Rotofunc - Non-traumatic Shoulder Instability and Total Rotator Cuff Function

NCT06261645 | Recruiting

• 1 other identifier: ROTOFUNK_2_2023
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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 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.

Conditions

Shoulder Dislocation or Subluxation

Keywords

physiotherapy; muscle control; non-surgical

Outcome Measures

Primary Outcomes (1)

• 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.

  Baseline One, Baseline Two (Delayed start,DS), 4 and 12 months

Secondary Outcomes (6)

• Clinical assessment - Active and passive range of motion

  Baseline One, Baseline Two (DS), 4 and 12 months

• Pain at rest

  Baseline One, Baseline Two (DS) 6 weeks, 4 and 12 months

• Pain during motion

  Baseline One, Baseline Two (DS) 6 weeks, 4 and 12 months

• Apprehension of instability during motion

  Baseline One, Baseline Two (DS) 6 weeks, 4 and 12 months

• Patient reported quality-of-life in relation to shoulder function

  Baseline One, Baseline Two (DS) 6 weeks, 4 and 12 months

Study Arms (2)

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.

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.

Other: Delayed Physiotherapist selected active exercises

Interventions

Early Physiotherapist selected active exercises OTHER

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

Early start

Delayed Physiotherapist selected active exercises OTHER

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

Eligibility Criteria

• Age: 16 Years - 35 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Sahlgrenska University Hospital: lead

Study Sites (1)

Sahlgrenska University Hospital/Mölndal, Physiotherapy Dpt

Gothenburg, Mölndal, SE 43180, Sweden

RECRUITING

Related Publications (13)

• 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.

  PMID: 16000093 BACKGROUND

• 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.

  PMID: 19812522 RESULT

• 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.

  PMID: 31378683 RESULT

• 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.

  PMID: 20452282 RESULT

• 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.

  PMID: 17578940 RESULT

• 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.

  PMID: 21601513 RESULT

• 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.

  PMID: 37308285 RESULT

• 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.

  PMID: 34847442 RESULT

• 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.

  PMID: 3685114 RESULT

• 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.

  PMID: 9850776 RESULT

• 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.

  PMID: 33290102 RESULT

• 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.

  PMID: 21978788 RESULT

• 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.

  PMID: 21333595 RESULT

MeSH Terms

Conditions

Shoulder Dislocation; Joint Dislocations

Condition Hierarchy (Ancestors)

Joint Diseases; Musculoskeletal Diseases; Wounds and Injuries; Shoulder Injuries

Study Officials

• Monika Fagevik Olsén, Professor

  Sahlgrenska Academy, Inst Neuroscience and Physiology/Physiotherapy

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ingrid K Hultenheim Klinberg, PhD

CONTACT

+46313430503; ingrid.hultenheim-klintberg@vgregion.se

Emil Steen, BSc

CONTACT

emil.steen@vgregion.se

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Investigator: 6 physiotherapists are care providers, responsible for the Intervention . Two independent investigators does not know who is the actual care provider. However, all patients recieve the same intervention. 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.
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: 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.

Study Record Dates

• First Submitted: February 7, 2024
• First Posted: February 15, 2024
• Study Start: May 1, 2023
• Primary Completion: December 1, 2025
• Study Completion (Estimated): December 1, 2026
• Last Updated: March 8, 2024

Record last verified: 2024-03

Locations

SE (1)