Influence of Beliefs on the Prognosis of Chronic Musculoskeletal Pain.
Condition: Chronic Musculoskeletal Pain
MeSH terms: Musculoskeletal Pain
Study type: Observational

Summary: 
      Chronic musculoskeletal pain (CMP) is highly prevalent, disabling, and with high
      socio-economic costs, with many negative effects on quality of life. CMP affects the ability
      to perform work, social, recreational and domestic tasks, changing the mood and concentration
      of this population. Despite the worldwide prevalence and socioeconomic burden of CMP, a clear
      understanding of its etiology and pathogenesis remains elusive.

      Aims:

      (i) to analyze the possible level of association between pain-related fear, fear of movement,
      self-efficacy, and pain acceptance with pain intensity and disability at the start of the
      study and prospectively evaluate its predictive function; (ii) to evaluate the possible
      mediating role of fear of movement and self-efficacy in the relationship between
      pain-disability in patients with CMP.
    

Detailed description: 
      The present study will be a prospective multi-centric 12-month study that will be conducted
      in four primary care centers and a hospital in the province of Malaga. Several questionnaires
      assessing different psychological factors will be administered to these participants. The
      results will be evaluated at baseline (t1) and at 3 follow-up (after 3 (t2), 6 (t3) and 12
      months (t4)). Ethical approval will be obtained from the Costal del Sol Ethics Committee,
      Malaga, Spain. This study will follow the recommendations of the Declaration of Helsinki. The
      study will be implemented and reported in line with the SPIRIT statement.

      Participants A consecutive sample of CMP participants will be recruited. The general
      practitioners will carry out the recruitment. Next, the physiotherapists attending the
      research project, which will be previously instructed by the research team, will evaluate the
      participants for their eligibility. If participants meet the eligibility criteria, they will
      be invited to participate in this study, and then evaluated at baseline and 3, 6, and 12
      months of follow-up. The inclusion criteria are: (i) men / women over the age of 18; (ii)
      participants with musculoskeletal pain (pain intensity of 3 or more on a numerical scale of
      pain 0-10) will be included in this study, among all of the following conditions: pain around
      the axial skeleton (neck, lower back and / or pelvis) or peripheral joints (shoulder, elbow,
      wrist, knee and / or ankle). We included people with clinical diagnoses of chronic pain
      (shoulder pain, neck pain, whiplash disorder, temporomandibular joint disorders, pelvic pain
      syndrome, ankle pain and epicondylalgia), non-specific low back pain, fibromyalgia, chronic
      fatigue syndrome and those with a radiological diagnosis of osteoarthritis. (iii) duration of
      symptoms: more than 3 months. Exclusion criteria are as follows: (i) musculoskeletal pain due
      to traumatic or systemic inflammatory autoimmune diseases such as rheumatoid arthritis,
      ankylosing spondylitis, spondylolisthesis or other defined rheumatological conditions; (ii)
      musculoskeletal pain associated with neurological dysfunction (ie, multiple sclerosis or
      stroke), osteoporosis, hemophilia and / or cancer; (iii) participants with post-fracture
      musculoskeletal pain; (iv) inability to provide informed consent and / or complete written
      questionnaires.

      Recruitment The age and sex of those participants who refuse to participate in the project
      will be noted anonymously, with the objective of evaluating the external validity of the
      sample recruited from participants.

      Eligible participants who are interested in the study will be asked to provide written
      informed consent to participate. Participants will complete several questionnaires at
      baseline, 3, 6, and 12 months after study initiation.

      Participant data files will be stored in numerical order and in a safe and accessible place.
    

Intervention name(s): Diagnosis/Prognosis
Intervention type(s): Other
Intervention description(s): The present study will be a prospective multi-centric 12-month study that will be conducted between May 2017 and April 2019 in four primary care centers and a hospital in the province of Malaga. Several questionnaires assessing different psychological factors will be administered to these participants. The results will be evaluated at baseline (t1) and at 3-fold follow-up (after 3 (t2), 6 (t3) and 12 months (t4)).
Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Subjects between 18-70 years with chronic musculoskeletal pain
      
Keywords: Chronic pain; Psychological factors; Musculoskeletal pain; Prognosis