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Musculoskeletal PainNCT06285864

Sense to Act: An Interoceptive Sensibility Intervention for Musculoskeletal Pain

A study testing Interoception-based intervention in people with Musculoskeletal Pain and Chronic Pain, run by Iscte-University Institute of Lisbon at 2 sites in Portugal.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Musculoskeletal Pain, Chronic Pain
What is being tested?
Interoception-based intervention
Could I receive a placebo?
No, everyone receives an active treatment
How many people
71 participants
Where
2 sitesPortugal
Study dates
11 Feb 2024to 30 Jun 2024
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

2 sites in 1 country.

Portugal2 sites

  • University of Évora

    Evora, Évora District, 7004-516

  • Iscte - University Institute of Lisbon

    Lisbon, Lisbon District, 1649-026

Other trials in Portugal

About this study

Official title: Sense to Act: Pilot Randomized-controlled Trial of an Interoceptive Sensibility Intervention for Musculoskeletal Pain

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.

Read the 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.

Being tested
Interoception-based intervention
Keywords
interoception, musculoskeletal pain, feasibility
Medical subject headings
Musculoskeletal Pain, Chronic Pain

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Interoception-based interventionBehavioural

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

Study groups in NCT06285864
Study groupRoleWhat they receive
Interoception-based interventionExperimentalThe 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).
Receives: Behavioral: Interoception-based intervention
Waiting listNo interventionThe waiting list group will maintain their treatments as usual and receive the interoception-based intervention, at the end of the study.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Feasibility - Sessions' acceptability

    Session evaluation checklist - 7 questions answered on a 5-point scale ranging from 1 (totally disagree) to 5 (completely agree), plus 1 open question asking for improvement suggestions.

    Measured: Up to 24 hours after each intervention session.

  2. Feasibility - Program acceptability, appropriateness, and feasibility

    Program evaluation checklist: 21 questions answered on a 5-point scale ranging from 1 (totally disagree) to 5 (completely agree) plus 3 open questions.

    Measured: Up to 72 hours after the end of the intervention (T2)

  3. Feasibility - Recruitment, retention, and attendance rates

    Number of participants recruited, number of participants included in the study (among those who are eligible), and average number of sessions attended in intervention by participants.

    Measured: Up to 12 weeks after the end of the intervention

  4. Feasibility - safety/unexpected events

    Number and type of unexpected events reported by the participants during their participation in the intervention.

    Measured: Up to 12 weeks after the end of the intervention

  5. Feasibility - Treatment Fidelity Check

    Sessions will be audio-recorded and an independent therapist will confirm if planned procedures were done.

    Measured: Up to 12 weeks after the end of the intervention.

Secondary outcomes (9)

  1. Interoceptive sensibility

    Multidimensional Assessment of Interoceptive Awareness assesses IS skills, such as identifying bodily sensations, body-mind relationships, and body trust, through 32 items rated on a 6-point Likert scale. Higher scores expresses higher IS levels.

    Measured: Within the 72-hour period before the first session (T0); up to 72 hours after the fourth session (T1), up to 72 hours after the last (eighth) session (T2), and one month after the last session (T3).

  2. Psychological flexibility

    The Portuguese Comprehensive Assessment of Acceptance and Commitment Therapy Processes is an 18-item scale that measures psychological flexibility (openness to experience, behavioral awareness, valued action) on a 7-point rating scale. Higher scores indicate greater psychological flexibility.

    Measured: Within the 72-hour period before the first session (T0); up to 72 hours after the fourth session (T1), up to 72 hours after the last (eighth) session (T2), and one month after the last session (T3).

  3. Emotion regulation

    Difficulties in Emotion Regulation Scale - Short Form assesses difficulties in emotion regulation (e.g., nonacceptance of emotional responses, difficulty engaging in goal-directed behavior or in impulse control, lack of emotional awareness), through 18 items. Higher scores correspond to more difficulty in emotion regulation.

    Measured: Within the 72-hour period before the first session (T0); up to 72 hours after the fourth session (T1), up to 72 hours after the last (eighth) session (T2), and one month after the last session (T3).

  4. Pain-related self-efficacy

    The Pain Self-Efficacy Questionnaire assesses the individuals' confidence level in reaching activities or goals, despite pain with 10 items rated on a 7-point scale. Higher scores represent higher self-efficacy levels.

    Measured: Within the 72-hour period before the first session (T0); up to 72 hours after the fourth session (T1), up to 72 hours after the last (eighth) session (T2), and one month after the last session (T3).

  5. Pain catastrophizing

    Pain Catastrophizing Scale measures pain-related catastrophic thinking through 13 items rated on a 5-point scale.Higher levels express higher levels of pain catastrophizing.

    Measured: Within the 72-hour period before the first session (T0); up to 72 hours after the fourth session (T1), up to 72 hours after the last (eighth) session (T2), and one month after the last session (T3).

  6. Activity patterns

    Activity Patterns Scale measures activity patterns through 24 questions responded to on a 5-point scale (avoidance, persistence, and pacing related patterns). Higher levels represent more use of the respective pattern.

    Measured: Within the 72-hour period before the first session (T0); up to 72 hours after the fourth session (T1), up to 72 hours after the last (eighth) session (T2), and one month after the last session (T3).

  7. Affective distress (depression and anxiety)

    Depression Anxiety Stress Scales evaluate depression/anxiety/stress levels experienced during the previous week, through 21 items rated on a 4-point scale. Higher levels represent higher depression and anxiety levels.

    Measured: Within the 72-hour period before the first session (T0); up to 72 hours after the fourth session (T1), up to 72 hours after the last (eighth) session (T2), and one month after the last session (T3).

  8. Pain severity

    Brief Pain Inventory assesses pain-related disability (e.g., general activities, walking, work, mood) through 7 items rated on 11-point numerical scales; Graded Chronic Pain Scale-Revised (Von Korff et al., 2020) identify chronic pain individuals, grading their pain severity, through 6 items.

    Measured: Within the 72-hour period before the first session (T0); up to 72 hours after the fourth session (T1), up to 72 hours after the last (eighth) session (T2), and one month after the last session (T3).

  9. Physical function and Vitality

    Medical Outcomes Study-36 - Short Form 36v2 assesses functional limitations in daily physical activities, and vitality, through 10 and 4 items, rated on 4 and 5-point scales, respectively. Higher scores correspond to higher physical function and vitality.

    Measured: Within the 72-hour period before the first session (T0); up to 72 hours after the fourth session (T1), up to 72 hours after the last (eighth) session (T2), and one month after the last session (T3).

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Feb 2024
  2. Study start11 Feb 2024
  3. Primary completion20 Jun 2024
  4. Study completion30 Jun 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Participant
Enrolment
71 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06285864
Sponsor's protocol ID
122/2023
Status last verified
Apr 2025
First submitted
1 Feb 2024
Last updated
29 Jun 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: IPD used in the results publication will be made available upon request (De-identified).

Publications

  • Ferreira PL. [Development of the Portuguese version of MOS SF-36. Part I. Cultural and linguistic adaptation]. Acta Med Port. 2000 Jan-Apr;13(1-2):55-66. Portuguese.

    PubMed 11059056

  • Ferreira PL. [Development of the Portuguese version of MOS SF-36. Part II --Validation tests]. Acta Med Port. 2000 May-Jun;13(3):119-27. Portuguese.

    PubMed 11026151

  • Sullivan, M. J. L., Bishop, S. R., & Pivik, J. (1995). The Pain Catastrophizing Scale: Development and validation. Psychological Assessment, 7(4), 524-532. https://doi.org/10.1037/1040-3590.7.4.524

  • Ferreira-Valente MA, Pais-Ribeiro JL, Jensen MP. Psychometric properties of the portuguese version of the Pain Self-Efficacy Questionnaire. Acta Reumatol Port. 2011 Jul-Sep;36(3):260-7.

    PubMed 22113601

  • Kaufman EA, Xia M, Fosco G, Yaptangco M, Skidmore CR, Crowell SE. The Difficulties in Emotion Regulation Scale Short Form (DERS-SF): Validation and Replication in Adolescent and Adult Samples. J Psychopathol Behav Assess. 2016 Sep;38(3):443-455. doi: 10.1007/s10862-015-9529-3. Epub 2015 Nov 23.

    PubMed 41522882

  • Nicholas MK. The pain self-efficacy questionnaire: Taking pain into account. Eur J Pain. 2007 Feb;11(2):153-63. doi: 10.1016/j.ejpain.2005.12.008. Epub 2006 Jan 30.

    PubMed 16446108

  • Azevedo LF, Altamiro CP, Cláudia D, Luís A, Laurinda L, José R, Teresa P, Sílvia VS, Rosário A, Carlos JC, Maria CC, Duarte C, José C, Georgina C, Beatriz CL, Maria CL, Beatriz S, José CL. Tradução, adaptação cultural e estudo multicêntrico de validação de instrumentos para rastreio e avaliação do impacto da dor crónica. Dor 2007;15:6-56.

  • Cleeland CS. Measurement of pain by subjective report. Advances in pain research and therapy: issues in pain measurement. Vol. 12. New York, NY: Raven Press, 1989. p. 391-403.

  • Pais-Ribeiro J, Honrado A, Leal I. Contribuição para o estudo da adaptação portuguesa das Escalas de Ansiedade, Depressão e Stress (EADS) de 21 itens de Lovibond e Lovibond. Psicol Saúde Doenc¸ as 2004; 5:229-39.

  • Lovibond PF, Lovibond SH. The structure of negative emotional states: comparison of the Depression Anxiety Stress Scales (DASS) with the Beck Depression and Anxiety Inventories. Behav Res Ther. 1995 Mar;33(3):335-43. doi: 10.1016/0005-7967(94)00075-u.

    PubMed 7726811

  • Von Korff M, DeBar LL, Krebs EE, Kerns RD, Deyo RA, Keefe FJ. Graded chronic pain scale revised: mild, bothersome, and high-impact chronic pain. Pain. 2020 Mar;161(3):651-661. doi: 10.1097/j.pain.0000000000001758.

    PubMed 31764390

  • Esteve R, Ramirez-Maestre C, Peters ML, Serrano-Ibanez ER, Ruiz-Parraga GT, Lopez-Martinez AE. Development and Initial Validation of the Activity Patterns Scale in Patients With Chronic Pain. J Pain. 2016 Apr;17(4):451-61. doi: 10.1016/j.jpain.2015.12.009. Epub 2015 Dec 23.

    PubMed 26724275

  • Mehling WE, Price C, Daubenmier JJ, Acree M, Bartmess E, Stewart A. The Multidimensional Assessment of Interoceptive Awareness (MAIA). PLoS One. 2012;7(11):e48230. doi: 10.1371/journal.pone.0048230. Epub 2012 Nov 1.

    PubMed 23133619

  • Machorrinho J, Veiga G, Fernandes J, Mehling W, Marmeleira J. Multidimensional Assessment of Interoceptive Awareness: Psychometric Properties of the Portuguese Version. Percept Mot Skills. 2019 Feb;126(1):87-105. doi: 10.1177/0031512518813231. Epub 2018 Nov 19.

    PubMed 30451581

  • Cimmino MA, Ferrone C, Cutolo M. Epidemiology of chronic musculoskeletal pain. Best Pract Res Clin Rheumatol. 2011 Apr;25(2):173-83. doi: 10.1016/j.berh.2010.01.012.

    PubMed 22094194

Questions about this trial

What is this clinical trial studying?

A study testing Interoception-based intervention in people with Musculoskeletal Pain and Chronic Pain, run by Iscte-University Institute of Lisbon at 2 sites in Portugal.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 29 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Portugal. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Feasibility - Sessions' acceptability (time frame: Up to 24 hours after each intervention session.). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06285864, which also lists 25 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jun 2025.

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