Chronic Shoulder PainNCT06542666
Cognitive Functional Therapy for Chronic Shoulder Pain: Pilot and Feasibility Study
A study testing Cognitive Functional Therapy and Exercises in people with Chronic Shoulder Pain and Exercise Therapy, run by Federal University of Paraíba at 1 site in Brazil.
Trial summary
This pilot randomized controlled clinical trial (RCT) will assess the feasibility and identify the key components necessary for conducting the main RCT, which will involve the comparison of Cognitive Functional Therapy with Therapeutic Exercises in individuals with chronic shoulder pain. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Chronic Shoulder Pain, Exercise Therapy, Psychosocial Rehabilitation
- What is being tested?
- Cognitive Functional Therapy and Exercises
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteBrazil
- Study dates
- 17 Feb 2025to 31 Dec 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 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Men and women;
- Age between 18 and 60 years;
- Presence of shoulder pain for more than 3 months;
- Pain intensity of 4 points or more on the 11-point Numeric Pain Rating Scale during the past week.
- High level of disability or moderate level of irritability.
Who cannot join
- History of fracture or surgery of the clavicle, scapula, and/or humerus, surgical stabilization or rotator cuff repair;
- History of dislocation, instability (positive sulcus sign or apprehension test), and/or rotator cuff tear (positive drop arm test);
- Adhesive capsulitis verified by the presence of gradual onset pain associated with stiffness and reduced passive and active mobility;
- Ongoing pregnancy;
- Reproduction of shoulder pain radiating to the entire upper limb during cervical or thoracic spine tests (positive Spurling test);
- Neurological or systemic diseases that may alter muscle strength and sensitivity such as rheumatoid arthritis, fibromyalgia, lupus, gout, and diabetes;
- Corticosteroid injection in the shoulder region in the last 3 months;
- Physiotherapy treatment in the last 6 months.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Cognitive Functional Therapy Versus Therapeutic Exercises for Treating Individuals With Chronic Shoulder Pain: A Pilot and Feasibility Study
This pilot randomized controlled clinical trial (RCT) will assess the feasibility and identify the key components necessary for conducting the main RCT, which will involve the comparison of Cognitive Functional Therapy with Therapeutic Exercises in individuals with chronic shoulder pain. The main questions it aims to answer are:
- What barriers to the participation of the included individuals might arise?
- Will the assessment procedures and outcome measures be feasible and suitable?
- What time will be necessary to conduct the assessments?
- Will participants be willing to be randomized to the proposed treatment groups?
- What barriers to the clinical delivery of Cognitive Functional Therapy in the healthcare system might exist?
- Will the treatment(s) be acceptable to patients?
- Will participants adhere to the treatment?
- What will the recruitment rates be per week/month?
- Will there be any selection bias?
- Will participant retention be high among the allocation groups?
- Will the data be complete?
- What will the data variability be?
- Will the treatment effects/outcomes be consistent with expectations and previous literature?
Read the detailed description
Shoulder pain is a potentially debilitating musculoskeletal condition, with functional, physical, and psychological impact. Its chronicity has been mainly correlated with affective-emotional and cognitive dimensions of pain. In this scenario, interventions for individuals with chronic shoulder pain should be seen within the biopsychosocial model. In this context, Cognitive Functional Therapy (CFT) emerges as a psychologically informed physiotherapeutic approach directed towards the biopsychosocial and multidimensional nature of pain, which is divided into three approaches to reduce pain and disability: (1) understanding pain, (2) controlled exposure, and (3) lifestyle change. The present study aims to verify the feasibility and viability of a randomized clinical trial to compare the effects of Cognitive Functional Therapy with therapeutic exercises in individuals with chronic shoulder pain.
- Being tested
- Cognitive Functional Therapy, Exercises
- Keywords
- Shoulder pain, Subacromial pain, Rotator cuff related pain, Shoulder Impingement, Chronic pain, Psychosocial, Rehabilitation, Biopsychosocial
- Medical subject headings
- Shoulder Pain, Shoulder Impingement Syndrome, Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive Functional TherapyOther
The intervention focuses on addressing the maladaptive cognitive, physical, and lifestyle behaviors related to the disorder.
Cognitive functional therapy will focus on factors considered to contribute to the pain disorder, addressing the following topics:
- The multidimensional nature of persistent pain, beliefs, emotions, and behaviors (movement and lifestyle) that can reinforce a vicious cycle of pain sensitization and disability.
- Specific functional training designed to normalize maladaptive and provocative postural and movement behaviors as directed by the individual's presentation.
- Targeted functional integration into daily activities that are avoided and/or provocative for the patient.
- Counseling on physical activity and lifestyle, which will include promoting a gradual increase in physical activity based on the individual's preference and availability, advice on sleep hygiene, stress management strategies, and social re-engagement
ExercisesOther
Individuals allocated to this group will perform stretching and strengthening exercises. The self-stretching exercises will target the upper trapezius and posterior shoulder region. Each stretching exercise will be performed for 3 repetitions of 30 seconds, with an interval of 10 seconds between repetitions.
The strengthening exercises will be performed using resistance elastic bands. Three sets of 10 repetitions will be performed for each strengthening exercise, with 1 minute of rest between sets. The strengthening exercises will target the lower and middle trapezius, anterior serratus, and the external and internal rotators of the shoulder.
| Study group | Role | What they receive |
|---|---|---|
| Cognitive Functional Therapy | Experimental | Cognitive Functional Therapy will be conducted once a week, in individual and in-person sessions lasting approximately 40 minutes, over eight weeks. Receives: Other: Cognitive Functional Therapy |
| Exercises | Active comparator | Twelve participants will be allocated to this group. They will perform strengthening and stretching exercises twice a week for eight weeks, with each session lasting approximately 30 to 40 minutes. Receives: Other: Exercises |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recruitment rate
Analyze the ability to recruit 12 individuals per group, totaling a sample of 24 individuals with chronic shoulder pain;
Measured: 8 weeks
Retention rate
This will be evaluated through individual follow-up by the responsible physiotherapist during the 8-week treatment period, during which the physiotherapist will fill out an attendance sheet at each session to also characterize the completion of the intervention by each participant;
Measured: 8 weeks
Acceptability of the intervention
This will be estimated through adherence to the appointment schedule and mainly through questioning after each intervention session.
Measured: 8 weeks
Secondary outcomes (9)
Pain intensity
The 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), 4 weeks, and post Treatment (8 weeks)
Shoulder Pain and Disability Index
Shoulder disability will be measured with Shoulder Pain and Disability Index (SPADI), with score ranging from 0 to 100, with higher scores indicating greater shoulder disability.
Measured: Pre (baseline), 4 weeks, and post Treatment (8 weeks)
Chronic Pain Self-Efficacy Scale
Self-efficacy will be measured using the Chronic Pain Self-Efficacy Scale (CPSS). The total score ranges from 30 to 300 points, with higher scores indicating greater self-efficacy.
Measured: Pre (baseline), 4 weeks, and post Treatment (8 weeks)
Tampa Scale for Kinesiophobia
Kinesiophobia will be measured using the Tampa Scale for Kinesiophobia (TSK). The total score ranges from 17 to 68 points, with higher scores indicating worse beliefs about pain related to movement.
Measured: Pre (baseline), 4 weeks, and post Treatment (8 weeks)
Pain Catastrophizing Scale
Pain catastrophizing will be measured using the Pain Catastrophizing Scale (PCS). The total score ranges from 0 to 52 points, with higher scores indicating greater pain catastrophizing.
Measured: Pre (baseline), 4 weeks, and post Treatment (8 weeks)
Pittsburgh Sleep Quality Index
Sleep quality will be measured using the Pittsburgh Sleep Quality Index (PSQI). The total score ranges from 0 to 21 points. A score greater than 5 indicates poor sleep quality, with significant difficulty in at least two components of the questionnaire or moderate difficulty in three components.
Measured: Pre (baseline), 4 weeks, and post Treatment (8 weeks)
Biopsychosocial aspects
Biopsychosocial aspects will be measured with short screening questions on biopsychosocial aspects of chronic pain.
Measured: Pre (baseline), 4 weeks, and post Treatment (8 weeks)
Patients' expectations of the treatment.
For the assessment of patients' expectations regarding their treatment, participants will respond to the question, "How much do you expect your shoulder problem to change as a result of treatment?" Their responses will be measured on a 7-point Likert scale, where 1 corresponds to "worse" and 7 corresponds to "completely recovered."
Measured: Baseline
Patient-Specific Functional Scale
The Patient-Specific Functional Scale (PSFS) will be used to assess functional status. Individuals will score on an 11-point scale, indicating how difficult it is to perform 3 to 5 activities that are important to them. A score of 0 on the 11-point scale indicates "unable to perform the activity," while a score of 10 indicates "able to perform the activity at the pre-injury level.
Measured: Pre (baseline), 4 weeks, and post Treatment (8 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2024
- Study start17 Feb 2025
- Primary completion31 Dec 2025
- Study completion31 Dec 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 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Federal University of Paraíba
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Danilo Harudy Kamonseki, Federal University of Paraíba
- Investigators
- VALÉRIA MA OLIVEIRA, PhD, Principal investigator, Universidade Federal da Paraíba
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06542666
- Sponsor's protocol ID
- 79422824.0.0000.5188
- Status last verified
- Sep 2026
- First submitted
- 23 Jul 2024
- Last updated
- 25 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The individual participant data will be shared under request.
Publications
Gava V, da Silva Eugenio JM, Meziat-Filho N, Almeida LA, Maciel DG, do Nascimento JDS, de Andrade PR, Santos Fonseca RN, Medeiros Barbosa G, de Oliveira VMA, Kamonseki DH. Cognitive functional therapy versus therapeutic exercises for the treatment of individuals with chronic shoulder pain: A protocol for a randomized controlled trial. PLoS One. 2025 Apr 21;20(4):e0320025. doi: 10.1371/journal.pone.0320025. eCollection 2025.
PubMed 40258003
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cognitive Functional Therapy Versus Therapeutic Exercises for Treating Individuals With Chronic Shoulder Pain: A Pilot and Feasibility Study
- ClinicalTrials.gov ID
- NCT06542666
- Acronym / sponsor ID
- 79422824.0.0000.5188
- Keywords
- Shoulder pain, Subacromial pain, Rotator cuff related pain, Shoulder Impingement, Chronic pain, Psychosocial, Rehabilitation, Biopsychosocial
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Federal University of ParaíbaUniversity, hospital or other
- Study start
- 17 Feb 2025 (actual)
- Primary completion
- 31 Dec 2025 (actual)
- Study completion
- 31 Dec 2025 (actual)
- First posted
- 7 Aug 2024 (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.
This pilot randomized controlled clinical trial (RCT) will assess the feasibility and identify the key components necessary for conducting the main RCT, which will involve the comparison of Cognitive Functional Therapy with Therapeutic Exercises in individuals with chronic shoulder pain. The main questions it aims to answer are:
- What barriers to the participation of the included individuals might arise?
- Will the assessment procedures and outcome measures be feasible and suitable?
- What time will be necessary to conduct the assessments?
- Will participants be willing to be randomized to the proposed treatment groups?
- What barriers to the clinical delivery of Cognitive Functional Therapy in the healthcare system might exist?
- Will the treatment(s) be acceptable to patients?
- Will participants adhere to the treatment?
- What will the recruitment rates be per week/month?
- Will there be any selection bias?
- Will participant retention be high among the allocation groups?
- Will the data be complete?
- What will the data variability be?
- Will the treatment effects/outcomes be consistent with expectations and previous literature?
Detailed description
Shoulder pain is a potentially debilitating musculoskeletal condition, with functional, physical, and psychological impact. Its chronicity has been mainly correlated with affective-emotional and cognitive dimensions of pain. In this scenario, interventions for individuals with chronic shoulder pain should be seen within the biopsychosocial model. In this context, Cognitive Functional Therapy (CFT) emerges as a psychologically informed physiotherapeutic approach directed towards the biopsychosocial and multidimensional nature of pain, which is divided into three approaches to reduce pain and disability: (1) understanding pain, (2) controlled exposure, and (3) lifestyle change. The present study aims to verify the feasibility and viability of a randomized clinical trial to compare the effects of Cognitive Functional Therapy with therapeutic exercises in individuals with chronic shoulder pain.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cognitive Functional Therapy | Experimental | Other: Cognitive Functional TherapyCognitive Functional Therapy will be conducted once a week, in individual and in-person sessions lasting approximately 40 minutes, over eight weeks. |
| Exercises | Active comparator | Other: ExercisesTwelve participants will be allocated to this group. They will perform strengthening and stretching exercises twice a week for eight weeks, with each session lasting approximately 30 to 40 minutes. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Men and women;
- Age between 18 and 60 years;
- Presence of shoulder pain for more than 3 months;
- Pain intensity of 4 points or more on the 11-point Numeric Pain Rating Scale during the past week.
- High level of disability or moderate level of irritability.
Key exclusion criteria (8 listed)
- History of fracture or surgery of the clavicle, scapula, and/or humerus, surgical stabilization or rotator cuff repair;
- History of dislocation, instability (positive sulcus sign or apprehension test), and/or rotator cuff tear (positive drop arm test);
- Adhesive capsulitis verified by the presence of gradual onset pain associated with stiffness and reduced passive and active mobility;
- Ongoing pregnancy;
- Reproduction of shoulder pain radiating to the entire upper limb during cervical or thoracic spine tests (positive Spurling test);
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 focuses on addressing the maladaptive cognitive, physical, and lifestyle behaviors related to the disorder. Cognitive functional therapy will focus on factors considered to contribute to the pain disorder, addressing the following topics: 1. The multidimensional nature of persistent pain, beliefs, emotions, and behaviors (movement and lifestyle) that can reinforce a vicious cycle of pain sensitization and disability. 2. Specific functional training designed to normalize maladaptive and provocative postural and movement behaviors as directed by the individual's presentation. 3. Targeted functional integration into daily activities that are avoided and/or provocative for the patient. 4. Counseling on physical activity and lifestyle, which will include promoting a gradual increase in physical activity based on the individual's preference and availability, advice on sleep hygiene, stress management strategies, and social re-engagement | Other | Cognitive Functional Therapy |
| ExercisesIndividuals allocated to this group will perform stretching and strengthening exercises. The self-stretching exercises will target the upper trapezius and posterior shoulder region. Each stretching exercise will be performed for 3 repetitions of 30 seconds, with an interval of 10 seconds between repetitions. The strengthening exercises will be performed using resistance elastic bands. Three sets of 10 repetitions will be performed for each strengthening exercise, with 1 minute of rest between sets. The strengthening exercises will target the lower and middle trapezius, anterior serratus, and the external and internal rotators of the shoulder. | Other | Exercises |
Primary outcome
Recruitment rate
Time frame: 8 weeks
Analyze the ability to recruit 12 individuals per group, totaling a sample of 24 individuals with chronic shoulder pain;
Retention rate
Time frame: 8 weeks
This will be evaluated through individual follow-up by the responsible physiotherapist during the 8-week treatment period, during which the physiotherapist will fill out an attendance sheet at each session to also characterize the completion of the intervention by each participant;
Acceptability of the intervention
Time frame: 8 weeks
This will be estimated through adherence to the appointment schedule and mainly through questioning after each intervention session.
9 secondary outcomes
Pain intensity
Time frame: Pre (baseline), 4 weeks, and post Treatment (8 weeks)
Shoulder Pain and Disability Index
Time frame: Pre (baseline), 4 weeks, and post Treatment (8 weeks)
Chronic Pain Self-Efficacy Scale
Time frame: Pre (baseline), 4 weeks, and post Treatment (8 weeks)
Tampa Scale for Kinesiophobia
Time frame: Pre (baseline), 4 weeks, and post Treatment (8 weeks)
Pain Catastrophizing Scale
Time frame: Pre (baseline), 4 weeks, and post Treatment (8 weeks)
Pittsburgh Sleep Quality Index
Time frame: Pre (baseline), 4 weeks, and post Treatment (8 weeks)
Biopsychosocial aspects
Time frame: Pre (baseline), 4 weeks, and post Treatment (8 weeks)
Patients' expectations of the treatment.
Time frame: Baseline
Patient-Specific Functional Scale
Time frame: Pre (baseline), 4 weeks, and post Treatment (8 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 25 Sep 2026.
- Derived from this study: PubMed 40258003Gava V, da Silva Eugenio JM, Meziat-Filho N, Almeida LA, Maciel DG, do Nascimento JDS, de Andrade PR, Santos Fonseca RN, Medeiros Barbosa G, de Oliveira VMA, Kamonseki DH. Cognitive functional therapy versus therapeutic exercises for the treatment of individuals with chronic shoulder pain: A protocol for a randomized controlled trial. PLoS One. 2025 Apr 21;20(4):e0320025. doi: 10.1371/journal.pone.0320025. eCollection 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. This study is not recruiting at the moment.
VALÉRIA MA OLIVEIRA, PhD principal investigator
Universidade Federal da Paraíba
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 Exercises in people with Chronic Shoulder Pain and Exercise Therapy, run by Federal University of Paraíba 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 5 inclusion and 8 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 25 Sep 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?
Recruitment rate (time frame: 8 weeks). The study lists 3 primary outcomes in all. 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 NCT06542666, 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 25 Sep 2026.