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

Healthy Clinical Trial

Official title:

Whiplash Associated Disorders - Sensory Changes During Rehabilitation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03784196
• Other study ID #: PI16/0132
• Status: Completed
• Start date: May 16, 2016
• Est. completion date: October 22, 2019

Study information

• Verified date: November 2020
• Source: Universidad San Jorge
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 44
• Est. completion date: October 22, 2019
• Est. primary completion date: April 22, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 50 Years

Eligibility

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.

Related Conditions & MeSH terms

• Healthy
• Neck Pain
• Whiplash
• Whiplash Injuries
• Whiplash Injury

Intervention

Other:
• Conservative rehabilitation
WAD participants underwent 2-weeks rehabilitation.

Locations

Country	Name	City	State
Spain	Universidad San Jorge	Villanueva De Gállego	Zaragoza

Sponsors (2)

Lead Sponsor	Collaborator
Universidad San Jorge	Aalborg University

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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