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

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

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

Brief Summary:

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 inve

Detailed Summary:
Sponsor: Linkoeping University

Current Primary Outcome: 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. ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

• 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).
• 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. ]
• 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. ]
• 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. ]
• 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. ]
• Euroquol [ Time Frame: before intervention, 3,6, 12, and 24 months follow-ups. The outcome measure is going to report a change over time. ]
• 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. ]
• 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. ]
• 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. ]
• 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.
• 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.
• 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.

Original Secondary Outcome:

• 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).
• 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. ]
• 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. ]
• 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. ]
• 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. ]
• Euroquol [ Time Frame: before intervention, 3,6, 12, and 24 months follow-ups. The outcome measure is going to report a change over time. ]
• 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. ]
• 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. ]
• 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. ]
• 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.
• 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.
• 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)

Dates:
Date Received: January 22, 2012
Date Started: March 2011
Date Completion:
Last Updated: March 6, 2017
Last Verified: March 2017