NCT Number: NCT06661681
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.
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
Danilo H Kamonseki, PhD
CONTACT
NEY MEZIAT-FILHO, PhD
PRINCIPAL_INVESTIGATOR
VALÉRIA MA OLIVEIRA, PhD
PRINCIPAL_INVESTIGATOR
VANDER GAVA, PhD
PRINCIPAL_INVESTIGATOR
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Cognitive 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.
Other names: CFT
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.
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.
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
Time frame: Baseline, 4-week, at the end of treatment (8-week), and 12-week follow-up
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.
Time frame: Baseline, 4-week, at the end of treatment (8-week), and 12-week follow-up
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.
Time frame: Baseline, 4-week, at the end of treatment (8-week), and 12-week follow-up
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.
Time frame: Baseline, 4-week, at the end of treatment (8-week), and 12-week follow-up
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.
Time frame: 4-week, at the end of treatment (8-week), and 12-week follow-up
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.
Time frame: Baseline, 4-week, at the end of treatment (8-week), and 12-week follow-up
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.
Time frame: Baseline, 4-week, at the end of treatment (8-week), and 12-week follow-up
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.
Time frame: Baseline, 4-week, at the end of treatment (8-week), and 12-week follow-up
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.
Contact information is provided by the study sponsor or research team.
Federal University of Paraíba
Other
Cognitive Functional Therapy Versus Therapeutic Exercises for the Treatment of Individuals With Chronic Shoulder Pain: A Randomized Controlled Trial
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