Clinical Trial: Influence of Beliefs on the Prognosis of Chronic Musculoskeletal Pain.

Study Status: Not yet recruiting
Recruit Status: Not yet recruiting
Study Type: Observational

Official Title: The Influence of Beliefs (Fear of Movement, Pain-related Fear, Self-efficacy, and Pain Acceptance) on the Prognosis of Chronic Musculoskeletal Pain: a Prospective Cohort S

Brief 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 Summary:

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 t
Sponsor: University of Malaga

Current Primary Outcome: Change from baseline the numerical pain rating scale (NRS) at 3,6,12 months [ Time Frame: Pain will be evaluated at baseline and 3 follow-ups (3,6,12 months). ]

Pain: The Numerical Rating Scale (NRS) will assess the pain intensity of each patient at baseline and prospectively. NRS scores range from 0 to 10, with 0 without pain and 10 with the worst pain imaginable. It has been shown that the NRS has a good test-retest reliability of the same day.


Original Primary Outcome: Same as current

Current Secondary Outcome: Change from baseline the pain disability index (PDI) at 3,6,12 months [ Time Frame: Disability will be evaluated at baseline and 3 follow-ups (3,6,12 months). ]

Disability: The Pain Disability Index (PDI) is a 7-question questionnaire that investigates the magnitude of disability due to pain in different situations such as work, leisure time, activities of daily living, and sports


Original Secondary Outcome: Same as current

Information By: University of Malaga

Dates:
Date Received: January 26, 2017
Date Started: May 2017
Date Completion: June 2019
Last Updated: March 12, 2017
Last Verified: March 2017