Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT04759430 |
| Other study ID # |
1506581 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
February 15, 2021 |
| Est. completion date |
May 14, 2021 |
Study information
| Verified date |
May 2021 |
| Source |
Bahçesehir University |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
This study aims to investigate the effects of telerehabilitation and supervised stabilization
exercises on pain, functionality, kinesophobia and quality of life in individuals with
non-specific chronic low back pain. 72 individuals who voluntarily agree to participate in
the study will be included. This study divides the patients in three groups: the supervised
group: face-to-face stabilization exercises are applied, the telerehabilitation group:
treatment through online meetings, and the control group: patients will do home-based
exercises that prescribed by physiothrerapist. Evaluations will be made by the same
physiotherapist. The researcher who will make the measurements in this study will not know
which treatment program was applied to the participants. In this study, The same
stabilization exercises will be applied in three different groups. Ten different
stabilization exercises will be applied to the participants. Exercises will be performed for
20-30 minutes in each session, three times a week, for four weeks in total, twelve sessions.
Clinical and demographic data of the 72 people participating in the study will be taken
before treatment. Participants will also fill out questionnaires before and after the
treatment that involve; the Oswestry Disability Index to measure(ODI) daily life activity
limitations; the Visual Analogue Scale(VAS) for assessing the intensity of pain; Tampa Scale
for Kinesiophobia(TSK) to assess fear of movement; and the Short Form(SF-36) in order to
assess self-perceived health-related quality of life. Statistical analysis is going to be
used in this research through the SPSS 20.0 package program.
Description:
Today, low back pain is one of the most common health problems in the world in which create a
considerable individual, social and financial burden on the society. Low back pain is
classified as specific and nonspecific. While, 10 percent of the paints are suffered from
specific low back pain, non-specific low back pain is occured in approximately 90 percent of
the population. If low back pain persists for six weeks, it is classified as acute back pain,
subacute back pain between six weeks and three months, and chronic low back pain if it lasts
for more than three months.
Chronic low back pain (CLBP) is a complex problem that continues for a long time without a
cause and is the most common in the musculoskeletal system, leading to disability.
Individuals with CLBP have a lower quality of life than the general population. It causes
individuals to decrease their activities due to pain and prepares the ground for the
continuation of pain. Lack of movement caused by pain in individuals; It negatively affects
the quality of life by triggering the continuation of symptoms, causing a decrease in
functional levels, limitation in daily life activities, problems in family and work life.
There are many physical, psychological and social factors that cause low back pain to become
chronic. Age, race, occupation, obesity, smoking, alcohol consumption and stress are the most
important factors that trigger the chronicity of low back pain. The effectiveness of a
multidisciplinary treatment program and determination of risk factors in the management of
CLBP is known. Treatment approaches include medical treatment, surgical treatment and
physiotherapy applications. In physiotherapy programs, patient education, back schools,
electrotherapy applications, traction, massage, superficial heat applications, corsets and
exercise approaches are used. Stretching exercises, trunk flexion-extension exercises,
resistantce exercises, stabilization exercises are the main exercise approaches used to cope
with low back pain. In addition to exercises performed under the supervision of a
physiotherapist, home exercise programs are also provided for low back pain. Stabilization
exercises have various benefits on the musculoskeletal system. Stabilization exercises that
aim to protect and support the spine by regenerating muscle control, applied in muscle
activation losses caused by injury or degenerative changes, increase strength and
flexibility. Stabilization exercise has been reported to be effective in reducing pain and
improving functional disability in patients with nonspecific CLBP, improving individuals
psychologically and also increasing the quality of life of patients. Stabilization exercises
have been found to be effective in increasing the cross-sectional area of the lumbar
multifidus muscle, which is one of the muscles needed to maintain the proper stability of the
spine.
Today, in line with technological developments, the use of common information processing,
sensor networks, three-dimensional (3D) computer graphics, internet and mobile phone
applications in healthcare services is widespread. Telerehabilitation refers to the provision
of rehabilitation services through information and communication technologies. Clinically
this term; covers a range of rehabilitation and habilitation services including assessment,
monitoring, prevention, response, control, training, consultation and counseling. Along with
telerehabilitation, rehabilitation practices can be applied in health centers as well as
homes, schools or community-based work sites. Mostly, there are studies in the literature
regarding its use in musculoskeletal disorders, coronary heart disease, some types of cancer,
type 2 diabetes, hypertension and physically disabled individuals. Due to the social distance
and isolation, which are the effects of the covid-19, which spread in a short time in our
country and all over the world, there are disruptions in individuals' continuing their
treatment. Telerehabilitation allows one-to-one physiotherapist-patient meetings without the
need for contact and provides flexibility to patients in terms of time. Exercise is one of
the treatments that physiotherapists can give using telerehabilitation. With the applications
made with telerehabilitation, individuals are provided to take an active role in their own
rehabilitation and individuals can have the ability to manage themselves.
