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

Primary Purpose

Whiplash

Status
Completed
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
Neck Specific Exercises
Behavioral approach combined with neck specific exercises
Prescribed Physical activity
Sponsored by
Linkoeping University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Whiplash focused on measuring Whiplash, Rehabilitation, Physiotherapy, Exercises

Eligibility Criteria

18 Years - 63 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Linköping University
  • Department of Medical and Health Sciences, physiotherapy

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Active Comparator

Arm Label

Neck Specific exercises

Behavioral approach

Prescribed physical activity

Arm Description

Neck Specific exercises from a structured frame of exercises

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.

Prescribed physical activity from a physiotherapist without neck specific exercises

Outcomes

Primary Outcome Measures

Neck Disability Index (NDI)
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
Pain intensity is measured on a 100mm Visual Analogue Scale (VAS).
Pain Disability Index
Neck muscle endurance in seconds
Self-efficacy scale
Work Ability Index
Euroquol
SF-36
Pain Catastrophizing Scale
Tampa Scale 11, short version
Neurological status
Sensibility, reflexes,motor function upper extremeties, nerve tension test median nerve.
Pain drawing
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
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.

Full Information

First Posted
January 22, 2012
Last Updated
March 6, 2017
Sponsor
Linkoeping University
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1. Study Identification

Unique Protocol Identification Number
NCT01528579
Brief Title
Effects of Different Exercise Programs for People With Chronic Whiplash Associated Disorders
Official Title
Effects of Different Exercise Programs for People With Chronic Whiplash Associated Disorders: a Prospective Randomized Study
Study Type
Interventional

2. Study Status

Record Verification Date
March 2017
Overall Recruitment Status
Completed
Study Start Date
March 2011 (undefined)
Primary Completion Date
December 2014 (Actual)
Study Completion Date
December 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Linkoeping University

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Whiplash
Keywords
Whiplash, Rehabilitation, Physiotherapy, Exercises

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
216 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Neck Specific exercises
Arm Type
Active Comparator
Arm Description
Neck Specific exercises from a structured frame of exercises
Arm Title
Behavioral approach
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Prescribed physical activity
Arm Type
Active Comparator
Arm Description
Prescribed physical activity from a physiotherapist without neck specific exercises
Intervention Type
Other
Intervention Name(s)
Neck Specific Exercises
Intervention Description
2 times a week for 3 months followed by encourages to continue on their own
Intervention Type
Behavioral
Intervention Name(s)
Behavioral approach combined with neck specific exercises
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Prescribed Physical activity
Intervention Description
Physical activity without neck specific exercises for 3 months
Primary Outcome Measure Information:
Title
Neck Disability Index (NDI)
Description
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.
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.
Secondary Outcome Measure Information:
Title
Pain intensity on VAS
Description
Pain intensity is measured on a 100mm Visual Analogue Scale (VAS).
Time Frame
before intervention, 3, 6, 12 and 24 months follow-up. The outcome measure is going to report a change over time.
Title
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.
Title
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.
Title
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.
Title
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.
Title
Euroquol
Time Frame
before intervention, 3,6, 12, and 24 months follow-ups. The outcome measure is going to report a change over time.
Title
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.
Title
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.
Title
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.
Title
Neurological status
Description
Sensibility, reflexes,motor function upper extremeties, nerve tension test median nerve.
Time Frame
before intervention, 3,6, 12, and 24 months follow-ups. The outcome measure is going to report a change over time.
Title
Pain drawing
Description
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.
Time Frame
before intervention, 3,6, 12, and 24 months follow-ups. The outcome measure is going to report a change over time.
Title
Clinical objective measures
Description
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.
Time Frame
before intervention, 3,6, 12, and 24 months follow-ups. The outcome measure is going to report a change over time.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
63 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Anneli Peolsson, PhD, RPT
Organizational Affiliation
Linköping University, Sweden
Official's Role
Study Chair
Facility Information:
Facility Name
Linköping University
City
Linköping
State/Province
Östergötland
ZIP/Postal Code
SE-58183
Country
Sweden
Facility Name
Department of Medical and Health Sciences, physiotherapy
City
Linköping
State/Province
Östergötland
Country
Sweden

12. IPD Sharing Statement

Citations:
PubMed Identifier
31169550
Citation
Liew BXW, Scutari M, Peolsson A, Peterson G, Ludvigsson ML, Falla D. Investigating the Causal Mechanisms of Symptom Recovery in Chronic Whiplash-associated Disorders Using Bayesian Networks. Clin J Pain. 2019 Aug;35(8):647-655. doi: 10.1097/AJP.0000000000000728.
Results Reference
derived
PubMed Identifier
30225786
Citation
Landen Ludvigsson M, Peterson G, Peolsson A. The effect of three exercise approaches on health-related quality of life, and factors associated with its improvement in chronic whiplash-associated disorders: analysis of a randomized controlled trial. Qual Life Res. 2019 Feb;28(2):357-368. doi: 10.1007/s11136-018-2004-3. Epub 2018 Sep 17.
Results Reference
derived
PubMed Identifier
27374016
Citation
Ardern CL, Peterson G, Ludvigsson ML, Peolsson A. Satisfaction With the Outcome of Physical Therapist-Prescribed Exercise in Chronic Whiplash-Associated Disorders: Secondary Analysis of a Randomized Clinical Trial. J Orthop Sports Phys Ther. 2016 Aug;46(8):640-9. doi: 10.2519/jospt.2016.6136. Epub 2016 Jul 3.
Results Reference
derived
PubMed Identifier
26031995
Citation
Ludvigsson ML, Peterson G, Dedering A, Falla D, Peolsson A. Factors associated with pain and disability reduction following exercise interventions in chronic whiplash. Eur J Pain. 2016 Feb;20(2):307-15. doi: 10.1002/ejp.729. Epub 2015 May 29.
Results Reference
derived
PubMed Identifier
24171699
Citation
Peolsson A, Landen Ludvigsson M, Overmeer T, Dedering A, Bernfort L, Johansson G, Kammerlind AS, Peterson G. Effects of neck-specific exercise with or without a behavioural approach in addition to prescribed physical activity for individuals with chronic whiplash-associated disorders: a prospective randomised study. BMC Musculoskelet Disord. 2013 Oct 30;14:311. doi: 10.1186/1471-2474-14-311.
Results Reference
derived

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

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