NCT02163590

Brief Summary

Passive mobilizations of the spine are widely used by physiotherapists in the management of neuromusculoskeletal disorders. There is a nascent body of work of the mechanical properties of joint mobilizations. Treatment dose is characterized by the direction of force applied, magnitude of force applied, frequency of oscillation, amplitude of displacement, repetition and time. Although the choice of better treatment dose is based on patient complaints and clinical reasoning, the comprehension of the effects of different parameters of joint mobilization will improve the decision making process. The optimal dose of treatment, however, is not already known. The primary aim of this study is to determine whether different rates of thoracic mobilization are capable to produces hypoalgesic effects, and secondarily investigate if such effects are local or widespread.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2014

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2014

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

June 10, 2014

Completed
3 days until next milestone

First Posted

Study publicly available on registry

June 13, 2014

Completed
18 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2014

Completed
Last Updated

March 6, 2015

Status Verified

March 1, 2015

Enrollment Period

4 months

First QC Date

June 10, 2014

Last Update Submit

March 5, 2015

Conditions

Keywords

Spinal mobilisationPressure pain thresholdThoracic spine

Outcome Measures

Primary Outcomes (1)

  • Pressure pain threshold

    Pressure pain threshold will be measured in five anatomic points on the spine, upper and lower limbs

    Change from baseline imediately after, and 15 minutes after the intervention

Study Arms (3)

2Hz mobilisation

EXPERIMENTAL

A bilateral postero-anterior mobilisation applied to the fourth thoracic vertebra, at a 2Hz frequency.

Other: 2Hz mobilisation

0,5Hz mobilisation

EXPERIMENTAL

A bilateral postero-anterior mobilisation applied to the fourth thoracic vertebra, at a 0,5Hz frequency.

Other: 0,5Hz mobilisation

Placebo

PLACEBO COMPARATOR

A simulation technique, that mimic the other groups, in this case only manual contact will be applied, without any oscillation.

Other: Placebo

Interventions

This intervention will be applied for 3 sets of 1 minute, with 1 minute rest period in between each set.

Also known as: Bilateral postero-anterior thoracic mobilisation
2Hz mobilisation

This intervention will be applied for 3 sets of 1 minute, with 1 minute rest period in between each set.

Also known as: Bilateral postero-anterior thoracic mobilisation
0,5Hz mobilisation
PlaceboOTHER

Intervention that mimics the experimental procedures

Also known as: Manual contact without oscillation
Placebo

Eligibility Criteria

Age18 Years - 40 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Healthy asymptomatic subjects
  • Manual therapy naive

You may not qualify if:

  • Any kind of history of trauma or surgery to the spine
  • Contraindications or precautions to manual therapy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Universidade Federal de Ciências da Saúde de Porto Alegre

Porto Alegre, Rio Grande do Sul, 90050-170, Brazil

Location

Study Officials

  • Francisco D Araujo, Pt

    Federal University of Health Science of Porto Alegre

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Physical therapist - Principal Investigator

Study Record Dates

First Submitted

June 10, 2014

First Posted

June 13, 2014

Study Start

March 1, 2014

Primary Completion

July 1, 2014

Study Completion

July 1, 2014

Last Updated

March 6, 2015

Record last verified: 2015-03

Locations