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Efficacy of Eccentric Exercises in Individuals With Frozen Shoulder

Primary Purpose

Frozen Shoulder, Capsulitis, Adhesive, Capsulitis of Shoulder

Status
Recruiting
Phase
Not Applicable
Locations
Argentina
Study Type
Interventional
Intervention
Physical therapy interventions
Sponsored by
Hospital Durand, Argentina
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Frozen Shoulder focused on measuring frozen shoulder, eccentric exercise, rehabilitation, physical therapy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • History of diffuse-onset shoulder pain of at least one month
  • Gradual loss of passive external rotation of at least 50% compared to the contralateral side

Exclusion Criteria:

- History of shoulder fracture/ surgery

  • Shoulder pain reproduced by passive movement of the cervical spine
  • History of rheumatoid arthritis
  • Shoulder immobilization for more than 5 days
  • Bilateral frozen shoulder

Sites / Locations

  • Durand HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Conventional treatment

Conventional treatment + eccentric exercises

Arm Description

Physical therapy: education, mobilizations, stretch, active exercises, home excercises.

Physical therapy: education, mobilizations, stretch, active exercises, home exercises, eccentric exercises.

Outcomes

Primary Outcome Measures

Shoulder Function
American Shoulder and Elbow Surgeons scale (ASES). This scale has a score between 0 to 100. When the score is more close to 0 Worst is the function of the shoulder and when is approximate 100, it is better.

Secondary Outcome Measures

Range of Movement
The range of movement is going to be assessed by an Inclinometer. When more higher is the value, the better it is.
Perceived Pain
The perceived pain is going to be assessed by a Visual Analogue Scale from 0 to 10, where the score close to 0 is worst, and approximate to 10 is better.
Pennation Angle
It is going to be assessed by an ultrasound device
Fear avoidance
Fear Avoidance Beliefs Questionnaire This scale has a score between 0 to 96. When the score is more close to 96 worst is the fear avoidance and when is approximate to 0, it is better.
Perceived Quality of life
European Quality of Life Scale of five domains (EQ5D-3L). This scale has five items with a score between 1 to 3. When the score is more close to 3 worst is the quality of life and when is approximate to 1, it is better in each item. Also has a visual analogue scale of 100 points to assess the health condition, when the score is more close to 0 worst is the quality of life and when is approximate to 100 it is better.
Muscle Thickness
It is going to be assessed by an ultrasound device
Pain Catastrophizing
Pain Catastrophizing Scale (PCS)

Full Information

First Posted
January 13, 2021
Last Updated
September 20, 2023
Sponsor
Hospital Durand, Argentina
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1. Study Identification

Unique Protocol Identification Number
NCT04715035
Brief Title
Efficacy of Eccentric Exercises in Individuals With Frozen Shoulder
Official Title
Efficacy of Eccentric Exercises in Individuals With Frozen Shoulder: A Randomized Controlled Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
August 3, 2022 (Actual)
Primary Completion Date
September 1, 2024 (Anticipated)
Study Completion Date
September 1, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hospital Durand, Argentina

4. Oversight

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

5. Study Description

Brief Summary
Frozen shoulder is a musculoskeletal condition with a strong negative impact on activities of daily living, producing pain, disability, anxiety, and sleep disorders. It has a worldwide prevalence of 5.3%, increasing from 10 to 38% in patients with diabetes and thyroid conditions. This clinical entity manifests itself mainly in women between 40 and 65 years of age. Its resolution time is long and can reach 42 months with symptoms that persist throughout life. In the clinical evaluation, patients with Frozen Shoulder are manifested mainly by presenting mobility deficits. Previous studies described different structural alterations that may justify this clinical condition and its consequences, such as, for example, fibrosis of the coracohumeral ligament, alterations of the rotator interval, and of the axillary recess. Although passive structures are believed to be primarily involved in this condition, A series of five cases in which patients with frozen shoulder presented a significant increase in mobility after a general anesthetic block. The data obtained from this study and the different complications presented by patients with CH suggest that it is necessary to further understand the role of the rotator cuff in this clinical condition. Eccentric exercises consist of contracting the muscle to control or decelerate a load while the muscle or tendon is lengthening or remaining stretched. This intervention has been proposed for the treatment of tendinopathies in different body regions.
Detailed Description
A randomized controlled clinical trial with two parallel groups will be carried out. Evaluators will be blinded to the treatment group and therapists will be unique to each group. This study will follow the CONSORT guidelines. Randomization by blocks between groups will be carried out through the website www.randomization.com and the sequence will be stored in sealed and opaque envelopes to maintain allocation confidentiality. This process will be carried out by an independent researcher, who will not be involved in the assessment and treatment. The allocation of subjects will be revealed to the researcher responsible for the treatment by opening the envelope before the start of the intervention. The researcher responsible for the evaluation will be blinded to the treatment group. The individuals will be blinded in relation to the study hypothesis and will not have contact with the participants of the same or the other group. Initially, all participants will undergo screening to assess the inclusion and non-inclusion criteria of the study. All individuals who meet the eligibility criteria will undergo an anamnesis to collect personal, sociodemographic, pain history, and primary and secondary outcomes measurements.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Frozen Shoulder, Capsulitis, Adhesive, Capsulitis of Shoulder
Keywords
frozen shoulder, eccentric exercise, rehabilitation, physical therapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Conventional treatment
Arm Type
Active Comparator
Arm Description
Physical therapy: education, mobilizations, stretch, active exercises, home excercises.
Arm Title
Conventional treatment + eccentric exercises
Arm Type
Experimental
Arm Description
Physical therapy: education, mobilizations, stretch, active exercises, home exercises, eccentric exercises.
Intervention Type
Other
Intervention Name(s)
Physical therapy interventions
Intervention Description
mobilization, stretch, education, eccentric exercises
Primary Outcome Measure Information:
Title
Shoulder Function
Description
American Shoulder and Elbow Surgeons scale (ASES). This scale has a score between 0 to 100. When the score is more close to 0 Worst is the function of the shoulder and when is approximate 100, it is better.
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Range of Movement
Description
The range of movement is going to be assessed by an Inclinometer. When more higher is the value, the better it is.
Time Frame
12 months
Title
Perceived Pain
Description
The perceived pain is going to be assessed by a Visual Analogue Scale from 0 to 10, where the score close to 0 is worst, and approximate to 10 is better.
Time Frame
12 months
Title
Pennation Angle
Description
It is going to be assessed by an ultrasound device
Time Frame
12 months
Title
Fear avoidance
Description
Fear Avoidance Beliefs Questionnaire This scale has a score between 0 to 96. When the score is more close to 96 worst is the fear avoidance and when is approximate to 0, it is better.
Time Frame
12 months
Title
Perceived Quality of life
Description
European Quality of Life Scale of five domains (EQ5D-3L). This scale has five items with a score between 1 to 3. When the score is more close to 3 worst is the quality of life and when is approximate to 1, it is better in each item. Also has a visual analogue scale of 100 points to assess the health condition, when the score is more close to 0 worst is the quality of life and when is approximate to 100 it is better.
Time Frame
12 months
Title
Muscle Thickness
Description
It is going to be assessed by an ultrasound device
Time Frame
12 months
Title
Pain Catastrophizing
Description
Pain Catastrophizing Scale (PCS)
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: History of diffuse-onset shoulder pain of at least one month Gradual loss of passive external rotation of at least 50% compared to the contralateral side Exclusion Criteria: - History of shoulder fracture/ surgery Shoulder pain reproduced by passive movement of the cervical spine History of rheumatoid arthritis Shoulder immobilization for more than 5 days Bilateral frozen shoulder
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Pablo O Policastro, PT
Phone
+5491155964311
Email
pablopolicastro@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Gaston Muhafara, PT
Email
muhafara@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Paula Camargo, PhD
Organizational Affiliation
University of São Carlos
Official's Role
Study Director
Facility Information:
Facility Name
Durand Hospital
City
Buenos Aires
State/Province
Buenos Aires City
ZIP/Postal Code
1405
Country
Argentina
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Pablo O Policastro, PT
Phone
+5491155964311
Email
pablopolicastro@gmail.com
First Name & Middle Initial & Last Name & Degree
Paula Rezende Camargo, PhD
First Name & Middle Initial & Last Name & Degree
Juan Cruz Porollan, PT
First Name & Middle Initial & Last Name & Degree
Santiago Soliño, PT
First Name & Middle Initial & Last Name & Degree
Vander Gava, PT
First Name & Middle Initial & Last Name & Degree
Santiago Molinas, Md
First Name & Middle Initial & Last Name & Degree
Emiliano Navarro, PT
First Name & Middle Initial & Last Name & Degree
Pablo Policastro, PT

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
Citation
1. 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. 2. Kelley MJ, McClure PW, Leggin BG. Frozen shoulder: evidence and a proposed model guiding rehabilitation. J Orthop Sports Phys Ther. 2009 Feb;39(2):135-48. 3. Lewis J. Frozen shoulder contracture syndrome - Aetiology, diagnosis and management. Man Ther. 2015 Feb;20(1):2-9. 4. Chan HBY, Pua PY, How CH. Physical therapy in the management of frozen shoulder. Singapore Med J. 2017 Dec;58(12):685-689. 5. Kelley MJ, Shaffer MA, Kuhn JE, Michener LA, Seitz AL, Uhl TL, Godges JJ, McClure PW. Shoulder pain and mobility deficits: adhesive capsulitis. J Orthop Sports Phys Ther. 2013 May;43(5):A1-31. 6. Hollmann L, Halaki M, Kamper SJ, Haber M, Ginn KA. Does muscle guarding play a role in range of motion loss in patients with frozen shoulder? Musculoskelet Sci Pract. 2018 Oct;37:64-68.
Results Reference
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Efficacy of Eccentric Exercises in Individuals With Frozen Shoulder

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