Recommendations for a first Core Outcome Measurement set for complex regional PAin syndrome Clinical sTudies (COMPACT)

Grieve, Sharon; Pérez, Roberto; Birklein, Frank; Brunner, Florian; Bruehl, Stephen; Harden, R. Norman; Packham, Tara; Gobeil, François; Haigh, Richard; Holly, Janet; Terkelsen, Astrid Juhl; Davies, Lindsay; Lewis, Jennifer; Thomassen, Ilona; Connett, Robyn; Worth, Tina; Vatine, Jean-Jacques; McCabe, Candy

doi:10.1097/j.pain.0000000000000866

Cited by 49 publications

(47 citation statements)

References 50 publications

(69 reference statements)

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“…The CRPS severity score assessment protocol follows the 16-points scoring system published by Harden and colleagues [35]. This continuous index of CRPS symptom severity has good discrimination abilities, concurrent validity and adequate sensitivity to change [35,52], and has been recommended as one of the core outcome measures for CRPS clinical studies [61].…”

Section: Primary Outcomesmentioning

confidence: 99%

Pain reduction by inducing sensory-motor adaptation in Complex Regional Pain Syndrome (CRPS PRISMA): protocol for a double-blind randomized controlled trial

et al. 2020

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Background: Complex Regional Pain Syndrome (CRPS) presents as chronic, continuous pain and sensory, autonomic, and motor abnormalities affecting one or more extremities. People with CRPS can also show changes in their perception of and attention to the affected body part and sensory information in the affected side of space. Prism Adaptation (PA) is a behavioural intervention targeted at reducing attention deficits in post-stroke hemispatial neglect. PA also appears to reduce pain and other CRPS symptoms; however, these therapeutic effects have been demonstrated only in small unblinded studies. This paper describes the protocol for an ongoing double-blind, randomized, sham-controlled clinical trial that will evaluate the efficacy of PA treatment for CRPS. The secondary aims of the study are to examine the relationships between neuropsychological changes (such as spatial attention, space and body representation, and motor spatial performance) and clinical manifestations of CRPS, as well as symptom improvement. Methods: Forty-two participants with upper-limb CRPS type I will undergo 2 weeks of twice-daily PA treatment or sham treatment. The primary outcome measures are current pain intensity and CRPS severity score, measured immediately before and after the treatment period. Secondary outcome measures include the results of self-report questionnaires about pain, movement, symptoms interference, and body representation; clinical assessments of sensory, motor, and autonomic functions; and computer-based psychophysical tests of neuropsychological functions. Data are collected in four research visits: 4 weeks and 1 day before treatment, and 1 day and 4 weeks after the end of treatment. Additional follow-up through postal questionnaires is conducted 3 and 6 months post-treatment. Discussion: It is hypothesised that participants undergoing PA treatment, compared to those receiving sham treatment, will show greater reduction in pain and CRPS severity score, and improvements on other clinical and neuropsychological measures. Also, more pronounced neuropsychological symptoms are predicted to correlate with more severe clinical CRPS symptoms. This study will provide the first randomized double-blind evaluation of the therapeutic effects of PA that could be implemented as a rehabilitation method for CRPS, and will contribute to the understanding of how neuropsychological changes in body representation and attention pertain to the manifestation and treatment of CRPS. Trial registration: (27/03/2017): ISRCTN46828292 (ISRCTN-ISRCTN46828292: Treatment of complex regional pain syndrome (CRPS) with sensory-motor adaptation).

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Section: Primary Outcomesmentioning

confidence: 99%

Pain reduction by inducing sensory-motor adaptation in Complex Regional Pain Syndrome (CRPS PRISMA): protocol for a double-blind randomized controlled trial

et al. 2020

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“…The summed CRPS severity score can range from 0 (no CRPS symptoms) to 16 (most severe CRPS symptoms). The CRPS severity score has good discrimination abilities, concurrent validity, and adequate sensitivity to change [33,34], and was recommended as the core outcome measure for CRPS clinical studies [28].…”

Section: Primary Outcomesmentioning

confidence: 99%

Prism adaptation treatment for upper-limb Complex Regional Pain Syndrome: a double-blind randomized controlled trial

Halicka

Vitterso

McCullough

et al. 2020

Preprint

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Initial evidence suggested that people with Complex Regional Pain Syndrome (CRPS) have reduced attention to the affected side of their body and the surrounding space, which might be related to pain and other clinical symptoms. Three previous unblinded, uncontrolled studies showed pain relief following treatment with prism adaptation, an intervention that has been used to counter lateralised attention bias in brain-lesioned patients. To provide a robust test of its effectiveness for CRPS, we conducted a double-blind randomized controlled trial of prism adaptation for unilateral upper-limb CRPS-I. Forty-nine eligible adults with CRPS were randomized to undergo two-weeks of twice-daily home-based prism adaptation treatment (n = 23) or sham treatment (n = 26). Outcomes were assessed in person four weeks prior to and immediately before treatment, and immediately after and four weeks post-treatment. Long-term postal follow-ups were conducted three and six months after treatment. We examined the effects of prism adaptation versus sham treatment on current pain intensity and CRPS symptom severity score (primary outcomes); as well as sensory, motor, and autonomic functions, self-reported psychological functioning, and experimentally tested neuropsychological functions (secondary outcomes). We found no evidence that primary or secondary outcomes differed between the prism adaptation and sham treatment groups when tested at either time point following treatment. Overall, CRPS severity significantly decreased over time for both groups, but we found no benefits of prism adaptation beyond sham treatment. Our findings do not support the efficacy of prism adaptation treatment for relieving upper-limb CRPS-I. This trial was prospectively registered (ISRCTN46828292).

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“…A core outcome measurement set can be defined as an agreed, standardized set of outcomes which should be measured and reported in all clinical trials in a particular condition (Williamson et al, ). Through a series of workshops and supplementary work, the consortium agreed, and published, the core set of questionnaire outcome measures, which was recommended for use in future CRPS clinical studies in an adult population (Grieve et al, ). The defined measures captured the domains within the overarching research question: “What is the clinical presentation and course of CRPS and what factors influence it?”, and comprised: pain, disease severity, participation and function, emotional and psychological function, self‐efficacy, catastrophizing and patient's global impression of change (Grieve et al, ).…”

Section: Introductionmentioning

confidence: 99%

“…The final COMPACT registry will comprise: Demographic data Patient‐reported questionnaire outcome measures (COMPACT) and one clinician‐reported questionnaire outcome measure (Grieve et al () Core clinical outcome measures (to be defined). …”

Section: Introductionmentioning

confidence: 99%

“…The defined measures captured the domains within the overarching research question: "What is the clinical presentation and course of CRPS and what factors influence it? ", and comprised: pain, disease severity, participation and function, emotional and psychological function, self-efficacy, catastrophizing and patient's global impression of change (Grieve et al, 2017). One clinician-reported measure captured the severity of CRPS .…”

Section: Introductionmentioning

confidence: 99%

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A multi‐centre study to explore the feasibility and acceptability of collecting data for complex regional pain syndrome clinical studies using a core measurement set: Study protocol

Grieve

Brunner

Buckle

et al. 2019

Musculoskeletal Care

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Objectives This international, multicentre study will inform the final data collection tools and processes which will comprise the first international, clinical research registry for complex regional pain syndrome (CRPS). This study will: (a) test the feasibility and acceptability of collecting outcome measurement data using a patient reported, questionnaire core measurement set (COMPACT [Core Outcome Measurement set for complex regional PAin syndrome Clinical sTudies]); and (b) test and refine an electronic data management system to collect and manage the data. Methods A maximum of 240 adults, meeting the Budapest diagnostic clinical criteria for CRPS type I or II, will be recruited across eight countries. The COMPACT questionnaire will be completed on two occasions: at baseline (T1) and 6 months later (T2). At T2, participants will choose to complete COMPACT using a paper or electronic version. Participants will be asked to feed back on their experience of completing COMPACT via a questionnaire. A separate questionnaire will ask clinicians to feed back their experience of data collection. Analysis The study is not aiming to derive statistically significant data but to ascertain the practicalities of collecting data, using the COMPACT questionnaire set, across a range of different cultures and populations. At the end of the study, a single workshop will be convened to review the findings and agree the final documents and processes for the international registry.

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Recommendations for a first Core Outcome Measurement set for complex regional PAin syndrome Clinical sTudies (COMPACT)

Cited by 49 publications

References 50 publications

Pain reduction by inducing sensory-motor adaptation in Complex Regional Pain Syndrome (CRPS PRISMA): protocol for a double-blind randomized controlled trial

Pain reduction by inducing sensory-motor adaptation in Complex Regional Pain Syndrome (CRPS PRISMA): protocol for a double-blind randomized controlled trial

Prism adaptation treatment for upper-limb Complex Regional Pain Syndrome: a double-blind randomized controlled trial

A multi‐centre study to explore the feasibility and acceptability of collecting data for complex regional pain syndrome clinical studies using a core measurement set: Study protocol

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