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

Pain Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04611451
• Other study ID #: 2016/70
• Status: Completed
• Phase: N/A
• Start date: January 1, 2017
• Est. completion date: January 1, 2021

Study information

• Verified date: July 2022
• Source: Yerkoy State Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 70
• Est. completion date: January 1, 2021
• Est. primary completion date: October 15, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Back Pain
• Disability Physical
• Labor Pain
• Low Back Pain
• Pain
• Quality of Life

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Yerkoy State Hospital

References & Publications (8)

Balagué F, Mannion AF, Pellisé 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. Review. — View Citation

cakar E, Özcan E, Özgörgü E, Durmus O, Karan A, Kiralp MZ. Health and labour questionnaire: Turkish adaptation for ankylosing spondylitis. Türk Fiz Tip Rehab Derg. 2012;58(3):205-12.

Duruöz MT, Özcan 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. — View 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. Review. — View 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. — View 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. — View Citation

Sitjà Rabert M, Rigau Comas D, Fort Vanmeerhaeghe A, Santoyo Medina C, Roqué i Figuls M, Romero-Rodríguez 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. Review. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	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
Primary	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
Primary	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)
Primary	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
Primary	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
Primary	Visual Analog Scale	Visual Analog Scale was used for pain	baseline (0 day)
Primary	Visual Analog Scale	Visual Analog Scale was used for pain	8 week
Primary	Visual Analog Scale	Visual Analog Scale was used for pain	20 week
Secondary	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)
Secondary	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
Secondary	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