Although shoulder surgeries can effectively relieve pain intensity and restore shoulder function, some patients reported persistent post-operative pain at the 6-month post-surgery follow-up visit. This randomized study aims to determine the effectiveness of three different types of bio-psychosocial support to pre-operative shoulder surgery patients. This study will examine the differential effects of brief mindfulness-based breathing, heart rate variability biofeedback (HRV-BF), and cognitive behavioral pain psychoeducation for pre-operative patients.
(1) pain ≥3months and ≥3 days per week
(2) pain intensity ≥ 40 (VAS scale from 0 no pain to 100 very painful)
(3) the surgical indication would be based on orthopedics opinions
history of shoulder surgery in the prior 3 years
osteoporotic vertebral fractures or rheumatologic diseases
chronic widespread pain syndromes (fibromyalgia or chronic fatigue syndrome)
neurological disease (i.e., stroke, parkinson's disease, etc..)
Parallel
Mindfulness-based breathing
BehavioralThe 20-minute mindfulness session is a scripted mindfulness exercise that incorporates mindfulness principles of intentionally paying attention to present-moment experiences in a non-judgmental fashion.
HRV biofeedback
BehavioralThe 20-minute HRV biofeedback is based on the resonant frequency breathing with an external pacemaker. Generally, the breath rhythm is between 4.5 and 6.5 times per min.
cognitive-behavioral pain psychoeducation
BehavioralThe 20-minute psychoeducation session is a supportive session where behavioral coping strategies for pain management are discussed.
Visual Analogue Scale change
Subjective post-surgical pain. Using a ruler, the score is determined by measuring the distance (mm) on the 10-cm line between the "no pain" anchor and the patient's mark, providing a range of scores from 0-100. A higher score indicates greater pain intensity.
Shoulder function change_1
American Shoulder and Elbow Surgeons Shoulder Score (ASES). Scores range from 0 to 100 with a score of 0 indicating a worse shoulder condition and 100 indicating a better shoulder condition.
Shoulder function change_2
Constant Score to measure the objective ROM. Scores range from 0 to 100 points, representing worst and best shoulder function, respectively.
Subjective sleep quality change
Pittsburgh sleep quality index (PSQI). The global PSQI score is then calculated by totaling the seven component scores, providing an overall score ranging from 0 to 21, where lower scores denote a healthier sleep quality.
Pain-related fear
Tampa scale of kinesiophobia. The lower TSK total scores means no or negligible kinesiophobia, and the higher scores indicate an increasing degree of kinesiophobia. Total scores range from 17 to 68 points.
Pain catastrophizing
Pain catastrophizing Scale (PCS). People are asked to indicate the degree to which they have the above thoughts and feelings when they are experiencing pain using the 0 (not at all) to 4 (all the time) scale. A total score is yielded (ranging from 0-52), along with three subscale scores assessing rumination, magnification and helplessness.
Neuropsychological change - general cognitive ability
Montreal Cognitive Assessment (MoCA) assesses general cognitive ability. The higher scores, the better the cognitive function. The total possible score is 0\~30 points; a score of 26 or above is considered normal.
Neuropsychological change - subjective cognitive ability
Everyday Cognition (Ecog-12) assesses subjective cognitive ability. The higher scores, the more subjective cognitive decline. The total possible score is 12\~48 points; a score of 14 or above is considered as subjective decline.
Cytokine
Joint fluid or plasma will be obtained via aspiration from the shoulder joint of each patient at the beginning of the surgery.
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Chang Gung Memorial Hospital
Lead sponsor
National Science and Technology Council
Collaborator
