Implementation and Evaluation of Neck-specific Exercises

NCT ID: NCT05198258

Last Updated: 2024-12-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-03-18
• Study Completion Date: 2024-11-30

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.

Detailed Description

The study is a prospective cluster-randomized study with hybrid II trial design.

In total will 20 physiotherapy clinics in primary health care be recruited. Reg. physiotherapists working in the twenty physiotherapy clinics will be included. The clinics will be randomised to two groups with different implementation strategy: (A, intervention) three theoretical on-line lectures and the three hours' practical training with additional support; (B, control) the same education and practical training as A but with no additional support. Twenty-five patients with neck pain will be consecutively recruited from each clinic, a total of 500 patients. Outcome measurements will be conducted at baseline, 3- and 12-months.

This trial will evaluate the implementation strategy in terms of adoption of and adherence to NSEIT and NSE in clinical primary health care, also measuring diffusion of the method to other neck pain patients. In parallel, effectiveness of the exercises are evaluated.

All analyses will be conducted in collaboration with a statistician using parametric or non-parametric statistics depending on the type of data.

1. The implementation strategy will be analyzed using parametric t-test and a linear mixed model Analysis of Variance (ANOVA) or non-parametric Mann-Whitney U test and Kruskal-Wallis to evaluate differences between group A and B and change in variables over time.

To further evaluate the implementation strategy will two focus group studies be conducted, with a purposeful sample of physiotherapists included in the cluster-randomized mixed-design study. The overall aim of these qualitative studies is to deepen the knowledge on the uptake of the new method, i.e., the NSEIT/NSE programme (adoption), the implementation in clinical practice (implementation), and how it continues to be used (maintenance).

2. The effectiveness of NSEIT and NSE will be analysed with a linear mixed model Analysis of Variance (ANOVA) or Kruskal-Wallis depending on the data.

The effect of neck-specific exercises in the present study will also be evaluated and compared to the results in our former RCT-studies.

Sample size and power regarding group differences were calculated by a statistician. Sample size calculation was based on the assumption that 15% more patients will receive neck-specific exercises in the intervention group (40% in the intervention group and 25% in the control group). The required sample size under individual randomization will be 150 patients in each arm. With ten physiotherapy clinics (clusters) in each arm (a total of 20 clusters), intra-cluster correlation of 0.02 and a cluster size of 21 patients, a total of 420 patients are recruited for 80% power and a significance level of 0.05. To ensure that enough people are in each group after dropouts, a total of 500 patients will be included, 25 patients from each cluster. The patients will be consecutively recruited.

Patients who are included in both the intervention and control groups and received neck-specific exercises will be treated as one group in terms of the effect of the intervention. The sample size calculation to evaluate effectiveness was based on a clinically relevant improvement of 7% on the Neck Disability Index (NDI), effect size 0.2 (Cohen's f) or 0.4 (Cohen's d), and correlation among repeated measures of 0.3, resulting in a total of 56 participants for 80% power and a significance level of 0.05. With an expected dropout rate of 20%, a total of 70 participating patients are needed.

The patients will be analysed as one group and the total number of patients may be more than 70 because patients will be included at each clinic. All analyses will be conducted in collaboration with a statistician using parametric or non-parametric statistics depending on the type of data. Data will be analysed according to intention to treat and supplemented with per protocol analysis.

Conditions

Neck Pain; Whiplash Injuries; Neck Disorder

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: SINGLE

Study Groups

Implementation study - experimental group

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

Group Type: EXPERIMENTAL

Implementation strategy - experimental group

Intervention Type: 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 - control group

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.

Group Type: ACTIVE_COMPARATOR

Implementation - control group

Intervention Type: 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.

Interventions

Implementation strategy - experimental group

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.

Intervention Type: OTHER

Implementation - control group

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.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

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

• 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

Exclusion Criteria

• No exclusion criterta

• 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).

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Division of Preventation,Rehabilitation av Community Science, Linköping University

UNKNOWN

Sponsor Role: collaborator

Institution of Medical Sciences, Örebro University

UNKNOWN

Sponsor Role: collaborator

Sormland County Council, Sweden

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Gunnel Peterson

Role: STUDY_CHAIR

Centre for Clinical Research Sörmland, Uppsala University, Sweden

Anneli Peolsson

Role: STUDY_CHAIR

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

Emma Nilsing-Strid

Role: STUDY_CHAIR

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

Siw Carlfjord

Role: STUDY_CHAIR

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

Locations

Gunnel Peterson

Leksand, Dalarna County, Sweden

Gunnel Peterson

Ljusdal, Gävleborg County, Sweden

Gunnel Peterson

Helsingborg, Skåne County, Sweden

Gunnel Peterson

Nyköping, Sörmland, Sweden

Gunnel Peterson

Uppsala, Uppsala County, Sweden

Sofia Ask

Västerås, Västmanland County, Sweden

Emma Nilsing-Strid

Örebro, , Sweden

Countries

Sweden

References

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.

Reference Type: DERIVED

PMID: 35637458 (View on PubMed)

Other Identifiers

SormlandCCGP

Identifier Type: -

Identifier Source: org_study_id