Whiplash SymptomsNCT01994044
Randomized WAD Study
A study testing Cervical fusion in people with Whiplash Symptoms, run by Spinal Surgery Clinic, Strängnäs at 1 site in Sweden.
Trial summary
Background: The majority of patients suffering a whiplash injury (WAD) will recover, but some may have symptoms for years despite all kinds of conservative treatment. The Neck Pain Task Force (2008) found no existing evidence for positive effects of fusion operations in such patients. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Whiplash Symptoms
- What is being tested?
- Cervical fusion
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- Not given
- Where
- 1 siteSweden
- Study dates
- Jul 1999to Oct 2013
- 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 60 years
- All sexes
- Adult
Who may be able to join
- The patients were to have been involved in a traffic accident as the origin of their pain and to have had pronounced symptoms lasting for at least one year.
- They should be in the age group 18 to 60 years,
- have been actively working up until the accident,
- should not have had previous neck pain.
- All patients should have had a plain X-ray and an MRI showing no specific changes.
- The patients should present with pronounced neck pain with the origin in the midline.
- The character of the pain should be dull, aching, and, with sudden movements, stabbing in the same area.
- Palpation and pressure in that area should provoke deep pain..
Who cannot join
- Previous pain in the neck, previous surgery
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Treating Selected Chronic WAD Patients: Cervical Fusion or Multidimensional Rehabilitation. A Randomized Study
Background: The majority of patients suffering a whiplash injury (WAD) will recover, but some may have symptoms for years despite all kinds of conservative treatment. The Neck Pain Task Force (2008) found no existing evidence for positive effects of fusion operations in such patients. Some of them, however, present with symptoms that might indicate pain from a motion segment, possibly the disc. Our aim was therefore to test this possibility by performing a randomized study comparing cervical fusion and multimodal rehabilitation in chronic WAD patients.
Methods: Patients with a specified symptomatology, all with pronounced symptoms for long periods of time, were recruited and randomized to surgery (25 pat.) or to multimodal rehabilitation (24 pat.). All patients were investigated before start of the study and at follow-up approximately two years after treatment by four independent examiners from disciplines usually involved in treating WAD patients. The patients also gave their own assessments of the treatment results. Seven patients in each group did not undergo the allocated treatment for various reasons.
Read the detailed description
Outcomes:
representing different disciplines: neurology, orthopedics, physical medicine and psychology. Each patient´s perceived change in outcome was also assessed. Assessment was made before treatment and at follow-up two years afterwards.
In addition to the assessments of outcome made by the examiners, the patients completed the SF-36, EQ-5D and BIS (Balanced Inventory for Spinal Disorders) questionnaires before treatment and at follow-up. The results of these assessments will be given in a forthcoming paper.
6b. No changes in trial outcomes were made during the study.
- Conditions
- Whiplash Symptoms
- Being tested
- Cervical fusion
- Keywords
- Whiplash, surgery, multimodal rehabilitation, independent examiners
- Medical subject headings
- Whiplash Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cervical fusionProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| Multimodal rehabilitation | Active comparator | Not described Receives: Procedure: Cervical fusion |
| Cervical fusion | Active comparator | Not described Receives: Procedure: Cervical fusion |
What is being measured
The primary outcome is the main question the study is designed to answer.
Complaints of WAD
Measured: Independent examiners
SF-36 questionnaire
Measured: Follow-up at 2 years
Secondary outcomes (2)
Complaints of WAD
Measured: SF-36
Range of neck movement
Measured: Follow-up at 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Nov 2013 (estimated)
- Study startJul 1999
- Primary completionOct 2005
- Study completionOct 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Whiplash SymptomsStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
Sponsor and investigators
- Lead sponsor
- Spinal Surgery Clinic, Strängnäs
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Bo Nyström, Spinal Surgery Clinic, Strängnäs
- Investigators
- Bo Nyström, MD, PhD, Principal investigator, Clinic of Spinal Surgery
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01994044
- Sponsor's protocol ID
- RKSWAD SpinalSC
- Other IDs
- SpinalSC
- Status last verified
- Nov 2013
- First submitted
- 13 Nov 2013
- Last updated
- 25 Nov 2013
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Carragee EJ, Hurwitz EL, Cheng I, Carroll LJ, Nordin M, Guzman J, Peloso P, Holm LW, Cote P, Hogg-Johnson S, van der Velde G, Cassidy JD, Haldeman S; Bone and Joint Decade 2000-2010 Task Force on Neck Pain and Its Associated Disorders. Treatment of neck pain: injections and surgical interventions: results of the Bone and Joint Decade 2000-2010 Task Force on Neck Pain and Its Associated Disorders. Spine (Phila Pa 1976). 2008 Feb 15;33(4 Suppl):S153-69. doi: 10.1097/BRS.0b013e31816445ea.
PubMed 18204388
Study at a glance
From the registry record, last updated by the sponsor on 25 Nov 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treating Selected Chronic WAD Patients: Cervical Fusion or Multidimensional Rehabilitation. A Randomized Study
- ClinicalTrials.gov ID
- NCT01994044
- Acronym / sponsor ID
- RKSWAD SpinalSC
- Conditions
- Whiplash Symptoms
- Keywords
- Whiplash, surgery, multimodal rehabilitation, independent examiners
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- Spinal Surgery Clinic, SträngnäsUniversity, hospital or other
- Study start
- Jul 1999
- Primary completion
- Oct 2005 (actual)
- Study completion
- Oct 2013 (actual)
- First posted
- 25 Nov 2013 (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.
Background: The majority of patients suffering a whiplash injury (WAD) will recover, but some may have symptoms for years despite all kinds of conservative treatment. The Neck Pain Task Force (2008) found no existing evidence for positive effects of fusion operations in such patients. Some of them, however, present with symptoms that might indicate pain from a motion segment, possibly the disc. Our aim was therefore to test this possibility by performing a randomized study comparing cervical fusion and multimodal rehabilitation in chronic WAD patients.
Methods: Patients with a specified symptomatology, all with pronounced symptoms for long periods of time, were recruited and randomized to surgery (25 pat.) or to multimodal rehabilitation (24 pat.). All patients were investigated before start of the study and at follow-up approximately two years after treatment by four independent examiners from disciplines usually involved in treating WAD patients. The patients also gave their own assessments of the treatment results. Seven patients in each group did not undergo the allocated treatment for various reasons.
Detailed description
Outcomes:
representing different disciplines: neurology, orthopedics, physical medicine and psychology. Each patient´s perceived change in outcome was also assessed. Assessment was made before treatment and at follow-up two years afterwards.
In addition to the assessments of outcome made by the examiners, the patients completed the SF-36, EQ-5D and BIS (Balanced Inventory for Spinal Disorders) questionnaires before treatment and at follow-up. The results of these assessments will be given in a forthcoming paper.
6b. No changes in trial outcomes were made during the study.
Study design
- Primary purpose
- Treatment
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Multimodal rehabilitation | Active comparator | Procedure: Cervical fusion |
| Cervical fusion | Active comparator | Procedure: Cervical fusion |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Age groups
- Adult
Key inclusion criteria (8 listed)
- The patients were to have been involved in a traffic accident as the origin of their pain and to have had pronounced symptoms lasting for at least one year.
- They should be in the age group 18 to 60 years,
- have been actively working up until the accident,
- should not have had previous neck pain.
- All patients should have had a plain X-ray and an MRI showing no specific changes.
Key exclusion criteria (1 listed)
- Previous pain in the neck, previous surgery
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 |
|---|---|---|
| Cervical fusion | Procedure or surgery | Cervical fusion, Multimodal rehabilitation |
Primary outcome
Complaints of WAD
Time frame: Independent examiners
SF-36 questionnaire
Time frame: Follow-up at 2 years
2 secondary outcomes
Complaints of WAD
Time frame: SF-36
Range of neck movement
Time frame: Follow-up at 2 years
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 25 Nov 2013.
- Background: PubMed 18204388Carragee EJ, Hurwitz EL, Cheng I, Carroll LJ, Nordin M, Guzman J, Peloso P, Holm LW, Cote P, Hogg-Johnson S, van der Velde G, Cassidy JD, Haldeman S; Bone and Joint Decade 2000-2010 Task Force on Neck Pain and Its Associated Disorders. Treatment of neck pain: injections and surgical interventions: results of the Bone and Joint Decade 2000-2010 Task Force on Neck Pain and Its Associated Disorders. Spine (Phila Pa 1976). 2008 Feb 15;33(4 Suppl):S153-69. doi: 10.1097/BRS.0b013e31816445ea.
- Related InfoLink provided by the sponsor.
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StressModex for Post-Traumatic Neck Pain
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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.
Bo Nyström, MD, PhD principal investigator
Clinic of Spinal Surgery
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cervical fusion in people with Whiplash Symptoms, run by Spinal Surgery Clinic, Strängnäs 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 8 inclusion and 1 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 25 Nov 2013. 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?
Complaints of WAD (time frame: Independent examiners). 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?
On the ClinicalTrials.gov record for NCT01994044, which also lists 1 linked publication.
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 25 Nov 2013.