Clinical trial NCT03036553: Influence of Beliefs on the Prognosis of Chronic Musculoskeletal Pain.
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 Study. Study Protocol
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Chronic Musculoskeletal Pain
Keywords: Chronic pain
Psychological factors
Musculoskeletal pain
Prognosis
Lead sponsor: University of Malaga
Sponsor class: OTHER
First posted: 2017-01-30
Enrollment: 307
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Subjects between 18-70 years with chronic musculoskeletal pain

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 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.

Eligibility criteria: Inclusion Criteria:

(i) men / women over 18 years of age; (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:

(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.

Primary outcomes:
measure: Change from baseline the numerical pain rating scale (NRS) at 3,6,12 months
timeFrame: Pain will be evaluated at baseline and 3 follow-ups (3,6,12 months).
Secondary outcomes:
measure: Change from baseline the pain disability index (PDI) at 3,6,12 months
timeFrame: Disability will be evaluated at baseline and 3 follow-ups (3,6,12 months).
Other outcomes:
measure: Change from baseline the tampa scale for kinsiophobia (TSK-11) at 3,6,12 months
timeFrame: Fear of movement will be evaluated at baseline and 3 follow-ups (3,6,12 months).
measure: Change from baseline the fear pain questionnaire (FPQ-III) at 3,6,12 months
timeFrame: Pain-related fear will be evaluated at baseline and 3 follow-ups (3,6,12 months).
measure: Change from baseline the chronic pain acceptance questionnaire (CPAQ) at 3,6,12 months
timeFrame: Pain acceptance will be evaluated at baseline and 3 follow-ups (3,6,12 months).
measure: Change from baseline the pain self-efficacy questionnaire (PSEQ) at 3,6,12 months
timeFrame: Self-efficacy will be evaluated at baseline and 3 follow-ups (3,6,12 months).
Locations:
city: Malaga
country: Spain
facility: Hospital Center
Study officials:
affiliation: University of Malaga
name: Alejandro Luque Suarez, PhD
role: PRINCIPAL_INVESTIGATOR
References: