Rehabilitation for Whiplash Associated Disorders

Whiplash Injury of Cervical Spine Clinical Trial

Official title:

Rehabilitation for Whiplash Associated Disorders; a Randomized Clinical Trial

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05319808
• Other study ID #: UI-123218
• Status: Active, not recruiting
• Phase: N/A
• Start date: May 27, 2022
• Est. completion date: April 30, 2024

Study information

• Verified date: November 2023
• Source: University of Iceland
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 180
• Est. completion date: April 30, 2024
• Est. primary completion date: June 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 63 Years

Eligibility

Inclusion Criteria:

• 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)

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Whiplash Injuries
• Whiplash Injury of Cervical Spine

Intervention

Other:
• Manual therapy
Individualized treatment of manual therapy provided by MT PTs, graduates from Curtin University of Technology, Perth, Australia (2008)

Device:
• Telehealth exercises
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.

Other:
• Non-computer based exercises
Home-exercises in the need of each subject (pragmatic approach) taught by MT PTs, graduates from Curtin University of Technology, Perth, Australia (2008)

Locations

Country	Name	City	State
Iceland	K!M Rehabilitaion	Kópavogur
Iceland	Hæfi Physiotherapy	Reykjavík
Iceland	Landspítali University Hospital	Reykjavík
Iceland	University of Iceland	Reykjavík

Sponsors (4)

Lead Sponsor	Collaborator
University of Iceland	Empowered Health, Landspitali University Hospital, Reykjavik University

Country where clinical trial is conducted

Iceland, 

References & Publications (1)

Lesaffre E. Superiority, equivalence, and non-inferiority trials. Bull NYU Hosp Jt Dis. 2008;66(2):150-4. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Background data, questionnaire	Background data that will be collected will include age, sex, date of birth, information on when the accident occurred and how, first symptoms, former healthcare, education, occupational classification, income, and information on insurance claim status. Furthermore, during the 6-month and 12-month follow-up participants will also be asked to give information on if they have met with a health care practitioner for treatment other than those of this study	7 minutes
Primary	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.	5 minutes
Primary	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	1 minutes
Primary	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.	5 minutes
Primary	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.	5 minutes
Primary	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.	5 minutes
Secondary	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.	10 minutes
Secondary	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.	5 minutes
Secondary	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	5 minutes