Rotator Cuff InjuriesNCT06482255
"Evidence of the Use of Virtual Reality Versus Manual Therapy and Therapeutic Exercise in Rotator Cuff Injury"
A study testing manual therapy and therapeutic exercise and manual therapy and therapeutic exercise and virtual reality in people with Rotator Cuff Injuries, run by University of Alcala.
Trial summary
This study evaluates the effectiveness of virtual reality (VR) compared to manual therapy and therapeutic exercise in treating rotator cuff injuries. It involves 108 participants divided into two groups: one receiving VR combined with manual therapy and therapeutic exercise, and the other receiving only manual therapy… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Rotator Cuff Injuries
- What is being tested?
- manual therapy and therapeutic exercise and manual therapy and therapeutic exercise and virtual reality
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 108 participants
- Where
- No sites listed yet
- Study dates
- Sep 2024to Nov 2024
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- be between 18 and 65 years old
- have a rotator cuff injury lasting less than 3 months
- have a limitation in strength of less than 30%
- pain in mobility greater than 4/10
Who cannot join
- previous shoulder surgeries, medical pathologies such as cancer
- rheumatoid disease, infections and/or fractures, and CNS involvement.
- In addition, physiotherapy treatment different from that of the study and not having an understanding of the Spanish language will be cause for exclusion.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Evidence of the Use of Virtual Reality Versus Manual Therapy and Therapeutic Exercise in Rotator Cuff Injury
This study evaluates the effectiveness of virtual reality (VR) compared to manual therapy and therapeutic exercise in treating rotator cuff injuries. It involves 108 participants divided into two groups: one receiving VR combined with manual therapy and therapeutic exercise, and the other receiving only manual therapy and therapeutic exercise. The study spans 10 weeks, with assessments at the beginning, midpoint, and end. Variables measured include quality of life, perceived pain, shoulder disability, strength, pain intensity, and shoulder mobility. The aim is to determine if VR provides better outcomes in these variables compared to conventional treatments.
Read the detailed description
Introduction Background: The shoulder is one of the most mobile yet unstable joints in the human body, making it prone to injuries like tendinopathies, which are among the most disabling injuries in the upper limb. Rotator cuff injuries are particularly prevalent.
Rotator Cuff: Comprises the supraspinatus, infraspinatus, subscapularis, and teres minor muscles, which provide stability, strength, and movement to the shoulder joint.
Treatment Options: There are conventional (non-surgical) and surgical treatments for rotator cuff injuries. Conventional treatments are often preferred due to fewer complications and lower costs.
Study Objective The study aims to assess the effectiveness of VR in comparison with traditional manual therapy and therapeutic exercise for treating rotator cuff injuries. The goal is to see if integrating VR can enhance patient outcomes.
Methodology Participants: 108 individuals will be recruited and divided into two groups. Group 1: Will receive a combination of VR, manual therapy, and therapeutic exercise.
Group 2: Will receive only manual therapy and therapeutic exercise. Duration: The treatment will last for 10 weeks.
Measurements: The study will measure various outcomes, including:
Quality of Life: Assessed using the SF-36 questionnaire. Perceived Pain and Shoulder Disability: Measured with the SPADI questionnaire. Strength: Evaluated using dynamometry. Pain Intensity: Assessed with the Numerical Rating Scale (NRS). Active Shoulder Mobility: Measured using an inclinometer. Assessment Points: Measurements will be taken before treatment, at the midpoint (5 weeks), and at the end of the treatment (10 weeks).
Data Collection and Analysis Data on pain, disability, strength, and range of motion will be collected at three intervals: pre-treatment, 5 weeks, and 10 weeks.
Quality of life will be assessed at the beginning and end of the treatment. Statistical Analysis: Using SPSS version 29.0, descriptive and inferential statistics will be conducted to analyze the data. An ANOVA will be used to study the treatment effects, considering group and time as factors.
Limitations Population Characteristics: The specific demographic characteristics of the study population might limit the generalizability of the results.
Lack of 3D Kinetic Evaluation: The absence of a three-dimensional kinetic evaluation protocol for scapular dyskinesia is noted as a limitation.
Cost of VR Technology: The expense associated with VR technology is highlighted as a limitation since it is still a growing and costly field.
Conclusion The study seeks to provide evidence on whether VR can be an effective tool alongside traditional therapies for rotator cuff injuries, potentially offering new avenues for rehabilitation practices.
.
- Conditions
- Rotator Cuff Injuries
- Being tested
- manual therapy and therapeutic exercise, manual therapy and therapeutic exercise and virtual reality
- Keywords
- rotator cuff, virtual reality, manual therapy, therapeutic exercise
- Medical subject headings
- Rotator Cuff Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
manual therapy and therapeutic exerciseOther
- Soft tissue massage
- Mobilization of the glenohumeral joint
- Scapular retraining Therapeutic Exercise
manual therapy and therapeutic exercise and virtual realityOther
- Soft tissue massage
- Mobilization of the glenohumeral joint
- Scapular retraining Therapeutic Exercise
- virtual reality
| Study group | Role | What they receive |
|---|---|---|
| virtual reality and manual therapy and therapeutic exercise | Experimental | * Soft tissue massage
* Mobilization of the glenohumeral joint
* Scapular retraining Therapeutic Exercise Receives: Other: manual therapy and therapeutic exercise and virtual reality |
| manual therapy and therapeutic exercise | Active comparator | * Soft tissue massage
* Mobilization of the glenohumeral joint
* Scapular retraining Receives: Other: manual therapy and therapeutic exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Perceived pain and disability regarding the shoulder
continuous metric quantitative variable. To measure it the investigators will use the SPADI questionnaire that takes values from or to 10 in each question. Reliability is greater than 0.7, with ranges between 0.7 and 0.9
Measured: 10 weeks
strength
continuous metric quantitative variable and the investigators will measure it using the dynamometer. It has a reliability of 0.90%, making it a useful force measurement instrument.
Measured: 10 weeks
Active shoulder mobility
continuous metric quantitative variable. The investigators will use an inclinometer to assess flexion, extension, rotation, abduction and adduction.
Measured: 10 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jul 2024
- Study startSep 2024 (estimated)
- Primary completionSep 2024 (estimated)
- Study completionNov 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (22)Papers the sponsor has linked to this study.
- Other trials for Rotator Cuff InjuriesStudies 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
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 108 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Alcala
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alejandro Nubla Romero, University of Alcala
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06482255
- Sponsor's protocol ID
- CEIM/2024/3/063
- Status last verified
- Jun 2024
- First submitted
- 25 Jun 2024
- Last updated
- 3 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
May T, Garmel GM. Rotator Cuff Injury. 2023 Jun 26. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2026 Jan-. Available from http://www.ncbi.nlm.nih.gov/books/NBK547664/
PubMed 31613444Jain NB, Luz J, Higgins LD, Dong Y, Warner JJ, Matzkin E, Katz JN. The Diagnostic Accuracy of Special Tests for Rotator Cuff Tear: The ROW Cohort Study. Am J Phys Med Rehabil. 2017 Mar;96(3):176-183. doi: 10.1097/PHM.0000000000000566.
PubMed 27386812Sgroi M, Loitsch T, Reichel H, Kappe T. Diagnostic Value of Clinical Tests for Supraspinatus Tendon Tears. Arthroscopy. 2018 Aug;34(8):2326-2333. doi: 10.1016/j.arthro.2018.03.030. Epub 2018 May 22.
PubMed 29802066Osma Rueda JL, Carreño Mesa FA. Manguito de los rotadores: epidemiología, factores deriesgo, historia natural de la enfermedad y pronóstico. Revisión de conceptos actuales. Revista Colombiana de Ortopedia y Traumatología. Octubre de 2016;30:2-12
González Lagunas J.. Plasma rico en plaquetas. Rev Esp Cirug Oral y Maxilofac [Internet]. 2006 Abr [citado 2024 Abr 04] ; 28( 2 ): 89-99.
Laserterapia [internet]. Barcelona: Top doctors; [citado el 5 de Julio de 2023.
Xiong J., Hsiang EL, He Z., Zhan T., Wu ST Pantallas de realidad aumentada y realidad virtual: tecnologías emergentes y perspectivas futuras. Ciencia ligera. Aplica. 2021; 10 :216. doi: 10.1038/s41377-021-00658-8
Carrie M.Hall, Lori Thein Brody. Ejercicio terapéutico. Recuperación funcional (ed. Paidotribo. Año 2006. (1-42),(587, 635)
Rutkowski S, Kiper P, Cacciante L, Cieslik B, Mazurek J, Turolla A, Szczepanska-Gieracha J. Use of virtual reality-based training in different fields of rehabilitation: A systematic review and meta-analysis. J Rehabil Med. 2020 Nov 19;52(11):jrm00121. doi: 10.2340/16501977-2755.
PubMed 33073855Dimbwaydo-Terrer I. Realidad Virtual en Procedimientos Quirúrgicos: Nuevos Entornos de Aplicación. NeuroRehab News 2017 nov; 2
Harvie DS, Broecker M, Smith RT, Meulders A, Madden VJ, Moseley GL. Bogus visual feedback alters onset of movement-evoked pain in people with neck pain. Psychol Sci. 2015 Apr;26(4):385-92. doi: 10.1177/0956797614563339. Epub 2015 Feb 17.
PubMed 25691362Tejera DM, Beltran-Alacreu H, Cano-de-la-Cuerda R, Leon Hernandez JV, Martin-Pintado-Zugasti A, Calvo-Lobo C, Gil-Martinez A, Fernandez-Carnero J. Effects of Virtual Reality versus Exercise on Pain, Functional, Somatosensory and Psychosocial Outcomes in Patients with Non-specific Chronic Neck Pain: A Randomized Clinical Trial. Int J Environ Res Public Health. 2020 Aug 16;17(16):5950. doi: 10.3390/ijerph17165950.
PubMed 32824394Guzmán DE, Londoño J. Rehabilitación de miembro superior con ambientes virtuales: revisión. Rev Mex Ing Biomed. 2016;37(3)
Chan E, Foster S, Sambell R, Leong P. Clinical efficacy of virtual reality for acute procedural pain management: A systematic review and meta-analysis. PLoS One. 2018 Jul 27;13(7):e0200987. doi: 10.1371/journal.pone.0200987. eCollection 2018.
PubMed 30052655Ingwersen KG, Christensen R, Sorensen L, Jorgensen HR, Jensen SL, Rasmussen S, Sogaard K, Juul-Kristensen B. Progressive high-load strength training compared with general low-load exercises in patients with rotator cuff tendinopathy: study protocol for a randomised controlled trial. Trials. 2015 Jan 27;16:27. doi: 10.1186/s13063-014-0544-6.
PubMed 25622594
Study at a glance
From the registry record, last updated by the sponsor on 3 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evidence of the Use of Virtual Reality Versus Manual Therapy and Therapeutic Exercise in Rotator Cuff Injury
- ClinicalTrials.gov ID
- NCT06482255
- Acronym / sponsor ID
- CEIM/2024/3/063
- Conditions
- Rotator Cuff Injuries
- Keywords
- rotator cuff, virtual reality, manual therapy, therapeutic exercise
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 108 participants (estimated)
- Lead sponsor
- University of AlcalaUniversity, hospital or other
- Study start
- Sep 2024 (estimated)
- Primary completion
- Sep 2024 (estimated)
- Study completion
- Nov 2024 (estimated)
- First posted
- 1 Jul 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.
This study evaluates the effectiveness of virtual reality (VR) compared to manual therapy and therapeutic exercise in treating rotator cuff injuries. It involves 108 participants divided into two groups: one receiving VR combined with manual therapy and therapeutic exercise, and the other receiving only manual therapy and therapeutic exercise. The study spans 10 weeks, with assessments at the beginning, midpoint, and end. Variables measured include quality of life, perceived pain, shoulder disability, strength, pain intensity, and shoulder mobility. The aim is to determine if VR provides better outcomes in these variables compared to conventional treatments.
Detailed description
Introduction Background: The shoulder is one of the most mobile yet unstable joints in the human body, making it prone to injuries like tendinopathies, which are among the most disabling injuries in the upper limb. Rotator cuff injuries are particularly prevalent.
Rotator Cuff: Comprises the supraspinatus, infraspinatus, subscapularis, and teres minor muscles, which provide stability, strength, and movement to the shoulder joint.
Treatment Options: There are conventional (non-surgical) and surgical treatments for rotator cuff injuries. Conventional treatments are often preferred due to fewer complications and lower costs.
Study Objective The study aims to assess the effectiveness of VR in comparison with traditional manual therapy and therapeutic exercise for treating rotator cuff injuries. The goal is to see if integrating VR can enhance patient outcomes.
Methodology Participants: 108 individuals will be recruited and divided into two groups. Group 1: Will receive a combination of VR, manual therapy, and therapeutic exercise.
Group 2: Will receive only manual therapy and therapeutic exercise. Duration: The treatment will last for 10 weeks.
Measurements: The study will measure various outcomes, including:
Quality of Life: Assessed using the SF-36 questionnaire. Perceived Pain and Shoulder Disability: Measured with the SPADI questionnaire. Strength: Evaluated using dynamometry. Pain Intensity: Assessed with the Numerical Rating Scale (NRS). Active Shoulder Mobility: Measured using an inclinometer. Assessment Points: Measurements will be taken before treatment, at the midpoint (5 weeks), and at the end of the treatment (10 weeks).
Data Collection and Analysis Data on pain, disability, strength, and range of motion will be collected at three intervals: pre-treatment, 5 weeks, and 10 weeks.
Quality of life will be assessed at the beginning and end of the treatment. Statistical Analysis: Using SPSS version 29.0, descriptive and inferential statistics will be conducted to analyze the data. An ANOVA will be used to study the treatment effects, considering group and time as factors.
Limitations Population Characteristics: The specific demographic characteristics of the study population might limit the generalizability of the results.
Lack of 3D Kinetic Evaluation: The absence of a three-dimensional kinetic evaluation protocol for scapular dyskinesia is noted as a limitation.
Cost of VR Technology: The expense associated with VR technology is highlighted as a limitation since it is still a growing and costly field.
Conclusion The study seeks to provide evidence on whether VR can be an effective tool alongside traditional therapies for rotator cuff injuries, potentially offering new avenues for rehabilitation practices.
.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| virtual reality and manual therapy and therapeutic exercise | Experimental | Other: manual therapy and therapeutic exercise and virtual reality* Soft tissue massage * Mobilization of the glenohumeral joint * Scapular retraining Therapeutic Exercise |
| manual therapy and therapeutic exercise | Active comparator | Other: manual therapy and therapeutic exercise* Soft tissue massage * Mobilization of the glenohumeral joint * Scapular retraining |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- be between 18 and 65 years old
- have a rotator cuff injury lasting less than 3 months
- have a limitation in strength of less than 30%
- pain in mobility greater than 4/10
Key exclusion criteria (3 listed)
- previous shoulder surgeries, medical pathologies such as cancer
- rheumatoid disease, infections and/or fractures, and CNS involvement.
- In addition, physiotherapy treatment different from that of the study and not having an understanding of the Spanish language will be cause for exclusion.
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 |
|---|---|---|
| manual therapy and therapeutic exercise* Soft tissue massage * Mobilization of the glenohumeral joint * Scapular retraining Therapeutic Exercise | Other | manual therapy and therapeutic exercise |
| manual therapy and therapeutic exercise and virtual reality* Soft tissue massage * Mobilization of the glenohumeral joint * Scapular retraining Therapeutic Exercise * virtual reality | Other | virtual reality and manual therapy and therapeutic exercise |
Primary outcome
Perceived pain and disability regarding the shoulder
Time frame: 10 weeks
continuous metric quantitative variable. To measure it the investigators will use the SPADI questionnaire that takes values from or to 10 in each question. Reliability is greater than 0.7, with ranges between 0.7 and 0.9
strength
Time frame: 10 weeks
continuous metric quantitative variable and the investigators will measure it using the dynamometer. It has a reliability of 0.90%, making it a useful force measurement instrument.
Active shoulder mobility
Time frame: 10 weeks
continuous metric quantitative variable. The investigators will use an inclinometer to assess flexion, extension, rotation, abduction and adduction.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jul 2024.
- Background: PubMed 31613444May T, Garmel GM. Rotator Cuff Injury. 2023 Jun 26. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2026 Jan-. Available from http://www.ncbi.nlm.nih.gov/books/NBK547664/
- Background: PubMed 27386812Jain NB, Luz J, Higgins LD, Dong Y, Warner JJ, Matzkin E, Katz JN. The Diagnostic Accuracy of Special Tests for Rotator Cuff Tear: The ROW Cohort Study. Am J Phys Med Rehabil. 2017 Mar;96(3):176-183. doi: 10.1097/PHM.0000000000000566.
- Background: PubMed 29802066Sgroi M, Loitsch T, Reichel H, Kappe T. Diagnostic Value of Clinical Tests for Supraspinatus Tendon Tears. Arthroscopy. 2018 Aug;34(8):2326-2333. doi: 10.1016/j.arthro.2018.03.030. Epub 2018 May 22.
- BackgroundOsma Rueda JL, Carreño Mesa FA. Manguito de los rotadores: epidemiología, factores deriesgo, historia natural de la enfermedad y pronóstico. Revisión de conceptos actuales. Revista Colombiana de Ortopedia y Traumatología. Octubre de 2016;30:2-12
- BackgroundGonzález Lagunas J.. Plasma rico en plaquetas. Rev Esp Cirug Oral y Maxilofac [Internet]. 2006 Abr [citado 2024 Abr 04] ; 28( 2 ): 89-99.
- BackgroundLaserterapia [internet]. Barcelona: Top doctors; [citado el 5 de Julio de 2023.
- BackgroundXiong J., Hsiang EL, He Z., Zhan T., Wu ST Pantallas de realidad aumentada y realidad virtual: tecnologías emergentes y perspectivas futuras. Ciencia ligera. Aplica. 2021; 10 :216. doi: 10.1038/s41377-021-00658-8
- BackgroundCarrie M.Hall, Lori Thein Brody. Ejercicio terapéutico. Recuperación funcional (ed. Paidotribo. Año 2006. (1-42),(587, 635)
- Background: PubMed 33073855Rutkowski S, Kiper P, Cacciante L, Cieslik B, Mazurek J, Turolla A, Szczepanska-Gieracha J. Use of virtual reality-based training in different fields of rehabilitation: A systematic review and meta-analysis. J Rehabil Med. 2020 Nov 19;52(11):jrm00121. doi: 10.2340/16501977-2755.
- BackgroundDimbwaydo-Terrer I. Realidad Virtual en Procedimientos Quirúrgicos: Nuevos Entornos de Aplicación. NeuroRehab News 2017 nov; 2
- Background: PubMed 25691362Harvie DS, Broecker M, Smith RT, Meulders A, Madden VJ, Moseley GL. Bogus visual feedback alters onset of movement-evoked pain in people with neck pain. Psychol Sci. 2015 Apr;26(4):385-92. doi: 10.1177/0956797614563339. Epub 2015 Feb 17.
- Background: PubMed 32824394Tejera DM, Beltran-Alacreu H, Cano-de-la-Cuerda R, Leon Hernandez JV, Martin-Pintado-Zugasti A, Calvo-Lobo C, Gil-Martinez A, Fernandez-Carnero J. Effects of Virtual Reality versus Exercise on Pain, Functional, Somatosensory and Psychosocial Outcomes in Patients with Non-specific Chronic Neck Pain: A Randomized Clinical Trial. Int J Environ Res Public Health. 2020 Aug 16;17(16):5950. doi: 10.3390/ijerph17165950.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
A study testing manual therapy and therapeutic exercise and manual therapy and therapeutic exercise and virtual reality in people with Rotator Cuff Injuries, run by University of Alcala.
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 4 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: status not confirmed, as of the sponsor's last update on 3 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Alejandro Nubla Romero (+34 637247797, alejandronublaromero@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Perceived pain and disability regarding the shoulder (time frame: 10 weeks). 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 NCT06482255, which also lists 22 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 3 Jul 2024.