Whiplash Associated Disorder Clinical Trial
Verified date | March 2017 |
Source | Linkoeping University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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 |
Country | Name | City | State |
---|---|---|---|
Sweden | Anneli Peolsson | Linköping | Östergötland |
Lead Sponsor | Collaborator |
---|---|
Linkoeping University |
Sweden,
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. |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT04622020 -
Cervical Plexus Block (CPB) in Whiplash Associated Disorder (WAD)
|