NCT02826590

Brief Summary

This study investigates the effects of spinal mobilizations on symptoms, 3D movement of the neck, neck muscle electromyography and sympathetic nervous system activity in people with neck pain.

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 Jun 2016

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

June 1, 2016

Completed
13 days until next milestone

First Submitted

Initial submission to the registry

June 14, 2016

Completed
27 days until next milestone

First Posted

Study publicly available on registry

July 11, 2016

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2017

Completed
Last Updated

October 3, 2017

Status Verified

September 1, 2017

Enrollment Period

1.2 years

First QC Date

June 14, 2016

Last Update Submit

October 2, 2017

Conditions

Outcome Measures

Primary Outcomes (5)

  • Change in muscle activity assessed by neck muscle electromyography

    Baseline and 2 minutes after intervention

  • Change in 3D neck movement assessed with a 10 camera Vicon system

    Baseline and 2 minutes after intervention

  • Change in sympathetic nervous system activity assessed by measuring right hand finger temperature

    Measurement unit: degrees celsius

    Baseline for 2 minutes immediately before intervention, during intervention (15 minutes) and for 2 minutes immediately after intervention

  • Change in sympathetic nervous system activity assessed by measuring right hand finger galvanic response

    Measurement unit: microsiemens

    Baseline for 2 minutes immediately before intervention, during intervention (15 minutes) and for 2 minutes immediately after intervention

  • Global rating of change scale

    Baseline and 10 minutes after intervention

Study Arms (2)

Neck passive mobilizations

EXPERIMENTAL

Neck passive mobilizations

Other: Neck passive mobilizations

Manual contact

PLACEBO COMPARATOR

Manual contact

Other: Manual contact

Interventions

Passive mobilizations performed to the neck of the participant by a Physiotherapist

Neck passive mobilizations

Manual contact applied to the neck of the participant by a Physiotherapist

Manual contact

Eligibility Criteria

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

You may qualify if:

  • Intermittent neck pain
  • That worsens or improves with certain neck movements or positions
  • Has not been caused by a blow, fall or accident

You may not qualify if:

  • Cervicobrachialgia
  • Has been treated with or is awaiting neck surgery
  • Diagnosed with a particular inflammatory disease or spinal condition
  • Where treatment with cervical mobilizations is contraindicated

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Atlas Fisioterapia

Donostia / San Sebastian, Gipuzkoa, 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
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 14, 2016

First Posted

July 11, 2016

Study Start

June 1, 2016

Primary Completion

July 31, 2017

Study Completion

July 31, 2017

Last Updated

October 3, 2017

Record last verified: 2017-09

Locations