Changes of Pain Sensitivity During Rehabilitation of Patients Suffering From Whiplash Associated Disorders

NCT03784196 | Completed

• 1 other identifier: PI16/0132
• Study Type: observational
• Target: 44
• Locations: 1 country
• Sites: 1

Brief Summary

This study investigates the sensory profile of people suffering from whiplash associated disorders (WAD) during rehabilitation.

Conditions

Whiplash; Whiplash Injury; Neck Pain; Healthy

Keywords

WAD; rehabilitation; whiplash; neck pain; pain sensitivity

Outcome Measures

Primary Outcomes (2)

• Changes in Pressure Pain Thresholds

  Changes in pressure pain thresholds will be determined with pressure algometry bilaterally over the neck and leg. PPT is defined as the exact time point where the pressure is first being perceived at painful.

  Baseline, 2 weeks, 6 months

• Changes in Conditioned Pain Modulation

  Changes in condition pain modulation (CPM) will be measures by recording PPT bilaterally over the neck and leg prior to and following a painful stimuli (a pressure cuff is inflated around the upper arm to create the conditioned stimulus). CPM value is calculated by subtracting raw PPT (without painful stimuli) from PPT under the conditioned stimulus.

  Baseline, 2 weeks, 6 months

Secondary Outcomes (1)

• Neck Disability Index (NDI)

  Baseline, 2 weeks, 6 months

Study Arms (2)

Acute Whiplash Associated Disorders

People suffering from acute WAD at the time of recruitment.

Other: Conservative rehabilitation

Healthy controls

Participants with no neck pain during the past 6 months, chronic pain or other medical disorders relevant to this study.

Interventions

Conservative rehabilitation OTHER

WAD participants underwent 2-weeks rehabilitation.

Acute Whiplash Associated Disorders

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Acute WAD following a motor vehicle accident (MVA) and age- and sex-matched healthy controls.

You may qualify if:

• WAD
• No more than 3 weeks since MVA/WAD
• WAD grade II defined by Quebec Task Force classification
• Controls • Being healthy and free from any pain specific to the low back and/or in general

You may not qualify if:

• Applies for both groups:
• Pain related to a specific pathology such as spinal stenosis, metastasis, fracture, nerve lesions or injuries to the brain etc.
• Previous painful condition (including neck pain) in the previous 6 months.
• Prior surgery in the neck or shoulder area.
• Radiculopathy.
• Multiple painful sites/areas unrelated to the neck pain.
• Operation to the spine.
• Any neurological or systemic diseases which can affect the outcome measures.
• Pregnancy.
• Lack of ability to cooperate.
• No current or previous history of on-going pain, defined as pain in the neck/shoulder region and/or elsewhere during the past 6 months.

Sponsors & Collaborators

• Universidad San Jorge: lead
• Aalborg University: collaborator

Study Sites (1)

Universidad San Jorge

Villanueva de Gállego, Zaragoza, 50830, Spain

Location

MeSH Terms

Conditions

Whiplash Injuries; Neck Pain

Condition Hierarchy (Ancestors)

Neck Injuries; Wounds and Injuries; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Steffan W Christensen, PhD

  Aalborg University

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Target Duration: 6 Months
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 10, 2018
• First Posted: December 21, 2018
• Study Start: May 16, 2016
• Primary Completion: April 22, 2019
• Study Completion: October 22, 2019
• Last Updated: November 10, 2020

Record last verified: 2020-11

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)