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Trial registered on ANZCTR


Registration number
ACTRN12617001041347
Ethics application status
Approved
Date submitted
17/06/2017
Date registered
17/07/2017
Date last updated
17/07/2017
Type of registration
Prospectively registered

Titles & IDs
Public title
Compliance with therapeutic exercise with the use of an app in patients with low back pain.
Scientific title
Compliance with therapeutic exercise with the use of an app in patients with low back pain.
Secondary ID [1] 292217 0
None.
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Low back pain 303711 0
Condition category
Condition code
Musculoskeletal 303085 303085 0 0
Other muscular and skeletal disorders
Physical Medicine / Rehabilitation 303086 303086 0 0
Physiotherapy

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
There are 2 groups in the study, an experimental group that will use the app to realize an exercise protocol for chronic nonspecific low back pain, and a control group who are going to realize the same exercises only with an explanatory sheet on them.

Both groups are going to go to the hospital for two weeks every day to learn how to do the exercise protocol including stretching and strengthening for lumbopelvic region and being supervised by the physiotherapists of the hospital. On the one hand at the end of these two weeks the control group is going to receive the explanatory sheets with the exercises (with the number of series and repetitions) to continue doing at home, and they are going to receive a compliance sheet in which it must reflect daily the realization of the exercises. On the other hand, the experimental group is going to be provided an app for continue to carry out the exercise protocol at home. In the app, the patient will see the exercises that must be done accompanied by an explanatory video of each one, and when completing them he can mark the number of series and repetitions that he has done, as well as being able to send at the end of the session a message to the physiotherapist informing of any incidence or level of pain he has suffered throughout the day. Patients in the control group are going to be provided with the e-mail of the physiotherapist to contact him.

Facilitators will be used in order to improve therapeutic compliance, some of them will be motivation, supervision, feedback, media, goal settings...

The tool that patients will use to measure compliance will be self-registration diaries where participants will fill some gaps related with number of sessions, number of series and number of exercises done. The experimental group is going to complete the diaries into smartphone through the app and the control group will complete them with physical form (paper sheet).

The exercises of protocol are simple strengthening exercises and streching of lumbopelvic region. Those exercises are commonly used for the management of low back pain and the scientific literature approves their use. They are going to be pelvic tilt, abdominal crunch, knee plank bridge, lumbosacral stretching and hamstring stretching. We will recomend to do it every day about 20-30 minutes per day and each session will include 4 exercises,T Patients will perform 3 series of 10 repetitions in strengthening exercises, however in stretching exercises they are going to do 3 series of 30 seconds.

Presently, the protocol of exercises and compliance diaries are going to be explained by a physical therapist (physical therapist number 1) in the Clinico San Carlos Hospital. This physical therapist is going to be blinded to the subsequent randomization of patients. A second physical therapist (number 2), who is going to be blinded, as the first one, will do the evaluation.
Later, the third physical therapist (number 3) is going to explain the use of app to the experimental group. Ultimately, the fourth physical therapist (number 4) is going to monitor and answer the questions of the patients by email. He is going to answer to the experimental group and the control group. Therefore, this physical therapist is going to be blinded because he doesn´t know the group where the patients are. In order to preserve this blinding, the physical therapist number 3 is going to send by email the questions´patient to the physical therapist number 4.

The patients must complete the exercise protocol in the hospital for two weeks. When the patients received the hospital dicharged our study begins. The patients will realice the same hospital exercises for 4 weeks at home, every day. The compliance diaries will be evaluated. Also will be evaluated other variables such as pain, low back disability and the quality of life.

At the end of four weeks the intervention ends. After three months post – intervention the patients are going to be cited to do the last evaluation of pain, disability and quality of life in order to estimate effects in the medium term.


Intervention code [1] 298378 0
Rehabilitation
Intervention code [2] 298379 0
Treatment: Other
Comparator / control treatment
The control group is going to receive the same rehabilitation treatment that the intervention group. Same exercises for lumbar spine during 4 weeks at home.
Control group
Active

Outcomes
Primary outcome [1] 302466 0
Compliance. It will be measured by self-registration diaries, where patients marks number of sessions, number of series and number of exercises done.
Timepoint [1] 302466 0
4 weeks post commencement of intervention.
Secondary outcome [1] 336093 0
Intensity of low back pain with the use of Visual Analogue Scale (VAS)
Timepoint [1] 336093 0
Baseline, 4 weeks, 3 months post commencement of intervention
Secondary outcome [2] 336094 0
To evaluate disability we will use Oswestry, low back pain disability questionnaire (OSW)
Timepoint [2] 336094 0
Baseline, 4 weeks, 3 months post commencement of intervention.
Secondary outcome [3] 336095 0
Quality of life will be measured with SF-12 Questionnaire
Timepoint [3] 336095 0
Baseline, 4 weeks, 3 months post commencement of intervention
Secondary outcome [4] 336096 0
To measure intensity of chronic pain and also it relationship with disability we are going to use the Graded Chronic Pain Scale 2.0 (GCPS).
Timepoint [4] 336096 0
Baseline, 4 weeks, 3 months post commencement of intervention

Eligibility
Key inclusion criteria
Subjects with non-specific chronic low back pain diagnosed by the San Carlos Clinical Hospital who were treated during two weeks with supervised therapeutic exercise in the Hospital
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Traumatic history in the last 3 months, diseases like cancer, infections, inflamatory diseases, fractures, psychiatric diseases, fibromyalgia, neurologic diseases, or pregnancy, severe cardiovascular and/or respiratory disease.

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)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?

The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
26/09/2017
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
30
Accrual to date
Final
Recruitment outside Australia
Country [1] 8993 0
Spain
State/province [1] 8993 0
Madrid

Funding & Sponsors
Funding source category [1] 296759 0
Hospital
Name [1] 296759 0
Hospital Clinico San Carlos
Country [1] 296759 0
Spain
Primary sponsor type
Hospital
Name
Hospital Clinico San Carlos
Address
Calle del Profesor Martin Lagos, s/n, 28040 Madrid
Country
Spain
Secondary sponsor category [1] 295741 0
None
Name [1] 295741 0
Address [1] 295741 0
Country [1] 295741 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 297986 0
CEIC Hospital Clinico San Carlos
Ethics committee address [1] 297986 0
Calle Doctor Martin Lagos, s/n. Madrid 28040
Ethics committee country [1] 297986 0
Spain
Date submitted for ethics approval [1] 297986 0
20/01/2017
Approval date [1] 297986 0
31/01/2017
Ethics approval number [1] 297986 0
17/039-E

Summary
Brief summary
The specific treatment is based on the realization of a home exercise program with the help of an app for the smartphone. The objective of the use of this app in the experimental group of the study will be increase the compliance of the exercise by app users. The normal treatment in almost all hospitals and clinics is the realization of the home exercises with the help of explanatory worksheets. The main hypothesis is that patients with nonspecific low back pain achieve better levels of compliance for home exercise than those who use the sheets, so they will also get improvements in terms of pain, disability and quality of life.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 75658 0
Dr Gustavo Plaza-Manzano
Address 75658 0
Departamento de Medicina Fisica y Rehabilitacion
Facultad de Medicina
Universidad Complutense de Madrid
Avenida Complutense s/n
28440 Madrid
Country 75658 0
Spain
Phone 75658 0
+34609578380
Fax 75658 0
Email 75658 0
[email protected]
Contact person for public queries
Name 75659 0
Mr Antonio Calvo-Fernandez
Address 75659 0
Departamento de Medicina Fisica y Rehabilitacion
Facultad de Medicina
Universidad Complutense de Madrid
Avenida Complutense s/n
28440 Madrid
Country 75659 0
Spain
Phone 75659 0
+34679595077
Fax 75659 0
Email 75659 0
[email protected]
Contact person for scientific queries
Name 75660 0
Dr Gustavo Plaza-Manzano
Address 75660 0
Departamento de Medicina Fisica y Rehabilitacion
Facultad de Medicina
Universidad Complutense de Madrid
Avenida Complutense s/n
28440 Madrid
Country 75660 0
Spain
Phone 75660 0
+34609578380
Fax 75660 0
Email 75660 0
[email protected]

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