Articular; RigidCH-CaseNCT05175586
Physiotherapeutic Case Studies in Frozen Shoulder Pathology
A study testing First data analysis, Second data analysis and database in people with Articular; Rigid, run by GEMA LEÓN BRAVO at 1 site in Spain.
Trial summary
The stiff shoulder presents symptoms such as pain, loss of mobility and strength, being more common the idiopathic origin associated to the female gender. The definitive diagnosis presents complications due to the number of etiologies that can cause it. Read more about this study
- Who is it for?
- Ages 21 to 76 years
- Conditions the study is for
- Articular; Rigid
- What is being tested?
- First data analysis, Second data analysis and database
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteSpain
- Study dates
- 3 Feb 2021to 7 Oct 2021
- 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 21 to 76 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with difficulty in activities of daily living ABVD 35.
- Patients with positive results in some of the physical examination tests.
- Patients with a previous diagnosis by ultrasound imaging.
- Patients with surgical intervention after 3 months of age.
Who cannot join
- Patients with mental disorders or deficits.
- Patients with needle phobia (belonephobia).
- Patients with recent surgery before 3 months of age.
- Patients with previous dislocation of the affected shoulder.
Trial locations and contacts
1 site in 1 country.
Spain1 site
Gema León Physiotherapy and Rehabilitation Clinic
Córdoba, Andalusia, 14011
About this study
Official title: Physiotherapeutic Case Reports in Frozen Shoulder Pathology: Clinical Trial
The stiff shoulder presents symptoms such as pain, loss of mobility and strength, being more common the idiopathic origin associated to the female gender. The definitive diagnosis presents complications due to the number of etiologies that can cause it. Epidemiologically, it presents from 2 to 5% of medical incapacities in the working population. Objective: To investigate the efficacy of percutaneous Neuromodulation together with Orthopedic Manual Therapy (Maitland and Mulligan) in comparison with Orthopedic Manual Therapy (Maitland and Mulligan) used in stiff shoulder.Design: Experimental clinical trial in 30 patients aged 21 to 76 years from a physiotherapy center divided into two groups: Group 1 (n=15) Percutaneous Neuromodulation + Orthopaedic Manual Therapy (Maitland and Mulligan) Group 2 (n=15) Orthopaedic Manual Therapy (Maitland and Mulligan).
Read the detailed description
The stiff shoulder is a pathology characterized by a biomechanical restriction of the active and passive movement of the shoulder, showing clinical pictures of local inflammation with a notorious hyper vascularization that helps the clinical manifestations painful flexion, stiffness, limitation of external rotation, pain over the lower cervical area or near the insertion of the deltoid muscle and pain when supporting the affected limb with body weight.
Etiologically there are idiopathic and external factors that cause disorders such as osteoarthritis, chronic subacromial bursitis, or rotator cuff tendinopathy. Likewise, trauma is involved in a secondary way as well as diseases such as Parkinson's, diabetes, thyroid disorders among others. These clinical factors present two types of diagnosis: primary idiopathic stiff shoulder and extrinsic stiff shoulder secondary to trauma or surgery.
Among the physiotherapeutic treatments provided are joint mobilizations, therapeutic exercises, deep Cyriax massage, osteopathic techniques, cryotherapy (inflammatory phase), thermotherapy (chronic phase), electrotherapy for pain and ultrasound.
From the economic point of view, it presents from 2 to 5% of the medical incapacities in the working population, being this disease one of the first 20 sick leaves that reaches up to 12 months, generating high public hospital expenses and difficulties for the business area. Due to the above, many patients enter the operating room as a quick option to return to normality. However, this option does not seem to be the best for this disease, since the hypomobility of the movement increases gradually and chronically, caused by the fibrotic processes in the anterior face of the capsule, generating long-term inability for the external rotation of the joint.
The aim of this study is to investigate the efficacy of Percutaneous Neuromodulation together with Orthopaedic Manual Therapy (Maitland and Mulligan) compared to Orthopaedic Manual Therapy (Maitland and Mulligan) used in the stiff shoulder.
- Conditions
- Articular; Rigid
- Being tested
- First data analysis, Second data analysis, database
- Keywords
- Stiff shoulder., Neuromodulation., Manual therapy., Rotator cuff., Physiotherapy.
- Medical subject headings
- Muscle Rigidity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
First data analysisDiagnostic test
A series of questions were asked to a number of patients with diagnoses related to primary idiopathic stiff shoulder and/or extrinsic stiff shoulder secondary to trauma or surgery. These patients are part of the physiotherapy clinic receiving the research. This questionnaire answers basic questions for the structure of the study such as age and sex, physical behaviour during the week, endurance, athletic disability, reason for attending the clinic, exploratory motor tests, etc. Subsequently, physiotherapeutic tests related to the pathology within the research were performed consisting of joint range, percentage of shoulder disability and pain scale.
Second data analysisProcedure or surgery
Three treatment sessions of Percutaneous Neuromodulation (PNM) and Orthopaedic Manual Therapy (OMT) (Maitland and Mulligan) (group 1) and three treatment sessions of Orthopaedic Manual Therapy (OMT) (Maitland and Mulligan) (group 2) were performed at a rate of two sessions per month for three months. These therapies were compared with the clinical examination performed prior to each new session to verify changes in joint range, percentage of shoulder disability, strength and pain scale.
databaseOther
Age and sex were expressed as mean ± standard deviation (SD). The rest of the variables were expressed as mean, absolute and relative frequency. The chi-square test was used to analyse the differences between the examinations in terms of the time taken and the treatments used in the two groups. A confidence level of 95% was established, considering a value of p<0.05 as statistically significant.
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Experimental | 15 patients in the experimental group of percutaneous neuromodulation together with orthopaedic manual therapy (Maitland and Mulligan) Receives: Diagnostic Test: First data analysis; Procedure: Second data analysis; Other: database |
| Group 2 | Active comparator | 15 patients in the experimental group of orthopaedic manual therapy (Maitland and Mulligan). Receives: Diagnostic Test: First data analysis; Procedure: Second data analysis; Other: database |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain scale (EVA)
The values of pain levels during the examination are reflected as follows:
0= No pain 1-2= Little pain 3-4= Moderate pain 5-6= Severe pain 7-8= Very severe pain 9-10= Unbearable pain
Measured: 3 months
Rigid shoulder type
Information on the type of stiff shoulder you have.
Measured: 3 months
Daniels Scale
Muscle function values during the scan are reflected as follows, with 0 being a negative value and 5 a positive value:
0= Muscle does not contract.
- Muscle contracts, but there is no movement.
- Muscle contracts and moves normally, but without resistance.
- Muscle contracts and resists to a good degree.
- Muscle contracts and resists to almost its full extent.
- The muscle contracts and resists at full amplitude.
Measured: 3 months
Joint range
The values of joint range during the examination are reflected by means of the joint range scale which emphasizes specific degrees for elevation, external rotation and internal rotation.
Measured: 3 months
Secondary outcomes (1)
Number of participants in each physical therapy application
Three reviews were carried out corresponding to the three months of treatment. During these three months, participants received two sessions per week, for a total of 24 sessions:
- Group 1 (n=15) received the percutaneous neuromodulation treatment together with orthopedic manual therapy (Maitland and Mulligan).
- Group 2 (n=15) received orthopedic manual therapy treatment (Maitland and Mulligan) only.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jan 2022
- Study start3 Feb 2021
- Primary completion1 Oct 2021
- Study completion7 Oct 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (15)Papers the sponsor has linked to this study.
- Other trials for Articular; RigidStudies 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
- Crossover
- Model description
- 30 divided into two groups: Group 1 (n=15) percutaneous neuromodulation together with orthopaedic manual therapy (Maitland and Mulligan) Group 2 (n=15) orthopaedic manual therapy (Maitland and Mulligan).
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- GEMA LEÓN BRAVO
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, GEMA LEÓN BRAVO, Clinica Gema Leon
- Investigators
- Gema León Bravo, Physiotherap, Principal investigator, Departamento de Enfermería, Farmacología y Fisioterapia, Universidad de Córdoba, Córdoba, EspañaJaime Rando Anaya, Physiotherap, Study chair, Universidad de Córdoba
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05175586
- Sponsor's protocol ID
- ART-GLB-HOM-CONG
- Other IDs
- TFG-EFCH-2021
- Acronym
- CH-Case
- Status last verified
- Jan 2022
- First submitted
- 21 Oct 2021
- Last updated
- 13 Jan 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The request for the data will be studied and considered upon prior and justified request.
Publications
Hiscock N, Bell S, Coghlan J. Pain, depression and the postoperative stiff shoulder. BMC Musculoskelet Disord. 2015 Dec 4;16:376. doi: 10.1186/s12891-015-0841-6.
PubMed 26637238Green HD, Jones A, Evans JP, Wood AR, Beaumont RN, Tyrrell J, Frayling TM, Smith C, Weedon MN. A genome-wide association study identifies 5 loci associated with frozen shoulder and implicates diabetes as a causal risk factor. PLoS Genet. 2021 Jun 10;17(6):e1009577. doi: 10.1371/journal.pgen.1009577. eCollection 2021 Jun.
PubMed 34111113Pandey V, Madi S. Clinical Guidelines in the Management of Frozen Shoulder: An Update! Indian J Orthop. 2021 Feb 1;55(2):299-309. doi: 10.1007/s43465-021-00351-3. eCollection 2021 Apr.
PubMed 33912325Challoumas D, Biddle M, McLean M, Millar NL. Comparison of Treatments for Frozen Shoulder: A Systematic Review and Meta-analysis. JAMA Netw Open. 2020 Dec 1;3(12):e2029581. doi: 10.1001/jamanetworkopen.2020.29581.
PubMed 33326025Akbar M, McLean M, Garcia-Melchor E, Crowe LA, McMillan P, Fazzi UG, Martin D, Arthur A, Reilly JH, McInnes IB, Millar NL. Fibroblast activation and inflammation in frozen shoulder. PLoS One. 2019 Apr 23;14(4):e0215301. doi: 10.1371/journal.pone.0215301. eCollection 2019.
PubMed 31013287Chan HBY, Pua PY, How CH. Physical therapy in the management of frozen shoulder. Singapore Med J. 2017 Dec;58(12):685-689. doi: 10.11622/smedj.2017107.
PubMed 29242941Ryan V, Brown H, Minns Lowe CJ, Lewis JS. The pathophysiology associated with primary (idiopathic) frozen shoulder: A systematic review. BMC Musculoskelet Disord. 2016 Aug 15;17(1):340. doi: 10.1186/s12891-016-1190-9.
PubMed 27527912Jeong, JY, Shim, SB, Hong, JH, Im, W., Lee, SM y Yoo, JC (2020). Efecto del hombro congelado preoperatorio sobre los resultados clínicos después de la reparación artroscópica del manguito rotador. Revista ortopédica de medicina deportiva , 8 (7), 2325967120934449. https://doi.org/10.1177/2325967120934449
Cho, CH, Bae, KC y Kim, DH (2019). Estrategia de tratamiento para hombro congelado. Clínicas de cirugía ortopédica , 11 (3), 249-257. https://doi.org/10.4055/cios.2019.11.3.249
Cui, J., Lu, W., He, Y., Jiang, L., Li, K., Zhu, W. y Wang, D. (2017). Biología molecular de la limitación inducida por el hombro congelado de los movimientos de la articulación del hombro. Revista de investigación en ciencias médicas: la revista oficial de la Universidad de Ciencias Médicas de Isfahan , 22 , 61. https://doi.org/10.4103/jrms.JRMS_1005_16
Vastamaki H, Ristolainen L, Vastamaki M. Range of motion of diabetic frozen shoulder recovers to the contralateral level. J Int Med Res. 2016 Dec;44(6):1191-1199. doi: 10.1177/0300060516675112. Epub 2016 Nov 18.
PubMed 27856934Uppal, HS, Evans, JP y Smith, C. (2015). Hombro congelado: una revisión sistemática de las opciones terapéuticas. Revista mundial de ortopedia , 6 (2), 263-268. https://doi.org/10.5312/wjo.v6.i2.263
Park, EW, Cho, JH, Cho, CH, Sung, DH y Kim, DH (2021). Comparación de evaluaciones ecográficas de hombro entre polimialgia reumática y hombro congelado en pacientes con dolor de hombro bilateral: un estudio retrospectivo comparativo. Revista de medicina personalizada ,
Dyer, BP, Burton, C., Rathod-Mistry, T., Blagojevic-Bucknall, M. y van der Windt, DA (2021). La diabetes como factor pronóstico en el hombro congelado: una revisión sistemática. Archivos de investigación en rehabilitación y traducción clínica , 3 (3), 100141. https://doi.org/10.1016/j.arrct.2021.100141
Song, C., Song, C. y Li, C. (2021). Resultado de la manipulación bajo anestesia con o sin inyección de esteroides intraarticulares para el tratamiento del hombro congelado: un estudio de cohorte retrospectivo. Medicina , 100 (13), e23893. https://doi.org/10.1097/MD.0000000000023893
Study at a glance
From the registry record, last updated by the sponsor on 13 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Physiotherapeutic Case Reports in Frozen Shoulder Pathology: Clinical Trial
- ClinicalTrials.gov ID
- NCT05175586
- Acronym / sponsor ID
- CH-Case / ART-GLB-HOM-CONG
- Conditions
- Articular; Rigid
- Keywords
- Stiff shoulder., Neuromodulation., Manual therapy., Rotator cuff., Physiotherapy.
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- GEMA LEÓN BRAVOUniversity, hospital or other
- Study start
- 3 Feb 2021 (actual)
- Primary completion
- 1 Oct 2021 (actual)
- Study completion
- 7 Oct 2021 (actual)
- First posted
- 4 Jan 2022 (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 stiff shoulder presents symptoms such as pain, loss of mobility and strength, being more common the idiopathic origin associated to the female gender. The definitive diagnosis presents complications due to the number of etiologies that can cause it. Epidemiologically, it presents from 2 to 5% of medical incapacities in the working population. Objective: To investigate the efficacy of percutaneous Neuromodulation together with Orthopedic Manual Therapy (Maitland and Mulligan) in comparison with Orthopedic Manual Therapy (Maitland and Mulligan) used in stiff shoulder.Design: Experimental clinical trial in 30 patients aged 21 to 76 years from a physiotherapy center divided into two groups: Group 1 (n=15) Percutaneous Neuromodulation + Orthopaedic Manual Therapy (Maitland and Mulligan) Group 2 (n=15) Orthopaedic Manual Therapy (Maitland and Mulligan).
Detailed description
The stiff shoulder is a pathology characterized by a biomechanical restriction of the active and passive movement of the shoulder, showing clinical pictures of local inflammation with a notorious hyper vascularization that helps the clinical manifestations painful flexion, stiffness, limitation of external rotation, pain over the lower cervical area or near the insertion of the deltoid muscle and pain when supporting the affected limb with body weight.
Etiologically there are idiopathic and external factors that cause disorders such as osteoarthritis, chronic subacromial bursitis, or rotator cuff tendinopathy. Likewise, trauma is involved in a secondary way as well as diseases such as Parkinson's, diabetes, thyroid disorders among others. These clinical factors present two types of diagnosis: primary idiopathic stiff shoulder and extrinsic stiff shoulder secondary to trauma or surgery.
Among the physiotherapeutic treatments provided are joint mobilizations, therapeutic exercises, deep Cyriax massage, osteopathic techniques, cryotherapy (inflammatory phase), thermotherapy (chronic phase), electrotherapy for pain and ultrasound.
From the economic point of view, it presents from 2 to 5% of the medical incapacities in the working population, being this disease one of the first 20 sick leaves that reaches up to 12 months, generating high public hospital expenses and difficulties for the business area. Due to the above, many patients enter the operating room as a quick option to return to normality. However, this option does not seem to be the best for this disease, since the hypomobility of the movement increases gradually and chronically, caused by the fibrotic processes in the anterior face of the capsule, generating long-term inability for the external rotation of the joint.
The aim of this study is to investigate the efficacy of Percutaneous Neuromodulation together with Orthopaedic Manual Therapy (Maitland and Mulligan) compared to Orthopaedic Manual Therapy (Maitland and Mulligan) used in the stiff shoulder.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- 30 divided into two groups: Group 1 (n=15) percutaneous neuromodulation together with orthopaedic manual therapy (Maitland and Mulligan) Group 2 (n=15) orthopaedic manual therapy (Maitland and Mulligan).
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Experimental | Diagnostic Test: First data analysis, Procedure: Second data analysis, Other: database15 patients in the experimental group of percutaneous neuromodulation together with orthopaedic manual therapy (Maitland and Mulligan) |
| Group 2 | Active comparator | Diagnostic Test: First data analysis, Procedure: Second data analysis, Other: database15 patients in the experimental group of orthopaedic manual therapy (Maitland and Mulligan). |
Who may qualify
- Ages
- 21 to 76 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients with difficulty in activities of daily living ABVD 35.
- Patients with positive results in some of the physical examination tests.
- Patients with a previous diagnosis by ultrasound imaging.
- Patients with surgical intervention after 3 months of age.
Key exclusion criteria (4 listed)
- Patients with mental disorders or deficits.
- Patients with needle phobia (belonephobia).
- Patients with recent surgery before 3 months of age.
- Patients with previous dislocation of the affected shoulder.
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 |
|---|---|---|
| First data analysisA series of questions were asked to a number of patients with diagnoses related to primary idiopathic stiff shoulder and/or extrinsic stiff shoulder secondary to trauma or surgery. These patients are part of the physiotherapy clinic receiving the research. This questionnaire answers basic questions for the structure of the study such as age and sex, physical behaviour during the week, endurance, athletic disability, reason for attending the clinic, exploratory motor tests, etc. Subsequently, physiotherapeutic tests related to the pathology within the research were performed consisting of joint range, percentage of shoulder disability and pain scale. | Diagnostic test | Group 1, Group 2 |
| Second data analysisThree treatment sessions of Percutaneous Neuromodulation (PNM) and Orthopaedic Manual Therapy (OMT) (Maitland and Mulligan) (group 1) and three treatment sessions of Orthopaedic Manual Therapy (OMT) (Maitland and Mulligan) (group 2) were performed at a rate of two sessions per month for three months. These therapies were compared with the clinical examination performed prior to each new session to verify changes in joint range, percentage of shoulder disability, strength and pain scale. | Procedure or surgery | Group 1, Group 2 |
| databaseAge and sex were expressed as mean ± standard deviation (SD). The rest of the variables were expressed as mean, absolute and relative frequency. The chi-square test was used to analyse the differences between the examinations in terms of the time taken and the treatments used in the two groups. A confidence level of 95% was established, considering a value of p<0.05 as statistically significant. | Other | Group 1, Group 2 |
Primary outcome
Pain scale (EVA)
Time frame: 3 months
The values of pain levels during the examination are reflected as follows: 0= No pain 1-2= Little pain 3-4= Moderate pain 5-6= Severe pain 7-8= Very severe pain 9-10= Unbearable pain
Rigid shoulder type
Time frame: 3 months
Information on the type of stiff shoulder you have.
Daniels Scale
Time frame: 3 months
Muscle function values during the scan are reflected as follows, with 0 being a negative value and 5 a positive value: 0= Muscle does not contract. 1. Muscle contracts, but there is no movement. 2. Muscle contracts and moves normally, but without resistance. 3. Muscle contracts and resists to a good degree. 4. Muscle contracts and resists to almost its full extent. 5. The muscle contracts and resists at full amplitude.
Joint range
Time frame: 3 months
The values of joint range during the examination are reflected by means of the joint range scale which emphasizes specific degrees for elevation, external rotation and internal rotation.
1 secondary outcome
Number of participants in each physical therapy application
Time frame: 3 months
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 13 Jan 2022.
- Background: PubMed 26637238Hiscock N, Bell S, Coghlan J. Pain, depression and the postoperative stiff shoulder. BMC Musculoskelet Disord. 2015 Dec 4;16:376. doi: 10.1186/s12891-015-0841-6.
- Background: PubMed 34111113Green HD, Jones A, Evans JP, Wood AR, Beaumont RN, Tyrrell J, Frayling TM, Smith C, Weedon MN. A genome-wide association study identifies 5 loci associated with frozen shoulder and implicates diabetes as a causal risk factor. PLoS Genet. 2021 Jun 10;17(6):e1009577. doi: 10.1371/journal.pgen.1009577. eCollection 2021 Jun.
- Background: PubMed 33912325Pandey V, Madi S. Clinical Guidelines in the Management of Frozen Shoulder: An Update! Indian J Orthop. 2021 Feb 1;55(2):299-309. doi: 10.1007/s43465-021-00351-3. eCollection 2021 Apr.
- Background: PubMed 33326025Challoumas D, Biddle M, McLean M, Millar NL. Comparison of Treatments for Frozen Shoulder: A Systematic Review and Meta-analysis. JAMA Netw Open. 2020 Dec 1;3(12):e2029581. doi: 10.1001/jamanetworkopen.2020.29581.
- Background: PubMed 31013287Akbar M, McLean M, Garcia-Melchor E, Crowe LA, McMillan P, Fazzi UG, Martin D, Arthur A, Reilly JH, McInnes IB, Millar NL. Fibroblast activation and inflammation in frozen shoulder. PLoS One. 2019 Apr 23;14(4):e0215301. doi: 10.1371/journal.pone.0215301. eCollection 2019.
- Background: PubMed 29242941Chan HBY, Pua PY, How CH. Physical therapy in the management of frozen shoulder. Singapore Med J. 2017 Dec;58(12):685-689. doi: 10.11622/smedj.2017107.
- Background: PubMed 27527912Ryan V, Brown H, Minns Lowe CJ, Lewis JS. The pathophysiology associated with primary (idiopathic) frozen shoulder: A systematic review. BMC Musculoskelet Disord. 2016 Aug 15;17(1):340. doi: 10.1186/s12891-016-1190-9.
- BackgroundJeong, JY, Shim, SB, Hong, JH, Im, W., Lee, SM y Yoo, JC (2020). Efecto del hombro congelado preoperatorio sobre los resultados clínicos después de la reparación artroscópica del manguito rotador. Revista ortopédica de medicina deportiva , 8 (7), 2325967120934449. https://doi.org/10.1177/2325967120934449
- BackgroundCho, CH, Bae, KC y Kim, DH (2019). Estrategia de tratamiento para hombro congelado. Clínicas de cirugía ortopédica , 11 (3), 249-257. https://doi.org/10.4055/cios.2019.11.3.249
- BackgroundCui, J., Lu, W., He, Y., Jiang, L., Li, K., Zhu, W. y Wang, D. (2017). Biología molecular de la limitación inducida por el hombro congelado de los movimientos de la articulación del hombro. Revista de investigación en ciencias médicas: la revista oficial de la Universidad de Ciencias Médicas de Isfahan , 22 , 61. https://doi.org/10.4103/jrms.JRMS_1005_16
- Background: PubMed 27856934Vastamaki H, Ristolainen L, Vastamaki M. Range of motion of diabetic frozen shoulder recovers to the contralateral level. J Int Med Res. 2016 Dec;44(6):1191-1199. doi: 10.1177/0300060516675112. Epub 2016 Nov 18.
- BackgroundUppal, HS, Evans, JP y Smith, C. (2015). Hombro congelado: una revisión sistemática de las opciones terapéuticas. Revista mundial de ortopedia , 6 (2), 263-268. https://doi.org/10.5312/wjo.v6.i2.263
- Individual participant dataSharing planned: No. The request for the data will be studied and considered upon prior and justified request.
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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.
Gema León Bravo, Physiotherap principal investigator
Departamento de Enfermería, Farmacología y Fisioterapia, Universidad de Córdoba, Córdoba, España
Jaime Rando Anaya, Physiotherap study chair
Universidad de Córdoba
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing First data analysis, Second data analysis and database in people with Articular; Rigid, run by GEMA LEÓN BRAVO at 1 site in Spain.
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 4 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 13 Jan 2022. 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 Spain. 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?
Pain scale (EVA) (time frame: 3 months). The study lists 4 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 NCT05175586, which also lists 15 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 13 Jan 2022.