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Trial registered on ANZCTR


Registration number
ACTRN12621000783820
Ethics application status
Approved
Date submitted
21/05/2020
Date registered
22/06/2021
Date last updated
3/11/2024
Date data sharing statement initially provided
22/06/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
Smartphone-based exercise intervention for chronic pain: a randomised clinical trial
Scientific title
Efficacy of a smartphone-based exercise therapy intervention on the level of pain, anxiety and depression, sleep and quality of life in patients with chronic pain: a randomised clinical trial
Secondary ID [1] 301283 0
None
Universal Trial Number (UTN)
Trial acronym
PainReApp (Pain Rehabilitation/Relief Application)
Linked study record

Health condition
Health condition(s) or problem(s) studied:
chronic pain 317460 0
chronic low back pain 317461 0
fibromyalgia 317462 0
diabetic neuropathic pain 317463 0
Condition category
Condition code
Musculoskeletal 315560 315560 0 0
Other muscular and skeletal disorders
Physical Medicine / Rehabilitation 315561 315561 0 0
Physiotherapy
Anaesthesiology 315562 315562 0 0
Pain management

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
PainReApp Group

Individuals of three different chronic pain conditions will be randomly selected: chronic low back pain, fibromyalgia and diabetic neuropathic pain.

The intervention group will complete a program of exercise guided by a m-health system for 24 weeks. Previously, their doctors determined whether patients would be able to exercise regularly.

A program of 60 min, 3 times per week, aimed to improve the general conditioning of the patients will be performed, following the recommendations of the American College of Sports Medicine for patients with chronic pain. The daily session will be divided into the warm-up, aerobic training, strengthening and calm down.

- Warm-up: It will consist of 5 min. walking in a way that allows the patient to have a conversation.
- Aerobic training: It will consist of 10 to 20 min. walking so the patient can have a conversation, but having to stop and breathe once in a while.
- Strengthening: It will be focused on 7 exercises. a) squats, b) stiff-legged deadlifts, c) lateral pull-down, d) reversed flies, e) flies, f) unilateral rows, and g) lateral raise.
- Calm down: It will consist of stretching exercises. a) shoulders, b) triceps, c) chest, d) quadriceps, e) hamstrings, and f) back.

Patients will have a first face-to-face session in which the use of the smartphone app and the conditioning program will be explained. This session will be performed in the Hospital Universitario Puerta del Mar (Cádiz, Spain). Strengthening exercises will be performed using an elastic band. During the first session, a physiotherapist will explain how to manage the elongation of the elastic band to increase or decrease the resistance intensity. The general recommendation will be 70-80% 1 repetition maximum that allows the patient to perform 8-10 repetitions. These home exercise sessions will be approximately 60 min. depending on the level of the patient. The PainReApp m-health system will provide videos and descriptions of exercises to be performed. The adherence to the intervention will be monitored through the PainReApp application.
Intervention code [1] 317589 0
Rehabilitation
Comparator / control treatment
Control group

Participants randomised from the three conditions (chronic low back pain, fibromyalgia and diabetic neuropathic pain) to the Control Group will receive the same intervention, but in paper format. Their doctors determined whether patients would be able to exercise regularly and they follow the same exercise program for 24 weeks.

This group also will receive a first face-to-face session in which the conditioning program will be explained by a professional physiotherapist. They will get a document with photos and descriptions about the exercises to be performed. The adherence to the intervention will be self-reported by patients when they will attend to the follow-up sessions.
Control group
Active

Outcomes
Primary outcome [1] 323892 0
Pain (Numeric Pain Rating Scale - NPRS)
Timepoint [1] 323892 0
Baseline, 4 weeks post-initiation of treatment, 12 weeks post-initiation of treatment (primary timepoint), and 24 weeks post-initiation of treatment.
Primary outcome [2] 323893 0
Quality of life (Health status questionnaire - SF-12v2)
Timepoint [2] 323893 0
Baseline, 4 weeks post-initiation of treatment, 12 weeks post-initiation of treatment (primary timepoint), and 24 weeks post-initiation of treatment.
Primary outcome [3] 323894 0
Adherence (PainReApp log registration and self-reported)
Timepoint [3] 323894 0
4 weeks post-initiation of treatment, 12 weeks post-initiation of treatment (primary timepoint), and 24 weeks post-initiation of treatment. The information of the PainReApp group will be registered by the system and the information of the Control Group will be asked during the assessment time points.
Secondary outcome [1] 383204 0
Use of alternative therapies, such as mindfulness, yoga, pilates, etc. (self-reported by patient)
Timepoint [1] 383204 0
Baseline, 4 weeks post-initiation of treatment, 12 weeks post-initiation of treatment, and 24 weeks post-initiation of treatment.
Secondary outcome [2] 383205 0
Height (standard height meter), weight, and body mass index (Tanita Model TBF-310 GS Weight Scale, Tanita Corporation of America, Inc., Arlington Heights, IL)
Timepoint [2] 383205 0
Baseline, 4 weeks post-initiation of treatment, 12 weeks post-initiation of treatment, and 24 weeks post-initiation of treatment.
Secondary outcome [3] 383206 0
Painkillers consumption (self-reported medication log)
Timepoint [3] 383206 0
Baseline, 4 weeks post-initiation of treatment, 12 weeks post-initiation of treatment, and 24 weeks post-initiation of treatment.
Secondary outcome [4] 383207 0
Depression and anxiety (Hospital Anxiety and Depression Scale - HADs)
Timepoint [4] 383207 0
Baseline, 4 weeks post-initiation of treatment, 12 weeks post-initiation of treatment, and 24 weeks post-initiation of treatment.
Secondary outcome [5] 383208 0
Social support (Duke Social Support Index (DSSI)
Timepoint [5] 383208 0
Baseline, 4 weeks post-initiation of treatment, 12 weeks post-initiation of treatment, and 24 weeks post-initiation of treatment.
Secondary outcome [6] 383209 0
Physical fitness (International Physical Activity Questionnaire - IPAQ)
Timepoint [6] 383209 0
Baseline, 4 weeks post-initiation of treatment, 12 weeks post-initiation of treatment, and 24 weeks post-initiation of treatment.
Secondary outcome [7] 383211 0
Sleeping disorders (Medical Outcomes Study - MOS)
Timepoint [7] 383211 0
Baseline, 4 weeks post-initiation of treatment, 12 weeks post-initiation of treatment, and 24 weeks post-initiation of treatment.
Secondary outcome [8] 383212 0
Upper limb strength (Arm curl test)
Timepoint [8] 383212 0
Baseline, 4 weeks post-initiation of treatment, 12 weeks post-initiation of treatment, and 24 weeks post-initiation of treatment.
Secondary outcome [9] 383213 0
Lower limb strength (Chair stand test)
Timepoint [9] 383213 0
Baseline, 4 weeks post-initiation of treatment, 12 weeks post-initiation of treatment, and 24 weeks post-initiation of treatment.
Secondary outcome [10] 383214 0
Functional capacity (Time Up and Go test - TUG)
Timepoint [10] 383214 0
Baseline, 4 weeks post-initiation of treatment, 12 weeks post-initiation of treatment, and 24 weeks post-initiation of treatment.
Secondary outcome [11] 383216 0
Exercise difficulty (Borg RPE)
Timepoint [11] 383216 0
Only PainReApp group: daily for the duration of the intervention.
Secondary outcome [12] 383217 0
Time of exercise execution (PainReApp system log)
Timepoint [12] 383217 0
Only PainReApp group: daily for the duration of the intervention.
Secondary outcome [13] 383218 0
PainReApp satisfaction (likert scale)
Timepoint [13] 383218 0
Only PainReApp group: Baseline, 4 weeks post-initiation of treatment, 12 weeks post-initiation of treatment, and 24 weeks post-initiation of treatment.

Eligibility
Key inclusion criteria
- Patients diagnosed with chronic low back pain, fibromyalgia or diabetic neuropathic pain.
- Over 18 years.
- Absence of cognitive and physical deficits that impede the physical exercise.
- Dispose of a smartphone with Internet access.
- Ability to understand and write Spanish.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Concomitant diseases that impede the physical exercise.
- Contraindications for physical exercise detected by the doctor.
- Participation in moderate-intensity activities (more than 30 minutes 3 times a week) at the time of the study beginning.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Central randomization by computer
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Through the Epidat 3.1 module of assignment of subjects to treatments, with groups of equal size, two lists (for each condition) of 50 random numbers between 1 and 100 will be obtained, without repetition. They will be used to determine in advance the group to which each patient will belong according to their order of arrival. In case of exceeding this initially estimated sample size, the randomisation process will continue to make use of the "balanced group" strategy, in which the probability of inclusion in each group will be inversely proportional to the number of subjects already in that group, so that, by probability, both groups will grow in a balanced way.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
A descriptive analysis of the data will be carried out, showing their distribution in terms of absolute frequencies (n) and relative frequencies (%) in the case of qualitative variables, and central tendency (mean) and dispersion (standard deviation) measures, in the case of quantitative variables. The normality of the distributions of the quantitative variables will be checked by means of the Kolmogorov-Smirnov test. Differences between groups (intervention vs. control) will be analysed by t-Student tests in case of normality, or Mann-Whitney U tests otherwise. Differences over time between groups will be analyzed by mixed ANOVA (with corrections such as Pillai's Trace, Roy's Largest Root, Greenhouse-Geiser or Lower Limit in case some assumption such as normality or equality of variances fails), where the intra-group factor will be the time and the inter-group factor will be the intervention group. In all cases, the confidence level will be set to 95%. To know the factors associated with the evolution of pain intensity and health-related quality of life, GEE models will be used, where the dependent variables will be the NPRS score and the SF-12 dimension score. In both cases, the independent variables will be the time itself, the intervention group, the scores of the HADs and MOS, the amount of exercise and the socio-demographic variables. The use of GEE models contemplates the case of missing values, due to the longitudinal nature of the measurement of these scales. Quasi-likelihood estimators will be used to estimate the model parameters. The structure of the correlation matrix will be defined according to the common structures and in accordance with the nature of the data (Independence, Interchangeable, Self-Regressive or No Structure). In addition, the model will be validated with the assumptions associated with the technique. The analyses will be carried out with the IBM SPSSv.24 statistical package.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
15/09/2021
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
300
Accrual to date
99
Final
Recruitment outside Australia
Country [1] 22566 0
Spain
State/province [1] 22566 0
Cádiz

Funding & Sponsors
Funding source category [1] 305728 0
Charities/Societies/Foundations
Name [1] 305728 0
Fundación Grünenthal España
Country [1] 305728 0
Spain
Funding source category [2] 305792 0
Charities/Societies/Foundations
Name [2] 305792 0
Instituto de investigación e innovación biomédica de Cádiz
Country [2] 305792 0
Spain
Primary sponsor type
Individual
Name
Jose A. Moral-Munoz
Address
Universidad de Cádiz
Facultad de Enfermería y Fisioterapia
Avda. Ana de Viya, 52
11009 Cádiz
Country
Spain
Secondary sponsor category [1] 306149 0
Individual
Name [1] 306149 0
Inmaculada Failde
Address [1] 306149 0
Universidad de Cádiz
Facultad de Enfermería y Fisioterapia
Avda. Ana de Viya, 52
11009 Cádiz
Country [1] 306149 0
Spain

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 306003 0
Comité de Ética de Investigación Provincial de Cádiz
Ethics committee address [1] 306003 0
Hospital Universitario Puerta del Mar
Avda. Ana de Viya, 52
11009 Cádiz
Ethics committee country [1] 306003 0
Spain
Date submitted for ethics approval [1] 306003 0
07/12/2018
Approval date [1] 306003 0
08/10/2019
Ethics approval number [1] 306003 0
SMART-PAIN-18

Summary
Brief summary
Chronic pain (CP) should be understood as a disease in itself, derived from changes in the Central Nervous System, and not as a symptom of another pathology. A multimodal intervention is needed that includes aspects such as physical exercise, diet, social and psychological support. There is evidence that physical exercise has benefits in reducing pain, physical limitations, disability and mental health. The implementation of m-Health technologies constitutes an alternative with proven effects in other patient groups, which improves the therapeutic adherence and autonomy of the patient. Because of this, the development and evaluation of the effectiveness of a m-Health system based on the physical exercise for application in patients with CP respond to a need.
Our hypothesis is that a m-health system based on physical exercise recommendations for patients with CP (low back pain, fibromyalgia and diabetic neuropathic pain) will improve pain intensity, presence of anxiety and/or depression, sleep quality and quality of life of this population. Therefore, this project aims to evaluate the effectiveness of a m-health system based on physical exercise recommendations for patients with CP based on its results on pain intensity, presence of anxiety and/or depression, sleep quality and quality of life. The achievement of the present project would serve to analyze the benefits of an exercise program in patients with CP and to identify those patients in whom the benefits would be greater and whose implementation would have greater priority. These results would be part of the future project to develop a multifactorial rehabilitation program based on the biopsychosocial model for patients with non-oncological CP.
Trial website
Trial related presentations / publications
Public notes
There was a misunderstanding and no patients were enrolled on the date registered (22/06/2021). The original recruitment date previously reported was 01/03/2021, but this date was set before the COVID-19 pandemic, and we made the mistake of not changing this date on the ANZCTR platform. The first participant was randomised on 15/09/2021 as we were waiting for confirmation of the clinical trial registration (22/06/2021) and we started before the summer holiday period (July-August) to ensure participation. Before 15/09/2021, we had pre-identified a number of patients (16) who could potentially participate in the trial from their medical records, but they were not enrolled after 15/09/2021.

Contacts
Principal investigator
Name 102382 0
Prof Jose A. Moral-Munoz
Address 102382 0
Universidad de Cádiz
Facultad de Enfermería y Fisioterapia
Avda. Ana de Viya, 52
11009 Cádiz
Country 102382 0
Spain
Phone 102382 0
+34 956 015699
Fax 102382 0
Email 102382 0
[email protected]
Contact person for public queries
Name 102383 0
Jose A. Moral-Munoz
Address 102383 0
Universidad de Cádiz
Facultad de Enfermería y Fisioterapia
Avda. Ana de Viya, 52
11009 Cádiz
Country 102383 0
Spain
Phone 102383 0
+34 956 015699
Fax 102383 0
Email 102383 0
[email protected]
Contact person for scientific queries
Name 102384 0
Jose A. Moral-Munoz
Address 102384 0
Universidad de Cádiz
Facultad de Enfermería y Fisioterapia
Avda. Ana de Viya, 52
11009 Cádiz
Country 102384 0
Spain
Phone 102384 0
+34 956 015699
Fax 102384 0
Email 102384 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
These data are considered as raw data, and we preserve patient's privacy.


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually

Documents added automatically
No additional documents have been identified.