Clinical trial NCT01528579: 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
Overall status: COMPLETED
Phase: NA
Conditions: Whiplash
Keywords: Whiplash
Rehabilitation
Physiotherapy
Exercises
Lead sponsor: Linkoeping University
Sponsor class: OTHER_GOV
First posted: 2012-02-08
Enrollment: 216
Sex: ALL
Minimum age (years): 18
Maximum age (years): 63
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Neck Disability Index (NDI)
timeFrame: 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 outcomes:
measure: Pain intensity on VAS
timeFrame: before intervention, 3, 6, 12 and 24 months follow-up. The outcome measure is going to report a change over time.
measure: Pain Disability Index
timeFrame: before intervention, 3,6, 12, and 24 months follow-ups. The outcome measure is going to report a change over time.
measure: Neck muscle endurance in seconds
timeFrame: before intervention, 3,6, 12, and 24 months follow-ups. The outcome measure is going to report a change over time.
measure: Self-efficacy scale
timeFrame: before intervention, 3,6, 12, and 24 months follow-ups. The outcome measure is going to report a change over time.
measure: Work Ability Index
timeFrame: before intervention and at 3, 6, 12 months and 24 months follow-up. The outcome measure is going to report a change over time.
measure: Euroquol
timeFrame: before intervention, 3,6, 12, and 24 months follow-ups. The outcome measure is going to report a change over time.
measure: SF-36
timeFrame: before intervention, 3,6, 12, and 24 months follow-ups. The outcome measure is going to report a change over time.
measure: Pain Catastrophizing Scale
timeFrame: before intervention, 3,6, 12, and 24 months follow-ups. The outcome measure is going to report a change over time.
measure: Tampa Scale 11, short version
timeFrame: before intervention, 6, 12, and 24 months follow-ups. The outcome measure is going to report a change over time.
measure: Neurological status
timeFrame: before intervention, 3,6, 12, and 24 months follow-ups. The outcome measure is going to report a change over time.
measure: Pain drawing
timeFrame: before intervention, 3,6, 12, and 24 months follow-ups. The outcome measure is going to report a change over time.
measure: Clinical objective measures
timeFrame: before intervention, 3,6, 12, and 24 months follow-ups. The outcome measure is going to report a change over time.
Other outcomes:
Locations:
city: Linköping
country: Sweden
facility: Linköping University
state: Östergötland
city: Linköping
country: Sweden
facility: Department of Medical and Health Sciences, physiotherapy
state: Östergötland
Study officials:
affiliation: Linkoeping University
name: Anneli Peolsson, PhD, RPT
role: STUDY_CHAIR
References:
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.
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.
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.
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.
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.