Neck PainNCT05198258
Implementation and Evaluation of Neck-specific Exercises
A study testing Implementation strategy - experimental group in people with Neck Pain and Whiplash Injuries, run by Sormland County Council, Sweden at 7 sites in Sweden.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Neck Pain, Whiplash Injuries, Neck Disorder
- What is being tested?
- Implementation strategy - experimental group
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 7 sitesSweden
- Study dates
- 18 Mar 2022to 30 Nov 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Reg. physiotherapists working in twenty physiotherapy clinics in primary health care.
Who cannot join
- No exclusion criterta
- Inclusion criteria to evaluate the effectiveness of neck-specific exercise
- 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.
Show all 16Show fewer
- 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).
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
Sweden7 sites
Gunnel Peterson
Helsingborg, Skåne County
Gunnel Peterson
Leksand, Dalarna County, SE-581 83
Gunnel Peterson
Ljusdal, Gävleborg County
Gunnel Peterson
Nyköping, Sörmland
Emma Nilsing-Strid
Örebro
Gunnel Peterson
Uppsala, Uppsala County
Sofia Ask
Västerås, Västmanland County, SE-581 83
About this study
Official title: Evaluation of Implementation and Effectiveness of Neck-specific Exercise for Persistent Disability and Pain After Whiplash Injury; a Randomized Controlled Study Using a Hybrid II Design
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.
Read the 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.
- 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).
- 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
- Being tested
- Implementation strategy - experimental group, Implementation - control group
- Keywords
- Whiplash-associated disorders, Implementation Science, Neck pain, Rehabilitation, Exercise, Internet, Randomized Controlled Trial
- Medical subject headings
- Neck Pain, Whiplash Injuries, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Implementation strategy - experimental groupOther
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 - control groupOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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. Receives: Other: Implementation - control group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Implementation - Adoption of neck-specific exercise programmes
Proportion of patients with neck pain receiving neck-specific exercise
Measured: 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
Measured: Change from baseline to 3 months (after treatment) and 12 months follow-up
Secondary outcomes (7)
Implementation - The Evidence-Based Practice Attitude Scale (EBPAS)
Physiotherapists attitudes to implementation of evidence-based practice
Measured: Baseline
Implementation - Practitioner Confidence Scale (PCS)
Self-efficacy and confidence to diagnose and treat patients with neck pain
Measured: 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)
Numeric Rating Scale (NRS); 0=no pain or dizziness, 10=worst imaginable pain or dizziness).
Measured: Change from baseline to 3 months (after treatment) and 12 months follow-up
Patient - rating of self-perceived health
How is your current health in general? Numeric Rating Scale 0-10, 0=the worst health; 10= "the best health you can imagine
Measured: Change from baseline to 3 months (after treatment) and 12 months follow-up
Patient - Workability
Self-reported workability measured with the Work Ability Score (WAS). The worker's self-assessment of his/her current ability to work compared to the lifetime best.WAS; (0 = currently can not work at all, 10=work ability at it's best
Measured: Change from baseline to 3 months (after treatment) and 12 months follow-up
Patient - The patient's assessment of perceived anxiety and depression
During the last week, have you felt anxious or depressed? Numeric Rating Scale (0-10), 0=no, not at all; 10= yes, very much
Measured: Change from baseline to 3 months (after treatment) and 12 months follow-up
Patient - Improvement or deterioration over time
Global Rating scale (GRS) (-5=vastly worse, 0=unchanged, 5=completely recovered)
Measured: Measured at 3 months and 15 months follow up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jan 2022
- Study start18 Mar 2022
- Primary completion30 Nov 2024
- Study completion30 Nov 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Neck PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sormland County Council, Sweden
- Sponsor type
- University, hospital or other
- Collaborators
- Division of Preventation,Rehabilitation av Community Science, Linköping University, Institution of Medical Sciences, Örebro University
- Responsible party
- Sponsor
- Investigators
- Gunnel Peterson, Study chair, Centre for Clinical Research Sörmland, Uppsala University, SwedenAnneli Peolsson, Study chair, Department of Health, Medicine and Caring Sciences, unit of Physiotherapy, Linköping UniversityEmma Nilsing-Strid, Study chair, University Health Care Research Center, Faculty of Medicine and Health, Örebro UniversitySiw Carlfjord, Study chair, Department of Health, Medicine and Caring Sciences, unit of Physiotherapy, Linköping University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05198258
- Sponsor's protocol ID
- SormlandCCGP
- Status last verified
- Nov 2024
- First submitted
- 4 Jan 2022
- Last updated
- 4 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 35637458
Study at a glance
From the registry record, last updated by the sponsor on 4 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Implementation and Effectiveness of Neck-specific Exercise for Persistent Disability and Pain After Whiplash Injury; a Randomized Controlled Study Using a Hybrid II Design
- ClinicalTrials.gov ID
- NCT05198258
- Acronym / sponsor ID
- SormlandCCGP
- Conditions
- Neck Pain, Whiplash Injuries, Neck Disorder
- Keywords
- Whiplash-associated disorders, Implementation Science, Neck pain, Rehabilitation, Exercise, Internet, Randomized Controlled Trial
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Sormland County Council, SwedenUniversity, hospital or other
- Collaborators
- Division of Preventation,Rehabilitation av Community Science, Linköping University, Institution of Medical Sciences, Örebro University
- Study start
- 18 Mar 2022 (actual)
- Primary completion
- 30 Nov 2024 (actual)
- Study completion
- 30 Nov 2024 (actual)
- First posted
- 20 Jan 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
- 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).
- 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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Implementation study - experimental group | Experimental | Other: Implementation strategy - experimental groupPhysiotherapists 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 |
| Implementation study - control group | Active comparator | Other: Implementation - control groupPhysiotherapists 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Reg. physiotherapists working in twenty physiotherapy clinics in primary health care.
Key exclusion criteria (16 listed)
- No exclusion criterta
- Inclusion criteria to evaluate the effectiveness of neck-specific exercise
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Implementation strategy - experimental groupOn-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. | Other | Implementation study - experimental group |
| Implementation - control groupPhysiotherapists 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. | Other | Implementation study - control group |
Primary outcome
Implementation - Adoption of neck-specific exercise programmes
Time frame: Baseline to 3 and 12 months (proportions of 500 patients with neck pain from 20 physiotherapy clinics)
Proportion of patients with neck pain receiving neck-specific exercise
Patient Effectiveness - Neck Disability Index
Time frame: Change from baseline to 3 months (after treatment) and 12 months follow-up
Self-reported neck-specific function
7 secondary outcomes
Implementation - The Evidence-Based Practice Attitude Scale (EBPAS)
Time frame: Baseline
Implementation - Practitioner Confidence Scale (PCS)
Time frame: 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)
Time frame: Change from baseline to 3 months (after treatment) and 12 months follow-up
Patient - rating of self-perceived health
Time frame: Change from baseline to 3 months (after treatment) and 12 months follow-up
Patient - Workability
Time frame: Change from baseline to 3 months (after treatment) and 12 months follow-up
Patient - The patient's assessment of perceived anxiety and depression
Time frame: Change from baseline to 3 months (after treatment) and 12 months follow-up
Patient - Improvement or deterioration over time
Time frame: Measured at 3 months and 15 months follow up
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Dec 2024.
- Derived from this study: PubMed 35637458Peterson 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gunnel Peterson study chair
Centre for Clinical Research Sörmland, Uppsala University, Sweden
Anneli Peolsson study chair
Department of Health, Medicine and Caring Sciences, unit of Physiotherapy, Linköping University
Emma Nilsing-Strid study chair
University Health Care Research Center, Faculty of Medicine and Health, Örebro University
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Implementation strategy - experimental group in people with Neck Pain and Whiplash Injuries, run by Sormland County Council, Sweden at 7 sites in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Implementation - Adoption of neck-specific exercise programmes (time frame: Baseline to 3 and 12 months (proportions of 500 patients with neck pain from 20 physiotherapy clinics)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05198258, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Dec 2024.