NCT02393521

Brief Summary

The aim of this study was to investigate the efficacy of a self-administered vibration therapy treatment on neck pain, disability and pressure pain thresholds in patients with non-specific neck pain and myofascial trigger points (MTrPs). The investigators hypothesized that patients receiving vibration therapy would report less perceived neck pain, disability and present higher PPTs after receiving vibration therapy when compared to a control no-treatment group.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
13

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Aug 2014

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2014

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

February 22, 2015

Completed
25 days until next milestone

First Posted

Study publicly available on registry

March 19, 2015

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2016

Completed
3.7 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2019

Completed
Last Updated

May 19, 2022

Status Verified

May 1, 2022

Enrollment Period

1.7 years

First QC Date

February 22, 2015

Last Update Submit

May 18, 2022

Conditions

Keywords

VibrationPressure Pain ThresholdTrigger PointsNeck Pain

Outcome Measures

Primary Outcomes (1)

  • Pressure Pain Threshold (PPT)

    Pain tolerance was measured at baseline (T0) and after the first (T1), five (T5) and 10 treatment sessions (T10).

    10 days

Secondary Outcomes (1)

  • Neck Disability Index (NDI)

    10 days

Study Arms (2)

Vibration group

EXPERIMENTAL

Patients in the vibration therapy group received 10 self-administered sessions of vibration therapy (45-50 Hz), one session per day, remaining on their Shindo® vibration mattress at home in supine for 15 min.

Device: Shindo® vibration mattress

Control group

NO INTERVENTION

Subjects in the control group did not receive vibration therapy

Interventions

vibration therapy was self-administered while the subject was laying in supine in a polyurethane mattress

Also known as: vibration therapy
Vibration group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • a score of ≥ 5/50 in Neck Disability Index
  • active or latent myofascial trigger points in upper trapezius or levator scapulae muscles

You may not qualify if:

  • previous cervical spine surgery
  • cervical radiculopathy
  • severe systemic disease
  • fibromyalgia
  • other widespread musculoskeletal pain syndromes
  • patients being treated with medication or physiotherapy within the last 4 weeks

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Universitat de Valencia

Valencia, 46020, Spain

Location

Related Publications (1)

  • Imtiyaz S, Veqar Z, Shareef MY. To Compare the Effect of Vibration Therapy and Massage in Prevention of Delayed Onset Muscle Soreness (DOMS). J Clin Diagn Res. 2014 Jan;8(1):133-6. doi: 10.7860/JCDR/2014/7294.3971. Epub 2014 Jan 12.

MeSH Terms

Conditions

Myofascial Pain SyndromesNeck Pain

Condition Hierarchy (Ancestors)

Muscular DiseasesMusculoskeletal DiseasesPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Sofía Pérez, PhD

    University of Valencia

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD

Study Record Dates

First Submitted

February 22, 2015

First Posted

March 19, 2015

Study Start

August 1, 2014

Primary Completion

April 1, 2016

Study Completion

December 1, 2019

Last Updated

May 19, 2022

Record last verified: 2022-05

Locations