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

This study is currently recruiting participants.
Verified February 2012 by Linkoeping University
Sponsor:
Information provided by (Responsible Party):
Anneli Peolsson, Linkoeping University
ClinicalTrials.gov Identifier:
NCT01528579
First received: January 22, 2012
Last updated: February 27, 2012
Last verified: February 2012
History of Changes
  Purpose

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.


Condition Intervention
Whiplash
 Other: Neck Specific Exercises
Behavioral: Behavioral approach combined with neck specific exercises
Other: Prescribed Physical activity

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Treatment
Official Title: Effects of Different Exercise Programs for People With Chronic Whiplash Associated Disorders: a Prospective Randomized Study

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Linkoeping University:

Primary Outcome Measures:
  • 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. ] [ Designated as safety issue: No ]
    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 Outcome Measures:
  • 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. ] [ Designated as safety issue: No ]
    Pain intensity is measured on a 100mm Visual Analogue Scale (VAS).

  • 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. ] [ Designated as safety issue: No ]
  • 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. ] [ Designated as safety issue: No ]
  • 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. ] [ Designated as safety issue: No ]
  • 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. ] [ Designated as safety issue: No ]
  • Euroquol [ Time Frame: before intervention, 3,6, 12, and 24 months follow-ups. The outcome measure is going to report a change over time. ] [ Designated as safety issue: No ]
  • 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. ] [ Designated as safety issue: No ]
  • 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. ] [ Designated as safety issue: No ]
  • 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. ] [ Designated as safety issue: No ]
  • 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. ] [ Designated as safety issue: No ]
    Sensibility, reflexes,motor function upper extremeties, nerve tension test median nerve.

  • 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. ] [ Designated as safety issue: No ]
    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.

  • 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. ] [ Designated as safety issue: No ]

    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.



Estimated Enrollment: 200
Study Start Date: March 2011
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Neck Specific exercises
Neck Specific exercises from a structured frame of exercises
 Other: Neck Specific Exercises
2 times a week for 3 months followed by encourages to continue on their own
Active Comparator: Behavioral approach
Behavioral physiotherapeutic approach in combination with neck specific exercises from a structured well defined frame of exercises and how to treat the patient. 2 times a week for 3 months.
 Behavioral: Behavioral approach combined with neck specific exercises
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.
Active Comparator: Prescribed physical activity
Prescribed physical activity from a physiotherapist without neck specific exercises
 Other: Prescribed Physical activity
Physical activity without neck specific exercises for 3 months

  Eligibility

Ages Eligible for Study:   18 Years to 63 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01528579

Contacts
Contact: Anneli Peolsson, Ass Prof, PhD +46-10-1031798 Anneli.Peolsson@liu.se
Contact: Gunnel Peterson, PhD stud +46-722100901 Gunnel.Peterson@liu.se

Locations
Sweden
Department of Medical and Health Sciences, physiotherapy Recruiting
Linköping, Östergötland, Sweden
Contact: Anneli Peolsson, Assoc Prof, PhD     +46-10-1031798        
Contact: Gunnel Peterson, PhD stud, MSc     +46-72-2100901        
Principal Investigator: Anneli Peolsson, PhD, RPT            
Principal Investigator: Gunnel Peterson, MSc, RPT            
Principal Investigator: Maria Landén Ludvigsson, MSc, RPT            
Linköping University Recruiting
Linköping, Östergötland, Sweden, SE-58183
Contact: Anneli Peolsson, PhD     +46-10-221798     Anneli.Peolsson@liu.se    
Contact: Gunnel Peterson, MSc     046-72-2100901     Gunnel.Peterson@liu.se    
Principal Investigator: Anneli Peolsson, PhD            
Sponsors and Collaborators
Linkoeping University
Investigators
Study Chair: Anneli Peolsson, PhD, RPT Linköping University, Sweden
  More Information

No publications provided

Responsible Party: Anneli Peolsson, Assoc Prof, PhD, Linkoeping University
ClinicalTrials.gov Identifier: NCT01528579     History of Changes
Other Study ID Numbers: PeolssonAWADlong-term
Study First Received: January 22, 2012
Last Updated: February 27, 2012
Health Authority: Sweden: Regional Ethical Review Board

Keywords provided by Linkoeping University:
Whiplash
Rehabilitation
Physiotherapy
Exercises

Additional relevant MeSH terms:
Whiplash Injuries
Neck Injuries
Wounds and Injuries

ClinicalTrials.gov processed this record on May 16, 2013