NCT02772042

Brief Summary

Manual therapy reduces symptoms in patients with cervicogenic dizziness. The mobilization and manipulation of upper cervical spine are the most popular treatment in this patients. The International Federation of Orthopaedic Manipulative Physical Therapists suggest different recommendations for the safety application of manual therapy techniques in the upper cervical spine, traction manipulation techniques complies with this conditions. However, there isn´t investigation about the effect of traction manipulation in patients with cervicogenic dizziness. The aim of this study is to investigate the effects of traction manipulation in dizziness intensity, range of motion of cervical spine and quality of life on patients with cervicogenic dizziness.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2015

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

October 1, 2015

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2015

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

May 5, 2016

Completed
8 days until next milestone

First Posted

Study publicly available on registry

May 13, 2016

Completed
12 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2017

Completed
Last Updated

May 7, 2018

Status Verified

May 1, 2018

Enrollment Period

1 month

First QC Date

May 5, 2016

Last Update Submit

May 1, 2018

Conditions

Keywords

Manual TherapyPhysiotherapyManipulation

Outcome Measures

Primary Outcomes (1)

  • Change of baseline in Dizziness Intensity (100mm VAS) at 1 week and 1 month

    Baseline- 1 week- 1 month

Secondary Outcomes (3)

  • Change of baseline in range of motion of cervical spine change (Tool: Cervical range of motion)

    Baseline- 1 week- 1 month

  • Change of baseline in upper cervical spine range of motion (Tool: Cervical range of motion)

    Baseline- 1 week- 1 month

  • Change of baseline in dizziness Handicap Inventory (questionnaire)

    Baseline- 1 week- 1 month

Study Arms (2)

Intervention Group

EXPERIMENTAL

Investigators will performed traction manipulation of those articulations of upper cervical spine with indication for this treatment. Before manipulation soft tissue techniques will be applied in order to prepare the joint. After manipulation the patient rest in supine position. The intervention will have a duration of 10 minutes.

Other: Intervention Group

Control Group

OTHER

The patient of the control group maintain the supine position for 10 minutes.

Other: Control Group

Interventions

Intervention Group
Control Group

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Dizziness associated with neck stiffness and/or neck pain.
  • Hypomobility of upper cervical spine.
  • Sing the informed consent form.

You may not qualify if:

  • Contraindications for Traction manipulation.
  • Pending litigation or legal claim.
  • Poor language and communication skills making difficult to understand the informed consent.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Unidad de Investgación en Fisioterapia. Universidad de Zaragoza

Zaragoza, 50009, Spain

Location

MeSH Terms

Conditions

DizzinessNeck Pain

Interventions

Control Groups

Condition Hierarchy (Ancestors)

Sensation DisordersNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsPain

Intervention Hierarchy (Ancestors)

Epidemiologic Research DesignEpidemiologic MethodsInvestigative TechniquesResearch DesignMethods

Study Officials

  • Andoni Carrasco, Pt

    Unidad de Investigación en Fisioterapia. Universidad de Zaragoza

    PRINCIPAL INVESTIGATOR

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
SPONSOR INVESTIGATOR
PI Title
PT

Study Record Dates

First Submitted

May 5, 2016

First Posted

May 13, 2016

Study Start

October 1, 2015

Primary Completion

November 1, 2015

Study Completion

May 1, 2017

Last Updated

May 7, 2018

Record last verified: 2018-05

Data Sharing

IPD Sharing
Will not share

Locations