NCT01161758

Brief Summary

Passive accessory cervical mobilization is widely used as a clinical approach to the management of musculoskeletal pain of spinal origin. The purpose of the study is to determine if passive cervical mobilization can improve motor function in situations where motor performance is not impaired by the presence of pain.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
24

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Apr 2005

Shorter than P25 for not_applicable

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

April 1, 2005

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2005

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2005

Completed
4.6 years until next milestone

First Submitted

Initial submission to the registry

July 8, 2010

Completed
6 days until next milestone

First Posted

Study publicly available on registry

July 14, 2010

Completed
Last Updated

July 14, 2010

Status Verified

November 1, 2005

Enrollment Period

6 months

First QC Date

July 8, 2010

Last Update Submit

July 13, 2010

Conditions

Keywords

physical therapypain thresholdelectromyographymusculoskeletal manipulationneck muscles

Outcome Measures

Primary Outcomes (1)

  • Electromyography of sternocleidomastoid muscle.

    Measurement of sternocleidomastoid muscle activation during deep neck flexion. The degree of neck flexion is determined by a pressure biofeedback unit place underneath the neck. EMG of the left and right sternocleidomastoids are recorded for 5seconds at each level of neck flexion

    Pre intervention (baseline) and 1 minute post intervention

Secondary Outcomes (1)

  • Pressure pain threshold

    Pre intervention (baseline) and 1 minute post intervention

Study Arms (3)

Passive cervical mobilisation

ACTIVE COMPARATOR

Grade III cervical mobilization technique as described by Maitland. Applied to left C5/6 Segment.

Other: Passive cervical mobilisation

Manual contact

PLACEBO COMPARATOR

Manual contact control, which involved light manual contact on the left C5/C6 segment as if to perform the treatment technique.

Other: Manual contact

Non-contact control

NO INTERVENTION

Non-contact control, which involved the subject resting in the treatment position without any physical contact between the researcher and the subject.

Interventions

Passive cervical mobilization which involved an oscillatory grade III unilateral postero-anterior mobilization applied to the left C5/C6 segment. The mobilization consisted of 3 periods of 1 minute applications with a resting period of 1 minute in between.

Also known as: Physiotherapy
Passive cervical mobilisation

Manual contact control, which involved light manual contact on the left C5/C6 segment as if to perform the treatment technique. The light manual contact consisted of 3 periods of 1 minute applications with a resting period of 1 minute in between.

Also known as: placebo light touch
Manual contact

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • No history of neck or back pain over the last six months
  • Without any previous experience with spinal manual therapy techniques

You may not qualify if:

  • History of musculoskeletal or rheumatologic conditions
  • Any kind of spinal surgery
  • Dizziness
  • Previous trauma to the cervical spine
  • Neurological signs or symptoms

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Neck Pain

Interventions

Physical Therapy Modalities

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

TherapeuticsRehabilitation

Study Officials

  • Benjamin Soon Tze Chin, MManipTher

    The University of Queensland

    PRINCIPAL INVESTIGATOR
  • Annina Schmid, MManipTher

    The University of Queensland

    PRINCIPAL INVESTIGATOR
  • Elias Fridriksson, MManipTher

    Curtin University

    PRINCIPAL INVESTIGATOR
  • Philip Cheong, MManipTher

    Curtin University

    PRINCIPAL INVESTIGATOR
  • Elisabeth Gresslos, MManipTher

    Curitn University of Technology

    PRINCIPAL INVESTIGATOR
  • Anthony Wright, PhD

    Curtin University

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
OTHER

Study Record Dates

First Submitted

July 8, 2010

First Posted

July 14, 2010

Study Start

April 1, 2005

Primary Completion

October 1, 2005

Study Completion

December 1, 2005

Last Updated

July 14, 2010

Record last verified: 2005-11