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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Anneli Peolsson, Linkoeping University
ClinicalTrials.gov Identifier:
NCT01547624
First received: February 28, 2012
Last updated: May 26, 2014
Last verified: May 2014
  Purpose

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.


Condition Intervention
Whiplash Associated Disorder
Other: Neck specific exercises

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Diagnostic

Resource links provided by NLM:


Further study details as provided by Linkoeping University:

Primary Outcome Measures:
  • Speckle tracking analysis of muscle function [ Time Frame: Baseline and at 3 and 6 months follow-up. The outcome measure is going to report a change over time. ] [ Designated as safety issue: No ]
    Measured with medical ultrasonography


Secondary Outcome Measures:
  • Background data [ Time Frame: Baseline ] [ Designated as safety issue: No ]
    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 [ Time Frame: Baseline and at 3 months follow-up. The outcome measure is going to report a change over time. ] [ Designated as safety issue: No ]
  • Pain intensity on visual analogue scale (VAS) [ Time Frame: Baseline and at 3 months follow-up. The outcome measure is going to report a change over time. ] [ Designated as safety issue: No ]
    Symptoms in general, Neck, Arm, Headache

  • 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. ] [ Designated as safety issue: No ]
  • Pain distribution on drawing [ Time Frame: Baseline and at 3 months follow-up. The outcome measure is going to report a change over time. ] [ Designated as safety issue: No ]
  • Pain Disability Index [ Time Frame: Baseline and at 3 months follow-up. The outcome measure is going to report a change over time ] [ Designated as safety issue: No ]
  • Neck Disability Index [ Time Frame: Baseline and at 3 month follow-up. The outcome measure is going to report a change over time. ] [ Designated as safety issue: No ]
  • 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. ] [ Designated as safety issue: No ]
  • Pain Catastrophizing Scale [ Time Frame: Baseline and at 3 month follow-up. The outcome measure is going to report a change over time. ] [ Designated as safety issue: No ]
  • 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. ] [ Designated as safety issue: No ]
  • Euroquol [ Time Frame: Baseline and at 3 month follow-up. The outcome measure is going to report a change over time. ] [ Designated as safety issue: No ]
    Euroquol 5D and thermometer

  • Exercise Self-Efficacy Scale [ Time Frame: Baseline and at 3 month follow-up. The outcome measure is going to report a change over time. ] [ Designated as safety issue: No ]
    "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 [ Time Frame: Baseline and at 3 month follow-up. The outcome measure is going to report a change over time. ] [ Designated as safety issue: No ]
    "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 [ Time Frame: Baseline and at 3 month follow-up. The outcome is going to report a change over time. ] [ Designated as safety issue: No ]
  • Physical Activity level [ Time Frame: Baseline and at 3 month follow-up. The outcome measure is going to report a change over time. ] [ Designated as safety issue: No ]
  • Physical Outcome Measures [ Time Frame: Baseline and at 3 month follow-up. The outcome is going to report a change over time. ] [ Designated as safety issue: No ]
    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 [ Time Frame: Baseline and at 3 month follow-up. The outcome measure is going to report a change over time. ] [ Designated as safety issue: No ]

Estimated Enrollment: 60
Study Start Date: February 2011
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Neck Specific exercises
3 months of neck specific exercises for 30 patients.
Other: Neck specific exercises
Neck specific exercises 2 times/week for 3 month at a physiotherapist. Home exercises.
Other Name: Physiotherapy with neck specific exercises
No Intervention: Waiting list
Thirty patients on the waiting list for 3 month before they have their intervention
No Intervention: Healthy controls
Forty healthy controls. Comparisons between forty included WAD patients and 40 healthy controls matched for age and gender will be investigated at baseline.

  Eligibility

Ages Eligible for Study:   18 Years to 63 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01547624

Locations
Sweden
Anneli Peolsson
Linköping, Östergötland, Sweden, SE-58183
Sponsors and Collaborators
Linkoeping University
Investigators
Study Chair: Anneli Peolsson, Assoc. Prof. Linköping university
  More Information

No publications provided

Responsible Party: Anneli Peolsson, Assoc. Prof., PhD, MSC PT, Linkoeping University
ClinicalTrials.gov Identifier: NCT01547624     History of Changes
Other Study ID Numbers: Ultrasound on neck muscles WAD
Study First Received: February 28, 2012
Last Updated: May 26, 2014
Health Authority: Sweden: Regional Ethical Review Board

Keywords provided by Linkoeping University:
Neck
Spine
Muscles
Activity
Coordination

Additional relevant MeSH terms:
Whiplash Injuries
Neck Injuries
Wounds and Injuries

ClinicalTrials.gov processed this record on September 22, 2014