Compliance with therapeutic exercise with the use of an app in patients with low back pain.

• Register: ANZCTR
• Last refreshed on: 21 August 2017
• Main ID: ACTRN12617001041347
• Date of registration: 17/07/2017
• Prospective Registration: Yes
• Primary sponsor: Hospital Clinico San Carlos
• 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.
• Date of first enrolment: 26/09/2017
• Target sample size: 30
• Recruitment status: Not yet recruiting
• URL: http://www.anzctr.org.au/ACTRN12617001041347.aspx
• Study type: Interventional
• Study design: Randomised controlled trial Parallel

Health Condition(s) or Problem(s) studied

Low back pain

Intervention(s)

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.