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Completed

NCT Number: NCT01528579

Effects of Different Exercise Programs for People With Chronic Whiplash Associated Disorders

Background:

Costs of health care consumption and sick leave 2006 in Sweden for Whiplash Associated Disorders (WAD) was estimated to be 4 billion Swedish crowns. Despite tremendous costs and personal sufferings there are only a few prospective randomized studies (RCT) in patients with chronic WAD, and none of them evaluating return to work, or the role of neck specific exercises with or without a combination of a behavioral approach compared with prescribed physical activity.

Aim:

The general aim of this RCT is to examine what neck-specific training with or without a combination with behavioral approach adds to prescribed physical activity of persons with chronic WAD with regard to pain intensity, physical and psychological function, health care consumption and return to work. Another aim is to study predictive factors of importance for a good outcome of rehabilitation.

Method:

After informed consent patients in age 18-63 years of age with WAD II-III with more than 6 months duration will be randomized to one out of the three alternatives of physiotherapy, treatment with medical exercise therapy with neck specific exercises (A),treatment with a behavioral approach combined with neck specific exercises (B), prescribed physical activity (C). Randomisation will be done by the central project leader. 200 patients will be included in the study. All physiotherapists engaged in the structured and well described treatment will be introduced in the program by the project leader. The measurements with good clinometric properties will be performed before treatment, after 12 weeks, 6, 12 and 24 months after inclusion into the study. Clinical measurements will be performed by a blinded investigator. Background data, disease-specific and generic data will be measured by self-evaluated answered questionnaires by the patients. Days of sick-leave will be collected from the Social Insurance Agency. Main outcomes of the measurements are pain intensity, neck specific disability and return to work. Cost-effectiveness will be calculated.

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Key information

Conditions

Whiplash Behavior Motor Activity Neck Injuries Whiplash Injuries Wounds and Injuries

Age range

18 year–63 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Medical and Health Sciences, physiotherapy, Linköping, Östergötland County, Sweden

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Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Age 18-63 years
  • WAD II-III
  • Remaining problems (>10mm on 100mm Visual Analogue Scale (VAS) or >20% on Neck Disability Index (NDI) or at least moderate pin on NDI) at least 6 months but no more than 3 years after whiplash trauma

Exclusion criteria

  • Myelopathy
  • Earlier fracture or luxation of the cervical column, earlier neck injury
  • Spinal tumour
  • Spinal infection
  • Surgery in the cervical column
  • Malignity
  • Systematic disease or another injury contraindicated to perform the treatment program or the measurements.
  • Diagnosed severe psychiatric disorder
  • Unconscious in connection to the trauma
  • Known drug abuse
  • Lack of familiarity with the Swedish language

Treatment and study plan

Neck specific exercises

Other

2 times a week for 3 months followed by encourages to continue on their own

Behavioral approach combined with neck specific exercises

Behavioral

Behavioral physiotherapeutic approach combined with neck specific exercises 2 times a week for 3 months. Exercises will be chosen from a well defined and structured frame of exercises.

Prescribed Physical activity

Other

Physical activity without neck specific exercises for 3 months

Primary outcomes

  1. Neck Disability Index (NDI)

    Time frame: Baseline and change after 3 and 6 months of exercises, 3 month, 6 month, 12 month and 24 month follow-up. Change from baseline to follow-ups. Twelve month follow-up is the most important follow-up to investigate change over time from baseline.

    NDI will be measured at baseline before intervention. Change from baseline in NDI will be measured at 3,6,12,and 24 months to investigate change over time. Baseline and change after three and six months of exercises and to investigate if a potential change of the exercises remain at 12 month and 24 month from baseline.

Secondary outcomes

  1. Pain intensity on VAS

    Time frame: before intervention, 3, 6, 12 and 24 months follow-up. The outcome measure is going to report a change over time.

    Pain intensity is measured on a 100mm Visual Analogue Scale (VAS).

  2. Pain Disability Index

    Time frame: before intervention, 3,6, 12, and 24 months follow-ups. The outcome measure is going to report a change over time.

  3. Neck muscle endurance in seconds

    Time frame: before intervention, 3,6, 12, and 24 months follow-ups. The outcome measure is going to report a change over time.

  4. Self-efficacy scale

    Time frame: before intervention, 3,6, 12, and 24 months follow-ups. The outcome measure is going to report a change over time.

  5. Work Ability Index

    Time frame: before intervention and at 3, 6, 12 months and 24 months follow-up. The outcome measure is going to report a change over time.

  6. Euroquol

    Time frame: before intervention, 3,6, 12, and 24 months follow-ups. The outcome measure is going to report a change over time.

  7. SF-36

    Time frame: before intervention, 3,6, 12, and 24 months follow-ups. The outcome measure is going to report a change over time.

  8. Pain Catastrophizing Scale

    Time frame: before intervention, 3,6, 12, and 24 months follow-ups. The outcome measure is going to report a change over time.

  9. Tampa Scale 11, short version

    Time frame: before intervention, 6, 12, and 24 months follow-ups. The outcome measure is going to report a change over time.

  10. Neurological status

    Time frame: before intervention, 3,6, 12, and 24 months follow-ups. The outcome measure is going to report a change over time.

    Sensibility, reflexes,motor function upper extremeties, nerve tension test median nerve.

  11. Pain drawing

    Time frame: before intervention, 3,6, 12, and 24 months follow-ups. The outcome measure is going to report a change over time.

    For the pain-drawing task, patients indicated the extent and the distribution of their pain on outlines of full front and back views of a human body. After the patients completed each pain-drawing, the distributions of symptoms will be coded on a seven-point scale (were 0 is no pain, and 6 is pain distributed in the hand), and where the pain was located in the cervical, thoracic, and/or the lumbar spine, in the front and the back of the body, will be indicated using a clear overlay template.

  12. Clinical objective measures

    Time frame: before intervention, 3,6, 12, and 24 months follow-ups. The outcome measure is going to report a change over time.

    Range of motion of the neck and cervical kinesthesia (ability to reproduce the neutral head position from 30° cervical rotation with the eyes closed) will be measured with Cervical range of motion device (CROM).

    Balance (Static:sharpened Romberg's position with eyes closed. Dynamic: Walking in a figure-of-eight). Hand strength measured with a Jamar dynamometer. Dorsal and ventral eck muscle endurance measured in seconds.

Sponsors and collaborators

Lead sponsor

Linkoeping University

Other Gov

Registry information

Official study title

Effects of Different Exercise Programs for People With Chronic Whiplash Associated Disorders: a Prospective Randomized Study

Important dates

Study start
2011
Primary completion
2014
Study completion
2014
First posted
Feb 8, 2012
Registry last updated
Mar 7, 2017

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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