Implementation and Evaluation of Neck-specific Exercises

NCT05198258 | Completed

• 1 other identifier: SormlandCCGP
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 7

Brief Summary

Persistent pain and disability in whiplash-associated disorders (WAD) grade II and III are common. Randomized controlled studies (RCTs) have shown promising result for neck-specific exercise (NSE) programmes in chronic WAD with clinically and statistically significant improvement in pain and disability. Neck-specific exercise with internet support (NSEIT) and four visits to a physiotherapist was non-inferior to NSE at a physiotherapist clinic 2 times a week in 12 weeks (24 visits). The aims of the proposed study are to evaluate an implementation strategy for NSE and NSEIT in primary health care and to evaluate the effectiveness of NSE and NSEIT in clinical practice.

Conditions

Neck Pain; Whiplash Injuries; Neck Disorder

Keywords

Whiplash-associated disorders; Implementation Science; Neck pain; Rehabilitation; Exercise; Internet; Randomized Controlled Trial

Outcome Measures

Primary Outcomes (2)

• Implementation - Adoption of neck-specific exercise programmes

  Proportion of patients with neck pain receiving neck-specific exercise

  Baseline to 3 and 12 months (proportions of 500 patients with neck pain from 20 physiotherapy clinics)

• Patient Effectiveness - Neck Disability Index

  Self-reported neck-specific function

  Change from baseline to 3 months (after treatment) and 12 months follow-up

Secondary Outcomes (7)

• Implementation - The Evidence-Based Practice Attitude Scale (EBPAS)

  Baseline

• Implementation - Practitioner Confidence Scale (PCS)

  Change from baseline to 3 months (after treatment) and 12 months follow-up

• Patient - Pain intensity (current, average last week, worst pain last week) in neck, head, and arm, and dizziness (current, average last week, worst dizziness last week)

  Change from baseline to 3 months (after treatment) and 12 months follow-up

• Patient - rating of self-perceived health

  Change from baseline to 3 months (after treatment) and 12 months follow-up

• Patient - Workability

  Change from baseline to 3 months (after treatment) and 12 months follow-up

Other Outcomes (2)

• Background data

  Baseline

• Implementation Qualitative data

  After 2 and 12 months

Study Arms (2)

Implementation study - experimental group

EXPERIMENTAL

Physiotherapists in the experimental group (group A) will receive on-line theoretical education including three hours of practical training by the project leaders. The standardized theoretical education includes three 45 minutes on-line lectures. The theoretical education will be followed by three hours practical training including clinical examination in patients with neck disability and instructions how to perform the neck-specific exercises.To facilitate the implementation process, group A will receive additional support; the physiotherapists can contact the project leader via e-mail, phone, online meetings and/or outreach visits

Other: Implementation strategy - experimental group

Implementation study - control group

ACTIVE COMPARATOR

Physiotherapists in the control group (group B) will receive the same theoretical and practical training as group A but without additional support from the research group or education after the first three theoretical on-line lectures and the three hours practical education.

Other: Implementation - control group

Interventions

Implementation strategy - experimental group OTHER

On-line theoretical education and three hours of practical training by the project leaders. Contact with the project team via e-mail, phone and on-line repetition of the education for remaining of the clinical examination, neck-specific program and the progression of exercises.

Implementation study - experimental group

Implementation - control group OTHER

Physiotherapists in the control group will receive the same theoretical and practical training as the experimental group but without repetition of the education or support from the research team.

Implementation study - control group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \- Reg. physiotherapists working in twenty physiotherapy clinics in primary health care.

You may not qualify if:

• The physiotherapists will include patients ≥ 18 years with neck pain.
• Patients are required to have internet access by phone, tablet, or computer
• Be able to read and understand Swedish
• Physiotherapists should exclude patients with "red flags"i.e., symptoms that suggest a serious illness or spinal abnormality.
• Serious trauma to the neck and no X-ray
• Preceding neck surgery
• Osteoporosis
• Myelopathy
• History of cancer
• Unexplained weight loss
• Present fever, history of infections
• Constant and progressive non-mechanical pain
• Insidious progression of pain
• Signs of spinal cord compression (neurological examination to exclude spinal cord or cervical myelopathy such as clumsy hands, altered gait, or disturbances of sexual, bladder or sphincter function).

Sponsors & Collaborators

• Sormland County Council, Sweden: lead
• Division of Preventation,Rehabilitation av Community Science, Linköping University: collaborator
• Institution of Medical Sciences, Örebro University: collaborator

Study Sites (7)

Gunnel Peterson

Leksand, Dalarna County, SE-581 83, Sweden

Location

Gunnel Peterson

Ljusdal, Gävleborg County, Sweden

Location

Gunnel Peterson

Helsingborg, Skåne County, Sweden

Location

Gunnel Peterson

Nyköping, Sörmland, Sweden

Location

Gunnel Peterson

Uppsala, Uppsala County, Sweden

Location

Sofia Ask

Västerås, Västmanland County, SE-581 83, Sweden

Location

Emma Nilsing-Strid

Örebro, Sweden

Location

Related Publications (1)

• Peterson G, Carlfjord S, Nilsing Strid E, Ask S, Jonsson M, Peolsson A. Evaluation of implementation and effectiveness of neck-specific exercise for persistent disability and pain after whiplash injury: study protocol for a randomized controlled study using a hybrid 2 design. BMC Musculoskelet Disord. 2022 May 30;23(1):516. doi: 10.1186/s12891-022-05470-y.

  PMID: 35637458 DERIVED

MeSH Terms

Conditions

Neck Pain; Whiplash Injuries; Motor Activity

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neck Injuries; Wounds and Injuries; Behavior

Study Officials

• Gunnel Peterson

  Centre for Clinical Research Sörmland, Uppsala University, Sweden

  STUDY CHAIR

• Anneli Peolsson

  Department of Health, Medicine and Caring Sciences, unit of Physiotherapy, Linköping University

  STUDY CHAIR

• Emma Nilsing-Strid

  University Health Care Research Center, Faculty of Medicine and Health, Örebro University

  STUDY CHAIR

• Siw Carlfjord

  Department of Health, Medicine and Caring Sciences, unit of Physiotherapy, Linköping University

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: The study is a prospective cluster-randomized mixed-design study with hybrid II trial design. Twenty physiotherapy clinics in primary health care will be included.

Study Record Dates

• First Submitted: January 4, 2022
• First Posted: January 20, 2022
• Study Start: March 18, 2022
• Primary Completion: November 30, 2024
• Study Completion: November 30, 2024
• Last Updated: December 4, 2024

Record last verified: 2024-11

Locations

SE (7)