WhiplashNCT03784196
Changes of Pain Sensitivity During Rehabilitation of Patients Suffering From Whiplash Associated Disorders
An observational study of Whiplash and Whiplash Injury, run by Universidad San Jorge at 1 site in Spain.
Trial summary
This study investigates the sensory profile of people suffering from whiplash associated disorders (WAD) during rehabilitation. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Whiplash, Whiplash Injury, Neck Pain
- What is being tested?
- Conservative rehabilitation
- How many people
- 44 participants
- Where
- 1 siteSpain
- Study dates
- 16 May 2016to 22 Oct 2019
- How long will I take part?
- 6 Months
- Phase
- Observational
- 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 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: Acute WAD following a motor vehicle accident (MVA) and age- and sex-matched healthy controls.
Who may be able to join
- WAD
- No more than 3 weeks since MVA/WAD
- WAD grade II defined by Quebec Task Force classification
- Controls • Being healthy and free from any pain specific to the low back and/or in general
Who cannot join
- Applies for both groups:
- Pain related to a specific pathology such as spinal stenosis, metastasis, fracture, nerve lesions or injuries to the brain etc.
- Previous painful condition (including neck pain) in the previous 6 months.
- Prior surgery in the neck or shoulder area.
- Radiculopathy.
- Multiple painful sites/areas unrelated to the neck pain.
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- Operation to the spine.
- Any neurological or systemic diseases which can affect the outcome measures.
- Pregnancy.
- Lack of ability to cooperate.
- Additional exclusion criteria for Controls:
- No current or previous history of on-going pain, defined as pain in the neck/shoulder region and/or elsewhere during the past 6 months.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Whiplash Associated Disorders - Sensory Changes During Rehabilitation
This study investigates the sensory profile of people suffering from whiplash associated disorders (WAD) during rehabilitation.
Read the detailed description
Altered pain sensitivity is commonly reported in WAD populations when compared to a healthy control group but how/if this changes over time during rehabilitation is unclear. This study investigates the effect of 2 weeks rehabilitation protocol on pain sensitivity in a group suffering from WAD compared to a healthy control group.
- Conditions
- Whiplash, Whiplash Injury, Neck Pain, Healthy
- Being tested
- Conservative rehabilitation
- Keywords
- WAD, rehabilitation, whiplash, neck pain, pain sensitivity
- Medical subject headings
- Whiplash Injuries, Neck Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Conservative rehabilitationOther
WAD participants underwent 2-weeks rehabilitation.
| Study group | Role | What they receive |
|---|---|---|
| Acute Whiplash Associated Disorders | People suffering from acute WAD at the time of recruitment. Receives: Other: Conservative rehabilitation | |
| Healthy controls | Participants with no neck pain during the past 6 months, chronic pain or other medical disorders relevant to this study. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in Pressure Pain Thresholds
Changes in pressure pain thresholds will be determined with pressure algometry bilaterally over the neck and leg. PPT is defined as the exact time point where the pressure is first being perceived at painful.
Measured: Baseline, 2 weeks, 6 months
Changes in Conditioned Pain Modulation
Changes in condition pain modulation (CPM) will be measures by recording PPT bilaterally over the neck and leg prior to and following a painful stimuli (a pressure cuff is inflated around the upper arm to create the conditioned stimulus). CPM value is calculated by subtracting raw PPT (without painful stimuli) from PPT under the conditioned stimulus.
Measured: Baseline, 2 weeks, 6 months
Secondary outcomes (1)
Neck Disability Index (NDI)
A validated and reliable questionnaire that estimates the impact of neck pain on normal daily activities (self-rated disability). NDI consists of 10 dimensions that all are score from 0-5 giving a maximum score of 50. The overall score indicates the level of disability. Below 5 = no disability whereas increased scores indicates increased levels of disability.
Measured: Baseline, 2 weeks, 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Dec 2018
- Study start16 May 2016
- Primary completion22 Apr 2019
- Study completion22 Oct 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for WhiplashStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 44 participants (actual)
- Target duration
- 6 Months
Sponsor and investigators
- Lead sponsor
- Universidad San Jorge
- Sponsor type
- University, hospital or other
- Collaborators
- Aalborg University
- Responsible party
- Sponsor
- Investigators
- Steffan W Christensen, PhD, Study director, Aalborg University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03784196
- Sponsor's protocol ID
- PI16/0132
- Status last verified
- Nov 2020
- First submitted
- 10 Dec 2018
- Last updated
- 10 Nov 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There are currently no plan on sharing data from this study with other researchers.
Study at a glance
From the registry record, last updated by the sponsor on 10 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Whiplash Associated Disorders - Sensory Changes During Rehabilitation
- ClinicalTrials.gov ID
- NCT03784196
- Acronym / sponsor ID
- PI16/0132
- Conditions
- Whiplash, Whiplash Injury, Neck Pain, Healthy
- Keywords
- WAD, rehabilitation, whiplash, neck pain, pain sensitivity
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- Universidad San JorgeUniversity, hospital or other
- Collaborators
- Aalborg University
- Study start
- 16 May 2016 (actual)
- Primary completion
- 22 Apr 2019 (actual)
- Study completion
- 22 Oct 2019 (actual)
- First posted
- 21 Dec 2018 (actual)
- 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.
This study investigates the sensory profile of people suffering from whiplash associated disorders (WAD) during rehabilitation.
Detailed description
Altered pain sensitivity is commonly reported in WAD populations when compared to a healthy control group but how/if this changes over time during rehabilitation is unclear. This study investigates the effect of 2 weeks rehabilitation protocol on pain sensitivity in a group suffering from WAD compared to a healthy control group.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 6 Months
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Acute Whiplash Associated Disorders | – | Other: Conservative rehabilitationPeople suffering from acute WAD at the time of recruitment. |
| Healthy controls | – | –Participants with no neck pain during the past 6 months, chronic pain or other medical disorders relevant to this study. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Acute WAD following a motor vehicle accident (MVA) and age- and sex-matched healthy controls.
Key inclusion criteria (4 listed)
- WAD
- No more than 3 weeks since MVA/WAD
- WAD grade II defined by Quebec Task Force classification
- Controls • Being healthy and free from any pain specific to the low back and/or in general
Key exclusion criteria (12 listed)
- Pain related to a specific pathology such as spinal stenosis, metastasis, fracture, nerve lesions or injuries to the brain etc.
- Previous painful condition (including neck pain) in the previous 6 months.
- Prior surgery in the neck or shoulder area.
- Radiculopathy.
- Multiple painful sites/areas unrelated to the neck pain.
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 |
|---|---|---|
| Conservative rehabilitationWAD participants underwent 2-weeks rehabilitation. | Other | Acute Whiplash Associated Disorders |
Primary outcome
Changes in Pressure Pain Thresholds
Time frame: Baseline, 2 weeks, 6 months
Changes in pressure pain thresholds will be determined with pressure algometry bilaterally over the neck and leg. PPT is defined as the exact time point where the pressure is first being perceived at painful.
Changes in Conditioned Pain Modulation
Time frame: Baseline, 2 weeks, 6 months
Changes in condition pain modulation (CPM) will be measures by recording PPT bilaterally over the neck and leg prior to and following a painful stimuli (a pressure cuff is inflated around the upper arm to create the conditioned stimulus). CPM value is calculated by subtracting raw PPT (without painful stimuli) from PPT under the conditioned stimulus.
1 secondary outcome
Neck Disability Index (NDI)
Time frame: Baseline, 2 weeks, 6 months
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 10 Nov 2020.
- Individual participant dataSharing planned: No. There are currently no plan on sharing data from this study with other researchers.
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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.
Steffan W Christensen, PhD study director
Aalborg University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Whiplash and Whiplash Injury, run by Universidad San Jorge at 1 site in Spain.
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 4 inclusion and 12 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 10 Nov 2020. 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 Spain. 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?
Changes in Pressure Pain Thresholds (time frame: Baseline, 2 weeks, 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 10 Nov 2020.