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

NCT01528579 | Completed DMC

• 1 other identifier: PeolssonAWADlong-term
• Study Type: interventional
• Target: 216
• Locations: 1 country
• Sites: 2

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.

Conditions

Whiplash

Keywords

Whiplash; Rehabilitation; Physiotherapy; Exercises

Outcome Measures

Primary Outcomes (1)

• 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.

  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 (12)

• Pain intensity on VAS

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

• Pain Disability Index

  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

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

• Self-efficacy scale

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

• Work Ability Index

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

Study Arms (3)

Neck Specific exercises

ACTIVE COMPARATOR

Neck Specific exercises from a structured frame of exercises

Other: Neck Specific Exercises

Behavioral approach

ACTIVE COMPARATOR

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

Prescribed physical activity

ACTIVE COMPARATOR

Prescribed physical activity from a physiotherapist without neck specific exercises

Other: Prescribed Physical activity

Interventions

Neck Specific Exercises OTHER

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

Neck Specific exercises

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.

Behavioral approach

Prescribed Physical activity OTHER

Physical activity without neck specific exercises for 3 months

Prescribed physical activity

Eligibility Criteria

• Age: 18 Years - 63 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Linkoeping University: lead

Study Sites (2)

Linköping University

Linköping, Östergötland County, SE-58183, Sweden

Location

Department of Medical and Health Sciences, physiotherapy

Linköping, Östergötland County, Sweden

Location

Related Publications (5)

• 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.

  PMID: 31169550 DERIVED

• 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.

  PMID: 30225786 DERIVED

• 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.

  PMID: 27374016 DERIVED

• 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.

  PMID: 26031995 DERIVED

• 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.

  PMID: 24171699 DERIVED

MeSH Terms

Conditions

Whiplash Injuries; Motor Activity

Condition Hierarchy (Ancestors)

Neck Injuries; Wounds and Injuries; Behavior

Study Officials

• Anneli Peolsson, PhD, RPT

  Linkoeping University

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assoc Prof, PhD

Study Record Dates

• First Submitted: January 22, 2012
• First Posted: February 8, 2012
• Study Start: March 1, 2011
• Primary Completion: December 1, 2014
• Study Completion: December 1, 2014
• Last Updated: March 7, 2017

Record last verified: 2017-03

Locations

SE (2)