Shoulder PainNCT04322864

Telerehabilitation Intervention for Individuals With Shoulder Pain

A study testing Therapeutic exercises in people with Shoulder Pain and Musculoskeletal Diseases, run by Universidade Federal de Sao Carlos at 1 site in Brazil.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 to 60 years
Conditions the study is for: Shoulder Pain, Musculoskeletal Diseases
What is being tested?: Therapeutic exercises
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 184 participants
Where: 1 siteBrazil
Study dates: 1 Oct 2021to 1 Oct 2024
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 to 60 years
All sexes
No healthy volunteers
Adult

Who may be able to join

Age 18-60;
Self-reported pain of intensity equal to or greater than 3 points on the numerical pain scale (NDT) at rest or arm movement in the anterolateral region of the shoulder;
Duration of at least 3 months of shoulder pain;

Who cannot join

History of trauma related to the onset of symptoms;
History of clavicle, scapula or humerus fracture;
History of surgical stabilization or rotator cuff repair;
History of shoulder dislocation;
Pain related to the cervical spine;
Adhesive capsulitis;
Systemic disease involving the joints and cognitive alteration that makes it impossible to carry out questionnaires or use the mobile application.

Trial locations and contacts

1 site in 1 country.

Brazil1 site

Universidade Federal de São Carlos
São Carlos, São Paulo, 13565-905

Other trials in Brazil

About this study

Official title: Telerehabilitation Intervention for Individuals With Shoulder Pain: Randomized Controlled Trial

Introduction: Shoulder pain is a condition of high prevalence in the general population. Studies indicate that physiotherapeutic treatment with exercise is effective in reducing pain and restoring function in patients with shoulder pain. Patients may have difficulty accessing the physiotherapy service due to the cost of treatment, transportation to the service, and long waiting lines. A possible solution is the use of a telerehabiliation intervention to increase access to physiotherapy for shoulder pain patients. Objective: To assess the effectiveness of telerehabilitation when compared to in-person physiotherapy on pain and disability in individuals with persistent rotator cuff related shoulder pain. Methods: This study is a controlled, randomized, blinded clinical trial. A total of 184 individuals with shoulder pain were randomly assigned to two groups. One group received a telerehabiliation intervention and the other group received the in-person intervention. The intervention consisted of strengthening exercises with emphasis on the lateral rotator and scapulothoracic muscles. The primary outcome was pain and disability (SPADI, Shoulder Pain and Disability Index), and the secondary outcomes were pain intensity (NPRS, Numerical Pain Rating Scale), function (DASH questionnaire, Disabilities of the Arm, Shoulder and Hand), self-efficacy (CPSS, Chronic Pain Self-Efficacy Scale), kinesiophobia (Cover Scale), patient expectation of treatment (7-point Likert Scale), and patient self-perceived improvement (Global Change Assessment Scale). All outcomes were measured before and after 12 weeks of treatment (2x/week). Normality of data was verified by Kolmogorov Smirnov's test. Differences between groups were assessed using the mixed linear models including the group × time interaction. The effect size was calculated for the variables between the groups. The significance level was set at 5%.

Conditions: Shoulder Pain, Musculoskeletal Diseases
Being tested: Therapeutic exercises
Medical subject headings: Shoulder Pain, Musculoskeletal Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Therapeutic exercisesOther
Patients will perform strengthening exercises focusing on scapulothoracic muscles and shoulder lateral rotators.

Study groups in NCT04322864
Study group	Role	What they receive
In-person supervised intervention	Active comparator	Not described Receives: Other: Therapeutic exercises
Web-based instrument intervention	Experimental	Not described Receives: Other: Therapeutic exercises

What is being measured

The primary outcome is the main question the study is designed to answer.

Change in baseline Shoulder Pain and Disability to 12 weeks
Shoulder Pain and Disability will be measured with Shoulder Pain and Disability Index with scores ranging from 0 to 100 (higher score reflects higher pain and disability)
Measured: Pre (baseline) treatment, post treatment (12 weeks)

Secondary outcomes (6)

Change in baseline Pain to 12 weeks
Pain will be measured with 11 point - Numerical Rating Pain Scale with scores ranging from 0 (no pain) to 10 (maximum pain).
Measured: Pre (baseline) treatment, post treatment (12 weeks)
Change in baseline Function to 12 weeks
Function will be measured with Disabilities of the Arm, Shoulder and Hand with scores ranging from 0 to 100 (higher score reflects higher disability)
Measured: Pre (baseline) treatment, post treatment (12 weeks)
Change in baseline Self-efficacy to 12 weeks
Self-efficacy will be measured with Chronic Pain Self-Efficacy Scale with scores ranging from 30 to 300 (higher score reflects greater self-efficacy)
Measured: Pre (baseline) treatment, post treatment (12 weeks)
Change in baseline Kinesiophobia to 12 weeks
Kinesiophobia will be measured with Tampa Scale of Kinesiophobia with scores ranging from 17 to 68 (higher score reflects higher kinesiophobia)
Measured: Pre (baseline) treatment, post treatment (12 weeks)
Patients' expectation with the treatment at baseline
Patients' expectation with the treatment will be measured with a 7-point Likert scale ranging from 1 (worse than ever) to 7 (totally recovered).
Measured: Pre (baseline) treatment
Patients' Self-perception of improvement with the treatment at 12 weeks
Self-perception of improvement will be measured with the Global Rating of Change Scale with scores ranging from -7 to +7 (A higher score indicates higher recovery from the condition).
Measured: Post treatment (12 weeks)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Oct 20211 Oct 2024

First posted26 Mar 2020
Study start1 Oct 2021
Primary completion1 Oct 2024
Study completion1 Oct 2024

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Shoulder PainStudies 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: Double blind
Who is masked: Investigator, Outcomes assessor
Enrolment: 184 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04322864
Sponsor's protocol ID: eHealthRCT
Status last verified: Jul 2026
First submitted: 23 Mar 2020
Last updated: 3 Aug 2026
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No: At the end of the clinical trial will be published the Study Protocol and Statistical Analysis Plan (SAP), if any researcher wants more information can request. The Informed Consent Form (ICF) can also be available.

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Recruiting
Effects of Cervicothoracic Mobilization in Patients With Supraspinatus Tendinitis
Rotator Cuff Tendonitis
Recruiting
Hybrid mHealth and Telerehabilitation vs Conventional Physiotherapy for Subacromial Pain Syndrome
Subacromial Pain Syndrome
Not yet recruiting
Magnesium Sulphate as an Adjuvant in Combined Costoclavicular Block and Suprascapular Block Versus Interscalene Block for Ambulatory Shoulder Arthroscopy
Postoperative Pain, Shoulder Arthroscopy
Active, not recruiting
Effects of Injection Combined With Spencer Technique on Painful Frozen Shoulder
Frozen Shoulder
Not yet recruiting
Laser Therapy Versus Transcutaneous Electical Nerve Stimulation at Hemiplegic Shoulder Pain
Hemiplegic Shoulder Pain

All Shoulder Pain trials

Study at a glance

From the registry record, last updated by the sponsor on 3 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Telerehabilitation Intervention for Individuals With Shoulder Pain: Randomized Controlled Trial
ClinicalTrials.gov ID: NCT04322864
Acronym / sponsor ID: eHealthRCT
Conditions: Shoulder Pain, Musculoskeletal Diseases
Study type: Interventional
Recruitment status: Completed
Enrolment: 184 participants (actual)
Lead sponsor: Universidade Federal de Sao CarlosUniversity, hospital or other
Study start: 1 Oct 2021 (actual)
Primary completion: 1 Oct 2024 (actual)
Study completion: 1 Oct 2024 (actual)
First posted: 26 Mar 2020 (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.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
In-person supervised intervention	Active comparator	Other: Therapeutic exercises
Web-based instrument intervention	Experimental	Other: Therapeutic exercises

Who may qualify

Ages: 18 to 60 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult

Key inclusion criteria (3 listed)

Age 18-60;
Self-reported pain of intensity equal to or greater than 3 points on the numerical pain scale (NDT) at rest or arm movement in the anterolateral region of the shoulder;
Duration of at least 3 months of shoulder pain;

Key exclusion criteria (7 listed)

History of trauma related to the onset of symptoms;
History of clavicle, scapula or humerus fracture;
History of surgical stabilization or rotator cuff repair;
History of shoulder dislocation;
Pain related to the cervical spine;

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
Therapeutic exercisesPatients will perform strengthening exercises focusing on scapulothoracic muscles and shoulder lateral rotators.	Other	In-person supervised intervention, Web-based instrument intervention

Primary outcome

Change in baseline Shoulder Pain and Disability to 12 weeks
Time frame: Pre (baseline) treatment, post treatment (12 weeks)
Shoulder Pain and Disability will be measured with Shoulder Pain and Disability Index with scores ranging from 0 to 100 (higher score reflects higher pain and disability)

6 secondary outcomes

Change in baseline Pain to 12 weeks
Time frame: Pre (baseline) treatment, post treatment (12 weeks)
Change in baseline Function to 12 weeks
Time frame: Pre (baseline) treatment, post treatment (12 weeks)
Change in baseline Self-efficacy to 12 weeks
Time frame: Pre (baseline) treatment, post treatment (12 weeks)
Change in baseline Kinesiophobia to 12 weeks
Time frame: Pre (baseline) treatment, post treatment (12 weeks)
Patients' expectation with the treatment at baseline
Time frame: Pre (baseline) treatment
Patients' Self-perception of improvement with the treatment at 12 weeks
Time frame: Post treatment (12 weeks)

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 3 Aug 2026.
Individual participant dataSharing planned: No. At the end of the clinical trial will be published the Study Protocol and Statistical Analysis Plan (SAP), if any researcher wants more information can request. The Informed Consent Form (ICF) can also be available.

Related trials for Shoulder Pain

Recruiting
Effects of Cervicothoracic Mobilization in Patients With Supraspinatus Tendinitis
Rotator Cuff Tendonitis
Recruiting
Hybrid mHealth and Telerehabilitation vs Conventional Physiotherapy for Subacromial Pain Syndrome
Subacromial Pain Syndrome
Not yet recruiting
Magnesium Sulphate as an Adjuvant in Combined Costoclavicular Block and Suprascapular Block Versus Interscalene Block for Ambulatory Shoulder Arthroscopy
Postoperative Pain, Shoulder Arthroscopy
Active, not recruiting
Effects of Injection Combined With Spencer Technique on Painful Frozen Shoulder
Frozen Shoulder
Not yet recruiting
Laser Therapy Versus Transcutaneous Electical Nerve Stimulation at Hemiplegic Shoulder Pain
Hemiplegic Shoulder Pain

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.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Therapeutic exercises in people with Shoulder Pain and Musculoskeletal Diseases, run by Universidade Federal de Sao Carlos at 1 site in Brazil.

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 3 inclusion and 7 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 3 Aug 2026. 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 Brazil. 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?

Change in baseline Shoulder Pain and Disability to 12 weeks (time frame: Pre (baseline) treatment, post treatment (12 weeks)). 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 NCT04322864.

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 3 Aug 2026.