Rotofunc - Non-traumatic Shoulder Instability and Total Rotator Cuff Function
NCT ID: NCT06261645
Last Updated: 2024-03-08
Study Results
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Basic Information
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RECRUITING
NA
100 participants
INTERVENTIONAL
2023-05-01
2026-12-31
Brief Summary
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Detailed Description
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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
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Study Design
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RANDOMIZED
SEQUENTIAL
In addition, the patient will receive education and guidance in the daily use of the arm to adjust to appropriate load on the shoulder.
TREATMENT
DOUBLE
Outcome assessor: each participant is given a research code. The results from the assessments are entered in the data base by a research assistant, not involved in the study on any level.
Individuals are not identifiable. The outcome assessor are planning for all statistics used and is not in other ways involved in the study.
Study Groups
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Early start
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.
Early Physiotherapist selected active exercises
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 start
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.
Delayed Physiotherapist selected active exercises
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
Interventions
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Early Physiotherapist selected active exercises
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 exercises
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
Eligibility Criteria
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Inclusion Criteria
* Understanding the Swedish language well, in speaking, in reading and writing.
Exclusion Criteria
* \<60% adherence to assigned exercises
16 Years
35 Years
ALL
No
Sponsors
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Sahlgrenska University Hospital
OTHER
Responsible Party
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Ingrid Hultenheim Klintberg
Principal Investigator
Principal Investigators
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Monika Fagevik Olsén, Professor
Role: PRINCIPAL_INVESTIGATOR
Sahlgrenska Academy, Inst Neuroscience and Physiology/Physiotherapy
Locations
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Sahlgrenska University Hospital/Mölndal, Physiotherapy Dpt
Gothenburg, Mölndal, Sweden
Countries
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Central Contacts
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Facility Contacts
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References
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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.
Boettcher 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.
Moroder 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.
Boettcher 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.
Dark 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.
Dube 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.
Jaggi 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.
Ginn 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.
Gajdosik 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.
Kirkley 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.
Nazari 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.
Wattanaprakornkul 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.
Wattanaprakornkul 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.
Other Identifiers
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ROTOFUNK_2_2023
Identifier Type: -
Identifier Source: org_study_id
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