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Combination therapies delivered remotely via the internet or mobile devices are increasingly being used to improve and promote the self-management of chronic conditions. However, little is known regarding the long-term effects of these interventions.
The aim of this study is to evaluate the effectiveness of a multimodal intervention program that measures associated variables such as catastrophizing, pain acceptance, and quality of life using a mobile device in people with chronic pain in an outpatient setting.
A randomized controlled clinical trial was performed using parallel treatment groups. A total of 209 patients with chronic musculoskeletal pain were randomly assigned to one of the two study arms. The intervention group received a standard
Positive effects were found in the intervention group (T2–T1) in catastrophizing between the baseline and posttreatment phases (
The results of our study suggest that app-based mobile multidimensional treatments for adults with chronic pain improve catastrophizing, quality of life, and psychological flexibility immediately after treatment and that the effects are maintained for the primary outcome of catastrophizing for at least 3 months following treatment. Moreover, they promote self-management and can be used to complement face-to-face pain treatments.
ClinicalTrials.gov NCT04509154; https://clinicaltrials.gov/ct2/show/NCT04509154
Pain is estimated to be among the top 10 conditions with the highest burden on health expenditure and health care resources and has a significant impact on patients’ quality of life [
There is a large body of research on multidisciplinary treatment programs for adults with chronic pain, including reviews of the clinical evidence, effectiveness of pain treatments, and cost-effectiveness of chronic pain programs in outpatient settings [
As chronic pain is a complex and multidimensional problem, it cannot be managed using medical therapies alone. Therefore, multidimensional treatments involving psychological therapies such as acceptance and commitment therapy (ACT), mindfulness, physical exercise, and health assets could play an important role in mitigating catastrophizing, improving pain acceptance, and reducing the use of psychotropic medications [
The available evidence supports the efficacy of several interventions for the self-management of chronic pain in outpatients. Some of the key components of these interventions are the administration of chronic pain medications according to the type of pain and patient comorbidities [
In addition to face-to-face interventions for chronic conditions, interventions are increasingly being delivered via mobile apps or the internet as these technologies have become an essential part of people’s daily lives and are always on call. In a systematic review of the use of information and communication technologies (ICTs) in chronically ill patients, 15.4% of the studies found that ICTs had a positive impact on patient empowerment or self-management, 14% showed an improvement in physical conditions and quality of life, and 5.1% reported greater self-efficacy for managing disease [
The aim of this study was to evaluate the effectiveness of a multimodal intervention program using a web-based smartphone or mobile device app. The app assesses pain perception by means of associated variables such as catastrophizing, pain acceptance, and quality of life in people with chronic pain.
The study was based on the hypothesis that participants assigned to the intervention group will exhibit less catastrophizing and emotional distress, more acceptance of pain, and improved ability to perform activities of daily living according to self-management values. Moreover, they will experience a better quality of life and fewer symptoms, pain intensity, anxiety, and depression. These outcomes will be measured after completion of the intervention period and at the 3-month follow-up and compared with a control group in line with the recommended outcomes in chronic pain research [
A randomized controlled clinical trial was performed using parallel treatment groups [
Flowchart of the recruitment process.
To develop the contents of the multimodal treatment for the mobile device app, a systematic literature review was carried out in a first phase following the Scottish Intercollegiate Guideline Network.
As part of a broader research program aimed at improving pain management, we first located articles that described the basic concepts of multi-professional treatments for chronic pain, provided recommendations, and included published evidence for the selected topics of interest. The purpose was to identify the characteristics of pharmacological and nonpharmacological interventions for people affected by chronic pain in different settings by means of a bibliographic search and reading of the literature, a synthesis of the results, and an assessment of the evidence. In the second part of our study, a participatory approach was used to prioritize self-management recommendations for chronic pain selected from the reviewed literature. Specifically, we designed a multimodal intervention protocol combining physical exercise, psychoeducational therapy, health assets, and pharmacological treatment that was delivered using a mobile device. The effectiveness of the intervention was subsequently evaluated by means of a clinical trial [
The interventions delivered in the mobile app include ACT and mindfulness exercises to promote greater pain acceptance, reduce the aversive component associated with pain, and help patients dispassionately recognize and observe both pain and related thoughts and emotions. Another group of activities aims to raise awareness of an individual’s own values through a series of activities to recover a meaningful life project [
Our research team developed an app called NO+Dolor (NO+Pain) that contains an Android or iOS user interface. The app includes links to several multimedia resources (mainly audios and videos) and was designed based on game dynamics (gamification) to improve users’ concentration, attention, and motivation. Indications on how to use the app and correctly perform the measures are provided in the instructions section of the app. Regarding the technical characteristics of the app, the information technology part required the design of a relational database implemented using MySQL Community Server 5.6. On the server side, a Java 1.8 communications application programming interface was implemented with representational state transfer architecture between the patients’ mobile apps and the database using a client-server pattern. On the client side, hybrid mobile apps were implemented for Android and iOS operating systems. Apache Cordova 9.0 and jQuery Mobile 1.4.5 frameworks were integrated into the app, and HTML5 and CSS3 technologies were used for the presentation layer [
The study population comprised residents of municipalities belonging to the Cordoba South Health District of the Andalusian Health Service, Spain, who were registered in the health service user database. Patients were recruited from each of the district’s 11 primary care centers by two collaborators: a nurse and a physician with experience in the follow-up of patients with chronic pain.
The sample was drawn from a database using Diraya electronic medical records. The inclusion criterion was being attended by primary care physicians and nurses. The database search was carried out on June 30, 2019, and identified 297 patients diagnosed with chronic musculoskeletal pain, of which 205 (69%) were women and 92 (31%) were men. Accepting an
All participants were under pharmacological treatment for chronic musculoskeletal pain (analgesics, anti-inflammatory drugs, antidepressants, anticonvulsants, or opioids) as previously indicated by their primary care physician and were asked to sign an informed consent form. The inclusion and exclusion criteria for the participants in the study are presented in
Patients aged ≥18 years with pain in any location
Pain with a duration of ≥3 months
Pain with an intensity of ≥4 on the Visual Numerical Scale
Presenting one of the following characteristics: continuous pain or intermittent pain ≥5 days a week
Able to use a smartphone
Not participating in another research project
Cancer-related or postsurgical pain, patients with palliative care, and pediatric population
Patients with acute pain (duration <3 months)
History of brain injury
Inability to complete the study forms because of mental disability or language barrier
This study was approved by the Cordoba Research Ethics Committee of the Andalusian Public Health System (CIF G-14825277; protocol code PI-0447-2017). Informed consent was approved by the Cordoba Research Ethics Committee and completed by the participants. This study is registered at ClinicalTrials.gov (NCT04509154).
Block randomization with a block size of 4 was used. The only stratification criterion was the reference health center of the patients. An automated recruitment form hosted on the REDCap (Research Electronic Data Capture; Vanderbilt University) platform of the Maimonides Biomedical Research Institute of Cordoba was used to randomize the patients by simply clicking a button. The data were transferred and recorded in an electronic notebook using the Data Entry Manager system. The statistician (Ipek Guler Caamaño and Juan Antonio Marín Sanz), principal investigator (YM-M), and coinvestigators (AJS-G, SC-F, and MIB-P) of the study who evaluated the results were not involved in patient recruitment and were blinded to the group assignment. A total of 22 recruiters from the 11 primary care health centers of the Cordoba South Health District recruited the patients in 2019. They were also responsible for randomizing the patients (by clicking a button on the automated recruitment form) and were not blinded.
All patients received a written invitation from their primary care physician or nurse to participate in the study. Two 8-hour face-to-face sessions were held at their reference health center led by a nurse and a primary care physician with experience in the follow-up of patients with chronic pain. At the group meeting, patients who agreed to participate voluntarily in the study were informed that they would receive instructions by email on how to download the mobile app with the treatment contents. The patients were also informed that, if they were selected to participate in the intervention group, the treatment would last from 6 to 8 weeks. The control group would only have access to the
The intervention group received the treatment via their smartphones for a period of 6 weeks after completing both face-to-face sessions. Pain intensity was measured daily on an 11-point numerical rating scale when the participants accessed the app.
To assess the treatments, self-reported questionnaires were sent to the participants by email and collected at three time points: upon admission to the program (T1), at week 6 of the intervention (T2), and at 3 months after the intervention (T3). The participants completed all 3 questionnaires at home and returned them by email.
The intervention consisted of the implementation of a program of standard, interactive psychosocial therapy activities. The pain management app enables automatic monitoring, skill training, social support, education, goal setting, and achievement of four components: psychological wellness, exercise, pharmacological treatment, and health assets. Each week, the participants received 3 activities for each of the aforementioned components via the NO+Dolor app until completing the 6 weeks of treatment. All the activities were designed to be performed weekly except for the walking challenge, which was performed daily. The first time the participants completed an activity, they were awarded a star. The participants could perform the proposed activity as many times as they liked, but no more rewards were given until the following week. The more activities they completed, the more stars they were awarded, and the higher the percentage of goals reached by the patients each week (
The Spanish adaptation [
The Spanish adaptation [
The Spanish adaptation of the EQ-5D [
A descriptive analysis was performed for the quantitative variables with mean and SD and for the qualitative variables with recounts (n) and proportions (%). Goodness-of-fit to a normal distribution was determined using the Shapiro-Wilk test, and homogeneity of variance was assessed using the Levene test. The quantitative variables of the treatment and control groups were compared using the Mann-Whitney
A linear mixed effects model [
A total of 297 participants (n=205, 69% women and n=92, 31% men) were initially invited to participate in the study. Of these 297 participants, 1 (0.3%) was excluded for not meeting the inclusion criteria, 67 (22.6%) were excluded because they did not attend the meeting, and 20 (6.7%) were excluded because they declined to participate. A total of 209 participants were randomized into 1 of the 2 study arms. After randomization, 2.4% (5/209) of the participants were excluded because they declined to participate, dropped out before the intervention, or did not know how to use the technologies. In the intervention group, 15% (15/98) of the patients did not complete the intervention. The analysis was performed on patients who completed all 3 questionnaires at baseline, upon completion of the intervention, and 3 months after the intervention (
Characteristics of the sample (N=194).
Characteristic | Intervention group (n=98) | Control group (n=96) | ||||||
Age (years), mean (SD) | 51.2 (11.2) | 50.3 (10.2) | .99a | |||||
|
.99 | |||||||
|
Female | 78 (80) | 77 (80) |
|
||||
|
Male | 20 (20) | 19 (20) |
|
||||
|
.59 | |||||||
|
Married | 81 (83) | 78 (81) |
|
||||
|
Divorced | 6 (6) | 8 (8) |
|
||||
|
Single | 6 (6) | 6 (6) |
|
||||
|
Widowed | 2 (2) | 4 (4) |
|
||||
|
.27 | |||||||
|
Unemployed | 17 (17) | 15 (16) |
|
||||
|
Employed full-time | 27 (28) | 29 (30) |
|
||||
|
Employed part-time | 13 (13) | 3 (3) |
|
||||
|
Disability | 11 (11) | 12 (13) |
|
||||
|
Home care | 22 (22) | 28 (29) |
|
||||
|
Other combination of the aforementioned characteristics or unknown | 8 (8) | 9 (9) |
|
||||
|
.16 | |||||||
|
No schooling | 13 (13) | 7 (7) |
|
||||
|
8 to 10 years (elementary) | 41 (42) | 54 (56) |
|
||||
|
10 to 12 years (high school) | 36 (37) | 26 (27) |
|
||||
|
>12 years (higher education) | 8 (8) | 9 (9) |
|
||||
|
.68 | |||||||
|
Yes | 96 (98) | 92 (96) |
|
||||
|
No | 2 (2) | 4 (4) |
|
||||
|
.45 | |||||||
|
<10,000 (10,857) | 11 (11) | 12 (26) |
|
||||
|
10,000 to 20,000 (10,857 to 21,714) | 73 (74) | 74 (77) |
|
||||
|
>20,000 (21,714) | 14 (14) | 10 (5) |
|
||||
|
56 (100) | 53 (100) | .34 | |||||
|
Moderate pain | 34 (61) | 27 (51) |
|
||||
|
Extreme pain | 22 (39) | 26 (49) |
|
||||
|
56 (100) | 52 (100) | .90 | |||||
|
I am not anxious or depressed | 13 (23) | 13 (25) |
|
||||
|
I am moderately anxious or depressed | 32 (57) | 30 (58) |
|
||||
|
I am extremely anxious or depressed | 11 (20) | 9 (17) |
|
||||
PCSb, mean (SD) | 29.86 (13.27)c | 27.7 (12.77)d | .20 | |||||
CPAQe, mean (SD) | 64.16 (18.89)d | 66.77 (18.4)f | .07 | |||||
EQ-5Dg, mean (SD) | 0.45 (0.19)h | 0.43 (0.21)i | .26 | |||||
EQ-VASj, mean (SD) | 48.22 (18.74)k | 44.23 (23.49)l | .16 |
an=194.
bPCS: Pain Catastrophizing Scale (score 0-52).
cn=55.
dn=54.
eCPAQ: Chronic Pain Acceptance Questionnaire (score 0-120).
fn=52.
gEQ-5D score −0.654 to 1.
hn=53.
in=51.
jEQ-VAS: EuroQol Visual Analogue Scale (0-100).
kn=50.
ln=47.
The descriptive results for the differences between the control and intervention groups regarding measures of catastrophizing at baseline, upon completion of the treatment, and during follow-up are presented in
Median, mean, SD, and differences between groups for the primary outcome measure at admission to the program (T1), immediately after treatment (T2), and at the 3-month follow-up (T3) for completers.
Primary outcome measure (scale) | T1a | T2a | T3a | |||||||||||||||
|
Median (IQR) | Mean (SD) | Median (IQR) | Mean (SD) | Median (IQR) | Mean (SD) | ||||||||||||
|
.20 |
|
|
.001 |
|
|
.09 | |||||||||||
|
Control | 26.5 (17.25-38.5) | 27.7 (12.77)c |
|
32.5 (23.75-42.0) | 31.82 (12.06)d |
|
31.0 (22.5-43.0) | 31.41 (12.61)e |
|
||||||||
|
Intervention | 29.0 (22.0-39.0) | 29.86 (13.27)f |
|
19.5 (14.25-28.25) | 20.86 (11.25)g |
|
27.0 (17.0-35.0) | 25.78 (14.12)h |
|
||||||||
|
.31 |
|
|
.001 |
|
|
.07 | |||||||||||
|
Control | 12.5 (8.0-16.25) | 12.48 (5.8)i |
|
14.0 (10.5-19.0) | 14.22 (5.82)e |
|
14.0 (9.75-18.75) | 13.65 (5.75)j |
|
||||||||
|
Intervention | 14.0 (8.25-18.0) | 13.09 (6.45)c |
|
8.5 (5.25-12.0) | 8.91 (5.38)g |
|
10.0 (6.0-17.0) | 11.09 (6.48)g |
|
||||||||
|
.14 |
|
|
.004 |
|
|
.12 | |||||||||||
|
Control | 10.0 (6.0-12.0) | 9.19 (4.16)k |
|
7.0 (4.0-8.25) | 6.32 (2.99)d |
|
6.0 (4.0-9.0) | 6.28 (2.84)l |
|
||||||||
|
Intervention | 10.0 (7.5-14.0) | 10.11 (4.11)m |
|
4.0 (2.0-5.0) | 4.05 (2.4)n |
|
5.0 (3.0-7.0) | 5.24 (3.16)n |
|
||||||||
|
.20 |
|
|
.007 |
|
|
.12 | |||||||||||
|
Control | 6.5 (4.0-8.75) | 6.57 (3.17)c |
|
13.0 (8.75-14.25) | 11.29 (4.28)d |
|
12.0 (7.5-15.5) | 11.33 (4.56)e |
|
||||||||
|
Intervention | 7.0 (4.25-9.75) | 7.06 (3.22)c |
|
8.0 (6.0-12.0) | 8.29 (4.14)n |
|
10.5 (5.75-12.0) | 9.55 (5.04)g |
|
aAt admission to the program (T1), at the end of the intervention at 6 weeks (T2), and at the 3-month follow-up (T3).
bPCS: Pain Catastrophizing Scale.
cn=54.
dn=28.
en=27.
fn=56.
gn=22.
hn=23.
in=52.
jn=26.
kn=53.
ln=25.
mn=55.
nn=21.
Between-group differences and changes over time for the primary outcome measure and Pain Catastrophizing Scale (PCS) subscales.
Primary outcome measure (scale) | T2–T1a | T3–T2a | T3–T1a | ||||||||||||||||||||||||
|
Median (IQR) | Mean (SD) | Median (IQR) | Mean (SD) | Median (IQR) | Mean (SD) | |||||||||||||||||||||
|
<.001 |
|
|
.24 |
|
|
.006 | ||||||||||||||||||||
|
Control | 0.05 (−0.11 to 0.73) | 0.29 (1.0)b |
|
−0.03 (−0.19 to 0.21) | −0.07 (0.32)c |
|
0.1 (−0.14 to 0.36) | 0.21 (1.13)d |
|
|||||||||||||||||
|
Intervention | −0.5 (−1.0 to −0.14) | −0.67 (0.72)e |
|
0.0 (−0.27 to 0.58) | 0.02 (0.65)f |
|
−0.15 (−1.0 to 0.08) | −0.59 (0.91)e |
|
|||||||||||||||||
|
.002 |
|
|
.21 |
|
|
.007 | ||||||||||||||||||||
|
Control | 0.0 (−0.23 to 0.4) | 0.1 (0.84)g |
|
−0.07 (−0.41 to 0.04) | −0.11 (0.33)h |
|
0.0 (−0.32 to 0.48) | 0.01 (0.88)i |
|
|||||||||||||||||
|
Intervention | −0.79 (−1.14 to −0.07) | −0.72 (0.78)j |
|
0.0 (−0.35 to 0.44) | 0.11 (0.8)f |
|
−0.33 (−1.06 to −0.08) | −0.65 (0.92)j |
|
|||||||||||||||||
|
<.001 |
|
|
.48 |
|
|
.049 | ||||||||||||||||||||
|
Control | −0.58 (−0.83 to 0.0) | −0.53 (0.89)k |
|
0.0 (0.0 to 0.39) | 0.29 (0.86)h |
|
−0.71 (−1.0 to −0.26) | −0.59 (0.96)i |
|
|||||||||||||||||
|
Intervention | −1.42 (−2.27 to −0.79) | −1.59 (0.95)l |
|
0.0 (0.0 to 0.57) | 0.22 (0.55)h |
|
−0.85 (−1.82 to −0.58) | −1.23 (0.84)l |
|
|||||||||||||||||
|
.14 |
|
|
.41 |
|
|
.03 | ||||||||||||||||||||
|
Control | 0.56 (0.32 to 0.97) | 0.77 (1.0)b |
|
0.12 (−0.14 to 0.22) | −0.02 (0.48)c |
|
0.68 (0.49 to 1.25) | 0.86 (1.02)d |
|
|||||||||||||||||
|
Intervention | 0.42 (0.29 to 0.66) | 0.2 (1.02)l |
|
0.0 (−0.13 to 0.46) | −0.03 (0.83)f |
|
0.58 (−0.43 to 0.68) | 0.1 (1.16)j |
|
aAt admission to the program (T1), at the end of the intervention at 6 weeks (T2), and at the 3-month follow-up (T3).
bn=26.
cn=16.
dn=27.
en=21.
fn=17.
gn=23.
hn=15.
in=24.
jn=20.
kn=25.
ln=19.
Immediately following the treatment (T2), statistically significant improvements were observed in the intervention group for catastrophizing (20.86 vs 31.82;
Positive effects were observed at the different treatment times according to the percentage change rescaled by log base 2. Specifically, positive effects were found for the intervention group (T2–T1) in catastrophizing between the baseline and posttreatment phases (
We also measured changes in the pain questionnaire scores between the control and treatment groups at the 3 time points by applying a linear mixed effects model. Statistical differences were found only between the 2 groups for changes in the PCS score over time. In addition, the interaction effect between time and the intervention group was −6.47 (
Changes between groups in Pain Catastrophizing Scale scores over time.
Coefficient | Values, mean (SD) | |
Intercept | 25.747 (2.572) | <.001 |
Time | 2.479 (1.336) | .07 |
Intervention (reference: control) | 7.528 (3.669) | .04 |
Timea intervention (reference: time control) | −6.476 (1.991) | .001 |
aPain Catastrophizing Scale scores over time in the intervention group compared with the control group.
Mean and SD for the secondary outcomes at admission (T1), immediately after treatment (T2), and 3 months after the intervention period (T3) for completers.
Secondary outcome measure (scale) | T1a | T2a | T3a | ||||||||||||||
|
Median (IQR) | Mean (SD) | Median (IQR) | Mean (SD) | Median (IQR) | Mean (SD) | |||||||||||
|
.07 |
|
|
.14 |
|
|
.47 | ||||||||||
|
Control | 68.0 (58.0-78.0) | 66.77 (18.4)c |
|
65.5 (52.75-72.5) | 63.82 (12.47)d |
|
65.0 (54.5-71.5) | 65.67 (16.06)e |
|
|||||||
|
Intervention | 63.0 (53.75-71.0) | 64.16 (18.89)f |
|
67.0 (59.0-78.0) | 68.23 (14.43)g |
|
62.0 (54.5-73.0) | 64.48 (21.76)h |
|
|||||||
|
.27 |
|
|
.008 |
|
|
.30 | ||||||||||
|
Control | 0.46 (0.22-0.59) | 0.43 (0.21)c |
|
0.36 (0.22-0.56) | 0.41 (0.22)d |
|
0.37 (0.22-0.52) | 0.39 (0.19)e |
|
|||||||
|
Intervention | 0.48 (0.23-0.59) | 0.45 (0.19)f |
|
0.56 (0.47-0.72) | 0.55 (0.17)g |
|
0.41 (0.22-0.59) | 0.43 (0.2)h |
|
|||||||
|
.16 |
|
|
.02 |
|
|
.03 | ||||||||||
|
Control | 44.0 (21.5-54.0) | 44.23 (23.49)j |
|
35.0 (25.25-56.0) | 38.68 (19.58)g |
|
30.0 (25.0-51.0) | 36.96 (20.15) |
|
|||||||
|
Intervention | 47.0 (33.5-60.0) | 48.22 (18.74)k |
|
53.0 (38.0-66.0) | 52.68 (18.27)l |
|
50.0 (31.5-75.0) | 51.05 (25.73)l |
|
aAt admission to the program (T1), at the end of the intervention at 6 to 7 weeks (T2), and at the 3-month follow-up (T3).
bCPAQ: Chronic Pain Acceptance Questionnaire.
cn=53.
dn=28.
en=27.
fn=56.
gn=22.
hn=23.
iEQ-VAS: EuroQol Visual Analogue Scale.
jn=47.
kn=50.
ln=19.
Within-group differences and variations over time for the secondary outcomes.
Secondary outcome measure (scale) | T2–T1a | T3–T2a | T3–T1a | |||||||||||||||
|
Median (IQR) | Mean (SD) | Median (IQR) | Mean (SD) | Median (IQR) | Mean (SD) | ||||||||||||
|
.001 |
|
|
.14 |
|
|
.30 | |||||||||||
|
Control | −0.16 (−0.27 to 0.1) | 0.05 (0.9)c |
|
0.02 (−0.12 to 0.25) | 0.08 (0.28)d |
|
−0.08 (−0.24 to 0.09) | 0.12 (0.92)e |
|
||||||||
|
Intervention | 0.22 (0.05 to 0.39) | 0.38 (0.86)f |
|
−0.1 (−0.24 to 0.16) | −0.22 (0.95)g |
|
0.0 (−0.18 to 0.25) | −0.1 (0.86)f |
|
||||||||
|
.002 |
|
|
.17 |
|
|
.48 | |||||||||||
|
Control | −0.12 (−0.53 to 0.08) | −0.1 (0.69)c |
|
0.0 (−0.03 to 0.22) | 0.04 (0.34)d |
|
0.0 (−0.4 to 0.45) | 0.12 (0.69)e |
|
||||||||
|
Intervention | 0.31 (0.0 to 0.92) | 0.43 (0.66)f |
|
0.0 (−0.31 to 0.13) | −0.09 (0.61)g |
|
0.0 (−0.1 to 0.35) | 0.08 (0.75)f |
|
||||||||
|
.13 |
|
|
.49 |
|
|
.34 | |||||||||||
|
Control | 0.14 (−0.77 to 0.49) | −0.27 (1.0) |
|
−0.05 (−0.28 to 0.17) | −0.08 (0.31) |
|
0.18 (−0.34 to 0.83) | 0.18 (1.22)i |
|
||||||||
|
Intervention | 0.28 (−0.12 to 0.42) | 0.25 (0.52) |
|
−0.14 (−0.37 to 0.24) | −0.05 (0.4) |
|
0.33 (−0.26 to 0.95) | 0.18 (0.93)d |
|
aAt admission to the program (T1), at the end of the intervention at 6 weeks (T2), and at the 3-month follow-up (T3).
bCPAQ: Chronic Pain Acceptance Questionnaire.
cn=26.
dn=16.
en=27.
fn=21.
gn=17.
hEQ-VAS: EuroQol Visual Analogue Scale.
in=24.
With regard to pain acceptance (CPAQ), no significant differences were found between the 2 groups after treatment (68.23 vs 63.82;
In terms of quality of life (EQ-5D), the intervention group showed significant improvement at the end of treatment (0.55 vs 0.41;
The assessment of overall health state (EQ-VAS) registered in the daily records showed significant improvements in the intervention group compared with the control group (52.68 vs 38.68;
Regarding variations between the different phases, a positive effect was observed immediately following the intervention (T2–T1) in both acceptance (0.38 vs 0.05;
No significant differences were found during follow-up for CPAQ (T3–T2: −0.22 vs 0.08 and
Proportion of patients to the EQ-5D subscale per time and group at admission (T1), immediately after treatment (T2), and 3 months after the intervention period (T3).
EQ-5D secondary outcome measure | T1 | T2 | T3 | |||||||||||||||
|
Intervention, n (%) | Control, n (%) | Overall |
Intervention, n (%) | Control, n (%) | Overall |
Intervention, n (%) | Control, n (%) | Overall |
|||||||||
|
.34 |
|
|
.004 |
|
|
.08 | |||||||||||
|
Moderate pain (VASa=4-7) | 34 (61) | 27 (51) |
|
16 (37) | 10 (78) |
|
13 (34) | 9 (53) |
|
||||||||
|
A lot of pain (VAS≥8) | 22 (39) | 26 (49) |
|
2 (23) | 17 (64) |
|
10 (46) | 17 (67) |
|
||||||||
|
.90 |
|
|
.27 |
|
|
.12 | |||||||||||
|
I am not anxious or depressed | 13 (23) | 13 (25) |
|
7 (32) | 8 (29) |
|
3 (13) | 8 (30) |
|
||||||||
|
I am moderately anxious or depressed | 32 (57) | 30 (58) |
|
13 (59) | 12 (43) |
|
16 (67) | 14 (52) |
|
||||||||
|
I am very anxious or depressed | 11 (20) | 9 (17) |
|
1 (9) | 7 (29) |
|
4 (21) | 4 (19) |
|
||||||||
|
.14 |
|
|
.04 |
|
|
.07 | |||||||||||
|
I have no problem walking | 9 (41) | 10 (36) |
|
12 (21) | 13 (25) |
|
7 (29) | 8 (30) |
|
||||||||
|
I have some trouble walking | 43 (77) | 39 (74) |
|
13 (59) | 18 (64) |
|
16 (67) | 19 (70) |
|
||||||||
|
I have to be in bed | 1 (2) | 1 (2) |
|
N/Ab | N/A |
|
1 (4) | N/A |
|
||||||||
|
.92 |
|
|
.77 |
|
|
.63 | |||||||||||
|
I have no problems with self-care | 33 (60) | 31 (59) |
|
14 (65) | 15 (56) |
|
12 (50) | 13 (50) |
|
||||||||
|
I have some problems washing or dressing | 22 (40) | 21 (40) |
|
8 (36) | 12 (44) |
|
12 (50) | 14 (50) |
|
||||||||
|
I am unable to wash or dress | N/A | 1 (2) |
|
N/A | N/A |
|
N/A | N/A |
|
||||||||
|
.14 |
|
|
.045 |
|
|
.86 | |||||||||||
|
I have no problem performing my daily activities | 5 (9) | 9 (17) |
|
5 (24) | 4 (14) |
|
2 (8) | 1 (4) |
|
||||||||
|
I have some trouble performing my daily activities | 49 (88) | 38 (72) |
|
16 (76) | 20 (71) |
|
20 (83) | 23 (85) |
|
||||||||
|
I am unable to perform my daily activities | 2 (4) | 6 (11) |
|
N/A | 4 (14) |
|
2 (8) | 3 (11) |
|
aVAS: Visual Analogue Scale.
bN/A: not applicable.
We performed a small randomized controlled clinical trial with a sample of mostly women (205/297, 69%). Randomization of both the sociodemographic characteristics of the study population and the study variables was homogeneous.
The results of the study clearly show that the main variable, catastrophizing, had a significant positive effect on the intervention group compared with the control group after the intervention and at the 3-month follow-up. This could be due to changes in cognition or maladaptive behavior that modified erroneous beliefs and decreased catastrophic thoughts. It should be noted that previous research has considered the beneficial effect of multimodal treatments in decreasing catastrophizing and fear. Thus, these results are in accordance with the more pronounced effect found in the intervention group [
These results are also in line with the findings of studies on the effects of monotherapies using ACT [
The analysis showed that the intervention group improved in both perceived quality of life and pain acceptance after treatment. This finding indicates that patients who accept pain better exhibit greater psychological flexibility (ie, less activity avoidance), less psychological distress, and less disability. Moreover, we found that patients with higher pain acceptance (psychological flexibility;
However, the results were inconclusive for these last 2 variables. Specifically, although the effect sizes of quality of life and pain acceptance were significant from before treatment to after treatment in the intervention group, no changes were observed 3 months after the treatment. This lack of significance may be explained by the fact that perceived quality of life is a multidimensional phenomenon, and some indicators may therefore have had a greater influence on this variable, such as the low educational level and low annual income of the sample. These results are consistent with those of other studies suggesting that low educational level and low income are associated with poorer perceived health [
With regard to the main aim of this work, we hypothesized that the participants assigned to the intervention group would experience fewer catastrophizing thoughts and emotional distress and more acceptance of pain and improve their ability to perform activities of daily living according to self-management values. The results are encouraging as the effects of the treatment were largely maintained over time and reduced catastrophizing and the three dimensions of the PCS (helplessness, rumination, and magnification). This may suggest that a combination of these interventions promotes skills that result in behavior changes, at least in the medium term.
A priori, this relationship could be explained by the additive effect of the combined components of psychoeducational therapy, exercise, pharmacological treatment, and health assets. It may also be explained by the fear avoidance model in that exercise contributes to the reconceptualization of pain and reduces catastrophic thinking and the threat value of pain related to functional limitations [
Physical activity likely helped the participants in our study learn about activities such as daily walking and low-intensity stretching to improve their physical, mental, and emotional well-being as well as acquire new habits and find alternatives to improve their quality of life [
ACT and mindfulness were also a treatment goal in our study [
Pain catastrophizing has been identified as a psychosocial factor that predicts adaptation to chronic pain and may contribute to its development and chronicity. In this regard, several studies [
However, another explanation for the effect of our multimodal treatment may be related to patient-treatment matching. Specifically, broader-spectrum multimodal treatments have a greater likelihood of matching at least one treatment component to a patient’s strength or deficit [
The overall health state self-reported by the intervention group improved after the intervention, although this effect was not maintained over time. This may be explained by the fact that the participants perceived an improvement in their health state when performing the proposed weekly activities during the treatment period because of the effort and time invested, which is known as the Hawthorne phenomenon [
Moreover, the descriptive analysis of the EQ-5D dimensions showed improvement in at least three of the five core outcome domains (pain intensity, mobility, and activities of daily living) compared with the control group. This finding corroborates the influence of attitudes and beliefs that may affect the development of passive coping mechanisms such as rest and medication versus the ability to adopt active strategies such as physical activity and pain acceptance [
This study has several strengths. First, we developed a multimodal program involving a variety of therapeutic activities that could be standardized and used in the future for other patients with chronic pain. An encouraging finding in this line was that the benefits of the treatment were largely maintained at follow-up, which may suggest that these interventions lead to the acquisition of skills that result in behavior change, at least in the medium term. Second, ICTs were used in combination with pharmacological and nonpharmacological therapeutic treatments in the outpatient setting to evaluate their impact on pain catastrophizing, pain acceptance, and quality of life. Third, the fact that the patients did the programmed activities in their natural environment is likely to promote self-efficacy, thus supporting the importance of the self-management component in interventions of this type [
One of the most important limitations of our study was the low response rate of the self-reported questionnaires sent via email. It should also be noted that the sample size was small. This may have affected the outcomes of the intervention and could explain the significant differences found between the groups. However, we cannot rule out the beneficial effect of the treatment on catastrophizing in the intervention group as a good prognosis of the disease and that, in the long term, these interventions (physical activity, psychoeducational therapies, pharmacological therapies, and health assets) are part of multi-professional treatments to achieve the desired effects. Nevertheless, as we used a multimodal therapy, we cannot really know the effect of each individual intervention on the outcomes, and more studies will be needed to determine the effects of specific interventions in patients with chronic pain. Therefore, caution must be exercised when extrapolating our findings to the general population.
With regard to treatment adherence [
According to our results and the available evidence, pharmacological treatments are most effective when they are part of an overall multidisciplinary pain management plan that also incorporates psychological, physical, and preventive components [
A large number of studies have been conducted on ICT-based interventions to promote self-management in people with chronic pain [
In future research, more attention should also be paid to the participants’ gender as this could have affected our findings. It is well-known that gender is strongly related to access to care and treatment response and that, although many patients who experience pain are women, many stigmas are associated with pain in men. Therefore, it is important that we gain a better understanding of the role of gender in health care access as well as gender biases in diagnoses, patient-professional interactions, and treatment.
Further lines of research could improve the efficacy of multimodal chronic pain interventions based on new technologies, such as the refinement of treatments, the identification of moderating factors that might influence psychosocial variables, and their association with treatment adherence. To evaluate which groups of patients are more competent to self-manage a technology-based multimodal intervention would have been ideal. In the same vein, it is also worth mentioning that, in our study, we did not specifically assess satisfaction in relation to the use of technologies, and this could be a promising line for future research.
In future research, it might be interesting to analyze data not included in this study, such as mobile sensor data using accelerometers, gyrometers, and other sensors to monitor engagement and assess the timing of the activities.
The results of our study suggest that multidimensional treatments for adults with chronic pain improve catastrophizing, quality of life, and psychological flexibility immediately after treatment and that the effects are maintained for the primary outcome of catastrophizing for at least 3 months following treatment. This study has also shown that nonpharmacological treatments that include physical and psychoeducational therapy to promote active participation work well in combination with pharmacological strategies and that such interventions improve self-reliance in patients with chronic pain and help them cope constructively with pain.
The NO+Dolor app we have developed uses gamification to teach patients distraction methods and divert their attention away from pain as well as mindfulness techniques to improve pain acceptance. It also provides patients with a well-paced program of exercises and information on the proper use of medications to avoid side effects and helps them identify health assets to engage in pleasurable activities or find the resources they need. Moreover, the app-based mobile interventions we have presented here are flexible and self-directed, promote self-management in patients with chronic pain, and can be used to complement face-to-face pain treatments.
Preventive interventions for people with chronic pain designed from a salutogenic approach, are essential to promote well-being and prevent further decline in health throughout life.
Key contents of the intervention.
CONSORT-eHEALTH checklist (V 1.6.1).
acceptance and commitment therapy
Chronic Pain Acceptance Questionnaire
EuroQol Visual Analogue Scale
information and communication technology
Pain Catastrophizing Scale
Research Electronic Data Capture
The authors would like to thank all the patients who selflessly collaborated in this study and the professionals who participated in the creation of the audiovisual materials as this work would not have been possible without them. This study was funded by the Regional Ministry of Health by Resolution of May 18, 2017, of the General Secretariat for Biomedical Research, Development, and Innovation and in Health Sciences of Andalusia with the collaboration of the Biomedical Research Foundation of Cordoba. The study has the authorization of the corresponding Research Ethics Committee and complies with the current law on data protection (promoter: Biomedical Research Foundation of Cordoba; protocol code: PI-0447-2017; study code: S0452). This study was conducted according to the guidelines of the Declaration of Helsinki and was approved by the Ethics Committee of the Foundation for Biomedical Research of Cordoba, Andalusia, Spain (CIF G-14825277; protocol code PI-0447-2017, resolution December 22, 2017, and published in the official bulletin of the Junta de Andalusia, Spain, October 5, 2018). Informed consent was obtained from all participants involved in the study. Written informed consent was obtained from the patients to publish this paper.
The data supporting the reported results can be found in the electronic notebook of the Data Entry Manager of the Maimonides Biomedical Research Institute of Cordoba. The statistician, principal investigator, and collaborators who evaluated the results did not participate in patient recruitment.
None declared.