Whiplash InjuriesNCT02692937
Is Chronic Whiplash-associated Pain of Neurogenic Origin?
A study testing Neurolysis and Traditional neck-specific exercise program in people with Whiplash Injuries, run by Region Skane at 1 site in Sweden.
Trial summary
The purpose of this study is to compare the effects of neurolysis with the effects of a exercise program on pain and other symptoms in individuals with chronic whiplash (WAD II-III). Read more about this study
- Who is it for?
- Ages 20 to 60 years
- Conditions the study is for
- Whiplash Injuries
- What is being tested?
- Neurolysis and Traditional neck-specific exercise program
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteSweden
- Study dates
- Jan 2011to Sep 2017
- 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 20 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- trauma that has caused a whiplash injury
- at least one year of incapacitating chronic neck pain/headache related to the injury (WAD II-III)
- typical trigger points in the back of the head or in the neck and significant pain relief with local anesthesia towards the painful areas
Who cannot join
- mental illness
- abuse of drugs/alcohol
- not understanding or reading the Swedish language
- previous surgery in the back of the head
Trial locations and contacts
1 site in 1 country.
Sweden1 site
The Department of Neurosurgery, Skåne University Hospital
Lund, Skåne County, 22185
About this study
Official title: Is Chronic Whiplash-associated Pain of Neurogenic Origin? A Study Protocol of a Randomized Controlled Trial Comparing Neurolysis of Peripheral Nerves With Traditional Neck-specific Exercise
The purpose of this study is to compare the effects of neurolysis with the effects of a exercise program on pain and other symptoms in individuals with chronic whiplash (WAD II-III).
Read the detailed description
People with whiplash associated disorders (WAD) grade II-III have chronic severe pain and symptoms and reduced quality of life. The origin of the symptoms is still unknown, and there are to date no available guidelines for treatment of this condition. The lack of effective treatment leads to high costs for the patients, and to society, due to considerable medical care and work loss.
After providing a written consent, the patients will be randomized to either surgical treatment with neurolysis of peripheral nerve/s in the back of the head and/or neck plus physiotherapy or to physiotherapy (care-as-usual) only. Both groups will be treated with the same traditional neck-specific exercise program for 12 months. All participants will be evaluated with patient-reported outcomes and clinical examination at baseline, and at 6, 12 and 24 months after inclusion.
The main outcome will be change in NDI from baseline to the 2-year follow-up. A preliminary sample-size calculation shows that 27 patients are needed for each treatment arm to detect a clinically important change of 10 points in NDI, with a between-group standard deviation of 13 point (statistical power of 80 % and a 5% significance level). To account for a 20% drop-out rate, 32 patients will be included per arm. Because this is the first RCT on neurolysis vs care-as-usual treatment, a second sample-size calculation including empirical data will performed by an independent statistician, without breaking the code, when 30 patients in each group have been included. Secondary outcomes include VAS (average pain including pain in the head, neck and face), symptom index, self-efficacy, HDI, WAD-DI, psychosomatic aspects, quality of life and clinical examination. Data will be performed with parametric, or non-parametric statistics, as appropriate, in IBM SPSS Statistics version 22 for Mac (IBM Corp., Armonk, NY, USA). Analysis will be performed according to both intention-to-treat and per protocol. To account for missing data, the previous group means value will be considered to remain form the last occasion and used as carry forward. For continuous data, differences in mean change (baseline vs follow-up) will be compared between groups and adjusted in relation to baseline values. For categorical data, differences in median change (baseline vs follow-up) will be compared between groups and adjusted in relation to baseline values. Effect sizes will be calculated for all measures.
This Randomized Controlled Study is approved and funded by the National Board of Health and Welfare in Sweden (project no 6168/2007).
- Conditions
- Whiplash Injuries
- Being tested
- Neurolysis, Traditional neck-specific exercise program
- Keywords
- Neurosurgical Procedures, Nerve Block, Exercise therapy, Physical Therapy Specialty
- Medical subject headings
- Whiplash Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NeurolysisProcedure or surgery
Traditional neck-specific exercise programOther
| Study group | Role | What they receive |
|---|---|---|
| Surgery and exercise | Experimental | Neurolysis of peripheral nerves in the back of the head and/or neck. Traditional neck-specific exercise program including five individual treatments sessions within 3 months plus home program over 9 months. Receives: Procedure: Neurolysis; Other: Traditional neck-specific exercise program |
| Exercise, Active Comparator | Active comparator | Traditional neck-specific exercise program including five individual treatments sessions within 3 months plus home program over 9 months. Receives: Other: Traditional neck-specific exercise program |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Neck Disability Index (NDI)
Questionnaire
Measured: 24 months
Secondary outcomes (11)
The Symptom index
Related symptoms (pain) psychosomatic aspects and any disability due to the neck complaint. Questionnaire.
Measured: 24 months
Self-Efficacy Scale (SES)
Questionnaire
Measured: 24 months
Headache Disability Index (HDI)
Questionnaire
Measured: 24 months
Whiplash Associated Disorders - Disability Index (WAD-DI)
Questionnaire
Measured: 24 months
Zung Self-Rating Depression Scale (Zung)
Questionnaire
Measured: 24 months
Modified Somatic Perception Questionnaire (MSPQ)
Questionnaire
Measured: 24 months
EuroQol questionnaire (EQ-5D)
Questionnaire
Measured: 24 months
EuroQol thermometer (EQ-VAS)
Questionnaire
Measured: 24 months
Cervical range of motion (CROM)
Measured: 12 months
Pain drawing, perceived face and body sensations
The characteristics of the patients sensations/pain are described on two different charts.
Measured: 12 months
Exploratory outcome. Perceived pain on a Numeric Rating Scale (NRS) for 14 specific trigger points in the muscles of the occipital region, neck and shoulder.
The physiotherapist palpates each trigger point, according to a detailed protocol developed for the present study.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Feb 2016 (estimated)
- Study startJan 2011
- Primary completionMar 2017
- Study completionSep 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Whiplash InjuriesStudies of the same condition, open and under way.
- More trials run by Region SkaneThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Region Skane
- Sponsor type
- University, hospital or other
- Collaborators
- Lund University
- Responsible party
- Sponsor
- Investigators
- Leif Anderberg, MD, PhD, Principal investigator, The Department of Neurosurgery, Skåne University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02692937
- Sponsor's protocol ID
- Project no 6168/2207
- Status last verified
- Apr 2020
- First submitted
- 15 Feb 2016
- Last updated
- 7 Apr 2020
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Is Chronic Whiplash-associated Pain of Neurogenic Origin? A Study Protocol of a Randomized Controlled Trial Comparing Neurolysis of Peripheral Nerves With Traditional Neck-specific Exercise
- ClinicalTrials.gov ID
- NCT02692937
- Acronym / sponsor ID
- Project no 6168/2207
- Conditions
- Whiplash Injuries
- Keywords
- Neurosurgical Procedures, Nerve Block, Exercise therapy, Physical Therapy Specialty
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Region SkaneUniversity, hospital or other
- Collaborators
- Lund University
- Study start
- Jan 2011
- Primary completion
- Mar 2017 (actual)
- Study completion
- Sep 2017 (actual)
- First posted
- 26 Feb 2016 (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.
The purpose of this study is to compare the effects of neurolysis with the effects of a exercise program on pain and other symptoms in individuals with chronic whiplash (WAD II-III).
Detailed description
People with whiplash associated disorders (WAD) grade II-III have chronic severe pain and symptoms and reduced quality of life. The origin of the symptoms is still unknown, and there are to date no available guidelines for treatment of this condition. The lack of effective treatment leads to high costs for the patients, and to society, due to considerable medical care and work loss.
After providing a written consent, the patients will be randomized to either surgical treatment with neurolysis of peripheral nerve/s in the back of the head and/or neck plus physiotherapy or to physiotherapy (care-as-usual) only. Both groups will be treated with the same traditional neck-specific exercise program for 12 months. All participants will be evaluated with patient-reported outcomes and clinical examination at baseline, and at 6, 12 and 24 months after inclusion.
The main outcome will be change in NDI from baseline to the 2-year follow-up. A preliminary sample-size calculation shows that 27 patients are needed for each treatment arm to detect a clinically important change of 10 points in NDI, with a between-group standard deviation of 13 point (statistical power of 80 % and a 5% significance level). To account for a 20% drop-out rate, 32 patients will be included per arm. Because this is the first RCT on neurolysis vs care-as-usual treatment, a second sample-size calculation including empirical data will performed by an independent statistician, without breaking the code, when 30 patients in each group have been included. Secondary outcomes include VAS (average pain including pain in the head, neck and face), symptom index, self-efficacy, HDI, WAD-DI, psychosomatic aspects, quality of life and clinical examination. Data will be performed with parametric, or non-parametric statistics, as appropriate, in IBM SPSS Statistics version 22 for Mac (IBM Corp., Armonk, NY, USA). Analysis will be performed according to both intention-to-treat and per protocol. To account for missing data, the previous group means value will be considered to remain form the last occasion and used as carry forward. For continuous data, differences in mean change (baseline vs follow-up) will be compared between groups and adjusted in relation to baseline values. For categorical data, differences in median change (baseline vs follow-up) will be compared between groups and adjusted in relation to baseline values. Effect sizes will be calculated for all measures.
This Randomized Controlled Study is approved and funded by the National Board of Health and Welfare in Sweden (project no 6168/2007).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Surgery and exercise | Experimental | Procedure: Neurolysis, Other: Traditional neck-specific exercise programNeurolysis of peripheral nerves in the back of the head and/or neck. Traditional neck-specific exercise program including five individual treatments sessions within 3 months plus home program over 9 months. |
| Exercise, Active Comparator | Active comparator | Other: Traditional neck-specific exercise programTraditional neck-specific exercise program including five individual treatments sessions within 3 months plus home program over 9 months. |
Who may qualify
- Ages
- 20 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- trauma that has caused a whiplash injury
- at least one year of incapacitating chronic neck pain/headache related to the injury (WAD II-III)
- typical trigger points in the back of the head or in the neck and significant pain relief with local anesthesia towards the painful areas
Key exclusion criteria (4 listed)
- mental illness
- abuse of drugs/alcohol
- not understanding or reading the Swedish language
- previous surgery in the back of the head
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 |
|---|---|---|
| Neurolysis | Procedure or surgery | Surgery and exercise |
| Traditional neck-specific exercise program | Other | Exercise, Active Comparator, Surgery and exercise |
Primary outcome
The Neck Disability Index (NDI)
Time frame: 24 months
Questionnaire
11 secondary outcomes
The Symptom index
Time frame: 24 months
Self-Efficacy Scale (SES)
Time frame: 24 months
Headache Disability Index (HDI)
Time frame: 24 months
Whiplash Associated Disorders - Disability Index (WAD-DI)
Time frame: 24 months
Zung Self-Rating Depression Scale (Zung)
Time frame: 24 months
Modified Somatic Perception Questionnaire (MSPQ)
Time frame: 24 months
EuroQol questionnaire (EQ-5D)
Time frame: 24 months
EuroQol thermometer (EQ-VAS)
Time frame: 24 months
Cervical range of motion (CROM)
Time frame: 12 months
Pain drawing, perceived face and body sensations
Time frame: 12 months
Exploratory outcome. Perceived pain on a Numeric Rating Scale (NRS) for 14 specific trigger points in the muscles of the occipital region, neck and shoulder.
Time frame: 12 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 7 Apr 2020.
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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.
Leif Anderberg, MD, PhD principal investigator
The Department of Neurosurgery, Skåne University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Neurolysis and Traditional neck-specific exercise program in people with Whiplash Injuries, run by Region Skane 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 3 inclusion and 4 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 7 Apr 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 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?
The Neck Disability Index (NDI) (time frame: 24 months). 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 7 Apr 2020.