Whiplash Associated DisorderNCT01547624
Neck Muscle Activation in Patients With Long Standing Problems After a Whiplash Trauma Registered With Ultrasound With Speckle Tracking
A study testing Neck specific exercises in people with Whiplash Associated Disorder, run by Linkoeping University at 1 site in Sweden.
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. Read more about this study
- Who is it for?
- Ages 18 to 63 yearsHealthy volunteers can take part
- Conditions the study is for
- Whiplash Associated Disorder
- What is being tested?
- Neck specific exercises
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteSweden
- Study dates
- Feb 2011to Dec 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 63 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- WAD II and III
- Age 18-63 years
- Remaining problems
- Right handed
- Pain on right or on both sides.
Who cannot join
- Myelopathy
- Earlier fracture or luxation of the cervical column, earlier neck injury
- Spinal tumour
- Spinal infection
- Surgery in the cervical column
- Malignity
Show all 11Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Whiplash Associated Disorder
- Being tested
- Neck specific exercises
- Keywords
- Neck, Spine, Muscles, Activity, Coordination
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Neck specific exercisesOther
Also called Physiotherapy with neck specific exercises
Neck specific exercises 2 times/week for 3 month at a physiotherapist. Home exercises.
| Study group | Role | What they receive |
|---|---|---|
| Neck Specific exercises | Experimental | 3 months of neck specific exercises for 30 patients. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Speckle tracking analysis of muscle function
Measured with medical ultrasonography
Measured: 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
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
Measured: Baseline
Symptom satisfaction
Measured: 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)
Symptoms in general, Neck, Arm, Headache
Measured: Baseline and at 3 months follow-up. The outcome measure is going to report a change over time.
Dizziness/ unsteadiness on visual analogue scale
Measured: Baseline and at 3 month follow-up. The outcome measure is going to report a change over time.
Pain distribution on drawing
Measured: Baseline and at 3 months follow-up. The outcome measure is going to report a change over time.
Pain Disability Index
Measured: Baseline and at 3 months follow-up. The outcome measure is going to report a change over time
Neck Disability Index
Measured: Baseline and at 3 month follow-up. The outcome measure is going to report a change over time.
Tampa Scale of Kinesiophobia (TSK-11 short version)
Measured: Baseline and at 3 month follow-up. The outcome measure is going to report a change over time.
Pain Catastrophizing Scale
Measured: Baseline and at 3 month follow-up. The outcome measure is going to report a change over time.
Hospital Anxiety and Depression Scale
Measured: Baseline and at 3 month follow-up. The outcome measure is going to report a change over time.
Euroquol
Euroquol 5D and thermometer
Measured: Baseline and at 3 month follow-up. The outcome measure is going to report a change over time.
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).
Measured: Baseline and at 3 month follow-up. The outcome measure is going to report a change over time.
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).
Measured: Baseline and at 3 month follow-up. The outcome measure is going to report a change over time.
Work Ability Index
Measured: Baseline and at 3 month follow-up. The outcome is going to report a change over time.
Physical Activity level
Measured: Baseline and at 3 month follow-up. The outcome measure is going to report a change over time.
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
Measured: Baseline and at 3 month follow-up. The outcome is going to report a change over time.
SF-36
Measured: Baseline and at 3 month follow-up. The outcome measure is going to report a change over time.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Mar 2012 (estimated)
- Study startFeb 2011
- Primary completionDec 2015
- Study completionDec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Whiplash Associated DisorderStudies of the same condition, open and under way.
- More trials run by Linkoeping UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Linkoeping University
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Anneli Peolsson, Linkoeping University
- Investigators
- Anneli Peolsson, Assoc. Prof., Study chair, Linkoeping University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01547624
- Sponsor's protocol ID
- Ultrasound on neck muscles WAD
- Status last verified
- Mar 2017
- First submitted
- 28 Feb 2012
- Last updated
- 13 Mar 2017
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Publications
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.
PubMed 26514296Landen 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.
PubMed 26277485
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neck Muscle Activation in Patients With Long Standing Problems After a Whiplash Trauma Registered With Ultrasound With Speckle Tracking
- ClinicalTrials.gov ID
- NCT01547624
- Acronym / sponsor ID
- Ultrasound on neck muscles WAD
- Conditions
- Whiplash Associated Disorder
- Keywords
- Neck, Spine, Muscles, Activity, Coordination
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Linkoeping UniversityOther government
- Study start
- Feb 2011
- Primary completion
- Dec 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 8 Mar 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Neck Specific exercises | Experimental | Other: Neck specific exercises3 months of neck specific exercises for 30 patients. |
| 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. |
Who may qualify
- Ages
- 18 to 63 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- WAD II and III
- Age 18-63 years
- Remaining problems
- Right handed
- Pain on right or on both sides.
Key exclusion criteria (11 listed)
- Myelopathy
- Earlier fracture or luxation of the cervical column, earlier neck injury
- Spinal tumour
- Spinal infection
- Surgery in the cervical column
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Neck specific exercisesAlso: Physiotherapy with neck specific exercisesNeck specific exercises 2 times/week for 3 month at a physiotherapist. Home exercises. | Other | Neck Specific exercises |
Primary outcome
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.
Measured with medical ultrasonography
17 secondary outcomes
Background data
Time frame: Baseline
Symptom satisfaction
Time frame: 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)
Time frame: Baseline and at 3 months follow-up. The outcome measure is going to report a change over time.
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.
Pain distribution on drawing
Time frame: Baseline and at 3 months follow-up. The outcome measure is going to report a change over time.
Pain Disability Index
Time frame: Baseline and at 3 months follow-up. The outcome measure is going to report a change over time
Neck Disability Index
Time frame: Baseline and at 3 month follow-up. The outcome measure is going to report a change over time.
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.
Pain Catastrophizing Scale
Time frame: Baseline and at 3 month follow-up. The outcome measure is going to report a change over time.
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.
Euroquol
Time frame: Baseline and at 3 month follow-up. The outcome measure is going to report a change over time.
Exercise Self-Efficacy Scale
Time frame: Baseline and at 3 month follow-up. The outcome measure is going to report a change over time.
Self-Efficacy Scale
Time frame: Baseline and at 3 month follow-up. The outcome measure is going to report a change over time.
Work Ability Index
Time frame: Baseline and at 3 month follow-up. The outcome is going to report a change over time.
Physical Activity level
Time frame: Baseline and at 3 month follow-up. The outcome measure is going to report a change over time.
Physical Outcome Measures
Time frame: Baseline and at 3 month follow-up. The outcome is going to report a change over time.
SF-36
Time frame: Baseline and at 3 month follow-up. The outcome measure is going to report a change over time.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Mar 2017.
- Derived from this study: PubMed 26514296Peolsson 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.
- Derived from this study: PubMed 26277485Landen 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Anneli Peolsson, Assoc. Prof. study chair
Linkoeping University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Neck specific exercises in people with Whiplash Associated Disorder, run by Linkoeping University at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01547624, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Mar 2017.