Chronic Shoulder PainNCT06854809
Cognitive Functional Therapy Versus Exercises for Chronic Shoulder Pain
A study testing Cognitive functional therapy and Therapeutic exercise in people with Chronic Shoulder Pain, run by Universidade Federal de Sao Carlos at 1 site in Brazil.
Trial summary
The objective of this clinical trial is to determine whether cognitive functional therapy is superior to therapeutic exercises for the treatment of chronic shoulder pain. The main questions it aims to answer are: Is cognitive functional therapy superior to therapeutic exercises for pain and disability in individuals… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Chronic Shoulder Pain
- What is being tested?
- Cognitive functional therapy and Therapeutic exercise
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 148 participants
- Where
- 1 siteBrazil
- Study dates
- Jul 2025to Mar 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Individuals of both sexes, aged between 18 and 65 years, will be included if they have had shoulder pain for at least 3 months and report a pain intensity of at least 3 points on the Numeric Pain Rating Scale (NPRS) at rest or during arm movement. Additionally, they must have a minimum score of 20 points on the Shoulder Pain and Disability Index (SPADI).
Who cannot join
- Individuals will not be included if they have adhesive capsulitis, defined as a loss of more than 50% of passive shoulder range of motion in external rotation; previous shoulder surgery; a history of shoulder fracture; systemic musculoskeletal diseases (e.g., rheumatoid arthritis, fibromyalgia); shoulder pain reproduced by active or passive cervical spine movement; signs of glenohumeral instability identified by a positive sulcus test or a positive apprehension test indicating laxity in the glenohumeral joint; self-reported systemic disease; a positive drop arm test; pregnancy; active cancer treatment; neurological diseases; cognitive impairments; corticosteroid injection within three months prior to the intervention; or physical therapy in the three months preceding the study.
- Participants will be discontinued from the study if they experience fractures, surgeries, musculoskeletal or neural injuries that prevent access to treatment, or receive corticosteroid injections during the treatment or follow-up period.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Brazil1 site, 1 recruiting
- Recruiting
Universidade Federal de Sao Carlos
São Carlos, São Paulo, 13568-110
Universidade Federal de São Carlos
About this study
Official title: Effects of Cognitive Functional Therapy Versus Therapeutic Exercises in Individuals With Chronic Shoulder Pain: A Randomized Controlled Trial
The objective of this clinical trial is to determine whether cognitive functional therapy is superior to therapeutic exercises for the treatment of chronic shoulder pain. The main questions it aims to answer are:
Is cognitive functional therapy superior to therapeutic exercises for pain and disability in individuals with chronic shoulder pain? Is cognitive functional therapy superior to therapeutic exercises for functionality and psychosocial factors?
Participants will:
Receive 4 to 8 sessions of cognitive functional therapy once a week for four to eight weeks.
Follow a therapeutic exercise protocol for eight weeks with a frequency of twice per week.
Read the detailed description
This will be a randomized controlled trial, single-blind, with two parallel groups. 148 individuals with chronic shoulder pain will be randomly assigned to one of two groups: Cognitive functional therapy (CFT) or therapeutic exercises. The interventions will last between four and eight weeks, with the CFT group receiving therapy once a week and the therapeutic exercise group receiving sessions twice a week for eight weeks. The primary outcomes will be pain intensity and disability, while the secondary outcomes will include specific function, kinesiophobia, self-efficacy, sleep quality, treatment expectations, perception of change, treatment satisfaction and exercise adherence.
- Conditions
- Chronic Shoulder Pain
- Being tested
- Cognitive functional therapy, Therapeutic exercise
- Keywords
- shoulder pain, Psychosocial Rehabilitation, exercise therapy
- Medical subject headings
- Shoulder Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive functional therapyBehavioural
The intervention consists of a Cognitive-Functional Therapy (CFT) program for individuals with shoulder pain, conducted by trained physiotherapists (106 hours of training) under the supervision of an expert with over 8 years of experience. CFT adopts a biopsychosocial approach and is structured into three main components:
Making Sense of Pain - A cognitive component aimed at reinterpreting dysfunctional beliefs about pain through a reflective process based on the patient's life history, promoting understanding and self-efficacy.
Graded Exposure with Control - Gradual exposure to functional activities, aiming to modify maladaptive associations between movement and pain, fostering the development of movement confidence.
Lifestyle Change - Discussion and implementation of strategies to promote a healthy lifestyle, including physical activity, sleep habits, and stress management.
All three components are integrated from the first session, with initial focus on building the therapeutic all.
Therapeutic exerciseOther
Participants in the Therapeutic Exercises Group will engage in individualized exercises targeting the scapulothoracic musculature and rotator cuff. The exercises, performed bilaterally, include lateral arm rotation, T, W, wall hand slide, and diagonal arm movement upwards. Each participant will be guided by one of two physiotherapists, randomly assigned. The exercises will follow a protocol consisting of 3 sets of 12 repetitions, with 1-minute rest between sets, using progressively resistant Thera-Bands®. Resistance will increase when pain is ≤2 on the Numerical Rating Scale and perceived exertion is <3 on the Borg Scale. The protocol was designed based on scientific literature and shoulder pain treatment guidelines to address muscle activation deficits and rotator cuff and scapulothoracic imbalances.
| Study group | Role | What they receive |
|---|---|---|
| Cognitive functional therapy | Experimental | Not described Receives: Behavioral: Cognitive functional therapy |
| Therapeutic exercise | Active comparator | Not described Receives: Other: Therapeutic exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain intensity
The intensity of shoulder pain will be assessed during arm movement in which the patient reports, pain using the Numeric pain rating scale (NPRS). The scale consists of an 11-point ordinal system, ranging from 0 to 10, where 0 represents no pain and 10 represents the worst possible pain.
Measured: Baseline, 4-week, at the end of treatment (8-week), and 12-week follow-up
Shoulder disability
Disability will be assessed using the Shoulder Pain and Disability Index (SPADI). The instrument is self-administered and consists of 13 items divided into 2 subscales (5 items for pain; 8 items for disability) and each item is scored from 0 to 10 points. The final score ranges from 0 to 100, with higher scores indicating greater shoulder disability.
Measured: Baseline, 4-week, at the end of treatment (8-week), and 12-week follow-up
Secondary outcomes (8)
Patient Specific Function
The Patient Specific Functional Scale (PSFS) will be used to assess the patient's specific functionality. Patients will be asked to identify up to three important activities that they are having difficulty with or are unable to perform due to their condition. Furthermore, patients must classify, on a scale of 11 points (ranging from 0 "unable to perform activity" to 10 "able to perform activity".
Measured: Baseline, 4-week, at the end of treatment (8-week), and 12-week follow-up
Kinesiophobia
Kinesiophobia will be assessed by the Tampa Kinesiophobia Scale 11 (TSK-11). The TSK is an instrument used to measure fear of movement. It is a self-administered questionnaire and presents 11 questions related to pain and intensity of symptoms. The score ranges from 11 to 44 points, in which higher scores indicate higher levels of kinesiophobia.
Measured: Baseline, 4-week, at the end of treatment (8-week), and 12-week follow-up
Pain Self-Efficacy
Self-efficacy will be assessed using the Pain Self-Efficacy Questionnaire (PSEQ). This is a 10-item self-report questionnaire that measures the degree of self-confidence in performing certain activities. Each item is rated on a 7-point Likert scale (0 = not at all confident; 6 = completely confident), with higher scores reflecting greater self-confidence.
Measured: Baseline, 4-week, at the end of treatment (8-week), and 12-week follow-up
Sleep Quality
Sleep quality will be assessed using the Insomnia Severity Index (ISI). This is a scale that assesses the nature, intensity, and impact of insomnia experienced in the last month. The self-report instrument consists of 7 questions, answered using a Likert scale ranging from 0 (no severity) to 4 (high severity). The total score ranges from 0 to 28, classified as follows: no insomnia (0-7), mild insomnia (8-14), moderate insomnia (15-21), and severe insomnia (22-28).
Measured: Baseline, 4-week, at the end of treatment (8-week), and 12-week follow-up
Expectations with Treatment
The patient's expectations regarding the treatment will be assessed by asking the question "How much do you expect your shoulder to improve at the end of the treatment?". The score will be measured on a 7-point Likert scale, with 1 being "worst possible" and 7 being "completely recovered". The assessment will be made before the intervention begins.
Measured: Baseline
Perception of Change
The individual's perception of changes in health status over time will be measured using the Global Change Assessment Scale. The score varies from 15 points, with -7 being "a very significant worsening", 0 indicating "no change" and +7 "a very significant improvement"
Measured: 4-week, at the end of treatment (8-week), and 12-week follow-up
Satisfaction with treatment
The individual's satisfaction with the treatment will be measured using the Global Rating of Change Scale. The score varies from 15 points, with -7 being "the worst possible satisfaction", 0 indicating "no change" and +7 "the best possible satisfaction".
Measured: At the end of treatment (8-week), and 12-week follow-up
Exercise adherence
To assess exercise adherence, sections B and C of the Brazilian version of the Exercise Adherence Rating Scale (EARS-Br) will be used. Section B consists of 6 items rated on a 5-point Likert scale ranging from 0 ("strongly agree") to 4 ("strongly disagree"). This section aims to measure the participant's level of adherence to the recommended exercises. The total score ranges from 0 to 24 points, with scores equal to or greater than 17 indicating good adherence to the home exercise program. Section C consists of 9 items, also organized on a 5-point Likert scale (0 = "strongly agree"; 4 = "strongly disagree"). This section explores factors that influence exercise adherence, divided into barriers (items 1, 2, 3, 8, and 9) and facilitators (items 4, 5, 6, and 7).
Measured: 4-week, at the end of treatment (8-week), and 12-week follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2025
- Study startJul 2025 (estimated)
- Primary completionJun 2027 (estimated)
- Study completionMar 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic 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
- Model description
- This is a superiority randomized controlled trial, single-blinded, with two parallel groups.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 148 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universidade Federal de Sao Carlos
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Matheus Dias Gregorio, Universidade Federal de Sao Carlos
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06854809
- Sponsor's protocol ID
- CFTandShoulderPain
- Status last verified
- Jun 2025
- First submitted
- 25 Feb 2025
- Last updated
- 18 Jun 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The individual participant data will be shared under request.
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Cognitive Functional Therapy Versus Therapeutic Exercises in Individuals With Chronic Shoulder Pain: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06854809
- Acronym / sponsor ID
- CFTandShoulderPain
- Conditions
- Chronic Shoulder Pain
- Keywords
- shoulder pain, Psychosocial Rehabilitation, exercise therapy
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 148 participants (estimated)
- Lead sponsor
- Universidade Federal de Sao CarlosUniversity, hospital or other
- Study start
- Jul 2025 (estimated)
- Primary completion
- Jun 2027 (estimated)
- Study completion
- Mar 2029 (estimated)
- First posted
- 3 Mar 2025 (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.
The objective of this clinical trial is to determine whether cognitive functional therapy is superior to therapeutic exercises for the treatment of chronic shoulder pain. The main questions it aims to answer are:
Is cognitive functional therapy superior to therapeutic exercises for pain and disability in individuals with chronic shoulder pain? Is cognitive functional therapy superior to therapeutic exercises for functionality and psychosocial factors?
Participants will:
Receive 4 to 8 sessions of cognitive functional therapy once a week for four to eight weeks.
Follow a therapeutic exercise protocol for eight weeks with a frequency of twice per week.
Detailed description
This will be a randomized controlled trial, single-blind, with two parallel groups. 148 individuals with chronic shoulder pain will be randomly assigned to one of two groups: Cognitive functional therapy (CFT) or therapeutic exercises. The interventions will last between four and eight weeks, with the CFT group receiving therapy once a week and the therapeutic exercise group receiving sessions twice a week for eight weeks. The primary outcomes will be pain intensity and disability, while the secondary outcomes will include specific function, kinesiophobia, self-efficacy, sleep quality, treatment expectations, perception of change, treatment satisfaction and exercise adherence.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- This is a superiority randomized controlled trial, single-blinded, with two parallel groups.
| Arm | Type | Receives |
|---|---|---|
| Cognitive functional therapy | Experimental | Behavioral: Cognitive functional therapy |
| Therapeutic exercise | Active comparator | Other: Therapeutic exercise |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Individuals of both sexes, aged between 18 and 65 years, will be included if they have had shoulder pain for at least 3 months and report a pain intensity of at least 3 points on the Numeric Pain Rating Scale (NPRS) at rest or during arm movement. Additionally, they must have a minimum score of 20 points on the Shoulder Pain and Disability Index (SPADI).
Key exclusion criteria (2 listed)
- Individuals will not be included if they have adhesive capsulitis, defined as a loss of more than 50% of passive shoulder range of motion in external rotation; previous shoulder surgery; a history of shoulder fracture; systemic musculoskeletal diseases (e.g., rheumatoid arthritis, fibromyalgia); shoulder pain reproduced by active or passive cervical spine movement; signs of glenohumeral instability identified by a positive sulcus test or a positive apprehension test indicating laxity in the glenohumeral joint; self-reported systemic disease; a positive drop arm test; pregnancy; active cancer treatment; neurological diseases; cognitive impairments; corticosteroid injection within three months prior to the intervention; or physical therapy in the three months preceding the study.
- Participants will be discontinued from the study if they experience fractures, surgeries, musculoskeletal or neural injuries that prevent access to treatment, or receive corticosteroid injections during the treatment or follow-up period.
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 |
|---|---|---|
| Cognitive functional therapyThe intervention consists of a Cognitive-Functional Therapy (CFT) program for individuals with shoulder pain, conducted by trained physiotherapists (106 hours of training) under the supervision of an expert with over 8 years of experience. CFT adopts a biopsychosocial approach and is structured into three main components: Making Sense of Pain - A cognitive component aimed at reinterpreting dysfunctional beliefs about pain through a reflective process based on the patient's life history, promoting understanding and self-efficacy. Graded Exposure with Control - Gradual exposure to functional activities, aiming to modify maladaptive associations between movement and pain, fostering the development of movement confidence. Lifestyle Change - Discussion and implementation of strategies to promote a healthy lifestyle, including physical activity, sleep habits, and stress management. All three components are integrated from the first session, with initial focus on building the therapeutic all. | Behavioural | Cognitive functional therapy |
| Therapeutic exerciseParticipants in the Therapeutic Exercises Group will engage in individualized exercises targeting the scapulothoracic musculature and rotator cuff. The exercises, performed bilaterally, include lateral arm rotation, T, W, wall hand slide, and diagonal arm movement upwards. Each participant will be guided by one of two physiotherapists, randomly assigned. The exercises will follow a protocol consisting of 3 sets of 12 repetitions, with 1-minute rest between sets, using progressively resistant Thera-Bands®. Resistance will increase when pain is ≤2 on the Numerical Rating Scale and perceived exertion is <3 on the Borg Scale. The protocol was designed based on scientific literature and shoulder pain treatment guidelines to address muscle activation deficits and rotator cuff and scapulothoracic imbalances. | Other | Therapeutic exercise |
Primary outcome
Pain intensity
Time frame: Baseline, 4-week, at the end of treatment (8-week), and 12-week follow-up
The intensity of shoulder pain will be assessed during arm movement in which the patient reports, pain using the Numeric pain rating scale (NPRS). The scale consists of an 11-point ordinal system, ranging from 0 to 10, where 0 represents no pain and 10 represents the worst possible pain.
Shoulder disability
Time frame: Baseline, 4-week, at the end of treatment (8-week), and 12-week follow-up
Disability will be assessed using the Shoulder Pain and Disability Index (SPADI). The instrument is self-administered and consists of 13 items divided into 2 subscales (5 items for pain; 8 items for disability) and each item is scored from 0 to 10 points. The final score ranges from 0 to 100, with higher scores indicating greater shoulder disability.
8 secondary outcomes
Patient Specific Function
Time frame: Baseline, 4-week, at the end of treatment (8-week), and 12-week follow-up
Kinesiophobia
Time frame: Baseline, 4-week, at the end of treatment (8-week), and 12-week follow-up
Pain Self-Efficacy
Time frame: Baseline, 4-week, at the end of treatment (8-week), and 12-week follow-up
Sleep Quality
Time frame: Baseline, 4-week, at the end of treatment (8-week), and 12-week follow-up
Expectations with Treatment
Time frame: Baseline
Perception of Change
Time frame: 4-week, at the end of treatment (8-week), and 12-week follow-up
Satisfaction with treatment
Time frame: At the end of treatment (8-week), and 12-week follow-up
Exercise adherence
Time frame: 4-week, at the end of treatment (8-week), and 12-week follow-up
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jun 2025.
- Individual participant dataSharing planned: Yes. The individual participant data will be shared under request.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cognitive functional therapy and Therapeutic exercise in people with Chronic Shoulder Pain, 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 1 inclusion and 2 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: looking for participants now, as of the sponsor's last update on 18 Jun 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 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Matheus Dias Gregorio (+55 (14) 99679-3919, matheusgregorio@estudante.ufscar.br), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain intensity (time frame: Baseline, 4-week, at the end of treatment (8-week), and 12-week follow-up). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 18 Jun 2025.