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Completed

NCT Number: NCT03784196

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

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

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Key information

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Universidad San Jorge

Villanueva de Gállego, Zaragoza, 50830, Spain

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Conservative rehabilitation

Other

WAD participants underwent 2-weeks rehabilitation.

Primary outcomes

  1. Changes in Pressure Pain Thresholds

    Time frame: 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.

  2. Changes in Conditioned Pain Modulation

    Time frame: 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 outcomes

  1. Neck Disability Index (NDI)

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Universidad San Jorge

Other

Collaborators

  • Aalborg University

Registry information

Official study title

Whiplash Associated Disorders - Sensory Changes During Rehabilitation

Important dates

Study start
2016
Primary completion
2019
Study completion
2019
First posted
Dec 21, 2018
Registry last updated
Nov 10, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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