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

Whiplash Associated Disorders - Sensory Changes During Rehabilitation

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

Study Overview

• Status: Completed
• Conditions: Healthy; Neck Pain; Whiplash Injury; Whiplash
• Intervention / Treatment: Other: Conservative rehabilitation

Detailed Description

Altered pain sensitivity is commonly reported in WAD populations when compared to a healthy control group but how/if this changes over time during rehabilitation is unclear. This study investigates the effect of 2 weeks rehabilitation protocol on pain sensitivity in a group suffering from WAD compared to a healthy control group.

• Study Type: Observational
• Enrollment (Actual): 44

Contacts and Locations

Study Locations

• Spain
  • Zaragoza
    • Villanueva De Gállego, Zaragoza, Spain, 50830
      • Universidad San Jorge

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 50 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

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

Description

Inclusion Criteria:

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

Exclusion Criteria:

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.

Additional exclusion criteria for Controls:

• 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.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Acute Whiplash Associated Disorders; People suffering from acute WAD at the time of recruitment.	Other: Conservative rehabilitation; WAD participants underwent 2-weeks rehabilitation.
Healthy controls; Participants with no neck pain during the past 6 months, chronic pain or other medical disorders relevant to this study.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Neck Disability Index (NDI)	A validated and reliable questionnaire that estimates the impact of neck pain on normal daily activities (self-rated disability). NDI consists of 10 dimensions that all are score from 0-5 giving a maximum score of 50. The overall score indicates the level of disability. Below 5 = no disability whereas increased scores indicates increased levels of disability.	Baseline, 2 weeks, 6 months

Collaborators and Investigators

• Sponsor: Universidad San Jorge
• Collaborators: Aalborg University
• Investigators: Study Director: Steffan W Christensen, PhD, Aalborg University

Study record dates

Study Major Dates

• Study Start (ACTUAL): May 16, 2016
• Primary Completion (ACTUAL): April 22, 2019
• Study Completion (ACTUAL): October 22, 2019

Study Registration Dates

• First Submitted: December 10, 2018
• First Submitted That Met QC Criteria: December 20, 2018
• First Posted (ACTUAL): December 21, 2018

Study Record Updates

• Last Update Posted (ACTUAL): November 10, 2020
• Last Update Submitted That Met QC Criteria: November 9, 2020
• Last Verified: November 1, 2020

More Information

Terms related to this study

• Keywords: rehabilitation; neck pain; whiplash; WAD; pain sensitivity
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Wounds and Injuries; Neck Injuries; Neck Pain; Whiplash Injuries
• Other Study ID Numbers: PI16/0132

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: There are currently no plan on sharing data from this study with other researchers.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No