Physiotherapeutic Case Studies in Frozen Shoulder Pathology

NCT05175586 | Completed DMC

• 2 other identifiers: ART-GLB-HOM-CONGTFG-EFCH-2021
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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. 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).

Conditions

Articular; Rigid

Keywords

Stiff shoulder.; Neuromodulation.; Manual therapy.; Rotator cuff.; Physiotherapy.

Outcome Measures

Primary Outcomes (4)

• 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

  3 months

• Rigid shoulder type

  Information on the type of stiff shoulder you have.

  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. 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.

  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.

  3 months

Secondary Outcomes (1)

• Number of participants in each physical therapy application

  3 months

Study Arms (2)

Group 1

EXPERIMENTAL

15 patients in the experimental group of percutaneous neuromodulation together with orthopaedic manual therapy (Maitland and Mulligan)

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).

Diagnostic Test: First data analysis; Procedure: Second data analysis; Other: database

Interventions

First data analysis DIAGNOSTIC_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.

Group 1; Group 2

Second data analysis PROCEDURE

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.

Group 1; Group 2

database OTHER

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.

Group 1; Group 2

Eligibility Criteria

• Age: 21 Years - 76 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• GEMA LEÓN BRAVO: lead

Study Sites (1)

Gema León Physiotherapy and Rehabilitation Clinic

Córdoba, Andalusia, 14011, Spain

Location

Related Publications (15)

• 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.

  PMID: 26637238 BACKGROUND

• Green 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.

  PMID: 34111113 BACKGROUND

• Pandey 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.

  PMID: 33912325 BACKGROUND

• Challoumas 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.

  PMID: 33326025 BACKGROUND

• Akbar 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.

  PMID: 31013287 BACKGROUND

• Chan 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.

  PMID: 29242941 BACKGROUND

• Ryan 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.

  PMID: 27527912 BACKGROUND

• Jeong, 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

  BACKGROUND

• 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

  BACKGROUND

• 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

  BACKGROUND

• Vastamäki, H., Ristolainen, L. y Vastamäki, M. (2016). El rango de movimiento del hombro congelado diabético se recupera al nivel contralateral. Revista de investigación médica internacional , 44 (6), 1191-1199. https://doi.org/10.1177/0300060516675112

  BACKGROUND

• Uppal, 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

  BACKGROUND

• 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 ,

  BACKGROUND

• 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

  BACKGROUND

• 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

  BACKGROUND

MeSH Terms

Conditions

Muscle Rigidity

Interventions

Database Management Systems

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Muscle Hypertonia; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Management Information Systems; Organization and Administration; Health Services Administration

Study Officials

• Gema León Bravo, Physiotherap

  Departamento de Enfermería, Farmacología y Fisioterapia, Universidad de Córdoba, Córdoba, España

  PRINCIPAL INVESTIGATOR

• Jaime Rando Anaya, Physiotherap

  Universidad de Córdoba

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Model Details: 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).

Study Record Dates

• First Submitted: October 21, 2021
• First Posted: January 4, 2022
• Study Start: February 3, 2021
• Primary Completion: October 1, 2021
• Study Completion: October 7, 2021
• Last Updated: January 13, 2022

Record last verified: 2022-01

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)