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

Primary Purpose

Pain, Labor Pain, Quality of Life

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
classic lumbar home exercise
Whole body vibration
Whole body vibration exercise
Sponsored by
Yerkoy State Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pain focused on measuring low back pain, whole body vibration, labor

Eligibility Criteria

20 Years - 50 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    whole body vibration group

    exercise

    Arm Description

    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

    The second group (control) only received classical lumbar home exercise program.

    Outcomes

    Primary Outcome Measures

    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
    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
    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
    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.
    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.
    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.
    Visual Analog Scale
    Visual Analog Scale was used for pain
    Visual Analog Scale
    Visual Analog Scale was used for pain
    Visual Analog Scale
    Visual Analog Scale was used for pain

    Secondary Outcome Measures

    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).
    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).
    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).

    Full Information

    First Posted
    October 20, 2020
    Last Updated
    July 11, 2022
    Sponsor
    Yerkoy State Hospital
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04611451
    Brief Title
    Effect of Whole Body Vibration Exercises for Patients wıth Chronic Nonspeific Low Back Pain
    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
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    July 2022
    Overall Recruitment Status
    Completed
    Study Start Date
    January 1, 2017 (Actual)
    Primary Completion Date
    October 15, 2020 (Actual)
    Study Completion Date
    January 1, 2021 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Yerkoy State Hospital

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    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).

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Pain, Labor Pain, Quality of Life, Disability Physical
    Keywords
    low back pain, whole body vibration, labor

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Crossover Assignment
    Masking
    Participant
    Allocation
    Randomized
    Enrollment
    70 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    whole body vibration group
    Arm Type
    Experimental
    Arm Description
    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
    Arm Title
    exercise
    Arm Type
    Active Comparator
    Arm Description
    The second group (control) only received classical lumbar home exercise program.
    Intervention Type
    Other
    Intervention Name(s)
    classic lumbar home exercise
    Intervention Description
    classic lumbar home exercise
    Intervention Type
    Device
    Intervention Name(s)
    Whole body vibration
    Intervention Description
    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
    Intervention Type
    Other
    Intervention Name(s)
    Whole body vibration exercise
    Intervention Description
    Whole body vibration exercise
    Primary Outcome Measure Information:
    Title
    Health and Labor Questionnaire (HLQ)
    Description
    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
    Time Frame
    baseline (0 day)
    Title
    Health and Labor Questionnaire (HLQ)
    Description
    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
    Time Frame
    8 week
    Title
    Health and Labor Questionnaire (HLQ)
    Description
    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
    Time Frame
    20 week
    Title
    Quality of life Short form-36 (SF-36)
    Description
    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.
    Time Frame
    baseline (0 day)
    Title
    Quality of life Short form-36 (SF-36)
    Description
    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.
    Time Frame
    8 week
    Title
    Quality of life Short form-36 (SF-36)
    Description
    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.
    Time Frame
    20 week
    Title
    Visual Analog Scale
    Description
    Visual Analog Scale was used for pain
    Time Frame
    baseline (0 day)
    Title
    Visual Analog Scale
    Description
    Visual Analog Scale was used for pain
    Time Frame
    8 week
    Title
    Visual Analog Scale
    Description
    Visual Analog Scale was used for pain
    Time Frame
    20 week
    Secondary Outcome Measure Information:
    Title
    disability
    Description
    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).
    Time Frame
    baseline (0 day)
    Title
    disability
    Description
    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).
    Time Frame
    8 week
    Title
    disability
    Description
    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).
    Time Frame
    20 week

    10. Eligibility

    Sex
    All
    Gender Based
    Yes
    Gender Eligibility Description
    20-50 years old
    Minimum Age & Unit of Time
    20 Years
    Maximum Age & Unit of Time
    50 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    Citations:
    PubMed Identifier
    21982256
    Citation
    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.
    Results Reference
    background
    PubMed Identifier
    20227647
    Citation
    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.
    Results Reference
    background
    PubMed Identifier
    21829982
    Citation
    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.
    Results Reference
    background
    PubMed Identifier
    22336858
    Citation
    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.
    Results Reference
    background
    PubMed Identifier
    22210985
    Citation
    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.
    Results Reference
    background
    PubMed Identifier
    23411648
    Citation
    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.
    Results Reference
    background
    PubMed Identifier
    10751295
    Citation
    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.
    Results Reference
    background
    Citation
    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.
    Results Reference
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    Effect of Whole Body Vibration Exercises for Patients wıth Chronic Nonspeific Low Back Pain

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