Cognitive Functional Therapy Versus Exercises for Chronic Shoulder Pain
ConditionChronic Shoulder Pain
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorUniversidade Federal de Sao Carlos
About this 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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
None
Disqualifiers
None
Trial design
Design model
Parallel
Treatments tested in this trial
Cognitive functional therapy
BehavioralThe 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 exercise
Other interventionParticipants 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.
Treatment groups
148 Participants
are divided into 2 treatment groupsGroup A: Cognitive functional therapyExperimental treatment 1 intervention
Group B: Therapeutic exerciseActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
Baseline, 4-week, at the end of treatment (8-week), and 12-week follow-up2
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.
Time frame
Baseline, 4-week, at the end of treatment (8-week), and 12-week follow-upSecondary outcomes
1
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".
Time frame
Baseline, 4-week, at the end of treatment (8-week), and 12-week follow-up2
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.
Time frame
Baseline, 4-week, at the end of treatment (8-week), and 12-week follow-up3
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.
Time frame
Baseline, 4-week, at the end of treatment (8-week), and 12-week follow-up4
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).
Time frame
Baseline, 4-week, at the end of treatment (8-week), and 12-week follow-upSponsors and contacts
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Source ClinicalTrials.gov