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Neck Muscle Activation in Patients With Long Standing Problems After a Whiplash Trauma Registered With Ultrasound With Speckle Tracking

Primary Purpose

Whiplash Associated Disorder

Status
Completed
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
Neck specific exercises
Sponsored by
Linkoeping University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Whiplash Associated Disorder focused on measuring Neck, Spine, Muscles, Activity, Coordination

Eligibility Criteria

18 Years - 63 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

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

Exclusion Criteria:

  • 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

Sites / Locations

  • Anneli Peolsson

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

No Intervention

No Intervention

Arm Label

Neck Specific exercises

Waiting list

Healthy controls

Arm Description

3 months of neck specific exercises for 30 patients.

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

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

Outcomes

Primary Outcome Measures

Speckle tracking analysis of muscle function
Measured with medical ultrasonography

Secondary Outcome Measures

Background data
Background data of age, gender, social situation, work, work situation, sick-leave, income, pain history, debute of symptoms, about the accident, earlier treatment, other diseases or pain problems, expectations of treatment
Symptom satisfaction
Pain intensity on visual analogue scale (VAS)
Symptoms in general, Neck, Arm, Headache
Dizziness/ unsteadiness on visual analogue scale
Pain distribution on drawing
Pain Disability Index
Neck Disability Index
Tampa Scale of Kinesiophobia (TSK-11 short version)
Pain Catastrophizing Scale
Hospital Anxiety and Depression Scale
Euroquol
Euroquol 5D and thermometer
Exercise Self-Efficacy Scale
"How confident you are to exercise when things get in the way" Exercise self-efficacy scale is a six item scale with a five point scale (1=not at all confident and 5=completely confident).
Self-Efficacy Scale
"People´s beliefs about their capabilities to produce designated levels of performance that exercise influence over events that affect their lives" Self-efficacy scale (by Altmaier) is a 20 item, 11 point scale (0=not at all confident, 10=completely confident).
Work Ability Index
Physical Activity level
Physical Outcome Measures
Active range of motion of the neck, Head repositioning accuracy, hand strength, neck muscle endurance, sharpened Romberg, walking in a figure of eight, neurological examination: reflexes, sensibility and motor function
SF-36

Full Information

First Posted
February 28, 2012
Last Updated
March 10, 2017
Sponsor
Linkoeping University
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1. Study Identification

Unique Protocol Identification Number
NCT01547624
Brief Title
Neck Muscle Activation in Patients With Long Standing Problems After a Whiplash Trauma Registered With Ultrasound With Speckle Tracking
Study Type
Interventional

2. Study Status

Record Verification Date
March 2017
Overall Recruitment Status
Completed
Study Start Date
February 2011 (undefined)
Primary Completion Date
December 2015 (Actual)
Study Completion Date
December 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Linkoeping University

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Whiplash Associated Disorder
Keywords
Neck, Spine, Muscles, Activity, Coordination

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Neck Specific exercises
Arm Type
Experimental
Arm Description
3 months of neck specific exercises for 30 patients.
Arm Title
Waiting list
Arm Type
No Intervention
Arm Description
Thirty patients on the waiting list for 3 month before they have their intervention
Arm Title
Healthy controls
Arm Type
No Intervention
Arm Description
Forty healthy controls. Comparisons between forty included WAD patients and 40 healthy controls matched for age and gender will be investigated at baseline.
Intervention Type
Other
Intervention Name(s)
Neck specific exercises
Other Intervention Name(s)
Physiotherapy with neck specific exercises
Intervention Description
Neck specific exercises 2 times/week for 3 month at a physiotherapist. Home exercises.
Primary Outcome Measure Information:
Title
Speckle tracking analysis of muscle function
Description
Measured with medical ultrasonography
Time Frame
Baseline and at 3 and 6 months follow-up. The outcome measure is going to report a change over time.
Secondary Outcome Measure Information:
Title
Background data
Description
Background data of age, gender, social situation, work, work situation, sick-leave, income, pain history, debute of symptoms, about the accident, earlier treatment, other diseases or pain problems, expectations of treatment
Time Frame
Baseline
Title
Symptom satisfaction
Time Frame
Baseline and at 3 months follow-up. The outcome measure is going to report a change over time.
Title
Pain intensity on visual analogue scale (VAS)
Description
Symptoms in general, Neck, Arm, Headache
Time Frame
Baseline and at 3 months follow-up. The outcome measure is going to report a change over time.
Title
Dizziness/ unsteadiness on visual analogue scale
Time Frame
Baseline and at 3 month follow-up. The outcome measure is going to report a change over time.
Title
Pain distribution on drawing
Time Frame
Baseline and at 3 months follow-up. The outcome measure is going to report a change over time.
Title
Pain Disability Index
Time Frame
Baseline and at 3 months follow-up. The outcome measure is going to report a change over time
Title
Neck Disability Index
Time Frame
Baseline and at 3 month follow-up. The outcome measure is going to report a change over time.
Title
Tampa Scale of Kinesiophobia (TSK-11 short version)
Time Frame
Baseline and at 3 month follow-up. The outcome measure is going to report a change over time.
Title
Pain Catastrophizing Scale
Time Frame
Baseline and at 3 month follow-up. The outcome measure is going to report a change over time.
Title
Hospital Anxiety and Depression Scale
Time Frame
Baseline and at 3 month follow-up. The outcome measure is going to report a change over time.
Title
Euroquol
Description
Euroquol 5D and thermometer
Time Frame
Baseline and at 3 month follow-up. The outcome measure is going to report a change over time.
Title
Exercise Self-Efficacy Scale
Description
"How confident you are to exercise when things get in the way" Exercise self-efficacy scale is a six item scale with a five point scale (1=not at all confident and 5=completely confident).
Time Frame
Baseline and at 3 month follow-up. The outcome measure is going to report a change over time.
Title
Self-Efficacy Scale
Description
"People´s beliefs about their capabilities to produce designated levels of performance that exercise influence over events that affect their lives" Self-efficacy scale (by Altmaier) is a 20 item, 11 point scale (0=not at all confident, 10=completely confident).
Time Frame
Baseline and at 3 month follow-up. The outcome measure is going to report a change over time.
Title
Work Ability Index
Time Frame
Baseline and at 3 month follow-up. The outcome is going to report a change over time.
Title
Physical Activity level
Time Frame
Baseline and at 3 month follow-up. The outcome measure is going to report a change over time.
Title
Physical Outcome Measures
Description
Active range of motion of the neck, Head repositioning accuracy, hand strength, neck muscle endurance, sharpened Romberg, walking in a figure of eight, neurological examination: reflexes, sensibility and motor function
Time Frame
Baseline and at 3 month follow-up. The outcome is going to report a change over time.
Title
SF-36
Time Frame
Baseline and at 3 month follow-up. The outcome measure is going to report a change over time.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
63 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: WAD II and III Age 18-63 years Remaining problems Right handed Pain on right or on both sides. Exclusion Criteria: 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Anneli Peolsson, Assoc. Prof.
Organizational Affiliation
Linkoeping University
Official's Role
Study Chair
Facility Information:
Facility Name
Anneli Peolsson
City
Linköping
State/Province
Östergötland
ZIP/Postal Code
SE-58183
Country
Sweden

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
26514296
Citation
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.
Results Reference
derived
PubMed Identifier
26277485
Citation
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.
Results Reference
derived

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Neck Muscle Activation in Patients With Long Standing Problems After a Whiplash Trauma Registered With Ultrasound With Speckle Tracking

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