Rehabilitation for Whiplash Associated Disorders

NCT05319808 | Unknown

• 1 other identifier: UI-123218
• Study Type: interventional
• Target: 180
• Locations: 1 country
• Sites: 4

Brief 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.

Conditions

Whiplash Injury of Cervical Spine

Keywords

Whiplash-Associated Disorders; Car-collision; Kinaesthesia; Telehealth; Motor Control; Treatment; Exercises; Manual Therapy; Objective measurements

Outcome Measures

Primary Outcomes (5)

• 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

• 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

• 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

• 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

• 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 Outcomes (3)

• SF-36 Health Survey (SF-36) RAND version

  10 minutes

• Dizziness Handicap Inventory (DHI)

  5 minutes

• Central Sensitization Inventory (CSI)

  5 minutes

Other Outcomes (1)

• Background data, questionnaire

  7 minutes

Study Arms (3)

Group A

EXPERIMENTAL

Telehealth using NeckCare equipment

Other: Manual therapy; Device: Telehealth exercises

Group B

ACTIVE COMPARATOR

Exercises without telehealth intervention

Other: Manual therapy; Other: Non-computer based exercises

Group C

NO INTERVENTION

No intervention provided by the researchers

Interventions

Manual therapy OTHER

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

Group A; Group B

Telehealth exercises DEVICE

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.

Group A

Non-computer based exercises OTHER

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

Group B

Eligibility Criteria

• Age: 18 Years - 63 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Iceland: lead
• Empowered Health: collaborator
• Reykjavik University: collaborator
• Landspitali University Hospital: collaborator

Study Sites (4)

K!M Rehabilitaion

Kopavogur, 203, Iceland

Location

University of Iceland

Reykjavik, 102, Iceland

Location

Landspítali University Hospital

Reykjavik, 108, Iceland

Location

Hæfi Physiotherapy

Reykjavik, 112, Iceland

Location

Related Publications (2)

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

  PMID: 18537788 BACKGROUND

• Ragnarsdottir 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.

  PMID: 37338163 DERIVED

MeSH Terms

Conditions

Motor Activity

Interventions

Musculoskeletal Manipulations

Condition Hierarchy (Ancestors)

Behavior

Intervention Hierarchy (Ancestors)

Complementary Therapies; Therapeutics; Physical Therapy Modalities; Rehabilitation

Study Officials

• Kristín Briem, PhD

  University of Iceland

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: March 31, 2022
• First Posted: April 8, 2022
• Study Start: May 27, 2022
• Primary Completion: June 30, 2023
• Study Completion: April 30, 2024
• Last Updated: December 8, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

IC (4)