Cognitive Functional Therapy Versus Exercises for Chronic Shoulder Pain

Condition(s) studied

Investigational drug(s) / intervention(s)

Cognitive functional therapy: The 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: Participants 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.

Study summary

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

Primary outcome measure(s)

• Pain intensity — Baseline, 4-week, at the end of treatment (8-week), and 12-week follow-up
  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.
• Shoulder disability — Baseline, 4-week, at the end of treatment (8-week), and 12-week follow-up
  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.

Trial sites (1)

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