Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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:
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cognitive Functional Therapy | Other | 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:
|
| Measure | Description | Time Frame |
|---|---|---|
| Recruitment rate | Analyze the ability to recruit 12 individuals per group, totaling a sample of 24 individuals with chronic shoulder pain; | 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; | 8 weeks |
| Acceptability of the intervention | This will be estimated through adherence to the appointment schedule and mainly through questioning after each intervention session. | 8 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | Pre (baseline), 4 weeks, and post Treatment (8 weeks) |
| Shoulder Pain and Disability Index |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| VALÉRIA MA OLIVEIRA, PhD | Contact | 55 83 32167200 | 7183 | valeria.mayaly@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| VALÉRIA MA OLIVEIRA, PhD | Universidade Federal da Paraíba | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Federal University of Paraíba | Recruiting | João Pessoa | Paraíba | 58051-970 | Brazil |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40258003 | Derived | 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. |
Not provided
Not provided
The individual participant data will be shared under request.
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D020069 | Shoulder Pain |
| D019534 | Shoulder Impingement Syndrome |
| D059350 | Chronic Pain |
| ID | Term |
|---|---|
| D018771 | Arthralgia |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D010146 | Pain |
Not provided
Not provided
| ID | Term |
|---|---|
| D015444 | Exercise |
| ID | Term |
|---|---|
| D009043 | Motor Activity |
| D009068 | Movement |
| D009142 | Musculoskeletal Physiological Phenomena |
| D055687 | Musculoskeletal and Neural Physiological Phenomena |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| Exercises | Other | 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. |
|
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.
| 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. | 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. | 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. | 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. | 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. | 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." | 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. | Pre (baseline), 4 weeks, and post Treatment (8 weeks) |
| D009461 |
| Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D000070599 | Shoulder Injuries |
| D014947 | Wounds and Injuries |