WhiplashNCT01528579
Effects of Different Exercise Programs for People With Chronic Whiplash Associated Disorders
A study testing Neck Specific Exercises, Behavioral approach combined with neck specific exercises and Prescribed Physical activity in people with Whiplash, run by Linkoeping University at 2 sites in Sweden.
Trial summary
Background: Costs of health care consumption and sick leave 2006 in Sweden for Whiplash Associated Disorders (WAD) was estimated to be 4 billion Swedish crowns. Despite tremendous costs and personal sufferings there are only a few prospective randomized studies (RCT) in patients with chronic WAD, and none of them… Read more about this study
- Who is it for?
- Ages 18 to 63 years
- Conditions the study is for
- Whiplash
- What is being tested?
- Neck Specific Exercises, Behavioral approach combined with neck specific exercises and Prescribed Physical activity
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 216 participants
- Where
- 2 sitesSweden
- Study dates
- Mar 2011to Dec 2014
- 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
- No healthy volunteers
- Adult
Who may be able to join
- Age 18-63 years
- WAD II-III
- Remaining problems (>10mm on 100mm Visual Analogue Scale (VAS) or >20% on Neck Disability Index (NDI) or at least moderate pin on NDI) at least 6 months but no more than 3 years after whiplash trauma
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
- Systematic 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
2 sites in 1 country.
Sweden2 sites
Linköping University
Linköping, Östergötland County, SE-58183
Department of Medical and Health Sciences, physiotherapy
Linköping, Östergötland County
About this study
Official title: Effects of Different Exercise Programs for People With Chronic Whiplash Associated Disorders: a Prospective Randomized Study
Background:
Costs of health care consumption and sick leave 2006 in Sweden for Whiplash Associated Disorders (WAD) was estimated to be 4 billion Swedish crowns. Despite tremendous costs and personal sufferings there are only a few prospective randomized studies (RCT) in patients with chronic WAD, and none of them evaluating return to work, or the role of neck specific exercises with or without a combination of a behavioral approach compared with prescribed physical activity.
Read more
Aim:
The general aim of this RCT is to examine what neck-specific training with or without a combination with behavioral approach adds to prescribed physical activity of persons with chronic WAD with regard to pain intensity, physical and psychological function, health care consumption and return to work. Another aim is to study predictive factors of importance for a good outcome of rehabilitation.
Method:
After informed consent patients in age 18-63 years of age with WAD II-III with more than 6 months duration will be randomized to one out of the three alternatives of physiotherapy, treatment with medical exercise therapy with neck specific exercises (A),treatment with a behavioral approach combined with neck specific exercises (B), prescribed physical activity (C). Randomisation will be done by the central project leader. 200 patients will be included in the study. All physiotherapists engaged in the structured and well described treatment will be introduced in the program by the project leader. The measurements with good clinometric properties will be performed before treatment, after 12 weeks, 6, 12 and 24 months after inclusion into the study. Clinical measurements will be performed by a blinded investigator. Background data, disease-specific and generic data will be measured by self-evaluated answered questionnaires by the patients. Days of sick-leave will be collected from the Social Insurance Agency. Main outcomes of the measurements are pain intensity, neck specific disability and return to work. Cost-effectiveness will be calculated.
- Conditions
- Whiplash
- Being tested
- Neck Specific Exercises, Behavioral approach combined with neck specific exercises, Prescribed Physical activity
- Keywords
- Whiplash, Rehabilitation, Physiotherapy, Exercises
- Medical subject headings
- Whiplash Injuries, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Neck Specific ExercisesOther
2 times a week for 3 months followed by encourages to continue on their own
Behavioral approach combined with neck specific exercisesBehavioural
Behavioral physiotherapeutic approach combined with neck specific exercises 2 times a week for 3 months. Exercises will be chosen from a well defined and structured frame of exercises.
Prescribed Physical activityOther
Physical activity without neck specific exercises for 3 months
| Study group | Role | What they receive |
|---|---|---|
| Neck Specific exercises | Active comparator | Neck Specific exercises from a structured frame of exercises Receives: Other: Neck Specific Exercises |
| Behavioral approach | Active comparator | Behavioral physiotherapeutic approach in combination with neck specific exercises from a structured well defined frame of exercises and how to treat the patient. 2 times a week for 3 months. Receives: Behavioral: Behavioral approach combined with neck specific exercises |
| Prescribed physical activity | Active comparator | Prescribed physical activity from a physiotherapist without neck specific exercises Receives: Other: Prescribed Physical activity |
What is being measured
The primary outcome is the main question the study is designed to answer.
Neck Disability Index (NDI)
NDI will be measured at baseline before intervention. Change from baseline in NDI will be measured at 3,6,12,and 24 months to investigate change over time. Baseline and change after three and six months of exercises and to investigate if a potential change of the exercises remain at 12 month and 24 month from baseline.
Measured: Baseline and change after 3 and 6 months of exercises, 3 month, 6 month, 12 month and 24 month follow-up. Change from baseline to follow-ups. Twelve month follow-up is the most important follow-up to investigate change over time from baseline.
Secondary outcomes (12)
Pain intensity on VAS
Pain intensity is measured on a 100mm Visual Analogue Scale (VAS).
Measured: before intervention, 3, 6, 12 and 24 months follow-up. The outcome measure is going to report a change over time.
Pain Disability Index
Measured: before intervention, 3,6, 12, and 24 months follow-ups. The outcome measure is going to report a change over time.
Neck muscle endurance in seconds
Measured: before intervention, 3,6, 12, and 24 months follow-ups. The outcome measure is going to report a change over time.
Self-efficacy scale
Measured: before intervention, 3,6, 12, and 24 months follow-ups. The outcome measure is going to report a change over time.
Work Ability Index
Measured: before intervention and at 3, 6, 12 months and 24 months follow-up. The outcome measure is going to report a change over time.
Euroquol
Measured: before intervention, 3,6, 12, and 24 months follow-ups. The outcome measure is going to report a change over time.
SF-36
Measured: before intervention, 3,6, 12, and 24 months follow-ups. The outcome measure is going to report a change over time.
Pain Catastrophizing Scale
Measured: before intervention, 3,6, 12, and 24 months follow-ups. The outcome measure is going to report a change over time.
Tampa Scale 11, short version
Measured: before intervention, 6, 12, and 24 months follow-ups. The outcome measure is going to report a change over time.
Neurological status
Sensibility, reflexes,motor function upper extremeties, nerve tension test median nerve.
Measured: before intervention, 3,6, 12, and 24 months follow-ups. The outcome measure is going to report a change over time.
Pain drawing
For the pain-drawing task, patients indicated the extent and the distribution of their pain on outlines of full front and back views of a human body. After the patients completed each pain-drawing, the distributions of symptoms will be coded on a seven-point scale (were 0 is no pain, and 6 is pain distributed in the hand), and where the pain was located in the cervical, thoracic, and/or the lumbar spine, in the front and the back of the body, will be indicated using a clear overlay template.
Measured: before intervention, 3,6, 12, and 24 months follow-ups. The outcome measure is going to report a change over time.
Clinical objective measures
Range of motion of the neck and cervical kinesthesia (ability to reproduce the neutral head position from 30° cervical rotation with the eyes closed) will be measured with Cervical range of motion device (CROM).
Balance (Static:sharpened Romberg's position with eyes closed. Dynamic: Walking in a figure-of-eight). Hand strength measured with a Jamar dynamometer. Dorsal and ventral eck muscle endurance measured in seconds.
Measured: before intervention, 3,6, 12, and 24 months follow-ups. 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 Feb 2012 (estimated)
- Study startMar 2011
- Primary completionDec 2014
- Study completionDec 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for WhiplashStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 216 participants (actual)
Sponsor and investigators
- Lead sponsor
- Linkoeping University
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Anneli Peolsson, Linkoeping University
- Investigators
- Anneli Peolsson, PhD, RPT, Study chair, Linkoeping University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01528579
- Sponsor's protocol ID
- PeolssonAWADlong-term
- Status last verified
- Mar 2017
- First submitted
- 22 Jan 2012
- Last updated
- 7 Mar 2017
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Liew BXW, Scutari M, Peolsson A, Peterson G, Ludvigsson ML, Falla D. Investigating the Causal Mechanisms of Symptom Recovery in Chronic Whiplash-associated Disorders Using Bayesian Networks. Clin J Pain. 2019 Aug;35(8):647-655. doi: 10.1097/AJP.0000000000000728.
PubMed 31169550Landen Ludvigsson M, Peterson G, Peolsson A. The effect of three exercise approaches on health-related quality of life, and factors associated with its improvement in chronic whiplash-associated disorders: analysis of a randomized controlled trial. Qual Life Res. 2019 Feb;28(2):357-368. doi: 10.1007/s11136-018-2004-3. Epub 2018 Sep 17.
PubMed 30225786Ardern CL, Peterson G, Ludvigsson ML, Peolsson A. Satisfaction With the Outcome of Physical Therapist-Prescribed Exercise in Chronic Whiplash-Associated Disorders: Secondary Analysis of a Randomized Clinical Trial. J Orthop Sports Phys Ther. 2016 Aug;46(8):640-9. doi: 10.2519/jospt.2016.6136. Epub 2016 Jul 3.
PubMed 27374016Ludvigsson ML, Peterson G, Dedering A, Falla D, Peolsson A. Factors associated with pain and disability reduction following exercise interventions in chronic whiplash. Eur J Pain. 2016 Feb;20(2):307-15. doi: 10.1002/ejp.729. Epub 2015 May 29.
PubMed 26031995Peolsson A, Landen Ludvigsson M, Overmeer T, Dedering A, Bernfort L, Johansson G, Kammerlind AS, Peterson G. Effects of neck-specific exercise with or without a behavioural approach in addition to prescribed physical activity for individuals with chronic whiplash-associated disorders: a prospective randomised study. BMC Musculoskelet Disord. 2013 Oct 30;14:311. doi: 10.1186/1471-2474-14-311.
PubMed 24171699
Study at a glance
From the registry record, last updated by the sponsor on 7 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Different Exercise Programs for People With Chronic Whiplash Associated Disorders: a Prospective Randomized Study
- ClinicalTrials.gov ID
- NCT01528579
- Acronym / sponsor ID
- PeolssonAWADlong-term
- Conditions
- Whiplash
- Keywords
- Whiplash, Rehabilitation, Physiotherapy, Exercises
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 216 participants (actual)
- Lead sponsor
- Linkoeping UniversityOther government
- Study start
- Mar 2011
- Primary completion
- Dec 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 8 Feb 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.
Background:
Costs of health care consumption and sick leave 2006 in Sweden for Whiplash Associated Disorders (WAD) was estimated to be 4 billion Swedish crowns. Despite tremendous costs and personal sufferings there are only a few prospective randomized studies (RCT) in patients with chronic WAD, and none of them evaluating return to work, or the role of neck specific exercises with or without a combination of a behavioral approach compared with prescribed physical activity.
Aim:
The general aim of this RCT is to examine what neck-specific training with or without a combination with behavioral approach adds to prescribed physical activity of persons with chronic WAD with regard to pain intensity, physical and psychological function, health care consumption and return to work. Another aim is to study predictive factors of importance for a good outcome of rehabilitation.
Method:
After informed consent patients in age 18-63 years of age with WAD II-III with more than 6 months duration will be randomized to one out of the three alternatives of physiotherapy, treatment with medical exercise therapy with neck specific exercises (A),treatment with a behavioral approach combined with neck specific exercises (B), prescribed physical activity (C). Randomisation will be done by the central project leader. 200 patients will be included in the study. All physiotherapists engaged in the structured and well described treatment will be introduced in the program by the project leader. The measurements with good clinometric properties will be performed before treatment, after 12 weeks, 6, 12 and 24 months after inclusion into the study. Clinical measurements will be performed by a blinded investigator. Background data, disease-specific and generic data will be measured by self-evaluated answered questionnaires by the patients. Days of sick-leave will be collected from the Social Insurance Agency. Main outcomes of the measurements are pain intensity, neck specific disability and return to work. Cost-effectiveness will be calculated.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Neck Specific exercises | Active comparator | Other: Neck Specific ExercisesNeck Specific exercises from a structured frame of exercises |
| Behavioral approach | Active comparator | Behavioral: Behavioral approach combined with neck specific exercisesBehavioral physiotherapeutic approach in combination with neck specific exercises from a structured well defined frame of exercises and how to treat the patient. 2 times a week for 3 months. |
| Prescribed physical activity | Active comparator | Other: Prescribed Physical activityPrescribed physical activity from a physiotherapist without neck specific exercises |
Who may qualify
- Ages
- 18 to 63 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Age 18-63 years
- WAD II-III
- Remaining problems (>10mm on 100mm Visual Analogue Scale (VAS) or >20% on Neck Disability Index (NDI) or at least moderate pin on NDI) at least 6 months but no more than 3 years after whiplash trauma
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 Exercises2 times a week for 3 months followed by encourages to continue on their own | Other | Neck Specific exercises |
| Behavioral approach combined with neck specific exercisesBehavioral physiotherapeutic approach combined with neck specific exercises 2 times a week for 3 months. Exercises will be chosen from a well defined and structured frame of exercises. | Behavioural | Behavioral approach |
| Prescribed Physical activityPhysical activity without neck specific exercises for 3 months | Other | Prescribed physical activity |
Primary outcome
Neck Disability Index (NDI)
Time frame: Baseline and change after 3 and 6 months of exercises, 3 month, 6 month, 12 month and 24 month follow-up. Change from baseline to follow-ups. Twelve month follow-up is the most important follow-up to investigate change over time from baseline.
NDI will be measured at baseline before intervention. Change from baseline in NDI will be measured at 3,6,12,and 24 months to investigate change over time. Baseline and change after three and six months of exercises and to investigate if a potential change of the exercises remain at 12 month and 24 month from baseline.
12 secondary outcomes
Pain intensity on VAS
Time frame: before intervention, 3, 6, 12 and 24 months follow-up. The outcome measure is going to report a change over time.
Pain Disability Index
Time frame: before intervention, 3,6, 12, and 24 months follow-ups. The outcome measure is going to report a change over time.
Neck muscle endurance in seconds
Time frame: before intervention, 3,6, 12, and 24 months follow-ups. The outcome measure is going to report a change over time.
Self-efficacy scale
Time frame: before intervention, 3,6, 12, and 24 months follow-ups. The outcome measure is going to report a change over time.
Work Ability Index
Time frame: before intervention and at 3, 6, 12 months and 24 months follow-up. The outcome measure is going to report a change over time.
Euroquol
Time frame: before intervention, 3,6, 12, and 24 months follow-ups. The outcome measure is going to report a change over time.
SF-36
Time frame: before intervention, 3,6, 12, and 24 months follow-ups. The outcome measure is going to report a change over time.
Pain Catastrophizing Scale
Time frame: before intervention, 3,6, 12, and 24 months follow-ups. The outcome measure is going to report a change over time.
Tampa Scale 11, short version
Time frame: before intervention, 6, 12, and 24 months follow-ups. The outcome measure is going to report a change over time.
Neurological status
Time frame: before intervention, 3,6, 12, and 24 months follow-ups. The outcome measure is going to report a change over time.
Pain drawing
Time frame: before intervention, 3,6, 12, and 24 months follow-ups. The outcome measure is going to report a change over time.
Clinical objective measures
Time frame: before intervention, 3,6, 12, and 24 months follow-ups. 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 7 Mar 2017.
- Derived from this study: PubMed 31169550Liew BXW, Scutari M, Peolsson A, Peterson G, Ludvigsson ML, Falla D. Investigating the Causal Mechanisms of Symptom Recovery in Chronic Whiplash-associated Disorders Using Bayesian Networks. Clin J Pain. 2019 Aug;35(8):647-655. doi: 10.1097/AJP.0000000000000728.
- Derived from this study: PubMed 30225786Landen Ludvigsson M, Peterson G, Peolsson A. The effect of three exercise approaches on health-related quality of life, and factors associated with its improvement in chronic whiplash-associated disorders: analysis of a randomized controlled trial. Qual Life Res. 2019 Feb;28(2):357-368. doi: 10.1007/s11136-018-2004-3. Epub 2018 Sep 17.
- Derived from this study: PubMed 27374016Ardern CL, Peterson G, Ludvigsson ML, Peolsson A. Satisfaction With the Outcome of Physical Therapist-Prescribed Exercise in Chronic Whiplash-Associated Disorders: Secondary Analysis of a Randomized Clinical Trial. J Orthop Sports Phys Ther. 2016 Aug;46(8):640-9. doi: 10.2519/jospt.2016.6136. Epub 2016 Jul 3.
- Derived from this study: PubMed 26031995Ludvigsson ML, Peterson G, Dedering A, Falla D, Peolsson A. Factors associated with pain and disability reduction following exercise interventions in chronic whiplash. Eur J Pain. 2016 Feb;20(2):307-15. doi: 10.1002/ejp.729. Epub 2015 May 29.
- Derived from this study: PubMed 24171699Peolsson A, Landen Ludvigsson M, Overmeer T, Dedering A, Bernfort L, Johansson G, Kammerlind AS, Peterson G. Effects of neck-specific exercise with or without a behavioural approach in addition to prescribed physical activity for individuals with chronic whiplash-associated disorders: a prospective randomised study. BMC Musculoskelet Disord. 2013 Oct 30;14:311. doi: 10.1186/1471-2474-14-311.
Related trials for Whiplash
Active, not recruiting
Neck-specific Exercises Effectively Improves Whiplash-associated Disorders.
Whiplash-associated Disorders
Not yet recruiting
StressModex for Post-Traumatic Neck Pain
Post-Traumatic Neck Pain, Whiplash-associated Disorders
Recruiting
Transauricular Vagus Nerve Stimulation for Chronic Whiplash Associated Disorders
Whiplash Associated Disorder (WAD)
Recruiting
Virtual Reality Rehabilitation in Neck Pain Subjects
Neck Pain, Chronic Pain
Not yet recruiting
Effectiveness of Percutaneous Electrolysis and Dry Needling vs. Standard Therapy for Whiplash Syndrome
Whiplash Injuries
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, PhD, RPT study chair
Linkoeping University
2 sites 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, Behavioral approach combined with neck specific exercises and Prescribed Physical activity in people with Whiplash, run by Linkoeping University at 2 sites 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 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 7 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 2 sites 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?
Neck Disability Index (NDI) (time frame: Baseline and change after 3 and 6 months of exercises, 3 month, 6 month, 12 month and 24 month follow-up. Change from baseline to follow-ups. Twelve month follow-up is the most important follow-up to investigate change over time from baseline.). 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 NCT01528579, which also lists 5 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 Mar 2017.