search
Back to results

Physiotherapeutic Case Studies in Frozen Shoulder Pathology (CH-Case)

Primary Purpose

Articular; Rigid

Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
First data analysis
Second data analysis
database
Sponsored by
GEMA LEÓN BRAVO
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Articular; Rigid focused on measuring Stiff shoulder., Neuromodulation., Manual therapy., Rotator cuff., Physiotherapy.

Eligibility Criteria

21 Years - 76 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Sites / Locations

  • Gema León Physiotherapy and Rehabilitation Clinic

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Group 1

Group 2

Arm Description

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

15 patients in the experimental group of orthopaedic manual therapy (Maitland and Mulligan).

Outcomes

Primary Outcome Measures

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
Rigid shoulder type
Information on the type of stiff shoulder you have.
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.
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.

Secondary Outcome Measures

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.

Full Information

First Posted
October 21, 2021
Last Updated
January 11, 2022
Sponsor
GEMA LEÓN BRAVO
search

1. Study Identification

Unique Protocol Identification Number
NCT05175586
Brief Title
Physiotherapeutic Case Studies in Frozen Shoulder Pathology
Acronym
CH-Case
Official Title
Physiotherapeutic Case Reports in Frozen Shoulder Pathology: Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
January 2022
Overall Recruitment Status
Completed
Study Start Date
February 3, 2021 (Actual)
Primary Completion Date
October 1, 2021 (Actual)
Study Completion Date
October 7, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
GEMA LEÓN BRAVO

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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).
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Articular; Rigid
Keywords
Stiff shoulder., Neuromodulation., Manual therapy., Rotator cuff., Physiotherapy.

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
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
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group 1
Arm Type
Experimental
Arm Description
15 patients in the experimental group of percutaneous neuromodulation together with orthopaedic manual therapy (Maitland and Mulligan)
Arm Title
Group 2
Arm Type
Active Comparator
Arm Description
15 patients in the experimental group of orthopaedic manual therapy (Maitland and Mulligan).
Intervention Type
Diagnostic Test
Intervention Name(s)
First data analysis
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
Second data analysis
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
database
Intervention Description
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.
Primary Outcome Measure Information:
Title
Pain scale (EVA)
Description
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
Time Frame
3 months
Title
Rigid shoulder type
Description
Information on the type of stiff shoulder you have.
Time Frame
3 months
Title
Daniels Scale
Description
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.
Time Frame
3 months
Title
Joint range
Description
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.
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Number of participants in each physical therapy application
Description
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.
Time Frame
3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
76 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gema León Bravo, Physiotherap
Organizational Affiliation
Departamento de Enfermería, Farmacología y Fisioterapia, Universidad de Córdoba, Córdoba, España
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Jaime Rando Anaya, Physiotherap
Organizational Affiliation
Universidad de Córdoba
Official's Role
Study Chair
Facility Information:
Facility Name
Gema León Physiotherapy and Rehabilitation Clinic
City
Córdoba
State/Province
Andalucía
ZIP/Postal Code
14011
Country
Spain

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
The request for the data will be studied and considered upon prior and justified request.
Citations:
PubMed Identifier
26637238
Citation
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.
Results Reference
background
PubMed Identifier
34111113
Citation
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.
Results Reference
background
PubMed Identifier
33912325
Citation
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.
Results Reference
background
PubMed Identifier
33326025
Citation
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.
Results Reference
background
PubMed Identifier
31013287
Citation
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.
Results Reference
background
PubMed Identifier
29242941
Citation
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.
Results Reference
background
PubMed Identifier
27527912
Citation
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.
Results Reference
background
Citation
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
Results Reference
background
Citation
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
Results Reference
background
Citation
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
Results Reference
background
PubMed Identifier
27856934
Citation
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.
Results Reference
background
Citation
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
Results Reference
background
Citation
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 ,
Results Reference
background
Citation
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
Results Reference
background
Citation
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
Results Reference
background

Learn more about this trial

Physiotherapeutic Case Studies in Frozen Shoulder Pathology

We'll reach out to this number within 24 hrs