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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01547624
Other study ID # Ultrasound on neck muscles WAD
Secondary ID
Status Completed
Phase N/A
First received February 28, 2012
Last updated March 10, 2017
Start date February 2011
Est. completion date December 2015

Study information

Verified date March 2017
Source Linkoeping University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 60
Est. completion date December 2015
Est. primary completion date December 2015
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 63 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
Sweden Anneli Peolsson Linköping Östergötland

Sponsors (1)

Lead Sponsor Collaborator
Linkoeping University

Country where clinical trial is conducted

Sweden, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 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 Baseline
Secondary Symptom satisfaction Baseline and at 3 months follow-up. The outcome measure is going to report a change over time.
Secondary Pain intensity on visual analogue scale (VAS) Symptoms in general, Neck, Arm, Headache Baseline and at 3 months follow-up. The outcome measure is going to report a change over time.
Secondary Dizziness/ unsteadiness on visual analogue scale Baseline and at 3 month follow-up. The outcome measure is going to report a change over time.
Secondary Pain distribution on drawing Baseline and at 3 months follow-up. The outcome measure is going to report a change over time.
Secondary Pain Disability Index Baseline and at 3 months follow-up. The outcome measure is going to report a change over time
Secondary Neck Disability Index Baseline and at 3 month follow-up. The outcome measure is going to report a change over time.
Secondary Tampa Scale of Kinesiophobia (TSK-11 short version) Baseline and at 3 month follow-up. The outcome measure is going to report a change over time.
Secondary Pain Catastrophizing Scale Baseline and at 3 month follow-up. The outcome measure is going to report a change over time.
Secondary Hospital Anxiety and Depression Scale Baseline and at 3 month follow-up. The outcome measure is going to report a change over time.
Secondary Euroquol Euroquol 5D and thermometer Baseline and at 3 month follow-up. The outcome measure is going to report a change over time.
Secondary 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). Baseline and at 3 month follow-up. The outcome measure is going to report a change over time.
Secondary Self-Efficacy Scale "PeopleĀ“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). Baseline and at 3 month follow-up. The outcome measure is going to report a change over time.
Secondary Work Ability Index Baseline and at 3 month follow-up. The outcome is going to report a change over time.
Secondary Physical Activity level Baseline and at 3 month follow-up. The outcome measure is going to report a change over time.
Secondary 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 Baseline and at 3 month follow-up. The outcome is going to report a change over time.
Secondary SF-36 Baseline and at 3 month follow-up. The outcome measure is going to report a change over time.
See also
  Status Clinical Trial Phase
Completed NCT04622020 - Cervical Plexus Block (CPB) in Whiplash Associated Disorder (WAD)