NCT Number: NCT06542666
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?
Interested in participating?
Request Info18 year–60 year
All sexes
Interventional
Not applicable
João Pessoa, Paraíba, 58051-970, Brazil
Location status: Recruiting
DANILO H KAMONSEKI, PhD
PRINCIPAL_INVESTIGATOR
JÉSSICA MS EUGÊNIO, PT
PRINCIPAL_INVESTIGATOR
RAQUEL MC DINIZ, PT
PRINCIPAL_INVESTIGATOR
VALÉRIA MA OLIVEIRA, PhD
CONTACT
VALÉRIA MA OLIVEIRA, PhD
PRINCIPAL_INVESTIGATOR
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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:
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.
Time frame: 8 weeks
Analyze the ability to recruit 12 individuals per group, totaling a sample of 24 individuals with chronic shoulder pain;
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;
Time frame: 8 weeks
This will be estimated through adherence to the appointment schedule and mainly through questioning after each intervention session.
Time frame: Pre (baseline), 4 weeks, and post Treatment (8 weeks)
The pain will be measured with 11 point - Numerical Rating Pain Scale with scores ranging from 0 (no pain) to 10 (maximum pain).
Time frame: Pre (baseline), 4 weeks, and post Treatment (8 weeks)
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.
Time frame: Pre (baseline), 4 weeks, and post Treatment (8 weeks)
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.
Time frame: Pre (baseline), 4 weeks, and post Treatment (8 weeks)
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.
Time frame: Pre (baseline), 4 weeks, and post Treatment (8 weeks)
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.
Time frame: Pre (baseline), 4 weeks, and post Treatment (8 weeks)
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.
Time frame: Pre (baseline), 4 weeks, and post Treatment (8 weeks)
Biopsychosocial aspects will be measured with short screening questions on biopsychosocial aspects of chronic pain.
Time frame: Baseline
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."
Time frame: Pre (baseline), 4 weeks, and post Treatment (8 weeks)
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.
Contact information is provided by the study sponsor or research team.
Federal University of Paraíba
Other
Cognitive Functional Therapy Versus Therapeutic Exercises for Treating Individuals With Chronic Shoulder Pain: A Pilot and Feasibility Study
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