Sense to Act: An Interoceptive Sensibility Intervention for Musculoskeletal Pain

NCT ID: NCT06285864

Last Updated: 2025-06-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 71 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-02-11
• Study Completion Date: 2024-06-30

Brief Summary

The ability to be connected and act according to bodily information is fundamental in chronic pain adjustment. This study aims to test the feasibility of an intervention designed to improve interoceptive sensibility, i.e., the ability to sense, interpret, and regulate bodily sensations in chronic musculoskeletal pain patients.

Detailed Description

Background: Interoceptive sensibility (IS), the self-reported experience of internal states, involves individuals' capacity to sense, interpret, integrate, and regulate their own bodily information. Disruptions in interoceptive processes are often associated with various health conditions, including mental illness and chronic pain (CP). Individuals with chronic musculoskeletal pain present disruptions in IS associated with worse pain adjustment.

While there is a growing body of research testing interoceptive-based interventions on both healthy and clinical samples, interventions specifically tailored for individuals with CP are limited. Furthermore, despite evidence that interventions such as mindfulness or meditation improve IS in incividuals with CP, the mechanisms contributing to enhanced pain-related outcomes remain unknown. Additionally, in Portugal, there is a lack of cost-effective interventions for CP in both public health services and the community.

This study aims to address these gaps by evaluating the feasibility of a program designed for a community setting. The program is specifically developed to enhance IS, potentially improving pain adjustment in individuals with chronic musculoskeletal pain - one of the most prevalent and burdensome types of pain globally. The study compares a group receiving an interoception-based intervention, intending to improve IS, against a control group on a waiting list, examining the intervention's acceptability, feasibility, appropriateness, and estimated treatment effects.

Method: The recruitment process will be conducted through the study website, providing information about the research team, study objectives, and general details about the intervention structure and session schedules. Potential participants must register on the website to enroll in the study. Measurements will be collected anonymously and online (via Qualtrics) using self-report questionnaires at four points in time: before (T0), in the middle (T1), at the end (T2), and one month after the intervention (T3). Additionally, participants in the intervention group will complete an anonymous evaluation checklist after each session and a final evaluation checklist assessing the study's acceptability, appropriateness, and feasibility. Block-stratified randomization of participants for each group (intervention/control), based on sex and geographical area (Lisbon/Évora), will be conducted using randomization software.

The intervention includes four stages addressing different IS skills with 8 weekly sessions (4-6 participants), each lasting 1.5 hours. These sessions will be delivered by two trained psychomotor therapists with clinical experience, supplemented by daily home exercises. To ensure fidelity of the procedures during sessions, recordings will be made for later review (therapists cross-confirm each other's sessions).

Discussion: It is expected that, with or without protocol modifications: 1) The protocol components are suitable to conduct a larger study; 2) the program has good acceptability, appropriateness, feasibility, and participant adherence.

Conditions

Musculoskeletal Pain; Chronic Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Interoception-based intervention

The interoception-based intervention group will receive the intervention, which consists of 8 weekly sessions, of 1h30 hour, in groups (4-8 participants in each group).

Group Type: EXPERIMENTAL

Interoception-based intervention

Intervention Type: BEHAVIORAL

Intervention will include body awareness, sensorial, and relaxation exercises, plus homework.

Waiting list

The waiting list group will maintain their treatments as usual and receive the interoception-based intervention, at the end of the study.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Interoception-based intervention

Intervention will include body awareness, sensorial, and relaxation exercises, plus homework.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• Adult individuals (over 18 years old)
• experiencing chronic musculoskeletal pain (≥ 3 months)
• able to understand and speak portuguese

Exclusion Criteria

• neurodegenerative diseases
• cancer pain
• recent fractures, or surgeries (< 3 months).

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Foundation for Science and Technology, Portugal

OTHER

Sponsor Role: collaborator

University of Évora

OTHER

Sponsor Role: collaborator

Iscte-University Institute of Lisbon

OTHER

Sponsor Role: lead

Responsible Party

Ines Oliveira

MSc

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Inês Oliveira, MSc

Role: PRINCIPAL_INVESTIGATOR

Iscte-University Institute of Lisbon

Sónia Bernardes, PhD

Role: STUDY_CHAIR

Iscte-University Institute of Lisbon

Margarida Garrido, PhD

Role: STUDY_CHAIR

Iscte-University Institute of Lisbon

Locations

Iscte - University Institute of Lisbon

Lisbon, Lisbon District, Portugal

University of Évora

Evora, Évora District, Portugal

Countries

Portugal

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Other Identifiers

122/2023

Identifier Type: -

Identifier Source: org_study_id