NCT01806519

Brief Summary

Neck pain is a common problem in the western world. There is a group of people suffering from neck pain with a reduced ability to maintain an upright posture showing a forward head position and an altered muscle function. The aim of the study was to evaluate a motor control intervention for patients with persistent neck pain and a forward head posture. This pilot study used a Single System Experimental Design (SSED) with an A-B-A-design and multiple baselines. The tailored motor control intervention addressed the faulty postural alignment and the deep muscles of the cervical spine.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
3

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2009

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, 2009

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2011

Completed
2.2 years until next milestone

First Submitted

Initial submission to the registry

March 4, 2013

Completed
3 days until next milestone

First Posted

Study publicly available on registry

March 7, 2013

Completed
Last Updated

March 7, 2013

Status Verified

March 1, 2013

Enrollment Period

1.3 years

First QC Date

March 4, 2013

Last Update Submit

March 6, 2013

Conditions

Keywords

neck painmotor controlinterventionforward head posture

Outcome Measures

Primary Outcomes (2)

  • Head posture

    The craniovertebral (CV) -angle was used to estimate the cervical curvature and head posture in relation to the thorax being measured with the Head Posture Spinal Curvature Instrument

    Effect from baseline to 8 weeks and being maintained to 12 month

  • Muscle function of the deep cervical flexors

    The Cranio-Cervical Flexion Test (C-CFT) was used to assess the tonic holding abilities of the deep cervical muscles by using a Pressure biofeedback unit.

    Effect from baseline to 8 weeks and being maintained to 12 month

Secondary Outcomes (2)

  • Disability

    Effect from baseline to 8 weeks and being maintained to 12 month

  • Pain intensity

    Effect from baseline to 8 weeks and being maintained to 12 month

Other Outcomes (1)

  • Posture

    Effect from baseline to 8 weeks and being maintained to 12 month

Interventions

The tailored motor control intervention used for motor learning-procedure described by Fitts and Posner, further developed and adapted to rehabilitation of the spine by O´Sullivan. The stages involved in the process was the Cognitive stage, Associative stage and the Autonomous stage

Eligibility Criteria

Age20 Years - 50 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • years of age with pain originating from the neck for at least three months.
  • A visual forward head posture.
  • Less than105 points on the Örebro musculoskeletal pain screening questionnaire

You may not qualify if:

  • neurological dysfunction.
  • former cervical surgery or compression fracture of the spine
  • no mental retardation
  • no physiotherapy treatment during the last 6 months.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

OMT-kliniken

Luleå, Luleå, 97238, Sweden

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
NA
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Senior lecturer, PhD.

Study Record Dates

First Submitted

March 4, 2013

First Posted

March 7, 2013

Study Start

September 1, 2009

Primary Completion

January 1, 2011

Study Completion

January 1, 2011

Last Updated

March 7, 2013

Record last verified: 2013-03

Locations