The Influence of Biopsychosocial Factors and Peripheral and/or Central Sensitization in Predicting the Recovery of Chronic Shoulder Pain: a Prospective Cohort Study. Study Protocol
Sponsor study identifier
observational
90
0 countries
N/A
Study Start
November 2016
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
November 2019
Actual (reported)Study Completion
March 2020
Actual (reported)Background: Shoulder pain is the third most common musculoskeletal condition presenting to physicians or physiotherapists ) in primary healthcare after low back and neck pain being a significant cause of morbidity and functional disability in both working and general population. Despite the large group of individuals seeking for primary care services, about 50% of patients with shoulder pain still report persistent pain after 12-18 months. As a result, socio-economic burdens are considerable due to extensive use of heath care services, sickness absence, disability pension, and loss of productivity as well as, patient´s suffering. Aims: the primary aim of this study was to evaluate what biopsychosocial factors predict a better and/or poor outcome in patients with Chronic shoulder pain. The secondary aim was to analyze the role of central sensitization in predicting a better and/or poor outcome in patients with Chronic shoulder pain. Hypothesis:
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
March 2020
Actual (reported)Click on a node to explore related trials.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
April 5, 2016
Actual (reported)April 14, 2016
Actual (reported)November 2016
Date type not reportedThis date has not been verified as actual or estimated.
November 2019
Actual (reported)March 2020
Actual (reported)Change from baseline The brief pain inventory short form (BIP-SF) at 3,6,12,18 and 24 months
Pain will be assessed with The brief pain inventory short form (BIP-SF). This will be used to assess how pain interferes with patient's functioning in addition to measuring the intensity and location of pain.
Pain will be evaluated at baseline and 5 follow-ups (3,6,12,18 and 24 months).
Change from baseline Pain catastrophizing at 3, 6, 12, 18 and 24 months assessed with The Pain Catastrophizing Scale (PSC)
Pain catastrophizing will be evaluated at baseline and 5 follow-ups (3,6,12,18 and 24 months).
Change from baseline Kinesiophobia at 3,6,12,18 and 24 months assessed with Tampa Scale For Kinesiophobia (TSK)
Kinesiophobia will be evaluated at baseline and 5 follow-ups (3,6,12,18 and 24 months).
Change from baseline Fear avoidance at 3,6,12,18 and 24 months assessed with Fear Avoidance Belief Questionnaire (FABQ)
Fear avoidance will be measured at baseline at 5 follow-ups (3,6,12,18 and 24 months)
Change from baseline Self-efficacy at 3,6,12,18 and 24 months assessed with Pain Self-Efficacy Questionnaire (PSEQ)
Self-efficacy will be measured at baseline at 5 follo-ups (3,6,12,18 and 24 months)
Change from baseline Shoulder Function at 3,6,12,18 and 24 months assessed with Shoulder Pain and Disability Index (SPADI)
Function will be measured at baseline and 5 follow-ups (3,6,12,18 and 24 months)
1. Men / women aged between 18 and 70 years. 2. Patients suffering from shoulder pain, defined as pain presented or exacerbated by movements in the shoulder, pain intensity ≥ 2 measured by a numerical scale with values from 0 to 10, meaning 0= no pain and 10= the worst pain, will be included in this study, among all these following shoulder pain conditions: (i) Rotator Cuff tendinopathy; (ii) Adhesive Capsulitis; (iii) glenohumeral instability; (iv) SLAP lesion; (v) and/or acromioclavicular pathology. Subjects will not be required to undergo diagnostic imaging (i.e. Magnetic Resonance Imaging) to diagnosis the pathology because of the recruitment will be carried out by clinical findings. 3. Duration of symptoms: greater than 3 months.
The present study will be a 24 months multi-center, triple-blind, prospective, cohort study which will be carried out between April 2016 and March 2018. Subjects diagnosed of rotator cuff (RC) tendinopathy, adhesive capsulitis (AC), glenohumeral instability, SLAP lesion, and/or acromioclavicular pathology and fulfill the inclusion criteria will be asked for participating in our study. Several questionnaires that will test the influence of different biopsychosocial factors and the presence of Central Sensitization will be administrated to these subjects. The outcomes will be assessed at baseline and 5 follow-ups (after 3, 6, 12, 18 and 24 months, t1-t6).
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Subjects between 18-70 years with chronic shoulder pain
Martinez-Calderon J, Struyf F, Meeus M, Morales-Ascencio JM, Luque-Suarez A. Influence of psychological factors on the prognosis of chronic shoulder pain: protocol for a prospective cohort study. BMJ Open. 2017 Mar 6;7(3):e012822. doi: 10.1136/bmjopen-2016-012822.
Alejandro Luque Suarez, PhD
University of Malaga
90 participants (actual enrollment reported by the registry).
First Submitted
April 5, 2016
First Posted
April 14, 2016
Study Start
November 2016
Date type not reportedThis date has not been verified as actual or estimated.
The Effect of High-intensity Laser Therapy in Patients With Chronic Shoulder Pain
Contact the study team to confirm eligibility.
Primary Completion
November 2019
Actual (reported)Study Completion
March 2020
Actual (reported)Last Updated
March 25, 2020
Record last verified: 2018-10
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Source: ClinicalTrials.gov.
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