Influence of Beliefs on the Prognosis of Chronic Musculoskeletal Pain.

August 9, 2021 updated by: Alejandro Luque-Suarez, University of Malaga

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

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.

Study Overview

Status

Completed

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Actual)

307

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Malaga, Spain
        • Hospital Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Subjects between 18-70 years with chronic musculoskeletal pain

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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.

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)).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Pain will be evaluated at baseline and 3 follow-ups (3,6,12 months).

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Disability will be evaluated at baseline and 3 follow-ups (3,6,12 months).

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from baseline the tampa scale for kinsiophobia (TSK-11) at 3,6,12 months
Time Frame: Fear of movement will be evaluated at baseline and 3 follow-ups (3,6,12 months).
Fear of movement: The short version of the Tampa Scale for Kinesiophobia (TSK-11) will be used to assess fear of movement
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
Time Frame: Pain-related fear will be evaluated at baseline and 3 follow-ups (3,6,12 months).
Pain-related fear: The short version (9-items) of the Fear of Pain Questionnaire (FPQ-III) will be used to assess the fear of pain in this population
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
Time Frame: Pain acceptance will be evaluated at baseline and 3 follow-ups (3,6,12 months).
Pain acceptance: The Chronic Pain Acceptance Questionnaire (CPAQ) will measure pain acceptance through 20 items
Pain acceptance will be evaluated at baseline and 3 follow-ups (3,6,12 months).
Change from baseline the pain self-efficacy questionnaire (PSEQ) at 3,6,12 months
Time Frame: Self-efficacy will be evaluated at baseline and 3 follow-ups (3,6,12 months).
Self-efficacy: The Pain Self-Efficacy Questionnaire (PSEQ) contains 10 questions that will measure the patient's confidence in performing certain activities despite pain.
Self-efficacy will be evaluated at baseline and 3 follow-ups (3,6,12 months).

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

August 1, 2020

Primary Completion (ACTUAL)

September 1, 2020

Study Completion (ACTUAL)

December 1, 2020

Study Registration Dates

First Submitted

January 26, 2017

First Submitted That Met QC Criteria

January 26, 2017

First Posted (ESTIMATE)

January 30, 2017

Study Record Updates

Last Update Posted (ACTUAL)

August 16, 2021

Last Update Submitted That Met QC Criteria

August 9, 2021

Last Verified

December 1, 2019

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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