Associations Between Pain Perceptions and Movement-evoked Pain.

Musculoskeletal Pain Clinical Trial

Official title:

Associations Between Pain Perceptions and Movement-evoked Pain: a Cross-sectional Study.

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT04545853
• Other study ID #: MEP_PC
• Status: Withdrawn
• Start date: October 1, 2020
• Est. completion date: June 1, 2021

Study information

• Verified date: December 2021
• Source: Vrije Universiteit Brussel
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The aim of this study is to investigate the associations between pain cognitions and movement-evoked pain in people with musculoskeletal pain complaints.

Description:

This study will investigate the associations between pain cognitions and movement-evoked pain in people with musculoskeletal pain complaints. This study will be carried out as a cross-sectional study. Participants will be recruited by means of flyers and social media.

Pain cognitions will be assessed using questionnaires (The Pain Catastrophizing Scale (PCS), The llness perception questionnaire-revised (IPQ-R), The Pain Vigilance and Awareness Questionnaire (PVAQ), The Tampa Scale for Kinesiophobia (TSK), The 36-item short form health survey (SF-36)), whilst movement-evoked pain will be assessed using a lifting task. Participants will need to rate the experienced pain immediately after completing the task. To estimate the extent to which pain cognitions explain movement-evoked pain, correlational analyses will first be conducted between all variables to determine what variables will be included in the hierarchical regression analysis.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: June 1, 2021
• Est. primary completion date: May 15, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 18 years or older,

• presence of musculoskeletal pain for more than three months,

• medically stable (no serious health conditions, no pending surgery or invasive medical procedure, no contraindication to physical activity).

Exclusion Criteria:

• Presence of co-existing pain conditions of other origins with chronic musculoskeletal pain not being the primary condition (i.e. predominant subject of symptom complaints)

• severe underlying comorbidity (like diagnosed diabetes, cardiovascular problems, etc.)

• pregnant or given birth in the preceding year.

Related Conditions & MeSH terms

• Musculoskeletal Pain

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Vrije Universiteit Brussel

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Movement-evoked pain	Pain that is experienced in response to a physical task. Participants will perform a lifting task. Participants will be asked to lift a series of 19-canisters that will be arranged in a standardized pattern on a waist-high table. Participants will provide a pain rating on a 11 points Numeric Rating Scale (NRS) with the endpoints no pain" (0) and "excruciating pain" (10)	Assessed only once at baseline.
Primary	Illness perceptions	The illness perception questionnaire-revised (IPQ-R) will be used to measure patients' illness perceptions. In the first domain, called illness identity, the perceived symptoms and their possible relation to the illness are evaluated. In this study, participants will indicate whether or not they believe that a specific symptom is related to pain ("yes" or "no"). The second domain, the beliefs domain, covers 7 dimensions: the acute/chronic timeline, the cyclical character of the illness, the consequences, controllability, curability, emotional representations and illness coherence. The third domain lists 18 possible causes to which individuals attribute their condition, the degree to which individuals perceive themselves as responsible for the illness, as well as the responsibility individuals take for curing themselves. For each item in the second and third domain, patients rate their level of agreement on a 5-point Likert scale, ranging from "strongly disagree" to "strongly agree"	Assessed only once at baseline
Primary	Pain catastrophizing	The Pain Catastrophizing Scale (PCS) is a questionnaire to objectify catastrophic thinking about pain. It consists of 13 items describing different thoughts and feelings that individuals may have when experiencing pain. Items are scored on a 5-point scale. A general score and scores on 3 subscales (i.e., helplessness (6 items), magnification (3 items), and rumination (4items)) will be obtained; higher scores indicate more severe catastrophic thoughts about pain	Assessed only once at baseline
Primary	Attention to pain	The Pain Vigilance and Awareness Questionnaire (PVAQ) will be used to investigate patients' attention to pain. It is a 16-item measure of attention to pain that assesses awareness, consciousness, vigilance, and observation of pain. Scores range from 0 to 80 and high scores correspond to hypervigilance for pain.	Assessed only once at baseline
Primary	Fear of injury due to movement	The Tampa Scale for Kinesiophobia (TSK) is a 17-item questionnaire that will be used to measure the fear of (re) injury due to movement. Scores range from 17 to 68, with scores = 37 suggesting low fear of movement and scores > 37 indicating high fear of movement.	Assessed only once at baseline
Primary	Quality of life, an individual's perception of their position in life in the context of the culture and value systems in which they live and in relation to their goals, expectations, standards and concerns.	The 36-item short form health survey (SF-36) is a multidimensional generic questionnaire assessing quality of life, which consists of 8 dimensions: physical functioning (10 items), role constraint caused by physical health problems (4 items), bodily pain (2 items), general health (5 items), vitality (4 items), social functioning (2 items), role constraint caused by emotional problems (3 items) and mental health (5 items). Higher scores reflecting a better health condition	Assessed only once at baseline