NCT04611451

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
70

participants targeted

Target at P50-P75 for not_applicable pain

Timeline
Completed

Started Jan 2017

Longer than P75 for not_applicable pain

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2017

Completed
3.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 15, 2020

Completed
5 days until next milestone

First Submitted

Initial submission to the registry

October 20, 2020

Completed
13 days until next milestone

First Posted

Study publicly available on registry

November 2, 2020

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2021

Completed
Last Updated

July 13, 2022

Status Verified

July 1, 2022

Enrollment Period

3.8 years

First QC Date

October 20, 2020

Last Update Submit

July 11, 2022

Conditions

Keywords

low back painwhole body vibrationlabor

Outcome Measures

Primary Outcomes (9)

  • 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 Outcomes (3)

  • disability

    baseline (0 day)

  • disability

    8 week

  • disability

    20 week

Study Arms (2)

whole body vibration group

EXPERIMENTAL

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 exerciseDevice: Whole body vibrationOther: Whole body vibration exercise

exercise

ACTIVE COMPARATOR

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

Other: classic lumbar home exercise

Interventions

classic lumbar home exercise

exercisewhole body vibration group

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

whole body vibration group

Whole body vibration exercise

whole body vibration group

Eligibility Criteria

Age20 Years - 50 Years
Sexall(Gender-based eligibility)
Gender Eligibility Details20-50 years old
Healthy VolunteersNo
Age GroupsAdult (18-64)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (8)

  • 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.

    PMID: 21982256BACKGROUND
  • 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.

    PMID: 20227647BACKGROUND
  • 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.

    PMID: 21829982BACKGROUND
  • 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.

    PMID: 22336858BACKGROUND
  • 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.

    PMID: 22210985BACKGROUND
  • 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.

    PMID: 23411648BACKGROUND
  • 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.

    PMID: 10751295BACKGROUND
  • 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.

    BACKGROUND

MeSH Terms

Conditions

PainLabor PainLow Back Pain

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsBack Pain

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
specialist

Study Record Dates

First Submitted

October 20, 2020

First Posted

November 2, 2020

Study Start

January 1, 2017

Primary Completion

October 15, 2020

Study Completion

January 1, 2021

Last Updated

July 13, 2022

Record last verified: 2022-07

Data Sharing

IPD Sharing
Will not share