Whiplash Injury of Cervical SpineNCT05319808
Rehabilitation for Whiplash Associated Disorders
A study testing Manual therapy, Telehealth exercises and Non-computer based exercises in people with Whiplash Injury of Cervical Spine, run by University of Iceland at 4 sites in Iceland.
Trial summary
Individuals (n=180) with subacute (<1 month, >3 months) WAD grade I and II with medium to high-risk symptoms of working age will be randomized into three groups with block randomization in a prospective, assessor-blinded randomized controlled trial. Read more about this study
- Who is it for?
- Ages 18 to 63 years
- Conditions the study is for
- Whiplash Injury of Cervical Spine
- What is being tested?
- Manual therapy, Telehealth exercises and Non-computer based exercises
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 180 participants
- Where
- 4 sitesIceland
- Study dates
- 27 May 2022to 30 Apr 2024
- 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
- subacute (>1 month, <3 months) neck problems corresponding to WAD grades I-II verified by WhipPredict
- medium to high risk symptoms (NDI score >32% OR subject is >36 years old) OR VAS score >4/10
- within daily reach of a computer/tablet/smartphone and Internet
- showed neck symptoms within the first week following the car collision (i.e. neck pain, neck stiffness)
Who cannot join
- WAD grades III-IV
- considerable degree of known or suspected physical pathology (Myelopathy, Spinal tumours, Spinal infection, Ongoing malignancy, Cervical spine surgery, Severe neck problems within their medical history which resulted in sick leave for more than a month in the year before the current whiplash injury, Other illness/injury that may prevent full participation from being feasible, Lack of ability to either understand or write Icelandic, Severe obesity (body mass index; BMI > 35), Pregnancy)
- unable to complete the assessment
Trial locations and contacts
4 sites in 1 country.
Iceland4 sites
K!M Rehabilitaion
Kopavogur, 203
University of Iceland
Reykjavik, 102
Landspítali University Hospital
Reykjavik, 108
Hæfi Physiotherapy
Reykjavik, 112
About this study
Official title: Rehabilitation for Whiplash Associated Disorders; a Randomized Clinical Trial
Individuals (n=180) with subacute (<1 month, >3 months) WAD grade I and II with medium to high-risk symptoms of working age will be randomized into three groups with block randomization in a prospective, assessor-blinded randomized controlled trial. Two primary intervention groups (A and B) will receive manual therapy (MT) in the same out-patient clinic. In addition, group A will receive a remote, novel, computer-based cervical kinaesthetic exercise program starting at visit two, whereby quality and quantity of exercise performance, as well as compliance (frequency and duration), will be registered into the physical therapy clinic's system for evaluation. Group B will receive neck exercises (not computer-based) provided by the corresponding physical therapist. Group A will continue remote exercise therapy until 6 months post baseline measurements regardless of whether they are still being treated in-clinic or discharged.
Hypothesis 1.a.: Internet-based neck-specific CKE combined with in-clinic manual therapy and exercises will be superior to manual therapy and exercises alone at a physiotherapy clinic (i.e., treatment A is superior to treatment B) for self-reported and measured (movement performance) outcome measures.
Read more
Hypothesis 1.b.: Improvements in self-reported outcomes will positively correlate with outcomes of movement performance testing, as will the pre- to post-intervention changes from baseline to follow-up assessments.
The groups will be compared to a "treatment as usual" group (C). Objective measures include measurements for motor control, proprioception, and cervical range of motion. Neck disability and pain intensity, general health, self-perceived handicap, and physical, emotional and functional difficulties due to dizziness will be measured using questionnaires. Short-term effects will be measured at 10-12 weeks and long-term effects at 6- and 12-months post baseline measurements.
Hypothesis 2.a.: Participants of groups A and B will improve significantly more than those in group C for subjective and objective outcome measures.
Read the detailed description
QUALITY ASSURANCE PLAN:
PhD student will monitor the data and guarantee high data quality. Data will be protected according to the Act on Data Protection and the Processing of Personal data (Icelandic law) and stored at the University Hospital or at a secure NeckCare database. Data will be registered into Microsoft Excel and shared through a secure network with other researchers to promote transparency.
DATA CHECKS:
Data will be checked for outliers.
SOURCE DATA VERIFICATION:
N/A
DATA DICTIONARY:
WAD: whiplash-associated disorders; MVC: motor vehicle collision; VR: virtual reality; NDI: neck disability index; ROM: range of motion; PTs: physiotherapists; MT: manual therapy; CKE: cervical kinaesthetic exercise; IT: information technology; IoT: internet of things; IMU: inertial monitoring unit; VAS: visual analog scale; SF-36: short form 36 item health survey; DHI: dizziness handicap inventory; CSI: central sensitisation inventory; CS: central sensitization; ToT: time on target; CI: confidence interval; MCIC: minimal clinically important changes.
STANDARD OPERATION PROCEDURES:
A total of 180 subjects (60 from each of the three groups) will be recruited through the databases of The Emergency Department of Landspitali University Hospital, Reykjavik, Iceland via phone call.
Subjective and objective outcome measures will be collected by a PhD student. In addition to questionnaire and clinical outcome measures, the pharmaceutical database of the Directorate of Health in Iceland will be accessed for data on subjects' drug use.
Data will be analysed by the PhD student using Microsoft Excel and R, a free software environment for statistical computing and graphics.
The PhD student will be responsible for reporting adverse events and change management.
SAMPLE SIZE ASSESSMENT:
Sample size and power regarding group differences will be calculated based on the primary outcome NDI. To detect a clinically relevant improvement of 8% in the NDI, 40 participants are needed in each group for 80% power. For non-inferiority tests, the significance level will be set to 5% (p > 0.05) which corresponds to the one-sided confidence interval (95% CI). To ensure that enough people are in each group after dropouts, for prediction analyses and the opportunity for subgroup analyses, 60 participants will be included in each group (n=180).
PLAN FOR MISSING DATA:
If data will be found to be missing by any reason, each incident will be assessed by the PhD student and her advisors. Imputation methods may be used, the subject involved may be asked to come back in for a measurement or answer questionnaires again (depending on the time that has passed from the measurement/questionnaires until data is discovered missing) or the subject involved will be removed from the study.
STATISTICAL ANALYSIS PLAN:
Data analyses and statistics Database monitoring will be performed by the primary researcher and statisticians involved, independent of sponsors and competing interests. Background data will be assessed after all subjects have completed their baseline measurements.
Background data and association of self-reported and clinical measures Background data will be evaluated with descriptive statistics and differences in baseline data determined using t-tests and (M)ANOVA (mean and standard deviation) or non-parametric tests where appropriate. Association of self-reported measurements and clinical measures will be assessed for baseline, 10-12-week, 6-month and 12-month measurements using Pearson or Spearman correlation depending on the distribution of the data. Subgroup analyses of CPS may possibly be performed.
Effectiveness of therapy Analyses will be performed primarily on an intention-to-treat basis (as individuals being randomized into the groups) and secondarily on a per protocol basis (individuals who fulfilled the programme for at least 50%). Imputation methods may be used when deemed to have additional value. Linear mixed models with time as a repeated factor will be used to assess the effect of treatment for each outcome. Correlation over time, within the PT and prognostic factors will be accounted for. Estimates of the effect of the intervention will be obtained by constructing linear contrasts to compare the mean change in outcome for each measurement (subjective and objective) to each time point between treatment groups and between each treatment group compared to control group. The main dependent variable will be score on NDI with independent fixed factors time (baseline, 10-12-week, 6-month, and 12-month) and group (A, B and C). If the non-inferiority of C to A or of C to B is concluded based on the 95% CI, a test of the superiority of C to A or of C to B will be performed as suggested by Lesaffre (see reference list). The variation in response to intervention (heterogeneity of treatment effect) will be evaluated using regression analysis.
- Conditions
- Whiplash Injury of Cervical Spine
- Being tested
- Manual therapy, Telehealth exercises, Non-computer based exercises
- Keywords
- Whiplash-Associated Disorders, Car-collision, Kinaesthesia, Telehealth, Motor Control, Treatment, Exercises, Manual Therapy, Objective measurements
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Manual therapyOther
Individualized treatment of manual therapy provided by MT PTs, graduates from Curtin University of Technology, Perth, Australia (2008)
Telehealth exercisesDevice
A novel, remote computer based cervical joint positioning exercise and cervical kinaesthetic exercise (CKE) program. A technical consultant monitors the data from the remote exercises and inform the PTs if someone has not done their exercises in over 2 weeks during the study period so subjects can be encouraged with a friendly reminder.
Non-computer based exercisesOther
Home-exercises in the need of each subject (pragmatic approach) taught by MT PTs, graduates from Curtin University of Technology, Perth, Australia (2008)
| Study group | Role | What they receive |
|---|---|---|
| Group A | Experimental | Telehealth using NeckCare equipment Receives: Other: Manual therapy; Device: Telehealth exercises |
| Group B | Active comparator | Exercises without telehealth intervention Receives: Other: Manual therapy; Other: Non-computer based exercises |
| Group C | No intervention | No intervention provided by the researchers |
What is being measured
The primary outcome is the main question the study is designed to answer.
Neck disability index (NDI)
the NDI is a 10-item self-report questionnaire that has been shown to demonstrate good validity and reliability. Each section is scored on a 0 to 5 rating scale, higher score represents more neck pain related disability.
Measured: 5 minutes
Visual Analog Scale (VAS)
Neck pain intensity during the past week prior to each measurement measured by a 100 mm visual analogue scale (VAS) with 0mm representing "no pain" and 100mm representing "worst pain imaginable
Measured: 1 minutes
Butterfly Test
- Procedure: The subject tracks an unpredictable path as accurately as possible using head movement to manipulate the on-screen cursor. There are different trajectories with increasing difficulty. The subject repeats each trajectory path 3 times.
- Metrics: (1) Amplitude Accuracy (AA): the absolute distance (radius) in mm between the cursor that represents the head position and the target. (2) Time On Target (ToT): the percentage of time the cursor that represents the head position spends in a mathematically determined, invisible free zone around the target. (3) Smoothness of Movement Index (SMI): The index is calculated based on the third positional derivative with respect to time and is scaled between 0 and 5 with 0 being the best and 5 being the worst.
Measured: 5 minutes
Whole Cervical Range of Motion (ROM) Test
- Procedure: The subject turns their head using four different types of movements: flexion, extension, rotation (left/right) and lateral flexion (left/right) to measure the maximum range ROM. Each movement is repeated 3 times.
- Metrics: An average degree value and standard deviation of the 3 measurements for each movement type.
Measured: 5 minutes
Head Neck Relocation Test (HNRT)
- Procedure: While blindfolded, the subject is asked to find their "neutral" position. The subject then turns their head to rotate left/right and up/down and attempts to return to the neutral/initial position following each movement, the subject informs the researcher by saying a simple "ok" when he believes he has reached the neutral position. The researcher marks this with one mouse click.
- Metrics: (1) Accuracy Error measures the deviation in degrees from the initial position; (2) Constant Error measures under-/overshooting; and (3) Variable Error measures the precision of the head posture.
Measured: 5 minutes
Secondary outcomes (3)
SF-36 Health Survey (SF-36) RAND version
SF-36 is the most frequently recommended questionnaire to rate general mental health for patients with chronic musculoskeletal disorders. It's a set of generic, coherent, and easily administered quality-of-life measures. These measures rely upon patient self-reporting, and the 36 items tap eight health concepts: physical functioning, bodily pain, role limitations due to physical health problems, role limitations due to personal or emotional problems, emotional well-being, social functioning, energy/fatigue, and general health perceptions. Each item is scored on a 0 to 100 range where higher score defines a more favorable health state.
Measured: 10 minutes
Dizziness Handicap Inventory (DHI)
the DHI is a 25-item self-assessment inventory designed to evaluate the self-perceived handicapping effects imposed by dizziness. Each item is scored on a 0 to 4 rating scale, with higher score representing more self-perceived handicapping.
Measured: 5 minutes
Central Sensitization Inventory (CSI)
the CSI is a self-reported tool to assess symptoms of CS (central sensitization). The list includes 25 items about CS-related symptoms, scored on a five-point Likert scale from 0-4. Higher total scores reflect higher CS symptomology
Measured: 5 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2022
- Study start27 May 2022
- Primary completion30 Jun 2023
- Study completion30 Apr 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Whiplash Injury of Cervical SpineStudies 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
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Two groups will receive physiotherapy. Both will receive a "hands-on" individualized treatment of manual therapy. The "hands-off" treatment differs between groups and goes as follows: Group A will receive a novel, remote computer based cervical joint positioning exercise and cervical kinaesthesia exercise program with a 6-month follow-up. Group B will receive a non-computer based exercise regime at the need of each individual (pragmatic approach). This group will not be followed up on their exercises post intervention but will be encouraged to continue doing their exercises. They will be asked during follow-up measurements if they have been doing their exercises. The "treatment as usual" group (group C) will/will not receive treatment at his/her own choice and/or convenience and without any instructions from research staff to reflect general practice. In addition to follow-up assessments, data will be collected which asks about treatment modalities used.
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 180 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Iceland
- Sponsor type
- University, hospital or other
- Collaborators
- Empowered Health, Reykjavik University, Landspitali University Hospital
- Responsible party
- Sponsor
- Investigators
- Kristín Briem, PhD, Study chair, University of Iceland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05319808
- Sponsor's protocol ID
- UI-123218
- Status last verified
- Nov 2023
- First submitted
- 31 Mar 2022
- Last updated
- 8 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Lesaffre E. Superiority, equivalence, and non-inferiority trials. Bull NYU Hosp Jt Dis. 2008;66(2):150-4.
PubMed 18537788Ragnarsdottir H, Briem K, Oddsdottir GL. Effects of a Novel Web-Based Sensorimotor Exercise Program for Patients With Subacute Whiplash-Associated Disorders: Protocol for a Randomized Clinical Trial. Phys Ther. 2023 Aug 1;103(8):pzad063. doi: 10.1093/ptj/pzad063.
PubMed 37338163
Study at a glance
From the registry record, last updated by the sponsor on 8 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Rehabilitation for Whiplash Associated Disorders; a Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT05319808
- Acronym / sponsor ID
- UI-123218
- Conditions
- Whiplash Injury of Cervical Spine
- Keywords
- Whiplash-Associated Disorders, Car-collision, Kinaesthesia, Telehealth, Motor Control, Treatment, Exercises, Manual Therapy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 180 participants (estimated)
- Lead sponsor
- University of IcelandUniversity, hospital or other
- Collaborators
- Empowered Health, Reykjavik University, Landspitali University Hospital
- Study start
- 27 May 2022 (actual)
- Primary completion
- 30 Jun 2023 (actual)
- Study completion
- 30 Apr 2024 (estimated)
- First posted
- 8 Apr 2022 (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.
Individuals (n=180) with subacute (<1 month, >3 months) WAD grade I and II with medium to high-risk symptoms of working age will be randomized into three groups with block randomization in a prospective, assessor-blinded randomized controlled trial. Two primary intervention groups (A and B) will receive manual therapy (MT) in the same out-patient clinic. In addition, group A will receive a remote, novel, computer-based cervical kinaesthetic exercise program starting at visit two, whereby quality and quantity of exercise performance, as well as compliance (frequency and duration), will be registered into the physical therapy clinic's system for evaluation. Group B will receive neck exercises (not computer-based) provided by the corresponding physical therapist. Group A will continue remote exercise therapy until 6 months post baseline measurements regardless of whether they are still being treated in-clinic or discharged.
Hypothesis 1.a.: Internet-based neck-specific CKE combined with in-clinic manual therapy and exercises will be superior to manual therapy and exercises alone at a physiotherapy clinic (i.e., treatment A is superior to treatment B) for self-reported and measured (movement performance) outcome measures.
Hypothesis 1.b.: Improvements in self-reported outcomes will positively correlate with outcomes of movement performance testing, as will the pre- to post-intervention changes from baseline to follow-up assessments.
The groups will be compared to a "treatment as usual" group (C). Objective measures include measurements for motor control, proprioception, and cervical range of motion. Neck disability and pain intensity, general health, self-perceived handicap, and physical, emotional and functional difficulties due to dizziness will be measured using questionnaires. Short-term effects will be measured at 10-12 weeks and long-term effects at 6- and 12-months post baseline measurements.
Hypothesis 2.a.: Participants of groups A and B will improve significantly more than those in group C for subjective and objective outcome measures.
Detailed description
QUALITY ASSURANCE PLAN:
PhD student will monitor the data and guarantee high data quality. Data will be protected according to the Act on Data Protection and the Processing of Personal data (Icelandic law) and stored at the University Hospital or at a secure NeckCare database. Data will be registered into Microsoft Excel and shared through a secure network with other researchers to promote transparency.
DATA CHECKS:
Data will be checked for outliers.
SOURCE DATA VERIFICATION:
N/A
DATA DICTIONARY:
WAD: whiplash-associated disorders; MVC: motor vehicle collision; VR: virtual reality; NDI: neck disability index; ROM: range of motion; PTs: physiotherapists; MT: manual therapy; CKE: cervical kinaesthetic exercise; IT: information technology; IoT: internet of things; IMU: inertial monitoring unit; VAS: visual analog scale; SF-36: short form 36 item health survey; DHI: dizziness handicap inventory; CSI: central sensitisation inventory; CS: central sensitization; ToT: time on target; CI: confidence interval; MCIC: minimal clinically important changes.
STANDARD OPERATION PROCEDURES:
A total of 180 subjects (60 from each of the three groups) will be recruited through the databases of The Emergency Department of Landspitali University Hospital, Reykjavik, Iceland via phone call.
Subjective and objective outcome measures will be collected by a PhD student. In addition to questionnaire and clinical outcome measures, the pharmaceutical database of the Directorate of Health in Iceland will be accessed for data on subjects' drug use.
Data will be analysed by the PhD student using Microsoft Excel and R, a free software environment for statistical computing and graphics.
The PhD student will be responsible for reporting adverse events and change management.
SAMPLE SIZE ASSESSMENT:
Sample size and power regarding group differences will be calculated based on the primary outcome NDI. To detect a clinically relevant improvement of 8% in the NDI, 40 participants are needed in each group for 80% power. For non-inferiority tests, the significance level will be set to 5% (p > 0.05) which corresponds to the one-sided confidence interval (95% CI). To ensure that enough people are in each group after dropouts, for prediction analyses and the opportunity for subgroup analyses, 60 participants will be included in each group (n=180).
PLAN FOR MISSING DATA:
If data will be found to be missing by any reason, each incident will be assessed by the PhD student and her advisors. Imputation methods may be used, the subject involved may be asked to come back in for a measurement or answer questionnaires again (depending on the time that has passed from the measurement/questionnaires until data is discovered missing) or the subject involved will be removed from the study.
STATISTICAL ANALYSIS PLAN:
Data analyses and statistics Database monitoring will be performed by the primary researcher and statisticians involved, independent of sponsors and competing interests. Background data will be assessed after all subjects have completed their baseline measurements.
Background data and association of self-reported and clinical measures Background data will be evaluated with descriptive statistics and differences in baseline data determined using t-tests and (M)ANOVA (mean and standard deviation) or non-parametric tests where appropriate. Association of self-reported measurements and clinical measures will be assessed for baseline, 10-12-week, 6-month and 12-month measurements using Pearson or Spearman correlation depending on the distribution of the data. Subgroup analyses of CPS may possibly be performed.
Effectiveness of therapy Analyses will be performed primarily on an intention-to-treat basis (as individuals being randomized into the groups) and secondarily on a per protocol basis (individuals who fulfilled the programme for at least 50%). Imputation methods may be used when deemed to have additional value. Linear mixed models with time as a repeated factor will be used to assess the effect of treatment for each outcome. Correlation over time, within the PT and prognostic factors will be accounted for. Estimates of the effect of the intervention will be obtained by constructing linear contrasts to compare the mean change in outcome for each measurement (subjective and objective) to each time point between treatment groups and between each treatment group compared to control group. The main dependent variable will be score on NDI with independent fixed factors time (baseline, 10-12-week, 6-month, and 12-month) and group (A, B and C). If the non-inferiority of C to A or of C to B is concluded based on the 95% CI, a test of the superiority of C to A or of C to B will be performed as suggested by Lesaffre (see reference list). The variation in response to intervention (heterogeneity of treatment effect) will be evaluated using regression analysis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 3
- Model description
- Two groups will receive physiotherapy. Both will receive a "hands-on" individualized treatment of manual therapy. The "hands-off" treatment differs between groups and goes as follows: Group A will receive a novel, remote computer based cervical joint positioning exercise and cervical kinaesthesia exercise program with a 6-month follow-up. Group B will receive a non-computer based exercise regime at the need of each individual (pragmatic approach). This group will not be followed up on their exercises post intervention but will be encouraged to continue doing their exercises. They will be asked during follow-up measurements if they have been doing their exercises. The "treatment as usual" group (group C) will/will not receive treatment at his/her own choice and/or convenience and without any instructions from research staff to reflect general practice. In addition to follow-up assessments, data will be collected which asks about treatment modalities used.
| Arm | Type | Receives |
|---|---|---|
| Group A | Experimental | Other: Manual therapy, Device: Telehealth exercisesTelehealth using NeckCare equipment |
| Group B | Active comparator | Other: Manual therapy, Other: Non-computer based exercisesExercises without telehealth intervention |
| Group C | No intervention | –No intervention provided by the researchers |
Who may qualify
- Ages
- 18 to 63 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- subacute (>1 month, <3 months) neck problems corresponding to WAD grades I-II verified by WhipPredict
- medium to high risk symptoms (NDI score >32% OR subject is >36 years old) OR VAS score >4/10
- within daily reach of a computer/tablet/smartphone and Internet
- showed neck symptoms within the first week following the car collision (i.e. neck pain, neck stiffness)
Key exclusion criteria (3 listed)
- WAD grades III-IV
- considerable degree of known or suspected physical pathology (Myelopathy, Spinal tumours, Spinal infection, Ongoing malignancy, Cervical spine surgery, Severe neck problems within their medical history which resulted in sick leave for more than a month in the year before the current whiplash injury, Other illness/injury that may prevent full participation from being feasible, Lack of ability to either understand or write Icelandic, Severe obesity (body mass index; BMI > 35), Pregnancy)
- unable to complete the assessment
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 |
|---|---|---|
| Manual therapyIndividualized treatment of manual therapy provided by MT PTs, graduates from Curtin University of Technology, Perth, Australia (2008) | Other | Group A, Group B |
| Telehealth exercisesA novel, remote computer based cervical joint positioning exercise and cervical kinaesthetic exercise (CKE) program. A technical consultant monitors the data from the remote exercises and inform the PTs if someone has not done their exercises in over 2 weeks during the study period so subjects can be encouraged with a friendly reminder. | Device | Group A |
| Non-computer based exercisesHome-exercises in the need of each subject (pragmatic approach) taught by MT PTs, graduates from Curtin University of Technology, Perth, Australia (2008) | Other | Group B |
Primary outcome
Neck disability index (NDI)
Time frame: 5 minutes
the NDI is a 10-item self-report questionnaire that has been shown to demonstrate good validity and reliability. Each section is scored on a 0 to 5 rating scale, higher score represents more neck pain related disability.
Visual Analog Scale (VAS)
Time frame: 1 minutes
Neck pain intensity during the past week prior to each measurement measured by a 100 mm visual analogue scale (VAS) with 0mm representing "no pain" and 100mm representing "worst pain imaginable
Butterfly Test
Time frame: 5 minutes
* Procedure: The subject tracks an unpredictable path as accurately as possible using head movement to manipulate the on-screen cursor. There are different trajectories with increasing difficulty. The subject repeats each trajectory path 3 times. * Metrics: (1) Amplitude Accuracy (AA): the absolute distance (radius) in mm between the cursor that represents the head position and the target. (2) Time On Target (ToT): the percentage of time the cursor that represents the head position spends in a mathematically determined, invisible free zone around the target. (3) Smoothness of Movement Index (SMI): The index is calculated based on the third positional derivative with respect to time and is scaled between 0 and 5 with 0 being the best and 5 being the worst.
Whole Cervical Range of Motion (ROM) Test
Time frame: 5 minutes
* Procedure: The subject turns their head using four different types of movements: flexion, extension, rotation (left/right) and lateral flexion (left/right) to measure the maximum range ROM. Each movement is repeated 3 times. * Metrics: An average degree value and standard deviation of the 3 measurements for each movement type.
Head Neck Relocation Test (HNRT)
Time frame: 5 minutes
* Procedure: While blindfolded, the subject is asked to find their "neutral" position. The subject then turns their head to rotate left/right and up/down and attempts to return to the neutral/initial position following each movement, the subject informs the researcher by saying a simple "ok" when he believes he has reached the neutral position. The researcher marks this with one mouse click. * Metrics: (1) Accuracy Error measures the deviation in degrees from the initial position; (2) Constant Error measures under-/overshooting; and (3) Variable Error measures the precision of the head posture.
3 secondary outcomes
SF-36 Health Survey (SF-36) RAND version
Time frame: 10 minutes
Dizziness Handicap Inventory (DHI)
Time frame: 5 minutes
Central Sensitization Inventory (CSI)
Time frame: 5 minutes
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Dec 2023.
- Background: PubMed 18537788Lesaffre E. Superiority, equivalence, and non-inferiority trials. Bull NYU Hosp Jt Dis. 2008;66(2):150-4.
- Derived from this study: PubMed 37338163Ragnarsdottir H, Briem K, Oddsdottir GL. Effects of a Novel Web-Based Sensorimotor Exercise Program for Patients With Subacute Whiplash-Associated Disorders: Protocol for a Randomized Clinical Trial. Phys Ther. 2023 Aug 1;103(8):pzad063. doi: 10.1093/ptj/pzad063.
- Individual participant dataSharing planned: No
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.
Kristín Briem, PhD study chair
University of Iceland
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Manual therapy, Telehealth exercises and Non-computer based exercises in people with Whiplash Injury of Cervical Spine, run by University of Iceland at 4 sites in Iceland.
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 3 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: status not confirmed, as of the sponsor's last update on 8 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Iceland. 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?
Results are not available in the source record.
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: 5 minutes). The study lists 5 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 NCT05319808, which also lists 2 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 8 Dec 2023; AzTrials last refreshed its copy on 6 Nov 2026.