NCT02051478

Brief Summary

The purpose of this randomized clinical trial was to examine the widespread effects of thoracic spine thrust manipulation and thoracic non-thrust mobilization on pressure pain sensitivity and neck pain intensity in patients with chronic mechanical neck pain.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
55

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2012

Shorter than P25 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

September 1, 2012

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2013

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

January 28, 2014

Completed
3 days until next milestone

First Posted

Study publicly available on registry

January 31, 2014

Completed
Last Updated

January 31, 2014

Status Verified

January 1, 2014

Enrollment Period

9 months

First QC Date

January 28, 2014

Last Update Submit

January 30, 2014

Conditions

Keywords

manipulationmobilizationspinepressure pain

Outcome Measures

Primary Outcomes (1)

  • Change in Pressure pain thresholds

    The amount of pressure applied for the pressure sensation to first change to pain will be assessed with an electronic algometer (Somedic AB, Farsta, Sweden) over the C5-C6 zygapophyseal joint, second metacarpal and tibialis anterior muscle

    Change between baseline and 1o minutes immediate after the intervention

Secondary Outcomes (1)

  • Change in Neck pain intensity

    Change between baseline and 1o minutes immediate after the intervention

Study Arms (2)

Thoracic manipulation

EXPERIMENTAL

A high-velocity, end range, anterior-posterior thrust applied through the elbows to the mid-thoracic spine will be applied.

Other: Thoracic manipulation

Thoracic mobilization

ACTIVE COMPARATOR

Patients will receive 20 seconds bouts of grade III-IV of central posterior-anterior (PA) non-thrust mobilization from T3 to T6 spinous process as described by Maitland et al for an overall intervention time of approximately 2 minutes

Other: Thoracic mobilization

Interventions

Patients will receive 20 seconds bouts of grade III-IV of central posterior-anterior (PA) non-thrust mobilization from T3 to T6 spinous process as described by Maitland et al for an overall intervention time of approximately 2 minutes

Thoracic mobilization

A high-velocity, end range, anterior-posterior thrust applied through the elbows to the mid-thoracic spine will be applied

Thoracic manipulation

Eligibility Criteria

Age20 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • mechanical idiopathic neck pain
  • bilateral pain symptoms
  • chronic pain (\>3 months of duration)

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Universidad Rey Juan Carlos

Alcorcón, Madrid, 28922, Spain

Location

MeSH Terms

Conditions

Neck Pain

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Jaime Salom.Moreno, PT, PhD

    Universidad Rey Juan Carlos

    PRINCIPAL INVESTIGATOR

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
PRINCIPAL INVESTIGATOR
PI Title
Head Division

Study Record Dates

First Submitted

January 28, 2014

First Posted

January 31, 2014

Study Start

September 1, 2012

Primary Completion

June 1, 2013

Study Completion

June 1, 2013

Last Updated

January 31, 2014

Record last verified: 2014-01

Locations