Frozen ShoulderNCT04715035
Efficacy of Eccentric Exercises in Individuals With Frozen Shoulder
A study testing Physical therapy interventions in people with Frozen Shoulder and Capsulitis, Adhesive, run by Hospital Durand, Argentina at 1 site in Argentina.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Frozen Shoulder, Capsulitis, Adhesive, Capsulitis of Shoulder
- What is being tested?
- Physical therapy interventions
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteArgentina
- Study dates
- 3 Aug 2022to 27 Jun 2025
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy of Eccentric Exercises in Individuals With Frozen Shoulder: A Randomized Controlled Clinical Trial
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.
Read more
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.
Read the 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.
- Being tested
- Physical therapy interventions
- Keywords
- frozen shoulder, eccentric exercise, rehabilitation, physical therapy
- Medical subject headings
- Bursitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Physical therapy interventionsOther
mobilization, stretch, education, eccentric exercises
| Study group | Role | What they receive |
|---|---|---|
| Conventional treatment | Active comparator | Physical therapy: education, mobilizations, stretch, active exercises, home excercises. Receives: Other: Physical therapy interventions |
| Conventional treatment + eccentric exercises | Experimental | Physical therapy: education, mobilizations, stretch, active exercises, home exercises, eccentric exercises. Receives: Other: Physical therapy interventions |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From enrollment to the end of treatment at 12 weeks. In the follow-up at 3 months and 9 months from the end of treatment.
Secondary outcomes (7)
Range of Movement
An inclinometer will assess flexion, external rotation, and internal rotation range of movement. The higher the value, the better.
Measured: From enrollment to the end of treatment at 12 weeks. In the follow-up at 3 months and 9 months from the end of treatment.
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.
Measured: From enrollment to the end of treatment at 12 weeks. In the follow-up at 3 months and 9 months from the end of treatment.
Pennation Angle
It is going to be assessed by an ultrasound device
Measured: From enrollment to the end of treatment at 12 weeks. In the follow-up at 3 months and 9 months from the end of treatment.
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.
Measured: From enrollment to the end of treatment at 12 weeks. In the follow-up at 3 months and 9 months from the end of treatment.
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.
Measured: From enrollment to the end of treatment at 12 weeks. In the follow-up at 3 months and 9 months from the end of treatment.
Muscle Thickness
It is going to be assessed by an ultrasound device
Measured: From enrollment to the end of treatment at 12 weeks. In the follow-up at 3 months and 9 months from the end of treatment.
Pain Catastrophizing
Pain Catastrophizing Scale (PCS)
Measured: From enrollment to the end of treatment at 12 weeks. In the follow-up at 3 months and 9 months from the end of treatment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jan 2021
- Study start3 Aug 2022
- Primary completion27 Jun 2025
- Study completion27 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Frozen ShoulderStudies 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital Durand, Argentina
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Pablo Policastro, Hospital Durand, Argentina
- Investigators
- Paula Camargo, PhD, Study director, University of São Carlos
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04715035
- Sponsor's protocol ID
- Policastro.ECA.HombroCongelado
- Status last verified
- Jun 2025
- First submitted
- 13 Jan 2021
- Last updated
- 1 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
Study at a glance
From the registry record, last updated by the sponsor on 1 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Eccentric Exercises in Individuals With Frozen Shoulder: A Randomized Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT04715035
- Acronym / sponsor ID
- Policastro.ECA.HombroCongelado
- Keywords
- frozen shoulder, eccentric exercise, rehabilitation, physical therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Hospital Durand, ArgentinaUniversity, hospital or other
- Study start
- 3 Aug 2022 (actual)
- Primary completion
- 27 Jun 2025 (actual)
- Study completion
- 27 Jun 2025 (actual)
- First posted
- 20 Jan 2021 (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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Conventional treatment | Active comparator | Other: Physical therapy interventionsPhysical therapy: education, mobilizations, stretch, active exercises, home excercises. |
| Conventional treatment + eccentric exercises | Experimental | Other: Physical therapy interventionsPhysical therapy: education, mobilizations, stretch, active exercises, home exercises, eccentric exercises. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (5 listed)
- 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
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 |
|---|---|---|
| Physical therapy interventionsmobilization, stretch, education, eccentric exercises | Other | Conventional treatment, Conventional treatment + eccentric exercises |
Primary outcome
Shoulder Function
Time frame: From enrollment to the end of treatment at 12 weeks. In the follow-up at 3 months and 9 months from the end of treatment.
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.
7 secondary outcomes
Range of Movement
Time frame: From enrollment to the end of treatment at 12 weeks. In the follow-up at 3 months and 9 months from the end of treatment.
Perceived Pain
Time frame: From enrollment to the end of treatment at 12 weeks. In the follow-up at 3 months and 9 months from the end of treatment.
Pennation Angle
Time frame: From enrollment to the end of treatment at 12 weeks. In the follow-up at 3 months and 9 months from the end of treatment.
Fear avoidance
Time frame: From enrollment to the end of treatment at 12 weeks. In the follow-up at 3 months and 9 months from the end of treatment.
Perceived Quality of life
Time frame: From enrollment to the end of treatment at 12 weeks. In the follow-up at 3 months and 9 months from the end of treatment.
Muscle Thickness
Time frame: From enrollment to the end of treatment at 12 weeks. In the follow-up at 3 months and 9 months from the end of treatment.
Pain Catastrophizing
Time frame: From enrollment to the end of treatment at 12 weeks. In the follow-up at 3 months and 9 months from the end of treatment.
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 1 Jul 2025.
- Background1. 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.
- 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.
Paula Camargo, PhD study director
University of São Carlos
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Physical therapy interventions in people with Frozen Shoulder and Capsulitis, Adhesive, run by Hospital Durand, Argentina at 1 site in Argentina.
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 2 inclusion and 5 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 1 Jul 2025. 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 Argentina. 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?
Shoulder Function (time frame: From enrollment to the end of treatment at 12 weeks. In the follow-up at 3 months and 9 months from the end of treatment.). 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 NCT04715035, which also lists 1 linked publication.
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 1 Jul 2025.