Effect of Whole Body Vibration Exercises for Patients wıth Chronic Nonspeific Low Back Pain

Effect of Whole Body Vibration Exercises for Patients wıth Chronic Nonspeific Low Back Pain on Labor and Quality of Life: a Randomized Controlled Trial

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.

Study Overview

• Status: Completed
• Conditions: Quality of Life; Pain; Labor Pain; Disability Physical
• Intervention / Treatment: Other: classic lumbar home exercise; Device: Whole body vibration; Other: Whole body vibration exercise

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).

• Study Type: Interventional
• Enrollment (Actual): 70
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 50 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• 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 Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: whole body vibration group; Patients in the WBV 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. Patients in the WBV exercise group were also shown a classic lumbar home exercise program and they were asked to apply for 8 weeks	Other: classic lumbar home exercise; classic lumbar home exercise; Device: Whole body vibration; 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; Other: Whole body vibration exercise; Whole body vibration exercise
Active Comparator: exercise; The second group (control) only received classical lumbar home exercise program.	Other: classic lumbar home exercise; classic lumbar home exercise

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Health and Labor Questionnaire (HLQ)	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	baseline (0 day)
Health and Labor Questionnaire (HLQ)	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 week
Health and Labor Questionnaire (HLQ)	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	20 week
Quality of life Short form-36 (SF-36)	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. This scale consisting of 36 questions; It has 8 subgroups as general health, physical function, physical role difficulty, pain, energy, social function, emotional role difficulty, mental health.	baseline (0 day)
Quality of life Short form-36 (SF-36)	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. This scale consisting of 36 questions; It has 8 subgroups as general health, physical function, physical role difficulty, pain, energy, social function, emotional role difficulty, mental health.	8 week
Quality of life Short form-36 (SF-36)	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. This scale consisting of 36 questions; It has 8 subgroups as general health, physical function, physical role difficulty, pain, energy, social function, emotional role difficulty, mental health.	20 week
Visual Analog Scale	Visual Analog Scale was used for pain	baseline (0 day)
Visual Analog Scale	Visual Analog Scale was used for pain	8 week
Visual Analog Scale	Visual Analog Scale was used for pain	20 week

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
disability	The Istanbul Low Back Pain Disability index is a self-reported measure of functional disability consisting of 18 questions about various activities related to back pain. Each question has 6 possible responses ranging from 0 to 5, with a total possible maximum score of 50. The total Istanbul Low Back Pain Disability index score is with higher percentages indicating greater levels of self-reported disability. The Istanbul Low Back Pain Disability index has reliability and validit(7).	baseline (0 day)
disability	The Istanbul Low Back Pain Disability index is a self-reported measure of functional disability consisting of 18 questions about various activities related to back pain. Each question has 6 possible responses ranging from 0 to 5, with a total possible maximum score of 50. The total Istanbul Low Back Pain Disability index score is with higher percentages indicating greater levels of self-reported disability. The Istanbul Low Back Pain Disability index has reliability and validit(7).	8 week
disability	The Istanbul Low Back Pain Disability index is a self-reported measure of functional disability consisting of 18 questions about various activities related to back pain. Each question has 6 possible responses ranging from 0 to 5, with a total possible maximum score of 50. The total Istanbul Low Back Pain Disability index score is with higher percentages indicating greater levels of self-reported disability. The Istanbul Low Back Pain Disability index has reliability and validit(7).	20 week

Collaborators and Investigators

• Sponsor: Yerkoy State Hospital

Publications and helpful links

General Publications

• Balague F, Mannion AF, Pellise F, Cedraschi C. Non-specific low back pain. Lancet. 2012 Feb 4;379(9814):482-91. doi: 10.1016/S0140-6736(11)60610-7. Epub 2011 Oct 6.
• Sitja Rabert M, Rigau Comas D, Fort Vanmeerhaeghe A, Santoyo Medina C, Roque i Figuls M, Romero-Rodriguez D, Bonfill Cosp X. Whole-body vibration training for patients with neurodegenerative disease. Cochrane Database Syst Rev. 2012 Feb 15;(2):CD009097. doi: 10.1002/14651858.CD009097.pub2.
• Weiner SS, Nordin M. Prevention and management of chronic back pain. Best Pract Res Clin Rheumatol. 2010 Apr;24(2):267-79. doi: 10.1016/j.berh.2009.12.001.
• Ladeira CE. Evidence based practice guidelines for management of low back pain: physical therapy implications. Rev Bras Fisioter. 2011 May-Jun;15(3):190-9. doi: 10.1590/s1413-35552011000300004.
• Perraton L, Machotka Z, Kumar S. Whole-body vibration to treat low back pain: fact or fad? Physiother Can. 2011 Winter;63(1):88-93. doi: 10.3138/ptc.2009.44. Epub 2011 Jan 20.
• Duruoz MT, Ozcan E, Ketenci A, Karan A. Development and validation of a functional disability index for chronic low back pain. J Back Musculoskelet Rehabil. 2013;26(1):45-54. doi: 10.3233/BMR-2012-00349.
• McGorry RW, Webster BS, Snook SH, Hsiang SM. The relation between pain intensity, disability, and the episodic nature of chronic and recurrent low back pain. Spine (Phila Pa 1976). 2000 Apr 1;25(7):834-41. doi: 10.1097/00007632-200004010-00012.
• cakar E, Özcan E, Özgörgü E, Durmuş O, Karan A, Kıralp MZ. Health and labour questionnaire: Turkish adaptation for ankylosing spondylitis. Türk Fiz Tıp Rehab Derg. 2012;58(3):205-12.

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2017
• Primary Completion (Actual): October 15, 2020
• Study Completion (Actual): January 1, 2021

Study Registration Dates

• First Submitted: October 20, 2020
• First Submitted That Met QC Criteria: October 26, 2020
• First Posted (Actual): November 2, 2020

Study Record Updates

• Last Update Posted (Actual): July 13, 2022
• Last Update Submitted That Met QC Criteria: July 11, 2022
• Last Verified: July 1, 2022

More Information

Terms related to this study

• Keywords: low back pain; labor; whole body vibration
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Back Pain; Low Back Pain; Labor Pain
• Other Study ID Numbers: 2016/70

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No