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

Sponsor

Universidad San Jorge (Other)

Overall Status

Completed

CT.gov ID

NCT03784196

Collaborator

Aalborg University (Other)

Enrollment

Location

41.2

Actual Duration (Months)

1.1

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Whiplash Whiplash Injury Neck Pain Healthy	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 Design

Study Type:

Observational [Patient Registry]

Actual Enrollment :

44 participants

Observational Model:

Case-Control

Time Perspective:

Prospective

Official Title:

Whiplash Associated Disorders - Sensory Changes During Rehabilitation

Actual Study Start Date :

May 16, 2016

Actual Primary Completion Date :

Apr 22, 2019

Actual Study Completion Date :

Oct 22, 2019

Arms and Interventions

Arm	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.

Arm

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.

Outcome Measures

Primary Outcome Measures

Changes in Pressure Pain Thresholds [Baseline, 2 weeks, 6 months]
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.
Changes in Conditioned Pain Modulation [Baseline, 2 weeks, 6 months]
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.

Secondary Outcome Measures

Neck Disability Index (NDI) [Baseline, 2 weeks, 6 months]
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 50 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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.