Influence of Beliefs on the Prognosis of Chronic Musculoskeletal Pain.

NCT03036553 | Completed DMC

• 1 other identifier: UNMalaga
• Study Type: observational
• Target: 307
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Musculoskeletal Pain

Keywords

Chronic pain; Psychological factors; Musculoskeletal pain; Prognosis

Outcome Measures

Primary Outcomes (1)

• Change from baseline the numerical pain rating scale (NRS) at 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.

  Pain will be evaluated at baseline and 3 follow-ups (3,6,12 months).

Secondary Outcomes (1)

• Change from baseline the pain disability index (PDI) at 3,6,12 months

  Disability will be evaluated at baseline and 3 follow-ups (3,6,12 months).

Other Outcomes (4)

• Change from baseline the tampa scale for kinsiophobia (TSK-11) at 3,6,12 months

  Fear of movement will be evaluated at baseline and 3 follow-ups (3,6,12 months).

• Change from baseline the fear pain questionnaire (FPQ-III) at 3,6,12 months

  Pain-related fear will be evaluated at baseline and 3 follow-ups (3,6,12 months).

• Change from baseline the chronic pain acceptance questionnaire (CPAQ) at 3,6,12 months

  Pain acceptance will be evaluated at baseline and 3 follow-ups (3,6,12 months).

Study Arms (1)

Chronic musculoskeletal pain

(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.

Other: Diagnosis/Prognosis

Interventions

Diagnosis/Prognosis OTHER

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)).

Chronic musculoskeletal pain

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Subjects between 18-70 years with chronic musculoskeletal pain

You may qualify if:

• (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.

You may not qualify if:

• (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.

Sponsors & Collaborators

• University of Malaga: lead

Study Sites (1)

Hospital Center

Málaga, Spain

Location

MeSH Terms

Conditions

Chronic Pain; Musculoskeletal Pain

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Muscular Diseases; Musculoskeletal Diseases

Study Officials

• Alejandro Luque Suarez, PhD

  University of Malaga

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD

Study Record Dates

• First Submitted: January 26, 2017
• First Posted: January 30, 2017
• Study Start: August 1, 2020
• Primary Completion: September 1, 2020
• Study Completion: December 1, 2020
• Last Updated: August 16, 2021

Record last verified: 2019-12

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)