NCT01547624

Brief Summary

Today there is evidence for that neck specific exercises reduce neck pain problems in patients with mechanical neck pain. However, there is a lack of consensus on how to optimize neck exercises and dosages in neck rehabilitation. More knowledge is needed to determine which and how muscles are activated in exercises thought to be neck-specific. There is neither enough knowledge of differences in neck muscle activation between patients with long standing neck problems after a whiplash trauma and healthy controls nor if the neck muscle function improved with specific neck exercises. One approach would be a real time study of deformation and deformation rate in different layers of neck muscles in patients with residual long-term neck pain and disability after a whiplash trauma. The purpose of the present study was to investigate deformation and deformation rate in different layers of dorsal and ventral neck muscles (including upper and middle part of trapezius muscle) during rest and during different exercises; arm flexion until 120 degrees, repeated arm flexion until 90 degrees, low loaded neck extension, low loaded neck muscle endurance test, shoulder elevation. Forty patients with long standing (more than 6 months but less than 3 years)patients and 40 controls matched for age and gender will be included for comparisons between patients and healthy in neck muscle activation. The investigators also include 60 patients with whiplash trauma, of those 30 patients will be randomized to A. neck specific exercises in a 3 months period and B. will 30 be on a waiting list for 3 months. Measurements are performed at baseline and at 3 months follow-up. Those patients who fulfilled the 3 months period of neck specific exercises will also be asked for a 6 months follow-up.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Feb 2011

Longer than P75 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

February 1, 2011

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

February 28, 2012

Completed
9 days until next milestone

First Posted

Study publicly available on registry

March 8, 2012

Completed
3.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2015

Completed
Last Updated

March 13, 2017

Status Verified

March 1, 2017

Enrollment Period

4.8 years

First QC Date

February 28, 2012

Last Update Submit

March 10, 2017

Conditions

Keywords

NeckSpineMusclesActivityCoordination

Outcome Measures

Primary Outcomes (1)

  • Speckle tracking analysis of muscle function

    Measured with medical ultrasonography

    Baseline and at 3 and 6 months follow-up. The outcome measure is going to report a change over time.

Secondary Outcomes (17)

  • Background data

    Baseline

  • Symptom satisfaction

    Baseline and at 3 months follow-up. The outcome measure is going to report a change over time.

  • Pain intensity on visual analogue scale (VAS)

    Baseline and at 3 months follow-up. The outcome measure is going to report a change over time.

  • Dizziness/ unsteadiness on visual analogue scale

    Baseline and at 3 month follow-up. The outcome measure is going to report a change over time.

  • Pain distribution on drawing

    Baseline and at 3 months follow-up. The outcome measure is going to report a change over time.

  • +12 more secondary outcomes

Study Arms (3)

Neck Specific exercises

EXPERIMENTAL

3 months of neck specific exercises for 30 patients.

Other: Neck specific exercises

Waiting list

NO INTERVENTION

Thirty patients on the waiting list for 3 month before they have their intervention

Healthy controls

NO INTERVENTION

Forty healthy controls. Comparisons between forty included WAD patients and 40 healthy controls matched for age and gender will be investigated at baseline.

Interventions

Neck specific exercises 2 times/week for 3 month at a physiotherapist. Home exercises.

Also known as: Physiotherapy with neck specific exercises
Neck Specific exercises

Eligibility Criteria

Age18 Years - 63 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • WAD II and III
  • Age 18-63 years
  • Remaining problems
  • Right handed
  • Pain on right or on both sides.

You may not qualify if:

  • Myelopathy
  • Earlier fracture or luxation of the cervical column, earlier neck injury
  • Spinal tumour
  • Spinal infection
  • Surgery in the cervical column
  • Malignity
  • Systemic disease or other disease or another injury contraindicated to perform the treatment program or the measurements
  • Diagnosed severe psychiatric disorder
  • Unconscious in connection to the trauma
  • Known drug abuse
  • Lack of familiarity with the Swedish language

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Anneli Peolsson

Linköping, Östergötland County, SE-58183, Sweden

Location

Related Publications (2)

  • Peolsson A, Landen Ludvigsson M, Tigerfors AM, Peterson G. Effects of Neck-Specific Exercises Compared to Waiting List for Individuals With Chronic Whiplash-Associated Disorders: A Prospective, Randomized Controlled Study. Arch Phys Med Rehabil. 2016 Feb;97(2):189-95. doi: 10.1016/j.apmr.2015.10.087. Epub 2015 Oct 26.

  • Landen Ludvigsson M, Peterson G, Jull G, Trygg J, Peolsson A. Mechanical properties of the trapezius during scapular elevation in people with chronic whiplash associated disorders--A case-control ultrasound speckle tracking analysis. Man Ther. 2016 Feb;21:177-82. doi: 10.1016/j.math.2015.07.009. Epub 2015 Aug 5.

MeSH Terms

Conditions

Motor Activity

Interventions

Physical Therapy Modalities

Condition Hierarchy (Ancestors)

Behavior

Intervention Hierarchy (Ancestors)

TherapeuticsRehabilitation

Study Officials

  • Anneli Peolsson, Assoc. Prof.

    Linkoeping University

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assoc. Prof., PhD, MSC PT

Study Record Dates

First Submitted

February 28, 2012

First Posted

March 8, 2012

Study Start

February 1, 2011

Primary Completion

December 1, 2015

Study Completion

December 1, 2015

Last Updated

March 13, 2017

Record last verified: 2017-03

Locations