A six-participant pilot single-subject study of an individualized pain management program for people with spinal cord injury

ABSTRACT STUDY DESIGN Single-subject repeated measures design. OBJECTIVES To explore the impacts of a novel individualized interdisciplinary pain self-management program for persons living

with spinal cord injury pain. SETTING A large rehabilitation institute for adults with physical disabilities in Quebec city (Quebec, Canada). METHODS Six persons having sustained a spinal

cord injury and experiencing chronic pain participated. Following a five-week pre-intervention phase (baseline repeated measures) and a clinical evaluation, individualized intervention

objectives were developed in collaboration with each participant. Then, participants completed a ten-week intensive intervention and a six-month consolidation phase. The program included

cognitive behavioral therapy, and physical and pharmacological interventions, which were group- and individual-based. Outcome measures were the Canadian Occupational Performance Measure

(COPM), the French-Canadian Chronic Pain Self-efficacy Scale (FC-CPSES), the Brief Pain Inventory (BPI), and the Hospital Anxiety and Depression Scale (HADS). RESULTS For five out of the six

participants, a majority of outcomes improved during either of the intervention phases or both. Improvements in occupational performance were clinically significant for three participants.

Pain interference and anxiety improved significantly in five participants, while pain self-efficacy and depressive symptoms improved in four participants. CONCLUSIONS The results suggest

that the pain self-management program was effective to reduce the impact of spinal cord injury pain. Further research is needed to replicate these results in a larger study and comprehend

the factors favoring or undermining improvements with such programs, as well as their persistence over time. You have full access to this article via your institution. Download PDF SIMILAR

CONTENT BEING VIEWED BY OTHERS PHYSICAL ACTIVITY INTERVENTIONS, CHRONIC PAIN, AND SUBJECTIVE WELL-BEING AMONG PERSONS WITH SPINAL CORD INJURY: A SYSTEMATIC SCOPING REVIEW Article 18

September 2020 TREATMENTS THAT ARE PERCEIVED TO BE HELPFUL FOR NON-NEUROPATHIC PAIN AFTER TRAUMATIC SPINAL CORD INJURY: A MULTICENTER CROSS-SECTIONAL SURVEY Article 19 March 2021 PRELIMINARY

EXAMINATION OF _COACHING IN CONTEXT_ WITH CLIENTS WITH SPINAL CORD INJURY Article 13 April 2021 INTRODUCTION Among the sequelae which can occur in people living with a SCI, pain is one of

the most common, with a prevalence around 60% [1]. Over half of persons having sustained SCI will develop chronic pain [2]. SCI pain is associated with negative psychosocial consequences,

notably on emotional functions (e.g., stress, depression, anxiety and diminished self-efficacy and wellbeing), as well as economic self-sufficiency [3]. Because SCI pain is often refractory

to curative treatment [2], a few programs targeting _pain management_ for persons living with a SCI have been developed [4,5,6,7,8,9,10,11]. Such pain management programs aim to improve

persons’ function and help them learn to live with pain [12]. Programs’ contents include interventions such as education about pain mechanisms, cognitive and behavioral therapy (CBT)

targeting self-management, exercise and relaxation. While their format varies, most programs offer multidisciplinary group interventions, based on cognitive-behavioral approaches, that

extend over several weeks. Studies have shown positive results for these programs on outcomes including pain intensity and interference with daily life, catastrophizing, self-efficacy,

anxiety, depression, function, social participation and life satisfaction [4, 6,7,8,9, 11]. Maintenance of improvements over time has however shown to be inconsistent across outcomes and

studies. Further focussing on relapse prevention and provision of booster sessions has been suggested for this purpose [4, 7, 8]. The core characteristics of these pain management programs

are in line with the needs expressed by persons living with SCI neuropathic pain in a qualitative study [13]. However, while persons living with SCI related pain need to meet with peers,

this study also revealed that it is important for them to be involved in the treatment plan and that the treatment also be individualized [13]. Thus, the main objective of this pilot study

was to assess the impact of a novel pain self-management program (PSMP) for persons living with chronic SCI pain, inspired by previously conducted programs, but with a specific focus on

individualization, and weaning intervention more gradually in order to help maintain gains over time. The PSMP was tailored to the needs of each participant by involving participants in the

determination of intervention objectives meaningful to them, providing individual sessions alternating with group sessions to work on their own objectives over an extended period of time,

and by using a client-centered primary outcome measure. METHODS STUDY DESIGN A single-subject (A – B) design [14] was used for this pilot study, comprising a five-week pre-intervention phase

(A) and a 36-week intervention phase (B). The intervention phase was further divided into a 10-week intensive phase (B1), followed by a 26-week consolidation phase (B2). Three baseline

measurement points took place during phase A, and seven measurement points during phase B. The detailed sequence of data collection points is presented in Table 1. STUDY SETTING AND

PARTICIPANTS The study took place at the _Institut de réadaptation en déficience physique de Québec_ (_IRDPQ_) of the _Centre intégré universitaire de santé et de services sociaux de la

Capitale-Nationale_, in Quebec, Canada. Participants recruited for the study were the first six patients to participate in this program, as part of its pilot implementation. The target

clientele for the PSMP consisted of 1) adults with traumatic or non-traumatic SCI; 2) living in the community in the territory of Eastern Quebec; and 3) presenting persistent or recurrent

pain having an important impact on the accomplishment of life habits or fulfillment of roles that had been refractory to other treatment approaches for more than six months. The study was

approved by the Research Ethics Committee of the _IRDPQ_ (IRB #2014–397). Each participant provided written informed consent. INTERVENTION The general aim of the PSMP was to make

accomplishment of life roles and habits possible in spite of pain. Program acceptability and feasibility were assessed prior to its implementation by conducting focus groups and interviews

with chronic pain experts and potential users [15]. The team providing the pilot program included a physiatrist, a physical therapist, a physical educator, an occupational therapist, a

psychologist and a clinical coordinator. Following phase A, the PSMP began with a three-week interdisciplinary clinical evaluation carried out for each participant as part of the program.

The results of all the measures and evaluations carried out were used by the clinicians to determine individualized intervention objectives in collaboration with each participant. Ten weeks

of intensive interventions (Phase B1) followed. Two four-hour group-based intervention sessions were provided during weeks 1, 4, 7, and 10. During weeks 2, 3, 5, 6, 8, and 9, interventions

were one-on-one and tailored to the specific needs of each participant. The consolidation phase (B2) consisted of follow-up group-based intervention sessions provided at weeks 16, 24, and

36. During the six-month duration of this phase, the participants could request an appointment with either of the health professionals of the team on a one-on-one basis. The interventions

included CBT, and physical and pharmacological interventions. The CBT sessions were made up of psychoeducation, self-management skills development and training, training for the management

of pain peaks and relapse prevention. Participants were allowed to choose topics beyond the pre-established content. Adapted exercise and relaxation sessions were provided. Participants also

met the physiatrist to adjust their medication. Every week, personal objectives were set by each of the participants along with the health professionals, and they were given homework linked

with their objectives. The detailed content and sequence of the interventions provided during phase B1 is presented in Table 2. DATA COLLECTION Participants’ demographics and clinical data

were drawn from clinical records. As the general aim of the PSMP was to improve the accomplishment of life roles and habits of persons living with SCI pain, the primary outcome in this study

was occupational performance, based on self-identification of functional goals. Pain self-efficacy, pain interference, pain intensity, as well as anxiety and depression symptoms were

secondary outcomes. All these outcomes fall within the most important measurement domains identified for the evaluation of chronic pain self-management programs by Taylor et al. [16].

Occupational performance was assessed through semi-structured interviews conducted by phone by the same evaluator on three occasions: at baseline and at the end of phases B1 and B2.

Secondary outcomes were measured with a single composite questionnaire self-administered online or in paper format, at each of the ten measurement points (see Table 1). STUDY INSTRUMENTS

CANADIAN OCCUPATIONAL PERFORMANCE MEASURE (COPM) Occupational performance was assessed using the French version of the COPM [17]. This outcome measure asks participants to identify five

problems important for them to address in regards to occupational performance, and rate their perceived performance level and satisfaction with performance in each of these problem areas, on

a scale from 1 (_poor_) to 10 (_very good_). The COPM demonstrated good concurrent criterion validity and sensitivity to change, as well as good acceptability for participants in another

study evaluating a chronic pain management program [18]. A 2-point difference in COPM scores is considered a clinically important change [17]. BRIEF PAIN INVENTORY (BPI) A French translation

of the pain interference subscale of the BPI adapted for persons with disabilities, the BPI-I10, was used to measure pain interference [19]. Participants rated the extent to which their

pain interfere with ten activities over the previous seven days on a scale ranging from 0 (_does not interfere_) to 10 (_interferes completely_). The English version of the BPI-I10 was

validated in the SCI population and demonstrated good reliability and convergent validity with other pain-related measures [19, 20]. Likewise, the French version of the original BPI

interference subscale (BPI-I7) showed good internal consistency as well as convergent validity in other populations [21, 22]. FRENCH-CANADIAN CHRONIC PAIN SELF-EFFICACY SCALE (FC-CPSES) Pain

self-efficacy was measured using the FC-CPSES, six-item version. This instrument is an adaptation of the Chronic Disease Self-Efficacy Scale, which measures perceived self-efficacy to

perform self-management behaviors, manage chronic disease in general and achieve outcomes [23]. Participants rated their level of confidence to perform six self-management activities for

pain and related symptoms on a scale from 1 (_not at all_) to 10 (_fully_). The six-item version of the FC-CPSES has been validated in chronic pain patients, demonstrating high internal

consistency, good convergent validity with measures of mental health-related quality of life and pain catastrophizing, as well as good sensitivity to change [23]. HOSPITAL ANXIETY AND

DEPRESSION SCALE (HADS) Anxiety and depression symptoms were measured using a French-Canadian version of the HADS [24]. Participants rated the frequency of anxiety-related symptoms (7

items), and depression-related symptoms (7 items), over the last week on a four-level Likert scale. The HADS has been validated in persons with SCI and both subscales demonstrate good

reliability, as well as good preliminary construct validity [25, 26]. NUMERICAL RATING SCALE TO MEASURE PAIN INTENSITY A French numerical rating scale, “_average pain experienced over the

last seven days_”, was used to measure pain intensity. Participants rated the intensity of their pain on a scale from 0 (_no pain_) to 10 (_worst possible pain_). Numerical rating scales for

measuring pain intensity demonstrate good validity and sensitivity to change among different populations and are recommended for use in studies of pain after SCI [19]. DATA ANALYSIS

Participants’ characteristics were synthesized using descriptive statistics. For all outcomes, data were analysed graphically for each participant at each measurement point. For all

secondary outcomes, means and standard deviations were computed for scores measured at baseline for each participant. Scores obtained during phases B1 and B2 were then compared visually to

the baseline mean. Two consecutive scores needed to be two standard deviations above or below the baseline mean for change to be considered significant [14]. In some cases, the standard

deviation for baseline scores was zero, because of missing data or because of consistency in scores between measurement points. In such cases, the zero standard deviation was replaced by

that of the other participant whose baseline mean for the same outcome was closest to the single measured value for that participant. RESULTS The six persons who took part in the pilot PSMP

agreed to participate in the study. Characteristics of the participants are presented in Table 3. OCCUPATIONAL PERFORMANCE Occupational performance and satisfaction with performance scores

improved for five participants (P2, P3, P4, P5, and P6) at the end of phase B1 compared to baseline. These improvements were clinically significant in one participant for performance (P6),

and in three participants for satisfaction (P4, P5, and P6). At the end of phase B2, both occupational performance and satisfaction with performance were improved in all participants. These

improvements were clinically significant in three participants for performance (P2, P4, and P6), and in five participants for satisfaction (P1, P2, P4, P5, and P6). These results are

displayed in Fig. 1. PAIN INTERFERENCE There was a significant decrease in pain interference with intervention for five participants (P2, P3, P4, P5, and P6) (see Fig. 2). For three of them

(P3, P4, and P5), the decrease occurred during phase B1, and it was maintained over phase B2 for participant 4. For participants 2 and 6, the significant decrease occurred only during phase

B2. For participant 1, pain interference remained relatively stable over the three phases of the study. PAIN SELF-EFFICACY Significant improvements in pain self-efficacy occurred during

phase B1 in four participants (P1, P3, P5, and P6) (see Fig. 3). For two of them (P3 and P6), the improvement was maintained over phase B2. For the other two participants (P1 and P5), the

level of pain self-efficacy fluctuated over the two phases of the intervention. For participants 2 and 4, there was a trend towards an increase in pain self-efficacy, but the improvement was

not significant. ANXIETY AND DEPRESSION SYMPTOMS The results for anxiety and depression symptoms are displayed in Figs. 4, 5, respectively. Anxiety decreased significantly with intervention

in five participants (P1, P2, P4, P5, and P6). The decrease occurred during phase B1 in three of them (P4, P5, and P6) and was maintained over phase B2 in participant 6. Depressive symptoms

decreased significantly with intervention in four participants (P2, P3, P5, and P6). For participant 6, the decrease occurred during phase B1 and was maintained over phase B2. Depression

scores followed quite variable patterns over phases B1 and B2 in the other three participants (P2, P3, and P5). For participant 4, there was a trend towards a decrease in depression-related

symptoms with intervention, but the improvement was not significant. PAIN INTENSITY The results for pain intensity are displayed in Fig. 6. There was a significant decrease in pain intensity

with intervention in one participant (P4), which occurred during phase B2. For the other five participants, there was either no significant change in pain intensity with intervention (P1,

P2, and P6), or a significant increase (P3 and P5). DISCUSSION This pilot study used a single-subject design to assess the effects of an interdisciplinary PSMP for persons living with SCI

and chronic pain. The PSMP was innovative in that it was tailored to the needs of participants, with individualized objectives for each of them. Visual analysis of data revealed either

significant improvement or a tendency towards improvement with intervention in all of the outcomes measured for a majority of participants, except pain intensity. For occupational

performance, the scores improved during both intervention phases in a majority of participants. This may reflect the fact that the tool used to measure this outcome, the COPM, is tailored to

the personal goals of the participants [17]. Participants were perhaps especially motivated to improve their performance in the areas they chose themselves. For satisfaction with

occupational performance, pain interference, pain self-efficacy and anxiety and depression symptoms, scores did not follow such a clear trend over time across participants, but rather tended

to return to baseline levels during the consolidation phase in some of them. Visual analysis of each participant’s data individually also reveals that the improvement or trend towards

improvement across outcomes was more consistent in some participants. In some cases, for a given participant, scores fluctuated across outcomes during the course of the intervention, or even

markedly worsened at some point. These variations may perhaps be explained by events in the life of the participants related to their SCI condition. Indeed, events such as urinary tract

infections, pressure sores or upper limb joints overuse are secondary health conditions commonly reported in people living with SCI [27] that can impact on outcomes such as pain, distress or

functioning. To our knowledge, our study is the first to have assessed occupational performance, especially using a client-centered primary outcome measure. Previous studies found

improvements in related outcomes such as pain-related disability [6, 7, 9] and participation in activities [6]. We also found improvements in pain interference, which is in line with other

similar studies [4, 8]. Improvements were found as well in other studies on pain self-efficacy [8, 9], and anxiety [6, 8, 9, 11] and depressive symptoms [9, 11]. However, some studies found

no significant change with intervention for this latter outcome [6,7,8]. In the present study, depressive symptoms are the outcome for which there was the greatest variability in scores

across participants. Finally, for pain intensity, the absence of change we found was not surprising as pain reduction was not the primary objective of the PSMP. We nonetheless measured this

outcome because it is important for people living with SCI and some studies on pain management programs in this population showed reductions in pain intensity reaching or approaching

significance [6,7,8,9]. Long term effects of pain management programs are a crucial issue. In their study, Burns et al. [4] suggested to pursue interventions with a “periodic booster” after

the end of the intensive program to help maintain improvements, because their outcomes tended to return to baseline levels after the end of the program. For the same reason, Nicholson Perry

et al. [8] suggested to further insist on relapse prevention in such programs. Both booster interventions and relapse prevention were integrated within the PSMP. To our knowledge, our study

is the first to have included a consolidation phase comprising periodic booster interventions provided over an extended period of time. The only study we have found which offered some

intervention following its intensive phase provided a single comeback session three weeks after the end of a ten-week weekly intervention [5]. Our results indicate that the progressive

weaning of the intervention and the relapse prevention may have been effective, as outcomes continued to improve or at least were maintained during the consolidation phase in many cases.

This study had certain limitations. First, as we conducted a pilot study, our results are based on a small sample of individuals with SCI and pain who were their own controls. Although the

study design does not allow making generalizations, it permitted to detect variability in results within and between participants. Second, additional measurement points prior to the

beginning of the PSMP would have permitted to better characterize the baseline level and the normal degree of variability for each participant on each of the outcome measures. Moreover, some

data at baseline were missing. Results in those cases should be interpreted with caution. In conclusion, our results are in line with those of the few other existing studies that assessed

the effects of a multidisciplinary pain self-management program for persons living with SCI. Findings suggest that the pain self-management program could be effective in improving pain

interference in daily life, pain self-efficacy, as well as mood in people living with SCI and chronic pain. The fact that occupational performance, which was measured with a client-centered

instrument, was the sole outcome that further improved during the consolidation phase in a majority of participants, suggests that tailoring the program to the individual needs of each

participant is useful. Further research is needed to replicate these results in a larger study and comprehend the factors favoring or undermining improvements with such programs, as well as

their persistence over time. DATA AVAILABILITY The datasets generated and analyzed during the current study could be made available from the corresponding author on reasonable request.

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the pain self-management program studied (managers, professionals and users), as well as Chantal Dufour for her help with documentary research. FUNDING This work was supported by funds

granted to KPe by the _Fonds de recherche du Québec – Santé_, through her Junior 1 Research Scholar grant; and start-up funds from the _Centre interdisciplinaire de recherche en réadaptation

et intégration sociale_. AUTHOR INFORMATION AUTHORS AND AFFILIATIONS * Centre interdisciplinaire de recherche en réadaptation et intégration sociale, Centre intégré universitaire de santé

et de services sociaux de la Capitale-Nationale, Quebec city, Quebec, Canada Ketsia Proulx, Marie-Eve Lamontagne, René Quirion, Catherine Mercier & Kadija Perreault * Département de

réadaptation, Faculté de médecine, Université Laval, Quebec city, Quebec, Canada Marie-Eve Lamontagne, René Quirion, Catherine Mercier & Kadija Perreault * Institut de réadaptation en

déficience physique de Québec, Centre intégré universitaire de santé et de services sociaux de la Capitale-Nationale, Quebec city, Quebec, Canada René Quirion & Isabelle Deaudelin

Authors * Ketsia Proulx View author publications You can also search for this author inPubMed Google Scholar * Marie-Eve Lamontagne View author publications You can also search for this

author inPubMed Google Scholar * René Quirion View author publications You can also search for this author inPubMed Google Scholar * Isabelle Deaudelin View author publications You can also

search for this author inPubMed Google Scholar * Catherine Mercier View author publications You can also search for this author inPubMed Google Scholar * Kadija Perreault View author

publications You can also search for this author inPubMed Google Scholar CONTRIBUTIONS MEL and RQ initiated and designed the study. The protocol was drafted by MEL, RQ, ID, KPe, and CM. Data

were collected by RQ, ID and KPe. KPr and KPe analysed and interpreted the data. The manuscript was drafted by KPr and KPe. All authors critically revised the manuscript and they have

accepted responsibility for its entire content and approved its submission. CORRESPONDING AUTHOR Correspondence to Kadija Perreault. ETHICS DECLARATIONS COMPETING INTERESTS The authors

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permissions ABOUT THIS ARTICLE CITE THIS ARTICLE Proulx, K., Lamontagne, ME., Quirion, R. _et al._ A six-participant pilot single-subject study of an individualized pain management program

for people with spinal cord injury. _Spinal Cord Ser Cases_ 9, 2 (2023). https://doi.org/10.1038/s41394-022-00557-z Download citation * Received: 21 March 2022 * Revised: 18 December 2022 *

Accepted: 29 December 2022 * Published: 16 January 2023 * DOI: https://doi.org/10.1038/s41394-022-00557-z SHARE THIS ARTICLE Anyone you share the following link with will be able to read

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