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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
16/06/2023
Date data sharing statement initially provided
22/06/2021
Type of registration
Retrospectively registered
Titles & IDs
Public title
Smartphone-based exercise intervention for chronic pain: a randomised clinical trial
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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
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Secondary ID [1]
301283
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None
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Universal Trial Number (UTN)
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Trial acronym
PainReApp (Pain Rehabilitation/Relief Application)
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
chronic pain
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chronic low back pain
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fibromyalgia
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diabetic neuropathic pain
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Condition category
Condition code
Musculoskeletal
315560
315560
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0
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Other muscular and skeletal disorders
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Physical Medicine / Rehabilitation
315561
315561
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0
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Physiotherapy
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Anaesthesiology
315562
315562
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0
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Pain management
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Intervention/exposure
Study type
Interventional
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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.
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Intervention code [1]
317589
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Rehabilitation
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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.
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Control group
Active
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Outcomes
Primary outcome [1]
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Pain (Visual Analogue Scale - VAS)
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Assessment method [1]
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Timepoint [1]
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Baseline, 4 weeks post-initiation of treatment, 12 weeks post-initiation of treatment (primary timepoint), and 24 weeks post-initiation of treatment.
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Primary outcome [2]
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Quality of life (Health status questionnaire - SF-12v2)
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Assessment method [2]
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Timepoint [2]
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Baseline, 4 weeks post-initiation of treatment, 12 weeks post-initiation of treatment (primary timepoint), and 24 weeks post-initiation of treatment.
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Primary outcome [3]
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Adherence (PainReApp log registration and self-reported)
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Assessment method [3]
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Timepoint [3]
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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.
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Secondary outcome [1]
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Use of alternative therapies, such as mindfulness, yoga, pilates, etc. (self-reported by patient)
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Assessment method [1]
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Timepoint [1]
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Baseline, 4 weeks post-initiation of treatment, 12 weeks post-initiation of treatment, and 24 weeks post-initiation of treatment.
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Secondary outcome [2]
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Height (standard height meter), weight, and body mass index (Tanita Model TBF-310 GS Weight Scale, Tanita Corporation of America, Inc., Arlington Heights, IL)
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Assessment method [2]
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Timepoint [2]
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Baseline, 4 weeks post-initiation of treatment, 12 weeks post-initiation of treatment, and 24 weeks post-initiation of treatment.
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Secondary outcome [3]
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Painkillers consumption (self-reported medication log)
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Assessment method [3]
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Timepoint [3]
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Baseline, 4 weeks post-initiation of treatment, 12 weeks post-initiation of treatment, and 24 weeks post-initiation of treatment.
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Secondary outcome [4]
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Depression and anxiety (Hospital Anxiety and Depression Scale - HADs)
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Assessment method [4]
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Timepoint [4]
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Baseline, 4 weeks post-initiation of treatment, 12 weeks post-initiation of treatment, and 24 weeks post-initiation of treatment.
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Secondary outcome [5]
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Social support (Duke Social Support Index (DSSI)
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Assessment method [5]
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Timepoint [5]
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Baseline, 4 weeks post-initiation of treatment, 12 weeks post-initiation of treatment, and 24 weeks post-initiation of treatment.
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Secondary outcome [6]
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Physical fitness (International Physical Activity Questionnaire - IPAQ)
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Assessment method [6]
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Timepoint [6]
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Baseline, 4 weeks post-initiation of treatment, 12 weeks post-initiation of treatment, and 24 weeks post-initiation of treatment.
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Secondary outcome [7]
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Exercise adherence (Exercise Adherence Rating Scale - EARS)
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Assessment method [7]
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Timepoint [7]
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4 weeks post-initiation of treatment, 12 weeks post-initiation of treatment, and 24 weeks post-initiation of treatment.
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Secondary outcome [8]
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Sleeping disorders (Medical Outcomes Study - MOS)
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Assessment method [8]
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Timepoint [8]
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Baseline, 4 weeks post-initiation of treatment, 12 weeks post-initiation of treatment, and 24 weeks post-initiation of treatment.
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Secondary outcome [9]
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Upper limb strength (Arm curl test)
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Assessment method [9]
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Timepoint [9]
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Baseline, 4 weeks post-initiation of treatment, 12 weeks post-initiation of treatment, and 24 weeks post-initiation of treatment.
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Secondary outcome [10]
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Lower limb strength (Chair stand test)
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Assessment method [10]
383213
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Timepoint [10]
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Baseline, 4 weeks post-initiation of treatment, 12 weeks post-initiation of treatment, and 24 weeks post-initiation of treatment.
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Secondary outcome [11]
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Functional capacity (Time Up and Go test - TUG)
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Assessment method [11]
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Timepoint [11]
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Baseline, 4 weeks post-initiation of treatment, 12 weeks post-initiation of treatment, and 24 weeks post-initiation of treatment.
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Secondary outcome [12]
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Blood pressure (Sphygmomanometer)
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Assessment method [12]
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Timepoint [12]
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Baseline, 4 weeks post-initiation of treatment, 12 weeks post-initiation of treatment, and 24 weeks post-initiation of treatment.
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Secondary outcome [13]
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Exercise difficulty (Borg RPE)
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Assessment method [13]
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Timepoint [13]
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Only PainReApp group: daily for the duration of the intervention.
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Secondary outcome [14]
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Time of exercise execution (PainReApp system log)
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Assessment method [14]
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Timepoint [14]
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Only PainReApp group: daily for the duration of the intervention.
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Secondary outcome [15]
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PainReApp satisfaction (likert scale)
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Assessment method [15]
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Timepoint [15]
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Only PainReApp group: Baseline, 4 weeks post-initiation of treatment, 12 weeks post-initiation of treatment, and 24 weeks post-initiation of treatment.
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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.
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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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.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Central randomization by computer
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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.
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people assessing the outcomes
The people analysing the results/data
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Intervention assignment
Parallel
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Other design features
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Phase
Not Applicable
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Type of endpoint/s
Efficacy
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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 VAS 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, MOS and EARS scales, 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.
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Recruitment
Recruitment status
Recruiting
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Date of first participant enrolment
Anticipated
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Actual
1/03/2021
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
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Sample size
Target
300
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Accrual to date
16
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Final
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Recruitment outside Australia
Country [1]
22566
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Spain
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State/province [1]
22566
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Cádiz
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Funding & Sponsors
Funding source category [1]
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Charities/Societies/Foundations
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Name [1]
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Fundación Grünenthal España
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Address [1]
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C/ Dr. Zamenhof, 36
28027 Madrid
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Country [1]
305728
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Spain
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Funding source category [2]
305792
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Charities/Societies/Foundations
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Name [2]
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Instituto de investigación e innovación biomédica de Cádiz
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Address [2]
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Avda. Ana de Viya, 21
11009 Cádiz
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Country [2]
305792
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Spain
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Primary sponsor type
Individual
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Name
Jose A. Moral-Munoz
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Address
Universidad de Cádiz
Facultad de Enfermería y Fisioterapia
Avda. Ana de Viya, 52
11009 Cádiz
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Country
Spain
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Secondary sponsor category [1]
306149
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Individual
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Name [1]
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Inmaculada Failde
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Address [1]
306149
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Universidad de Cádiz
Facultad de Enfermería y Fisioterapia
Avda. Ana de Viya, 52
11009 Cádiz
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Country [1]
306149
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Spain
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
306003
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Comité de Ética de Investigación Provincial de Cádiz
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Ethics committee address [1]
306003
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Hospital Universitario Puerta del Mar
Avda. Ana de Viya, 52
11009 Cádiz
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Ethics committee country [1]
306003
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Spain
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Date submitted for ethics approval [1]
306003
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07/12/2018
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Approval date [1]
306003
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08/10/2019
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Ethics approval number [1]
306003
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SMART-PAIN-18
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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.
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Trial website
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Prof Jose A. Moral-Munoz
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Address
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Universidad de Cádiz
Facultad de Enfermería y Fisioterapia
Avda. Ana de Viya, 52
11009 Cádiz
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Country
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Spain
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Phone
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+34 956 015699
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Fax
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Email
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[email protected]
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Contact person for public queries
Name
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Prof Jose A. Moral-Munoz
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Address
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Universidad de Cádiz
Facultad de Enfermería y Fisioterapia
Avda. Ana de Viya, 52
11009 Cádiz
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Country
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Spain
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Phone
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+34 956 015699
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Fax
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Email
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[email protected]
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Contact person for scientific queries
Name
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Prof Jose A. Moral-Munoz
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Address
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Universidad de Cádiz
Facultad de Enfermería y Fisioterapia
Avda. Ana de Viya, 52
11009 Cádiz
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Country
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Spain
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Phone
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+34 956 015699
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Fax
102384
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Email
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[email protected]
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Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
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No/undecided IPD sharing reason/comment
These data are considered as raw data, and we preserve patient's privacy.
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What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
Documents added manually
No documents have been uploaded by study researchers.
Documents added automatically
No additional documents have been identified.
Download to PDF