOther
Exercises to restore total rotator cuff function selected and progressed according to patients performance. Performance is assessed by the physiotherapist regarding available range of motion, comfort during as well as pain-free performance.
Education on shoulder muscles functional anatomy and on effect of pain on muscle performance
| Study group | Role | What they receive |
|---|---|---|
| Early start | Experimental | According to result from the random allocation patients in Early Start will initiate their treatment within two weeks following the Baseline assessment.The intervention consists of a 16 week exercise program with specific exercises to restore total rotator cuff function individually selected during clinical physiotherapy visits and performed 2 - 4 times daily.
According to progression, a mean of 10 visits are anticipated over the 16 weeks In addition, the patient will receive education and guidance in the daily use of the arm to adjust to appropriate load on the shoulder. Receives: Other: Early Physiotherapist selected active exercises |
| Delayed start | Experimental | According to result from the random allocation patients in Delayed Start will delay the start of their treatment with 16 weeks.
Participants in Delayed Start will undergo the same Baseline assessment a second time, and initiate their treatment within 2 weeks thereafter. The intervention consists of a 16 week exercise program with specific exercises to restore total rotator cuff function individually selected during clinical physiotherapy visits and performed 2 - 4 times daily.
According to progression, a mean of 10 visits are anticipated over the 16 weeks In addition, the patient will receive education and guidance in the daily use of the arm to adjust to appropriate load on the shoulder. Receives: Other: Delayed Physiotherapist selected active exercises |
What is being measured
The primary outcome is the main question the study is designed to answer.
Neuromuscular control
Available range of motion during shoulder rotation during 8 different test situations, in prone and in supine with support and without support for the upper arm (degrees). The performance, sway and halting during motion, will be graded using a Likert scale: no deviation, small deviation, medium- or important deviation from optimal non-symptomatic shoulder function.
Measured: Baseline One, Baseline Two (Delayed start,DS), 4 and 12 months
Secondary outcomes (6)
Clinical assessment - Active and passive range of motion
will be assessed in standing and in lying supine in both shoulders. Flexion, abduction and external and internal rotation with shoulders at 90° abduction.
Measured: Baseline One, Baseline Two (DS), 4 and 12 months
Pain at rest
- during the last week will be assessed using an 11-graded numeric rating scale (NRS).
Measured: Baseline One, Baseline Two (DS) 6 weeks, 4 and 12 months
Pain during motion
Four activities that affect the patients every-day life will be selected and assessed using Patient Specific Functional scale, each graded 0 -10, with a higher score indicating higher, better function.
Measured: Baseline One, Baseline Two (DS) 6 weeks, 4 and 12 months
Apprehension of instability during motion
Four activities that affects the patients every-day life by discomfort and apprehension will be selected and assessed using Patient Specific Functional scale, each graded 0 -10, with a higher score indicating higher, better function.
Measured: Baseline One, Baseline Two (DS) 6 weeks, 4 and 12 months
Patient reported quality-of-life in relation to shoulder function
- will be assessed using Western Ontario Shoulder Instability Index [9]. The questionnaire consists of 21 items. Patients rate their percieved function for each item using Visual Analogue Scales, 0 - 100 mm, with a lower score indicating better function. The result of the total score is presented in percentage of full (100%) shoulder function i.e. perceived quality of life using related to shoulder function. Higher percent indicates better function.
Measured: Baseline One, Baseline Two (DS) 6 weeks, 4 and 12 months
Patient's satisfaction
- of being treated according to the novel concept will be assessed using a five-graded Likert scale: Very dissatisfied; Dissatisfied; neither dissatisfied nor satisfied; Satisfied and Very satisfied.
As well as: Would you recommend this treatment concept to a friend or relative with similar shoulder dysfunction as yours?, will be assessed using the three response options: Yes, No, or Do not know
Measured: At 4 and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2024
- Study start1 May 2023
- Primary completionDec 2025 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (13)Papers the sponsor has linked to this study.
- Other trials for Shoulder Dislocation or SubluxationStudies 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
- Sequential
- Model description
- A 16 week exercise program with specific exercises to restore total rotator cuff function individually selected during clinical physiotherapy visits and performed 2 - 4 times daily. In addition, the patient will receive education and guidance in the daily use of the arm to adjust to appropriate load on the shoulder.
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sahlgrenska University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ingrid Hultenheim Klintberg, Sahlgrenska University Hospital
- Investigators
- Monika Fagevik Olsén, Professor, Principal investigator, Sahlgrenska Academy, Inst Neuroscience and Physiology/Physiotherapy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06261645
- Sponsor's protocol ID
- ROTOFUNK_2_2023
- Acronym
- ROTOFUNC
- Status last verified
- Mar 2024
- First submitted
- 7 Feb 2024
- Last updated
- 8 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Williamson A, Hoggart B. Pain: a review of three commonly used pain rating scales. J Clin Nurs. 2005 Aug;14(7):798-804. doi: 10.1111/j.1365-2702.2005.01121.x.
PubMed 16000093Boettcher CE, Ginn KA, Cathers I. Which is the optimal exercise to strengthen supraspinatus? Med Sci Sports Exerc. 2009 Nov;41(11):1979-83. doi: 10.1249/MSS.0b013e3181a740a7.
PubMed 19812522Moroder P, Danzinger V, Maziak N, Plachel F, Pauly S, Scheibel M, Minkus M. Characteristics of functional shoulder instability. J Shoulder Elbow Surg. 2020 Jan;29(1):68-78. doi: 10.1016/j.jse.2019.05.025. Epub 2019 Aug 1.
PubMed 31378683Boettcher CE, Cathers I, Ginn KA. The role of shoulder muscles is task specific. J Sci Med Sport. 2010 Nov;13(6):651-6. doi: 10.1016/j.jsams.2010.03.008. Epub 2010 May 7.
PubMed 20452282Dark A, Ginn KA, Halaki M. Shoulder muscle recruitment patterns during commonly used rotator cuff exercises: an electromyographic study. Phys Ther. 2007 Aug;87(8):1039-46. doi: 10.2522/ptj.20060068. Epub 2007 Jun 19.
PubMed 17578940Dube JA, Mercier C. Effect of pain and pain expectation on primary motor cortex excitability. Clin Neurophysiol. 2011 Nov;122(11):2318-23. doi: 10.1016/j.clinph.2011.03.026. Epub 2011 May 20.
PubMed 21601513Jaggi A, Herbert RD, Alexander S, Majed A, Butt D, Higgs D, Rudge W, Ginn KA. Arthroscopic capsular shift surgery in patients with atraumatic shoulder joint instability: a randomised, placebo-controlled trial. Br J Sports Med. 2023 Dec;57(23):1484-1489. doi: 10.1136/bjsports-2022-106596. Epub 2023 Jun 12.
PubMed 37308285Ginn KA, Cathers I, Boettcher C, Halaki M. Analysis of phase detects altered timing of muscle activation in subjects with chronic shoulder pain. J Electromyogr Kinesiol. 2022 Feb;62:102621. doi: 10.1016/j.jelekin.2021.102621. Epub 2021 Nov 22.
PubMed 34847442Gajdosik RL, Bohannon RW. Clinical measurement of range of motion. Review of goniometry emphasizing reliability and validity. Phys Ther. 1987 Dec;67(12):1867-72. doi: 10.1093/ptj/67.12.1867.
PubMed 3685114Kirkley A, Griffin S, McLintock H, Ng L. The development and evaluation of a disease-specific quality of life measurement tool for shoulder instability. The Western Ontario Shoulder Instability Index (WOSI). Am J Sports Med. 1998 Nov-Dec;26(6):764-72. doi: 10.1177/03635465980260060501.
PubMed 9850776Nazari G, Bobos P, Lu Z, Reischl S, MacDermid JC. Psychometric properties of Patient-Specific Functional Scale in patients with upper extremity disorders. A systematic review. Disabil Rehabil. 2022 Jun;44(13):2958-2967. doi: 10.1080/09638288.2020.1851784. Epub 2020 Dec 8.
PubMed 33290102Wattanaprakornkul D, Halaki M, Cathers I, Ginn KA. Direction-specific recruitment of rotator cuff muscles during bench press and row. J Electromyogr Kinesiol. 2011 Dec;21(6):1041-9. doi: 10.1016/j.jelekin.2011.09.002. Epub 2011 Oct 5.
PubMed 21978788Wattanaprakornkul D, Cathers I, Halaki M, Ginn KA. The rotator cuff muscles have a direction specific recruitment pattern during shoulder flexion and extension exercises. J Sci Med Sport. 2011 Sep;14(5):376-82. doi: 10.1016/j.jsams.2011.01.001. Epub 2011 Feb 17.
PubMed 21333595
Study at a glance
From the registry record, last updated by the sponsor on 8 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ROTOFUNC - a Randomized and Controlled Study to Evaluate the Effect of a Novel Assessment and Treatment Strategy for Patients With Non-traumatic Shoulder Instability
- ClinicalTrials.gov ID
- NCT06261645
- Acronym / sponsor ID
- ROTOFUNC / ROTOFUNK_2_2023
- Conditions
- Shoulder Dislocation or Subluxation
- Keywords
- physiotherapy, muscle control, non-surgical
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Sahlgrenska University HospitalUniversity, hospital or other
- Study start
- 1 May 2023 (actual)
- Primary completion
- Dec 2025 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 15 Feb 2024 (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 goal of this clinical trial is to test the effect of a novel assessment and treatment strategy for young adults with severely disabling non-traumatic shoulder instability. The main question it aims to answer is if this treatment will substantially change the patients shoulder function to a more stable and controllable state and thereby give a higher quality of life. Participants failure in active shoulder muscle function will be assessed and exercises will be selected individually. Patients will be asked to perform the exercises twice per day. At clinical visits to a specialized physiotherapist the exercises will be upgraded to restore full dynamic stability throughout shoulder movement range. The active treatment period will be 4 months. Researchers will compare two groups. One group will start directly after a baseline assessment is fulfilled. The other group will receive the treatment with a delay of 4 months to evaluate if the selected exercises can substantially change the shoulder stability compared to no treatment, the natural course of the condition.
Detailed description
Impaired shoulder function and pain results in decreased quality-of-life, reduced working capacity and affect both society and individuals with high costs. Young adults with non-traumatic shoulder instability are one of the most difficult patient groups to treat. Surgery has previously been the treatment offered for these patients. Today, surgery is more and more questioned and physiotherapy and now active exercises are suggested to be the first - line of treatment.
A novel physiotherapy treatment strategy has been developed during the recent years.
The intervention is based on an entirely updated mode to assess and restore shoulder muscle function. The development has been initiated by new data from EMG- studies that has given a deepened understanding of the complex stabilizing muscle function of the shoulder. The hypothesis is that the main stabilizing muscles, the rotator cuff has by franc dislocations, subluxations and pain lost its rapidness, precision, and endurance to keep the humeral head stabilized and centered within the glenoid fossa.
The hypothesis is that with restored, full rotator cuff function, i. e. a rotator cuff able to perform its stabilizing role and the mover role into the extremes of the range of motion, where the fibers act from their most shortened to their most lengthened positions and during concentric as well as eccentric muscle action, will regain the sense of shoulder stability, pain-free shoulder function and higher quality-of-life.
The purpose of this study is to evaluate the effect of this new active exercise-based intervention in patients with non-traumatic shoulder instability.
Methods: A total of 100 patients randomly be allocated into two different groups, Early start and Delayed start. Both groups will receive the same 16-week physiotherapy supervised exercise program, however the latter group with a delay of four months.
The primary outcome is assessment of neuromuscular control during active rotation movements documented with video. The range of motion is measured, and sway and steadiness are graded. The secondary outcomes include: 1) active and passive range of motion; 2) shoulder pain at rest using an 11-graded numeric rating scale; 3) Pain during motion, and 4) Apprehension during motion using Patient Specific Functional Scale; 5) Quality-of-life will be assessed using Western Ontario Shoulder Instability Index (WOSI) Patients will be assessed by one of two independent investigators at baseline (second baseline if Delayed Start), 6 weeks, 4 and 12 months. At 4 and 12 months also Patient's Satisfaction of being treated with the novel strategy will be assessed.
The statistical analysis will assess change over time and differences between groups using ANOVA and Tukey's PostHoc-test as well as Kruskal- Wallis and Mann-Whitney-U test with the significant level was set at 0.05.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- A 16 week exercise program with specific exercises to restore total rotator cuff function individually selected during clinical physiotherapy visits and performed 2 - 4 times daily. In addition, the patient will receive education and guidance in the daily use of the arm to adjust to appropriate load on the shoulder.
| Arm | Type | Receives |
|---|---|---|
| Early start | Experimental | Other: Early Physiotherapist selected active exercisesAccording to result from the random allocation patients in Early Start will initiate their treatment within two weeks following the Baseline assessment.The intervention consists of a 16 week exercise program with specific exercises to restore total rotator cuff function individually selected during clinical physiotherapy visits and performed 2 - 4 times daily. According to progression, a mean of 10 visits are anticipated over the 16 weeks In addition, the patient will receive education and guidance in the daily use of the arm to adjust to appropriate load on the shoulder. |
| Delayed start | Experimental | Other: Delayed Physiotherapist selected active exercisesAccording to result from the random allocation patients in Delayed Start will delay the start of their treatment with 16 weeks. Participants in Delayed Start will undergo the same Baseline assessment a second time, and initiate their treatment within 2 weeks thereafter. The intervention consists of a 16 week exercise program with specific exercises to restore total rotator cuff function individually selected during clinical physiotherapy visits and performed 2 - 4 times daily. According to progression, a mean of 10 visits are anticipated over the 16 weeks In addition, the patient will receive education and guidance in the daily use of the arm to adjust to appropriate load on the shoulder. |
Who may qualify
- Ages
- 16 to 35 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- young adults, non traumatic as well as non-controllable, positional, functional shoulder instability according to Moroder et al. demonstrating a lack of ≥ 20%, active, dynamic control compared with the total passive range of motion in shoulder rotation with or without previous shoulder stabilizing surgery
- Understanding the Swedish language well, in speaking, in reading and writing.
Key exclusion criteria (2 listed)
- Other significant shoulder pathologies, patients diagnosed with severe systemic connective tissue, congenital anatomic abnormalities, or psychiatric diagnoses according to previous medical records
- <60% adherence to assigned exercises
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 |
|---|---|---|
| Early Physiotherapist selected active exercisesExercises to restore total rotator cuff function selected and progressed according to patients performance. Performance is assessed by the physiotherapist regarding available range of motion, comfort during as well as pain-free performance. Education on shoulder muscles functional anatomy and on effect of pain on muscle performance | Other | Early start |
| Delayed Physiotherapist selected active exercisesExercises to restore total rotator cuff function selected and progressed according to patients performance. Performance is assessed by the physiotherapist regarding available range of motion, comfort during as well as pain-free performance. Education on shoulder muscles functional anatomy and on effect of pain on muscle performance | Other | Delayed start |
Primary outcome
Neuromuscular control
Time frame: Baseline One, Baseline Two (Delayed start,DS), 4 and 12 months
Available range of motion during shoulder rotation during 8 different test situations, in prone and in supine with support and without support for the upper arm (degrees). The performance, sway and halting during motion, will be graded using a Likert scale: no deviation, small deviation, medium- or important deviation from optimal non-symptomatic shoulder function.
6 secondary outcomes
Clinical assessment - Active and passive range of motion
Time frame: Baseline One, Baseline Two (DS), 4 and 12 months
Pain at rest
Time frame: Baseline One, Baseline Two (DS) 6 weeks, 4 and 12 months
Pain during motion
Time frame: Baseline One, Baseline Two (DS) 6 weeks, 4 and 12 months
Apprehension of instability during motion
Time frame: Baseline One, Baseline Two (DS) 6 weeks, 4 and 12 months
Patient reported quality-of-life in relation to shoulder function
Time frame: Baseline One, Baseline Two (DS) 6 weeks, 4 and 12 months
Patient's satisfaction
Time frame: At 4 and 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Mar 2024.
- Background: PubMed 16000093Williamson A, Hoggart B. Pain: a review of three commonly used pain rating scales. J Clin Nurs. 2005 Aug;14(7):798-804. doi: 10.1111/j.1365-2702.2005.01121.x.
- Results publication: PubMed 19812522Boettcher CE, Ginn KA, Cathers I. Which is the optimal exercise to strengthen supraspinatus? Med Sci Sports Exerc. 2009 Nov;41(11):1979-83. doi: 10.1249/MSS.0b013e3181a740a7.
- Results publication: PubMed 31378683Moroder P, Danzinger V, Maziak N, Plachel F, Pauly S, Scheibel M, Minkus M. Characteristics of functional shoulder instability. J Shoulder Elbow Surg. 2020 Jan;29(1):68-78. doi: 10.1016/j.jse.2019.05.025. Epub 2019 Aug 1.
- Results publication: PubMed 20452282Boettcher CE, Cathers I, Ginn KA. The role of shoulder muscles is task specific. J Sci Med Sport. 2010 Nov;13(6):651-6. doi: 10.1016/j.jsams.2010.03.008. Epub 2010 May 7.
- Results publication: PubMed 17578940Dark A, Ginn KA, Halaki M. Shoulder muscle recruitment patterns during commonly used rotator cuff exercises: an electromyographic study. Phys Ther. 2007 Aug;87(8):1039-46. doi: 10.2522/ptj.20060068. Epub 2007 Jun 19.
- Results publication: PubMed 21601513Dube JA, Mercier C. Effect of pain and pain expectation on primary motor cortex excitability. Clin Neurophysiol. 2011 Nov;122(11):2318-23. doi: 10.1016/j.clinph.2011.03.026. Epub 2011 May 20.
- Results publication: PubMed 37308285Jaggi A, Herbert RD, Alexander S, Majed A, Butt D, Higgs D, Rudge W, Ginn KA. Arthroscopic capsular shift surgery in patients with atraumatic shoulder joint instability: a randomised, placebo-controlled trial. Br J Sports Med. 2023 Dec;57(23):1484-1489. doi: 10.1136/bjsports-2022-106596. Epub 2023 Jun 12.
- Results publication: PubMed 34847442Ginn KA, Cathers I, Boettcher C, Halaki M. Analysis of phase detects altered timing of muscle activation in subjects with chronic shoulder pain. J Electromyogr Kinesiol. 2022 Feb;62:102621. doi: 10.1016/j.jelekin.2021.102621. Epub 2021 Nov 22.
- Results publication: PubMed 3685114Gajdosik RL, Bohannon RW. Clinical measurement of range of motion. Review of goniometry emphasizing reliability and validity. Phys Ther. 1987 Dec;67(12):1867-72. doi: 10.1093/ptj/67.12.1867.
- Results publication: PubMed 9850776Kirkley A, Griffin S, McLintock H, Ng L. The development and evaluation of a disease-specific quality of life measurement tool for shoulder instability. The Western Ontario Shoulder Instability Index (WOSI). Am J Sports Med. 1998 Nov-Dec;26(6):764-72. doi: 10.1177/03635465980260060501.
- Results publication: PubMed 33290102Nazari G, Bobos P, Lu Z, Reischl S, MacDermid JC. Psychometric properties of Patient-Specific Functional Scale in patients with upper extremity disorders. A systematic review. Disabil Rehabil. 2022 Jun;44(13):2958-2967. doi: 10.1080/09638288.2020.1851784. Epub 2020 Dec 8.
- Results publication: PubMed 21978788Wattanaprakornkul D, Halaki M, Cathers I, Ginn KA. Direction-specific recruitment of rotator cuff muscles during bench press and row. J Electromyogr Kinesiol. 2011 Dec;21(6):1041-9. doi: 10.1016/j.jelekin.2011.09.002. Epub 2011 Oct 5.
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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.
Emil Steen, BSc contact
Monika Fagevik Olsén, Professor principal investigator
Sahlgrenska Academy, Inst Neuroscience and Physiology/Physiotherapy
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Early Physiotherapist selected active exercises and Delayed Physiotherapist selected active exercises in people with Shoulder Dislocation or Subluxation, run by Sahlgrenska University Hospital at 1 site in Sweden.
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 2 inclusion and 2 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: looking for participants now, as of the sponsor's last update on 8 Mar 2024. 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 Sweden. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ingrid K Hultenheim Klinberg, PhD (+46313430503, ingrid.hultenheim-klintberg@vgregion.se), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Neuromuscular control (time frame: Baseline One, Baseline Two (Delayed start,DS), 4 and 12 months). 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 NCT06261645, which also lists 13 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 8 Mar 2024.