Neck-specific Exercise in Chronic Whiplash

NCT03022812 | Completed

• 1 other identifier: 2016/135-31
• Study Type: interventional
• Target: 140
• Locations: 1 country
• Sites: 1

Brief Summary

Neck pain is fourth among the most common conditions worldwide associated with longer periods of living with disability. Annually, about 30 000 people in Sweden undergo a whiplash trauma (WAD), and half of those individuals will develop chronic problems with high costs for the individual and society. Evidence for chronic WAD treatment is scarce, although neck-specific training at a physiotherapy clinic (2 times a week for 3 months) has demonstrated good results. A more efficient, flexible rehabilitation with reduced waiting times and lower costs is needed, ideally replacing lengthy on-site treatment series by health care providers. Internet-based care has proven to be a viable alternative to personal care meetings for a variety of diseases and interventions, but studies are lacking on Internet-based interventions for individuals with chronic neck problems. The purpose of this study is to investigate if A) neck-specific training delivered through Internet-based care differs from B) a longer series of treatments at a physiotherapy clinic regarding, e.g., work ability, sick-leave and disability. This prospective, randomized study involves 140 participants. Measurement is done at baseline, 3 months (end of treatment), and 15 months (12 months after end of treatment in the study) and will include ratings of work ability, sick-leave, work presenteeism, disability, pain, health, satisfaction with care, quality of life, and cost-effectiveness. The study results may contribute to the development of a more effective rehabilitation, flexible and equal care, shorter waiting times, increased availability and lower costs for health care and society. The program can be implemented on a broader scale in neck pain patients.

Conditions

Whiplash Associated Disorders

Keywords

Neck pain; Rehabilitation; Exercise Therapy; Internet

Outcome Measures

Primary Outcomes (1)

• Neck Disability Index (NDI)

  Self-reported neck-specific function

  Change from baseline to 3 months (the end of treatment) and 15 months (1 year after study treatment is finalized) follow-up

Secondary Outcomes (31)

• Whiplash Disability Questionnaire

  Change from baseline to 3 months (the end of treatment) and 15 months (1 year after study treatment is finalized) follow-up

• Patient-specific functional scale (PSFS)

  Change from baseline to 3 months (the end of treatment) and 15 months (1 year after study treatment is finalized) follow-up

• Pain intensity in neck, head, and arm and dizziness by a VAS (0-100 mm)

  Change from baseline to 3 months (the end of treatment) and 15 months (1 year after study treatment is finalized) follow-up

• Distribution of pain by a pain drawing assessed with images

  Change from baseline to 3 months (the end of treatment) and 15 months (1 year after study treatment is finalized) follow-up

• Frequency of pain

  Change from baseline to 3 months (the end of treatment) and 15 months (1 year after study treatment is finalized) follow-up

Other Outcomes (3)

• Background data such as age and gender

  Baseline

• Work Ability Index (WAI)

  Change from baseline to 3 months (the end of treatment) and 15 months (1 year after study treatment is finalized) follow-up

• Global rating of change scale

  Change from baseline to 3 months and 15 months follow-up, measured at follow-ups

Study Arms (2)

Exercises at a physiotherapy clinic

ACTIVE COMPARATOR

Neck-specific exercise at a physiotherapy clinic, 24 times during 12 weeks (plus an additional first visit).

Other: Neck-specific exercise

Exercises with Internet support

EXPERIMENTAL

Neck-specific exercise with Internet support combined with 3 visits at a physiotherapy clinic (plus an additional first visit), exercises mainly performed outside the health care system during 12 weeks.

Other: Neck-specific exercise

Interventions

Neck-specific exercise OTHER

Neck-specific exercise

Exercises at a physiotherapy clinic; Exercises with Internet support

Eligibility Criteria

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

You may qualify if:

• Individuals with a whiplash injury in a traffic accident with a four-wheeled motor vehicle at least 6 months ago but less than 5 years ago, with chronic neck problems corresponding to Quebec Task Force (QTF) grades 2-3 verified in clinical examination
• No participation in a neck-specific exercise program in a previous research study;
• Average estimated pain in the preceding week more than 20 mm on the visual analogue scale (VAS)
• Neck disability for more than 20% of the Neck Disability Index
• Working age, between 18 and 63 years
• Daily access to computer/tablet/smart phone and Internet
• Time to follow the treatment program
• Neck symptoms within the first week after the injury (neck pain, neck stiffness, or radiculopathy from the neck).

You may not qualify if:

• Any of the following signs of brain damage at the time of injury: loss of consciousness, amnesia before or after the injury, altered mental status (e.g., confusion, disorientation), focal neurological changes (changes in smell and taste)
• Previous fractures or dislocation of the cervical column
• Known or suspected serious physical pathology included myelopathy, spinal tumours, spinal infection, or ongoing malignancy
• Previous severe neck problems that resulted in sick leave for more than a month in the year before the current whiplash injury
• Surgery in the cervical column
• Generalized or more dominant pain elsewhere in the body
• Other illness/injury that may prevent full participation in the study and/or where neck exercises are contraindicated
• Inability to understand and write in Swedish
• Diagnosed severe mental illness, e.g., psychosis, schizophrenia, personality disorders
• Current alcohol or drug abuse.

Sponsors & Collaborators

• Linkoeping University: lead

Study Sites (1)

Anneli Peolsson

Linköping, 58929, Sweden

Location

Related Publications (5)

• Dalal K, Peterson G, Peolsson A. Health related quality of life (HRQOL) from the perspective of patients with chronic whiplash-associated disorders (WAD) in Sweden. BMC Musculoskelet Disord. 2025 Feb 14;26(1):154. doi: 10.1186/s12891-025-08397-2.

  PMID: 39953445 DERIVED

• Peolsson A, Wirqvist S, Kammerlind AS, Peterson G. Effectiveness of neck-specific exercises with and without internet-based support on dizziness/unsteadiness in chronic whiplash-associated disorders: Secondary analyses of a randomised controlled trial. PLoS One. 2024 Oct 7;19(10):e0311145. doi: 10.1371/journal.pone.0311145. eCollection 2024.

  PMID: 39374216 DERIVED

• Peolsson A, Nilsing Strid E, Peterson G. Novel Internet Support for Neck-Specific Rehabilitation Improves Work-Related Outcomes to the Same Extent as Extensive Visits to a Physiotherapy Clinic in Individuals with Chronic Whiplash-Associated Disorders: A Prospective Randomised Study. J Occup Rehabil. 2024 Dec;34(4):873-883. doi: 10.1007/s10926-024-10176-0. Epub 2024 Mar 25.

  PMID: 38526764 DERIVED

• Peterson G, Peolsson A. Efficacy of Neck-Specific Exercise With Internet Support Versus Neck-Specific Exercise at a Physiotherapy Clinic in Chronic Whiplash-Associated Disorders: Multicenter Randomized Controlled Noninferiority Trial. J Med Internet Res. 2023 Jun 20;25:e43888. doi: 10.2196/43888.

  PMID: 37338972 DERIVED

• Peolsson A, Landen Ludvigsson M, Peterson G. Neck-specific exercises with internet-based support compared to neck-specific exercises at a physiotherapy clinic for chronic whiplash-associated disorders: study protocol of a randomized controlled multicentre trial. BMC Musculoskelet Disord. 2017 Dec 12;18(1):524. doi: 10.1186/s12891-017-1853-1.

  PMID: 29233141 DERIVED

MeSH Terms

Conditions

Neck Pain

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Anneli Peolsson, Professor

  Dep. Medical and Health Sciences, Physiotherapy, Linköping University, Linköping, Sweden

  PRINCIPAL INVESTIGATOR

• Gunnel Peterson, PhD

  Dep. Medical and Health Sciences, Physiotherapy, Linköping University, Linköping, Sweden

  STUDY CHAIR

• Maria Landén Ludvigsson, PhD

  Dep. Medical and Health Sciences, Physiotherapy, Linköping University, Linköping, Sweden

  STUDY CHAIR

Study Design

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

Study Record Dates

• First Submitted: December 20, 2016
• First Posted: January 18, 2017
• Study Start: April 6, 2017
• Primary Completion: September 15, 2020
• Study Completion: September 15, 2020
• Last Updated: February 17, 2021

Record last verified: 2021-02

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)