Influence of Biopsychosocial Factors and Central Sensitization in Predicting the Recovery of Chronic Shoulder Pain
Condition: Chronic Shoulder Pain
MeSH terms: Shoulder Pain
Study type: Observational [Patient Registry]

Summary: 
      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:

        1. A high level of physical inactivity, kinesiophobia, fear avoidance and pain
           catastrophizing and low level of self-efficacy will ease the perpetuation of Chronic
           shoulder pain.

        2. The presence of central sensitization will predict a poor outcome in patients with
           chronic shoulder pain.
    

Detailed description: 
      The present study will be a 24 months multi-center, double-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, superior labrum
      anterior to posterior (SLAP) lesion, and/or acromioclavicular pathology and fulfill the
      inclusion criteria will be asked for participating in the investigators 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).

      Subjects will attend for their routine clinical appointment. The examiners will carry out the
      clinical consultation according to usual practice. Subjects who fulfill the selection
      criteria will be asked whether they wish to be considered for trial participation. Examiners
      will inform subjects who are interested in participation. Ineligible subjects and those who
      do not wish to participate in the trial will receive normal clinical care delivered by
      clinicians according to the best clinical practice.

      Anonymized age, gender and visual analogue scale (VAS)- verbal numeric rating scale (VNRS)
      for pain will be collected for those subjects who decline to take part in the project, in
      order to assess the external validity of the recruited sample of subjects.

      Eligible patients who are interested in the trial will be asked to provide written informed
      consent to participate. The examiners will allocate the participants in an unique study
      group. Participants will then complete several questionnaires at baseline, 3, 6, 12, 18 and
      24 months after the beginning of the study. A blinded examiner will deliver these
      questionnaires. Subsequent sessions will occur at the follow-up visits. Participants will be
      asked about any problems they had had during the previous months before following-up. There
      will be brief discussion about whether participants have subjected for any treatment
      (physical, pharmacological, injection and/or no treatment).
    

Intervention name(s): Diagnosis/Prognosis
Intervention type(s): Other
Intervention description(s): 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).
Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Subjects between 18-70 years with chronic shoulder pain
      
Keywords: Chronic Pain; Biopsychosocial Factors; Shoulder pain; Prognosis; Central Nervous System Sensitization