The Effects of Telerehabilitation and Supervised Stabilization Exercises in Individuals With Nonspecific Chronic Low Back Pain

NCT04759430 | Completed DMC

• 1 other identifier: 1506581
• Study Type: interventional
• Target: 66
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Low Back Pain

Keywords

chronic pain; exercise; low back pain; quality of life; telerehabilitation

Outcome Measures

Primary Outcomes (4)

• Oswestry Disability Index(ODI)

  The Oswestry Disability Index(ODI) is an extremely important tool that researchers and disability evaluators use to measure a patient's permanent functional disability. The test is considered the 'gold standard' of low back functional outcome tools. Scores between 0-5 are given for each question on the scale consisting of 10 questions. Questions are on travel, social life, sex life, sleeping, standing, sitting, walking, lifting things and personal precautions. Maximum score is 50, minimum score is 0.

  Change between baseline and 4 weeks

• Visual Analogue Scale(VAS)

  The Visual Analog Scale (VAS) is a scale used to determine the intensity of pain experienced by individuals. It consists of a line approximately 10-15 cm long; the patient is asked to mark his pain level on the line between the two endpoints. The distance between 'no pain at all' and the mark then defines the subject's pain the left side means no pain with 0 points, while the right side means 10 points the worst pain ever.

  Change between baseline and 4 weeks

• Tampa Scale for Kinesiophobia(TSK)

  The Tampa Scale of Kinesiophobiais (TSK) is 17 items a self-reporting questionnaire based on evaluation of fear of movement, fear of physical activity, and fear avoidance. It was first developed to distinguish between non-excessive fear and phobia in patients with chronic musculoskeletal pain, specifically the fear of movement in patients with chronic low back pain then widely used for different parts of the body. The questionnaire using 4 points to assess that are based on; the model of fear-avoidance, fear of work-related activities, fear of movement, and fear of re-injury.(1 = Strongly Disagree, 4 = Strongly Agree).The total score of the scale range from 17-68, where 17 means no kinesiophobia, 68 means severe kinesiophobia.

  Change between baseline and 4 weeks

• Short Form(SF-36)

  The 36-Item Short Form Survey (SF-36) is an oft-used, well-researched, self-reported measure of health. It comprises 36 questions which cover eight domains of health:1) Limitations in physical activities because of health problems 2) Limitations in social activities because of physical or emotional problems 3) Limitations in usual role activities because of physical health problems 4) Bodily pain 5) General mental health (psychological distress and well-being) 6) Limitations in usual role activities because of emotional problems 7) Vitality (energy and fatigue) 8) General health perceptions. The SF-36 is often used as a measure of a person or population's quality of life (QOL). In addition, each item is scored on a 0 to 100 range so that the lowest and highest possible scores are 0 and 100, respectively.

  Change between baseline and 4 weeks

Study Arms (3)

Supervised Group

ACTIVE COMPARATOR

24 individuals will participate in the Supervised group. Patients in the supervised group will be treated individually by the researcher at the hospital. During the application, individuals will apply ten different stabilization exercises in company with a physiotherapist. Exercises will be applied under the supervision of a physiotherapist in the center where the work will be done for 20-30 minutes in each session, three days a week, for a total of 12 sessions for four weeks. The exercises program to be applied to the participants in the group is listed below: Supine position; Abdominal bracing, while continuing the abdominal bracing; heel slides, bridging, 90 degrees hip flexion. Quadruped position; Abdominal bracing while continuing the abdominal bracing; single arm lift, single leg lift, cross-arm leg raises activities. Standing position; Abdominal bracing.

Other: Supervised Group

Telerehabilitation Group

EXPERIMENTAL

24 individuals will participate in the Telerehabilitation group. Patients in the telerehabilitation group will attend the treatment from their homes. The exercises will be performed online with the patient by the researcher physiotherapist and supervised through the video conference or phone. The same stabilization exercises will be applied to the participants in the supervised group. Exercises will be applied for 20-30 minutes in each session, three days a week, for a total of 12 sessions for four weeks.

Other: Telerehabilitation group

Control Group

NO INTERVENTION

Interventions

Supervised Group OTHER

Individuals will apply ten different stabilization exercises in company with a physiotherapist.

Supervised Group

Telerehabilitation group OTHER

Same stabilization exercises will be performed online with the patient by the researcher physiotherapist and supervised through the video conference or phone.

Telerehabilitation Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Having non-specific chronic low back pain
• Non-specific chronic low back pain ⩾three months
• Being over the age of 18
• Score of ⩾4 on the Roland-Morris Disability Questionnaire (RMQ)
• Agree to voluntarily participate in the research

You may not qualify if:

• Presence of lumbar stenosis
• Presence of clinical signs or symptoms of radiculopathy
• Diagnosis of spondylolisthesis
• Diagnosis of fibromyalgia
• Treatment with corticosteroids or other drugs in the previous two weeks
• History of spinal surgery
• Presence of central or peripheral system pathology (i.e. stroke, peripheral nerve etc.)
• Have received a physiotherapy treatment for low back pain before 6 months

Sponsors & Collaborators

• Bahçeşehir University: lead

Study Sites (1)

Private Medigold Sultan Hospital

Istanbul, Sultangazi, 34265, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Low Back Pain; Chronic Pain; Motor Activity

Condition Hierarchy (Ancestors)

Back Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavior

Study Officials

• Leyla ATAŞ BALCI, Assist Prof

  Bahçeşehir University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The researcher who will make the measurements will not know the treatment groups of the individuals.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Physical Therapist

Model Details: The individuals are randomly allocated into supervised group, telerehabilitation group and control group

Study Record Dates

• First Submitted: February 15, 2021
• First Posted: February 18, 2021
• Study Start: February 15, 2021
• Primary Completion: March 19, 2021
• Study Completion: May 14, 2021
• Last Updated: May 17, 2021

Record last verified: 2021-05

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)