Ignite Creation Date:
2025-12-24 @ 11:49 PM
Ignite Modification Date:
2025-12-25 @ 9:43 PM
Study NCT ID:
NCT04611451
Status:
COMPLETED
Last Update Posted:
2022-07-13
First Post:
2020-10-20
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Effect of Whole Body Vibration Exercises for Patients wıth Chronic Nonspeific Low Back Pain
Sponsor:
Yerkoy State Hospital
Organization:
Study Overview
Official Title:
Effect of Whole Body Vibration Exercises for Patients wıth Chronic Nonspeific Low Back Pain on Labor and Quality of Life: a Randomized Controlled Trial
Status:
COMPLETED
Status Verified Date:
2022-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Whole body vibration (WBV), which is a new treatment method and applied through the device, is defined as mechanical repetitive motion or oscillatory motion occurring around a balance point (5). Chronic nonspecific low back pain is still a serious clinical, social and economic health problem. There are few studies and limited evidence evaluating the effectiveness of WBV exercises in chronic nonspecific low back pain. Different protocols are used for wbv exercise in studies (6). Our aim is to compare the effects of whole body vibration exercise modality on pain, functional recovery, laboor impact, quality of life with control group in patients with chronic nonspecific low back pain.
Detailed Description:
Low back pain is a prevalent problem all over the World. low back pain prevalence is 84% by lifetime Chronic low back pain prevalence is 23%. Low back pain causing disability prevalence is also11% (1). Increasing sedentary lifestyle and obesity, aging of the population and inappropriate ergonomic work activities and working environment in the working society contribute to this increase (2).
Chronic low back pain is an important cause of labor losses and also it is the most common functional insufficiency under 45 years of age (3). Treatment approaches such as exercise and education in which the patient is actively involved in the treatment are recommended for the treatment of non-specific acute, subacute and especially chronic low back pain (4).
Whole body vibration (WBV), which is a new treatment method and applied through the device, is defined as mechanical repetitive motion or oscillatory motion occurring around a balance point (5). Chronic nonspecific low back pain is still a serious clinical, social and economic health problem. There are few studies and limited evidence evaluating the effectiveness of WBV exercises in chronic nonspecific low back pain. Different protocols are used for wbv exercise in studies (6). Our aim is to compare the effects of whole body vibration exercise modality on pain, functional recovery, laboor impact, quality of life with control group in patients with chronic nonspecific low back pain.
MATERYAL METHOD
This prospective, randomized and controlled study include 70 patients who were diagnosed chronic nonspecific low back pain. Patients were randomized into two groups using the 1:1 method. The first group was the treatment group in which applied the whole body vibration exercise and classical lumbar home exercise program. The second group (control) only received classical lumbar home exercise program.
Inclusion criterias are non-specific LBP (LBP other than those excluded, see exclusion criteria below) of a more than 3 months in patients aged 20 to 50 years, with average pain intensity evaluated Visaual Analog Scale (VAS) (1-10) that is higher than 5 Exclusion criterias are participants with likely specific causes of LBP This includes exclusion of history of malignancy, history of recent spinal surgery, dislocation, fracture, rheumatoid arthritis and ankylosing spondylitis and history of weakness of lower extremity or loss of sensation in lower extremity. Additionally, current pregnancy, , lactation, uncontrolled hypertension and history of diagnosed mental health conditions that would limit adherence to the trial procedures will be excluded.
Patients in the TVT exercise group; 24 sessions of TVT exercise 3 days a week (with at least 1 day of rest between each session) was performed under the supervision of a physician for a total of 8 weeks. . The vibration was given by the Power Plate® (pro5TM; Power Plate North America, Inc., Northbrook, IL, USA) device where a three-plan oscillation took place (most vertical, Z-axis).The Istanbul Low Back Pain Disability index is a self-reported measure of functional disability . The Istanbul Low Back Pain Disability index has reliability and validit(7). Quality of life was assessed using Short form-36 (SF-36). SF-36 is a widely used and validated scale in assessing quality of life. It is not specific to any disease group. Health and Labor Questionnaire (HLQ) was used in our study to evaluate job performance. HLQ is designed to collect quantitative data on the treatment of disease and its relationship to work performance. Intercultural adaptation was made to Turkish. HLQ data allow to estimate the production losses (costs) of paid and unpaid labor (8).
Chronic low back pain is an important cause of labor losses and also it is the most common functional insufficiency under 45 years of age (3). Treatment approaches such as exercise and education in which the patient is actively involved in the treatment are recommended for the treatment of non-specific acute, subacute and especially chronic low back pain (4).
Whole body vibration (WBV), which is a new treatment method and applied through the device, is defined as mechanical repetitive motion or oscillatory motion occurring around a balance point (5). Chronic nonspecific low back pain is still a serious clinical, social and economic health problem. There are few studies and limited evidence evaluating the effectiveness of WBV exercises in chronic nonspecific low back pain. Different protocols are used for wbv exercise in studies (6). Our aim is to compare the effects of whole body vibration exercise modality on pain, functional recovery, laboor impact, quality of life with control group in patients with chronic nonspecific low back pain.
MATERYAL METHOD
This prospective, randomized and controlled study include 70 patients who were diagnosed chronic nonspecific low back pain. Patients were randomized into two groups using the 1:1 method. The first group was the treatment group in which applied the whole body vibration exercise and classical lumbar home exercise program. The second group (control) only received classical lumbar home exercise program.
Inclusion criterias are non-specific LBP (LBP other than those excluded, see exclusion criteria below) of a more than 3 months in patients aged 20 to 50 years, with average pain intensity evaluated Visaual Analog Scale (VAS) (1-10) that is higher than 5 Exclusion criterias are participants with likely specific causes of LBP This includes exclusion of history of malignancy, history of recent spinal surgery, dislocation, fracture, rheumatoid arthritis and ankylosing spondylitis and history of weakness of lower extremity or loss of sensation in lower extremity. Additionally, current pregnancy, , lactation, uncontrolled hypertension and history of diagnosed mental health conditions that would limit adherence to the trial procedures will be excluded.
Patients in the TVT exercise group; 24 sessions of TVT exercise 3 days a week (with at least 1 day of rest between each session) was performed under the supervision of a physician for a total of 8 weeks. . The vibration was given by the Power Plate® (pro5TM; Power Plate North America, Inc., Northbrook, IL, USA) device where a three-plan oscillation took place (most vertical, Z-axis).The Istanbul Low Back Pain Disability index is a self-reported measure of functional disability . The Istanbul Low Back Pain Disability index has reliability and validit(7). Quality of life was assessed using Short form-36 (SF-36). SF-36 is a widely used and validated scale in assessing quality of life. It is not specific to any disease group. Health and Labor Questionnaire (HLQ) was used in our study to evaluate job performance. HLQ is designed to collect quantitative data on the treatment of disease and its relationship to work performance. Intercultural adaptation was made to Turkish. HLQ data allow to estimate the production losses (costs) of paid and unpaid labor (8).
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: