Neck PainWADNECXTNCT01431261
Neck Exercises, Training and Pain Management as a Treatment for Whiplash Patients With Chronic Neck Pain
A study testing Education and training and Pain management in people with Neck Pain and Chronic Pain Syndrome, run by University of Southern Denmark at 1 site in Denmark.
Trial summary
The purpose of this study is to test whether a physiotherapy intervention containing pain management, general training and specific neck exercises can improve function for patients with chronic neck pain. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Neck Pain, Chronic Pain Syndrome
- What is being tested?
- Education and training and Pain management
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteDenmark
- Study dates
- Jan 2012to Jun 2016
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- chronic neck pain for at least 6 months
- reduced physical neck function (NDI minimum 10)
- pain primarily in the neck region,
- finished any medical /radiological examinations
- able to read and understand Danish and
- able to participate in the exercise program.
Who cannot join
- radiculopathies upper extremity
- neurological deficits
- in a process of examining for unknown pathology,
- experimental medical treatment,
- being in a unstable social situation
- pregnancy
Show all 9Show fewer
- fractures
- suffering from depression
- other known coexisting medical conditions which would severely restrict participation in the exercise program
Trial locations and contacts
1 site in 1 country.
Denmark1 site
University of Southern Denmark, Research Unit for Musculoskeletal Function and Physiotherapy, Institute of Sports Science and Clinical Biomechanics
Odense, 5230
About this study
Official title: Neck Exercises, Physical and Cognitive Behavioural Graded Activity as a Treatment for Adult Whiplash Patients With Chronic Neck Pain
The purpose of this study is to test whether a physiotherapy intervention containing pain management, general training and specific neck exercises can improve function for patients with chronic neck pain.
Read the detailed description
Neck pain is widespread problem. The prevalence of neck pain in the Scandinavian countries is 36%. Of the working population the prevalence of chronic neck pain is 10 - 20%.The National Board of Health estimates that 5-6000 subjects per year in Denmark are involved in a traffic accident evoking whiplash-induced chronic neck pain. The main problems for patients with chronic neck pain are cervical dysfunction, reduced neck mobility and stability in addition to local and possibly generalised pain Besides chronic neck pain, patients may suffer from poor pain coping strategies and physical inactivity which influences physical function, general health and causes a poor quality of life.
Physical training including specific exercises targeting the deep postural muscles of the spine is effective in reducing neck pain for patients with chronic neck pain. Physical behavioural graded activity is a treatment approach with focus on increasing general physical fitness, reducing fear of movements and increasing psychological function. Educational sessions, where the focus is on understanding complex chronic pain mechanisms and development of appropriate pain coping and/or cognitive behavioural strategies have shown reduced general pain.
Thus this project is formulated on the expectation that rehabilitation of patients with chronic neck pain after a whiplash accident must target cervical dysfunctions, training of physical function and the understanding and management of chronic pain in a combined therapy approach.
The study is designed as a randomized control study including 200 patients. All participate in the educational sessions. The training group receives on top of that instruction in specific neck exercises and general training.
- Conditions
- Neck Pain, Chronic Pain Syndrome
- Being tested
- Education and training, Pain management
- Keywords
- Chronic neck pain, Whiplash, Whiplash Associated Disorders, Chronic Pain, Neck exercises, Training, Pacing, Patient Education, Pain Management, Whiplash Injuries, Musculoskeletal
- Medical subject headings
- Neck Pain, Whiplash Injuries, Chronic Pain, Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Education and trainingOther
Educational sessions in pain management 4 times and treatment sessions including instructions in training and specific exercises 8 times
Pain managementBehavioural
Educational sessions in pain management 4 times
| Study group | Role | What they receive |
|---|---|---|
| Pain Management + Training | Active comparator | Education in pain management strategies and treatment sessions including instructions in neck exercises and aerobic training Receives: Other: Education and training |
| Pain Management | Active comparator | Education in pain management strategies Receives: Behavioral: Pain management |
What is being measured
The primary outcome is the main question the study is designed to answer.
Medical Outcomes Study Short Form 36 (SF36) - Physical Component Summary (PCS)
Measured: 12 months
Secondary outcomes (11)
craniocervical flexion test
test for the deep cervical flexor muscles
Measured: 12 months
cervical range of motion
Measured: 12 months
neck positioning test
neck joint position error test and gaze stability test
Measured: 12 months
Self-rated measure Global Perceived Effect
questionnaire
Measured: 12 months
Neck Disability Index
questionnaire
Measured: 12 months
Pain Bothersomeness
questionnaire
Measured: 12 months
Pain Specific Functioning Scale
questionnaire
Measured: 4 months and 12 months
TAMPA scale of Kinesiophobia
questionnaire
Measured: 12 months
Impact of Event scale
questionnaire
Measured: 12 months
Euroqol-5D
questionnaire
Measured: 12 months
Mechanical allodynia
Pressure pain treshold for selected points
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 posted9 Sep 2011 (estimated)
- Study startJan 2012
- Primary completionJun 2016
- Study completionJun 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Neck PainStudies of the same condition, open and under way.
- More trials run by University of Southern DenmarkThe 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Southern Denmark
- Sponsor type
- University, hospital or other
- Collaborators
- Region of Southern Denmark, Association of Danish Physiotherapists
- Responsible party
- Principal investigator, Inge Ris Hansen, University of Southern Denmark
- Investigators
- Birgit Juul-Kristensen, ph.d., Study chair, University of Southern Denmark
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01431261
- Sponsor's protocol ID
- WADNECXT
- Acronym
- WADNECXT
- Status last verified
- Oct 2016
- First submitted
- 30 Aug 2011
- Last updated
- 7 Oct 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Ris I, Juul-Kristensen B, Boyle E, Kongsted A, Manniche C, Sogaard K. Chronic neck pain patients with traumatic or non-traumatic onset: Differences in characteristics. A cross-sectional study. Scand J Pain. 2017 Jan;14:1-8. doi: 10.1016/j.sjpain.2016.08.008. Epub 2016 Oct 12.
PubMed 28850421Ris I, Sogaard K, Gram B, Agerbo K, Boyle E, Juul-Kristensen B. Does a combination of physical training, specific exercises and pain education improve health-related quality of life in patients with chronic neck pain? A randomised control trial with a 4-month follow up. Man Ther. 2016 Dec;26:132-140. doi: 10.1016/j.math.2016.08.004. Epub 2016 Aug 20.
PubMed 27598552Hansen IR, Sogaard K, Christensen R, Thomsen B, Manniche C, Juul-Kristensen B. Neck exercises, physical and cognitive behavioural-graded activity as a treatment for adult whiplash patients with chronic neck pain: design of a randomised controlled trial. BMC Musculoskelet Disord. 2011 Dec 2;12:274. doi: 10.1186/1471-2474-12-274.
PubMed 22136113
Study at a glance
From the registry record, last updated by the sponsor on 7 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neck Exercises, Physical and Cognitive Behavioural Graded Activity as a Treatment for Adult Whiplash Patients With Chronic Neck Pain
- ClinicalTrials.gov ID
- NCT01431261
- Acronym / sponsor ID
- WADNECXT / WADNECXT
- Conditions
- Neck Pain, Chronic Pain Syndrome
- Keywords
- Chronic neck pain, Whiplash, Whiplash Associated Disorders, Chronic Pain, Neck exercises, Training, Pacing, Patient Education
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- University of Southern DenmarkUniversity, hospital or other
- Collaborators
- Region of Southern Denmark, Association of Danish Physiotherapists
- Study start
- Jan 2012
- Primary completion
- Jun 2016 (actual)
- Study completion
- Jun 2016 (actual)
- First posted
- 9 Sep 2011 (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 test whether a physiotherapy intervention containing pain management, general training and specific neck exercises can improve function for patients with chronic neck pain.
Detailed description
Neck pain is widespread problem. The prevalence of neck pain in the Scandinavian countries is 36%. Of the working population the prevalence of chronic neck pain is 10 - 20%.The National Board of Health estimates that 5-6000 subjects per year in Denmark are involved in a traffic accident evoking whiplash-induced chronic neck pain. The main problems for patients with chronic neck pain are cervical dysfunction, reduced neck mobility and stability in addition to local and possibly generalised pain Besides chronic neck pain, patients may suffer from poor pain coping strategies and physical inactivity which influences physical function, general health and causes a poor quality of life.
Physical training including specific exercises targeting the deep postural muscles of the spine is effective in reducing neck pain for patients with chronic neck pain. Physical behavioural graded activity is a treatment approach with focus on increasing general physical fitness, reducing fear of movements and increasing psychological function. Educational sessions, where the focus is on understanding complex chronic pain mechanisms and development of appropriate pain coping and/or cognitive behavioural strategies have shown reduced general pain.
Thus this project is formulated on the expectation that rehabilitation of patients with chronic neck pain after a whiplash accident must target cervical dysfunctions, training of physical function and the understanding and management of chronic pain in a combined therapy approach.
The study is designed as a randomized control study including 200 patients. All participate in the educational sessions. The training group receives on top of that instruction in specific neck exercises and general training.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pain Management + Training | Active comparator | Other: Education and trainingEducation in pain management strategies and treatment sessions including instructions in neck exercises and aerobic training |
| Pain Management | Active comparator | Behavioral: Pain managementEducation in pain management strategies |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- chronic neck pain for at least 6 months
- reduced physical neck function (NDI minimum 10)
- pain primarily in the neck region,
- finished any medical /radiological examinations
- able to read and understand Danish and
Key exclusion criteria (9 listed)
- radiculopathies upper extremity
- neurological deficits
- in a process of examining for unknown pathology,
- experimental medical treatment,
- being in a unstable social situation
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 |
|---|---|---|
| Education and trainingEducational sessions in pain management 4 times and treatment sessions including instructions in training and specific exercises 8 times | Other | Pain Management + Training |
| Pain managementEducational sessions in pain management 4 times | Behavioural | Pain Management |
Primary outcome
Medical Outcomes Study Short Form 36 (SF36) - Physical Component Summary (PCS)
Time frame: 12 months
11 secondary outcomes
craniocervical flexion test
Time frame: 12 months
cervical range of motion
Time frame: 12 months
neck positioning test
Time frame: 12 months
Self-rated measure Global Perceived Effect
Time frame: 12 months
Neck Disability Index
Time frame: 12 months
Pain Bothersomeness
Time frame: 12 months
Pain Specific Functioning Scale
Time frame: 4 months and 12 months
TAMPA scale of Kinesiophobia
Time frame: 12 months
Impact of Event scale
Time frame: 12 months
Euroqol-5D
Time frame: 12 months
Mechanical allodynia
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 Oct 2016.
- Derived from this study: PubMed 28850421Ris I, Juul-Kristensen B, Boyle E, Kongsted A, Manniche C, Sogaard K. Chronic neck pain patients with traumatic or non-traumatic onset: Differences in characteristics. A cross-sectional study. Scand J Pain. 2017 Jan;14:1-8. doi: 10.1016/j.sjpain.2016.08.008. Epub 2016 Oct 12.
- Derived from this study: PubMed 27598552Ris I, Sogaard K, Gram B, Agerbo K, Boyle E, Juul-Kristensen B. Does a combination of physical training, specific exercises and pain education improve health-related quality of life in patients with chronic neck pain? A randomised control trial with a 4-month follow up. Man Ther. 2016 Dec;26:132-140. doi: 10.1016/j.math.2016.08.004. Epub 2016 Aug 20.
- Derived from this study: PubMed 22136113Hansen IR, Sogaard K, Christensen R, Thomsen B, Manniche C, Juul-Kristensen B. Neck exercises, physical and cognitive behavioural-graded activity as a treatment for adult whiplash patients with chronic neck pain: design of a randomised controlled trial. BMC Musculoskelet Disord. 2011 Dec 2;12:274. doi: 10.1186/1471-2474-12-274.
- University of Southern DenmarkLink provided by the sponsor.
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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.
Birgit Juul-Kristensen, ph.d. study chair
University of Southern Denmark
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Education and training and Pain management in people with Neck Pain and Chronic Pain Syndrome, run by University of Southern Denmark at 1 site in Denmark.
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 6 inclusion and 9 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 Oct 2016. 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 Denmark. 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?
Medical Outcomes Study Short Form 36 (SF36) - Physical Component Summary (PCS) (time frame: 12 months). 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 NCT01431261, which also lists 3 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 7 Oct 2016.