Chronic Shoulder PainNCT06661681
Cognitive Functional Therapy for Treating Individuals With Chronic Shoulder Pain
A study testing Cognitive Functional Therapy (CFT) and Therapeutic exercises group in people with Chronic Shoulder Pain and Exercise Therapy, run by Federal University of Paraíba at 1 site in Brazil.
Trial summary
Shoulder pain is a debilitating musculoskeletal condition with functional, physical, and psychological impacts. Interventions for chronic shoulder pain should address the biopsychosocial model, with Cognitive Functional Therapy emerging as a promising physiotherapy approach. 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 (CFT) and Therapeutic exercises group
- Type of treatment
- Injection or infusion, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 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 or 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.
- 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;
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- Corticosteroid injection in the shoulder region in the last 3 months;
- Physiotherapy treatment in the last 6 months.
- Active treatment for cancer
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Cognitive Functional Therapy Versus Therapeutic Exercises for the Treatment of Individuals With Chronic Shoulder Pain: A Randomized Controlled Trial
Shoulder pain is a debilitating musculoskeletal condition with functional, physical, and psychological impacts. Interventions for chronic shoulder pain should address the biopsychosocial model, with Cognitive Functional Therapy emerging as a promising physiotherapy approach. Cognitive Functional Therapy approaches the multidimensional nature of pain, integrating physical and cognitive aspects.
The aim of this randomized controlled trial is to compare the effects of Cognitive Functional Therapy with therapeutic exercise on biological aspects of pain (pain intensity, disability, function, perception of improvement/deterioration, and central pain processing), and psychosocial aspects of pain (sleep quality, self-efficacy, and biopsychosocial factors). The hypothesis of this study is that CFT will lead to greater improvements in these outcomes compared to therapeutic exercise.
Read the detailed description
This will be a randomized controlled trial, single-blinded with two parallel groups. Seventy-two individuals with chronic shoulder pain will be randomly assigned to one of two groups: CFT or Therapeutic exercises. The interventions will last eight weeks, with the CFT group receiving therapy once a week and the therapeutic exercise group receiving sessions twice weekly. The primary outcomes will be pain intensity and disability, while the secondary outcomes will include function, self-efficacy, sleep quality, biopsychosocial factors, perception of improvement/deterioration, and central pain processing.
- Being tested
- Cognitive Functional Therapy (CFT), Therapeutic exercises group
- Keywords
- Shoulder pain, Subacromial pain, Rotator cuff related shoulder 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 Therapy (CFT)Behavioural
Also called CFT
Cognitive Functional Therapy (CFT) is underpinned by a strong therapeutic alliance, active listening, and motivational interviewing style, covering the following domains:
- Making sense of pain involves discussing the multidimensional nature of persistent pain, as well as the beliefs, emotions, and behaviors that can perpetuate the vicious cycle of pain and disability. ii) Exposure with control involves a functional training designed to normalize maladaptive and provocative postural and movement behaviors, where individuals will learn strategies to improve their body awareness and control and modify postures and tasks commonly associated with pain. iii) Lifestyle change aims to help patients embrace a healthy lifestyle, which will include promoting a gradual increase in physical activity, sleep hygiene counseling, stress management strategies, and social re-engagement.
Therapeutic exercises groupOther
Each session will include stretching exercises targeting the following muscles i) Upper trapezius; ii) Pectoralis minor; iii) Posterior shoulder region, and strengthening exercises targeting the following muscles i) Lower trapezius, ii) Middle trapezius, iii) Serratus punch exercise, iv) Shoulder external rotators, and v) Shoulder internal rotators.
| Study group | Role | What they receive |
|---|---|---|
| Cognitive Functional Therapy | Experimental | Cognitive Functional Therapy (CFT) will be conducted weekly in sessions lasting approximately 60 minutes over 8 weeks. Receives: Behavioral: Cognitive Functional Therapy (CFT) |
| Therapeutic exercises group | Active comparator | Individuals assigned to this group will be treated twice a week for eight weeks, wich each session will last approximately 40 to 60 minutes. Receives: Other: Therapeutic exercises group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain intensity: Numerical Pain Rating Scale (NPRS)
The pain intensity will be measured with 11 point - Numerical Rating Pain Scale (NPRS) with scores ranging from 0 (no pain) to 10 (maximum pain). Higher scores indicate greater pain intensity.
Measured: Baseline, 4-week, at the end of treatment (8-week), and 12-week follow-up
Disability: Shoulder Pain and Disability Index (SPADI)
Disability will be assessed with Shoulder Pain and Disability Index (SPADI). which is composed of 13 questions related to two domains: disability (eight items) and pain (five items). 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)
Shoulder function: Patient Specific Functional Scale
Shoulder functional ability will be measured with Patient Specific Functional Scale. The individuals will select three to five important activities that are challenging to perform due to shoulder pain. For each reported activity, the individual will score on an 11-point scale, where 0 is (unable to perform the activity) and 10 is (able to perform the activity at the level prior to the injury). Score ranges from 0 (unable to perform) to 10 (able to perform at preinjury level). Higher score means better function.
Measured: Baseline, 4-week, at the end of treatment (8-week), and 12-week follow-up
Self-efficacy: Pain Self-Efficacy Questionnaire (PSEQ)
Self-efficacy will be assessed with Pain Self-Efficacy Questionnaire (PSEQ) will be used to assess, which is composed of of 10 items. The total score ranges from 0 to 60 points, with the higher score indicating greater self-efficacy.
Measured: Baseline, 4-week, at the end of treatment (8-week), and 12-week follow-up
Sleep quality: Pittsburgh Sleep Quality Index (PSQI)
Sleep quality will be assessed with Pittsburgh Sleep Quality Index (PSQI), which is composed of 19 items, resulting in a total score ranging from 0 to 21, and covering 7 domains: (1) subjective sleep quality, (2) sleep latency, (3) sleep duration, (4) habitual sleep efficiency, (5) sleep disturbance, (6) medication use and (7) dysfunction during the day. The total score ranges from 0 to 21, with higher scores indicating worse sleep quality.
Measured: Baseline, 4-week, at the end of treatment (8-week), and 12-week follow-up
Biopsychosocial Aspects: Brief Screening Questions for Biopsychosocial Aspects
Biopsychosocial Aspects will be assessed with the Brief Screening Questions for Biopsychosocial, which is composed of six questions covering five domains: anxiety, kinesiophobia, stress, catastrophizing, and depression. The scores for each question range from 0 to 10, with higher scores indicating worse symptoms.
Measured: Baseline, 4-week, at the end of treatment (8-week), and 12-week follow-up
Perception of improvement/deterioration over time: Global Rating of Change Scale
The individual's perception of improvement/deterioration over time will be measured with the Global Rating of Change Scale, which ranges from -7 to 7, with positive and higher scores indicating a greater perception of health improvement, negative and lower scores indicating a worsening perception of health, and a score of zero representing no change.
Measured: 4-week, at the end of treatment (8-week), and 12-week follow-up
Central pain processing: Pressure Pain Threshold (PPT)
Pressure Pain Threshold (PPT) is defined as the minimum amount of pressure that triggers the first sensation of pain. Pressure Pain Threshold will be measured by a digital pressure algometer (AlgoMed ®, Hӧrby, Sweden) with 1 cm2 circular rubber probe tip and a pressure rate of approximately 40 kPa/s. The Pressure Pain Threshold test will be performed at the acromion and muscle bellies of the deltoid, upper trapezius, and tibialis anterior.
Measured: Baseline, 4-week, at the end of treatment (8-week), and 12-week follow-up
Central pain processing: Temporal summation
Temporal summation refers to increased perceived pain from repetitive nociceptive stimuli at the same site, which is related to the modulation mechanism occurring in second-order sensory neurons in the spinal cord. The temporal summation will be measured at the deltoid and tibialis anterior. Sequential stimulation will involve 10 pressure stimuli at the pre-established Pressure Pain Threshold level, with a one-second interval between stimuli. Each pressure increment will be approximately 40 kPa/s. After the first and tenth stimuli, participants will rate their pain intensity using the Numerical Rating Pain Scale (NPRS) with scores ranging from 0 (no pain) to 10 (maximum pain), and higher scores indicate greater pain intensity. The temporal summation will be quantified by subtracting the pain intensity rating for the first stimulus from the pain rating for the tenth.
Measured: Baseline, 4-week, at the end of treatment (8-week), and 12-week follow-up
Central pain processing: Conditioned Pain Modulation
Conditioned Pain Modulation (CPM) refers to the central nervous system's ability to inhibit pain through mechanisms related to endogenous descending inhibition. Individuals will immerse their hand in a cold-water bath for 2 minutes. Pressure Pain Threshold (PPT) at the deltoid of the affected (or most affected) side will be assessed at baseline, during immersion (after 30, 60, and 90 seconds), and after immersion (immediately post-withdrawal and at 30 and 60 seconds after withdrawal). Participants will rate their pain intensity on the Numerical Rating Pain Scale (NPRS) with scores ranging from 0 (no pain) to 10 (maximum pain), and higher scores indicate greater pain intensity, every 30 seconds from immersion until hand withdrawal, and 30 and 60 seconds after withdrawal. CPM will be calculated by subtracting the PPT of the deltoid from PPT measures during and after Conditioned Pain Modulation.
Measured: Baseline, 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 posted28 Oct 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.
- 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
- 72 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
- Danilo H Kamonseki, PhD, Principal investigator, Universidade Federal da Paraíba
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06661681
- Sponsor's protocol ID
- 409730/2023-8
- Status last verified
- Sep 2026
- First submitted
- 25 Oct 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.
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 the Treatment of Individuals With Chronic Shoulder Pain: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06661681
- Acronym / sponsor ID
- 409730/2023-8
- Keywords
- Shoulder pain, Subacromial pain, Rotator cuff related shoulder pain, Shoulder Impingement, Chronic pain, Psychosocial, Rehabilitation, Biopsychosocial
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 72 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
- 28 Oct 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.
Shoulder pain is a debilitating musculoskeletal condition with functional, physical, and psychological impacts. Interventions for chronic shoulder pain should address the biopsychosocial model, with Cognitive Functional Therapy emerging as a promising physiotherapy approach. Cognitive Functional Therapy approaches the multidimensional nature of pain, integrating physical and cognitive aspects.
The aim of this randomized controlled trial is to compare the effects of Cognitive Functional Therapy with therapeutic exercise on biological aspects of pain (pain intensity, disability, function, perception of improvement/deterioration, and central pain processing), and psychosocial aspects of pain (sleep quality, self-efficacy, and biopsychosocial factors). The hypothesis of this study is that CFT will lead to greater improvements in these outcomes compared to therapeutic exercise.
Detailed description
This will be a randomized controlled trial, single-blinded with two parallel groups. Seventy-two individuals with chronic shoulder pain will be randomly assigned to one of two groups: CFT or Therapeutic exercises. The interventions will last eight weeks, with the CFT group receiving therapy once a week and the therapeutic exercise group receiving sessions twice weekly. The primary outcomes will be pain intensity and disability, while the secondary outcomes will include function, self-efficacy, sleep quality, biopsychosocial factors, perception of improvement/deterioration, and central pain processing.
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 (CFT)Cognitive Functional Therapy (CFT) will be conducted weekly in sessions lasting approximately 60 minutes over 8 weeks. |
| Therapeutic exercises group | Active comparator | Other: Therapeutic exercises groupIndividuals assigned to this group will be treated twice a week for eight weeks, wich each session will last approximately 40 to 60 minutes. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Men or 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.
- High level of disability or moderate level of irritability.
Key exclusion criteria (9 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 Therapy (CFT)Also: CFTCognitive Functional Therapy (CFT) is underpinned by a strong therapeutic alliance, active listening, and motivational interviewing style, covering the following domains: i) Making sense of pain involves discussing the multidimensional nature of persistent pain, as well as the beliefs, emotions, and behaviors that can perpetuate the vicious cycle of pain and disability. ii) Exposure with control involves a functional training designed to normalize maladaptive and provocative postural and movement behaviors, where individuals will learn strategies to improve their body awareness and control and modify postures and tasks commonly associated with pain. iii) Lifestyle change aims to help patients embrace a healthy lifestyle, which will include promoting a gradual increase in physical activity, sleep hygiene counseling, stress management strategies, and social re-engagement. | Behavioural | Cognitive Functional Therapy |
| Therapeutic exercises groupEach session will include stretching exercises targeting the following muscles i) Upper trapezius; ii) Pectoralis minor; iii) Posterior shoulder region, and strengthening exercises targeting the following muscles i) Lower trapezius, ii) Middle trapezius, iii) Serratus punch exercise, iv) Shoulder external rotators, and v) Shoulder internal rotators. | Other | Therapeutic exercises group |
Primary outcome
Pain intensity: Numerical Pain Rating Scale (NPRS)
Time frame: Baseline, 4-week, at the end of treatment (8-week), and 12-week follow-up
The pain intensity will be measured with 11 point - Numerical Rating Pain Scale (NPRS) with scores ranging from 0 (no pain) to 10 (maximum pain). Higher scores indicate greater pain intensity.
Disability: Shoulder Pain and Disability Index (SPADI)
Time frame: Baseline, 4-week, at the end of treatment (8-week), and 12-week follow-up
Disability will be assessed with Shoulder Pain and Disability Index (SPADI). which is composed of 13 questions related to two domains: disability (eight items) and pain (five items). The final score ranges from 0 to 100, with higher scores indicating greater shoulder disability
8 secondary outcomes
Shoulder function: Patient Specific Functional Scale
Time frame: Baseline, 4-week, at the end of treatment (8-week), and 12-week follow-up
Self-efficacy: Pain Self-Efficacy Questionnaire (PSEQ)
Time frame: Baseline, 4-week, at the end of treatment (8-week), and 12-week follow-up
Sleep quality: Pittsburgh Sleep Quality Index (PSQI)
Time frame: Baseline, 4-week, at the end of treatment (8-week), and 12-week follow-up
Biopsychosocial Aspects: Brief Screening Questions for Biopsychosocial Aspects
Time frame: Baseline, 4-week, at the end of treatment (8-week), and 12-week follow-up
Perception of improvement/deterioration over time: Global Rating of Change Scale
Time frame: 4-week, at the end of treatment (8-week), and 12-week follow-up
Central pain processing: Pressure Pain Threshold (PPT)
Time frame: Baseline, 4-week, at the end of treatment (8-week), and 12-week follow-up
Central pain processing: Temporal summation
Time frame: Baseline, 4-week, at the end of treatment (8-week), and 12-week follow-up
Central pain processing: Conditioned Pain Modulation
Time frame: Baseline, 4-week, at the end of treatment (8-week), and 12-week follow-up
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.
- 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.
Danilo H Kamonseki, 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 (CFT) and Therapeutic exercises group 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 9 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?
Pain intensity: Numerical Pain Rating Scale (NPRS) (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 25 Sep 2026.