NCT03149614

Brief Summary

The aim of this study is to compare the clinical effects of spinal mobilization versus vertebral resonant oscillation (POLD) in patients with bilateral mechanical neck pain on pain sensitivity and neck pain intensity.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started May 2017

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

First Submitted

Initial submission to the registry

May 9, 2017

Completed
1 day until next milestone

Study Start

First participant enrolled

May 10, 2017

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 11, 2017

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2018

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 25, 2018

Completed
Last Updated

October 31, 2018

Status Verified

October 1, 2018

Enrollment Period

9 months

First QC Date

May 9, 2017

Last Update Submit

October 28, 2018

Conditions

Keywords

mobilizationresonant oscillation

Outcome Measures

Primary Outcomes (1)

  • Changes in pain intensity before and after the intervention

    A 10-point Numerical Pain Rating Scale (NPRS; 0: no pain, 10: maximum pain) will be used to assess the patients' current level of neck pain

    Baseline, one week after the last session, 1 months and 3 months after the last session.

Secondary Outcomes (1)

  • Changes in disability before and after the intervention

    Baseline, one week after the last session, 1 months and 3 months after the last session.

Study Arms (2)

Spine Mobilizations

ACTIVE COMPARATOR

Patients receive spinal mobilizations in grades II to III of central posterior-anterior from cervical and thoracic spine as described Maitland in 2000.

Other: Spine Mobilizations

Vertebral Resonant Oscillation (POLD method)

EXPERIMENTAL

The vertebral resonant oscillation using the POLD method is similar to spine mobilizations, but there are some differens; the oscillatory movement has a sinusoidal waveform, the frequency used between 1.2 and 2 Hz and the amplitude is similar to "neutral zone" to described by Panjabi 1992.

Other: Vertebral Resonant Oscillation

Interventions

Patients receive spinal mobilizations in grades II to III of central posterior-anterior from cervical and thoracic spine as described Maitland in 2000

Spine Mobilizations

The vertebral resonant oscillation using the POLD method is similar to spine mobilizations, but there are some differens ; the oscillatory movement has a sinusoidal waveform, the frequency used between 1.2 and 2 Hz and the amplitude is similar to "neutral zone" to described by Panjabi 1992.

Vertebral Resonant Oscillation (POLD method)

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • neck pain symptoms of mechanical nature
  • age from 18 to 60 years
  • bilateral symptoms
  • symptoms for at least 3 month of duration

You may not qualify if:

  • whiplash injury
  • previous spine surgery
  • diagnosis of cervical radiculopathy or myelopathy
  • having undergone any physical therapy intervention in the previous 6 month
  • pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Universidad Rey Juan Carlos

Madrid, 282922, Spain

Location

MeSH Terms

Conditions

Neck Pain

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

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

Study Record Dates

First Submitted

May 9, 2017

First Posted

May 11, 2017

Study Start

May 10, 2017

Primary Completion

February 1, 2018

Study Completion

October 25, 2018

Last Updated

October 31, 2018

Record last verified: 2018-10

Data Sharing

IPD Sharing
Will not share

Locations