Musculoskeletal DiseasesVIPPNCT07788651
Video-based First-contact Physiotherapy in Primary Care
A study testing Video-based first-contact physiotherapy consultation and In-person first-contact physiotherapy consultation in people with Musculoskeletal Diseases, run by Vastra Gotaland Region.
Trial summary
This study aims to evaluate the effects and implications of using video-based first-contact consultation in primary care physiotherapy, compared with traditional in-person consultation for musculoskeletal symptoms. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Musculoskeletal Diseases
- What is being tested?
- Video-based first-contact physiotherapy consultation and In-person first-contact physiotherapy consultation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 208 participants
- Where
- No sites listed yet
- Study dates
- 1 Oct 2026to 31 Dec 2030
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- Age 18 years or older.
- Musculoskeletal complaints.
- Sufficient linguistic and cognitive ability to read, understand, and complete a web-based application form and provide informed consent in Swedish.
- Willing to attend the clinic in person.
Who cannot join
- Ongoing treatment for the current condition with planned follow-up by a physiotherapist.
- Lack of access to technology capable of supporting video consultations (e.g., smartphone, computer, or tablet).
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Video-based First-contact Consultation With a Physiotherapist in Primary Care for Patients With Musculoskeletal Symptoms
This study aims to evaluate the effects and implications of using video-based first-contact consultation in primary care physiotherapy, compared with traditional in-person consultation for musculoskeletal symptoms. The participants with musculoskeletal symptoms will receive either a video-based first contact physiotherapy consultation or an in-person first-contact physiotherapy consultation and will be followed for up to two years. The project addresses clinical effectiveness, healthcare utilisation, cost-effectiveness, and carbon footprint, according to the following specific aims.
Objectives
- To evaluate whether a video-based first-contact consultation with a physiotherapist is not clinically inferior to an in-person first-contact consultation, using the Patient-Specific Functional Scale (PSFS) as the primary outcome measure and multiple secondary outcomes assessed over time.
- To analyse healthcare utilisation in primary and specialist care at 12 and 24 months following a video-based first-contact consultation, compared with an in-person first contact consultation.
- To evaluate whether a video-based first-contact consultation with a physiotherapist is cost-effective from a healthcare perspective and in terms of environmental impact compared with an in-person first contact consultation.
Read the detailed description
Background The digitalisation of health care has accelerated in recent years, driven by the World Health Organisation's Global Strategy on Digital Health. Musculoskeletal conditions include diseases and disorders affecting the joints, bones, muscles and related connective tissues. These conditions can affect multiple body areas or systems. Furthermore, the conditions are often characterised by pain and limitations in mobility and activities of daily living. Globally, musculoskeletal conditions are estimated to affect 1.7 billion people. Musculoskeletal conditions represent approximately two-thirds of all adults requiring rehabilitation. Physiotherapy plays a central role in the management and rehabilitation of musculoskeletal conditions. When provided as first-line primary care, physiotherapy has proven both efficient and cost-effective . Furthermore, video-based physiotherapy has been associated with improved attendance and adherence, factors that are critical for treatment effectiveness.
Video-based assessment in physiotherapy has been shown to be partially valid and reliable, but the methods remain poorly standardised, and the use of approaches and technical tools varies considerably. Overall, the evidence is limited, and existing descriptions are insufficient to support implementation in clinical practice. The transition to video-based care is described as a paradigm shift, and the profession expresses uncertainty regarding its effectiveness.
Despite the promising potential of digital health encounters, several challenges remain. A substantial proportion of patients initially assessed via video subsequently require in-person visits. Moreover, the therapeutic relationship may be affected by the video-based format. Taken together, these factors highlight an urgent need for robust, long-term evaluations of video-based first-contact physiotherapy.
Methods Study design A pragmatic randomised controlled trial (RCT) with a non-inferiority design will be conducted. The study will evaluate whether a video-based first-contact consultation with a physiotherapy yields outcomes that are not clinically inferior to those of a standard in-person first-contact physiotherapy consultation in primary care. The study will be reported in accordance with the CONSORT 2010 Statement for non-inferiority trials.
A non-inferiority analysis will be conducted, as the study aims to determine whether video-based first-contact physiotherapy consultation is not clinically inferior to an in-person first-contact physiotherapy. The analysis will use a predefined margin (∆) based on both statistical considerations and clinical judgement. The minimal clinically important difference and change for the PSFS was considered to define the non-inferiority margin. Previous literature reports that the minimal clinically important change for the PSFS ranges from approximately 1.3 and 2.3 points, depending on the diagnostic area. To ensure that any potential difference between groups is not clinically relevant, the non-inferiority margin has been set at ∆ = 1.5 points, which is also consistent with previous research in digital physiotherapy. The standard deviation (SD) will be set to 2, based on previous studies .
Sample size calculations based on the primary outcome variable PSFS, with ∆ = 1.5, indicate that 78 participants per group are required to achieve 80% statistical power with a one-sided alpha of 2.5%. Assuming a 25 % dropout rate, 104 participants will be included in each group, for a total of 208 participants.
Participant Selection and Recruitment Participants aged 18 years or older with musculoskeletal symptoms will be recruited. The study will be conducted at approximately six regional primary care rehabilitation units in Region Västra Götaland, Sweden, representing both geographic and demographic variation.
Potential participants will be identified through advertisement via social media, through posters and telephone. Potential participants will be screened to ensure that they meet the inclusion and exclusion criteria. They will receive written participant information digitally, will have the opportunity to ask questions, and will be offered verbal information. Informed consent will be obtained digitally.
Participants will be stratified by age, randomised, and scheduled for the type of consultation (video or in-person) corresponding to their allocated group with participating physiotherapist. All collected data will be handled in accordance with the principal investigator's data management procedures and applicable legislation.
Procedures The video-based first-contact consultation and the in-person first-contact consultation will be conducted within routine care. Participating physiotherapists will undergo approximately five hours of training in a structured model for conducting video-based physiotherapeutic assessments.
Participants will complete digital questionnaires before the first consultation, immediately after the first consultation, and at 6 weeks, 3 months, 6 months, and 12 months. The estimated time required to complete the digital questionnaires is approximately 10-20 minutes. Medical records and registry data will be collected in 6, 12 and 24 months.
Statistical Analysis The analyses will be conducted using IBM SPSS Statistics for Windows, (IBM Corp., Armonk, NY, USA). Descriptive statistics will be presented as means, standard deviations, and medians for continuous variables, and as frequencies for categorical variables.
Comparisons of improvement levels will be conducted using regression models, controlling for potential confounders (e.g., age, gender, trust). Comparisons of proportions showing improvement will be performed using a two-proportion Z-test. Exploratory analyses will be conducted to identify predictors of outcomes within the video consultation group.
For the health economic analysis, QALYs will be calculated from EQ-5D-5L data, and cost data will be obtained from healthcare registers and patient records. Incremental cost-effectiveness ratios (ICERs) will be calculated, with uncertainty analyses performed using bootstrapping and cost-effectiveness acceptability curves.
Estimates of carbon dioxide emissions will be performed from a life-cycle perspective, based on patient travel and estimates from the Swedish Transport Administration, healthcare utilisation based on estimates from the National Health Service in England, and the use of digital technology.
Comparisons between groups and over time will be conducted using appropriate parametric or non-parametric tests and regression models, depending on the characteristics of the data. Matched analyses will be applied where relevant.
- Conditions
- Musculoskeletal Diseases
- Being tested
- Video-based first-contact physiotherapy consultation, In-person first-contact physiotherapy consultation
- Keywords
- Remote Consultation, Physical Therapy Modalities, Digital Health, Telemedicine
- Medical subject headings
- Musculoskeletal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Video-based first-contact physiotherapy consultationOther
Participants receive a video-based first-contact physiotherapy consultation. Following the assessment, individualised standard physiotherapy treatment is provided as needed. During the video-based assessment, participants will be in a setting of their choice and will meet a physiotherapist via video. The physiotherapists will be trained in a structured model for conducting video-based physiotherapeutic assessments. The rehabilitation clinic's standard platform for real-time audio and video healthcare visits will be used. The estimated time will be approximately 30-45 minutes.
In-person first-contact physiotherapy consultationOther
Participants receive an in-person physiotherapy consultation at a primary care rehabilitation clinic. Following the assessment, individualised standard physiotherapy treatment is provided as needed. The traditional in-person consultation will be conducted at a rehabilitation clinic within the public healthcare system in Region Västra Götaland. The estimated time will be approximately 30-45 minutes.
| Study group | Role | What they receive |
|---|---|---|
| Video-based first-contact physiotherapy | Experimental | Participants receive a video-based first-contact physiotherapy consultation. Following the first-contact consultation, participants will receive standard individualised physiotherapy treatment which falls outside the scope of the study. Receives: Other: Video-based first-contact physiotherapy consultation |
| Traditional in-person first-contact physiotherapy | Active comparator | Participants receive an in-person physiotherapy consultation at a primary care rehabilitation clinic. Following the first-contact consultation, participants will receive standard individualised physiotherapy treatment which falls outside the scope of the study. Receives: Other: In-person first-contact physiotherapy consultation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient-Specific Functional Scale (PSFS) at 6 weeks
Evaluates treatment outcomes by having the patient identify three activities limited by their condition and rate them on a scale from 0 to 10, where 0 = "unable to perform activity" and 10 = "able to perform activity at the same level as before injury or problem" (Stratford et al., 1995).
Measured: 6 weeks
Secondary outcomes (23)
Patient-Specific Functional Scale (PSFS) at baseline
Evaluates treatment outcomes by having the patient identify three activities limited by their condition and rate them on a scale from 0 to 10, where 0 = "unable to perform activity" and 10 = "able to perform activity at the same level as before injury or problem" (Stratford et al., 1995).
Measured: Baseline
Patient-Specific Functional Scale (PSFS) at 3 months
Evaluates treatment outcomes by having the patient identify three activities limited by their condition and rate them on a scale from 0 to 10, where 0 = "unable to perform activity" and 10 = "able to perform activity at the same level as before injury or problem" (Stratford et al., 1995).
Measured: 3 months
Patient-Specific Functional Scale (PSFS) at 6 months
Evaluates treatment outcomes by having the patient identify three activities limited by their condition and rate them on a scale from 0 to 10, where 0 = "unable to perform activity" and 10 = "able to perform activity at the same level as before injury or problem" (Stratford et al., 1995).
Measured: 6 months
Patient-Specific Functional Scale (PSFS) at 12 months
Evaluates treatment outcomes by having the patient identify three activities limited by their condition and rate them on a scale from 0 to 10, where 0 = "unable to perform activity" and 10 = "able to perform activity at the same level as before injury or problem" (Stratford et al., 1995).
Measured: 12 months
Pain intensity using Numeric Rating Scale (NRS) at baseline
Current pain is rated on a numeric scale from 0 to 10, where 0 represents no pain and 10 represents the worst imaginable pain (Hjermstad et al., 2011).
Measured: Baseline
Pain intensity using Numeric Rating Scale (NRS) at 6 weeks
Current pain is rated on a numeric scale from 0 to 10, where 0 represents no pain and 10 represents the worst imaginable pain (Hjermstad et al., 2011).
Measured: 6 weeks
Pain intensity using Numeric Rating Scale (NRS) at 3 months
Current pain is rated on a numeric scale from 0 to 10, where 0 represents no pain and 10 represents the worst imaginable pain (Hjermstad et al., 2011).
Measured: 3 months
Pain intensity using Numeric Rating Scale (NRS) at 6 months
Current pain is rated on a numeric scale from 0 to 10, where 0 represents no pain and 10 represents the worst imaginable pain (Hjermstad et al., 2011).
Measured: 6 months
Pain intensity using Numeric Rating Scale (NRS) at 12 months
Current pain is rated on a numeric scale from 0 to 10, where 0 represents no pain and 10 represents the worst imaginable pain (Hjermstad et al., 2011).
Measured: 12 months
Patient's Global Impression of Change (PGIC) at 6 weeks
The Patient's Global Impression of Change (PGIC) assesses the patient's perception of change. Patients rate their change since the start of treatment on a 7-point scale, where 1 indicates "very much improved" and 7 indicates "very much worse" (Hurst \& Bolton, 2004).
Measured: 6 weeks
Patient's Global Impression of Change (PGIC) at 3 months
The Patient's Global Impression of Change (PGIC) assesses the patient's perception of change. Patients rate their change since the start of treatment on a 7-point scale, where 1 indicates "very much improved" and 7 indicates "very much worse" (Hurst \& Bolton, 2004).
Measured: 3 months
Perceived quality of care, Quality from the Patient's Perspective (QPP) at day 1
Perceived quality of care will be assessed using the Quality from the Patient's Perspective (QPP) questionnaire, which measure patients 'experiences of healthcare quality from the patient's perspective across several domains/factors medical-technical competence, physical-technical conditions identity-oriented approach, socio-cultural atmosphere. Patients first rate their experience based on "this is how it was for me", which reflects the perceived reality. They then rate "this is how important it was for me", corresponding to subjective importance. Responses are provided using Likert scale. (Wilde Larsson \& Larsson).
Measured: Day 1
Perceived quality of care, Quality from the Patient's Perspective (QPP) at 6 weeks
Perceived quality of care will be assessed using the Quality from the Patient's Perspective (QPP) questionnaire, which measure patients 'experiences of healthcare quality from the patient's perspective across several domains/factors medical-technical competence, physical-technical conditions identity-oriented approach, socio-cultural atmosphere. Patients first rate their experience based on "this is how it was for me", which reflects the perceived reality. They then rate "this is how important it was for me", corresponding to subjective importance. Responses are provided using Likert scale. (Wilde Larsson \& Larsson).
Measured: 6 weeks
Quality of life measured with EuroQol Dimensions - 5 Levels (EQ-5D-5L) at Baseline
The EQ-5D-5L is a health-related quality of life instrument consisting of two parts. The first part is a self-assessment of quality of life across five dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression, with each dimension rated on five levels of severity. The second part is a rating using a visual analogue scale (VAS) from 0 to 100, where 0 represents the worst imaginable health and 100 represents the best imaginable health (EuroQol Research Foundation, n.d.).
Measured: Baseline
Quality of life measured with EuroQol Dimensions - 5 Levels (EQ-5D-5L) at 6 weeks
The EQ-5D-5L is a health-related quality of life instrument consisting of two parts. The first part is a self-assessment of quality of life across five dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression, with each dimension rated on five levels of severity. The second part is a rating using a visual analogue scale (VAS) from 0 to 100, where 0 represents the worst imaginable health and 100 represents the best imaginable health (EuroQol Research Foundation, n.d.).
Measured: 6 weeks
Quality of life measured with EuroQol Dimensions - 5 Levels (EQ-5D-5L) at 3 months
The EQ-5D-5L is a health-related quality of life instrument consisting of two parts. The first part is a self-assessment of quality of life across five dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression, with each dimension rated on five levels of severity. The second part is a rating using a visual analogue scale (VAS) from 0 to 100, where 0 represents the worst imaginable health and 100 represents the best imaginable health (EuroQol Research Foundation, n.d.).
Measured: 3 months
Quality of life measured with EuroQol Dimensions - 5 Levels (EQ-5D-5L) at 6 months
The EQ-5D-5L is a health-related quality of life instrument consisting of two parts. The first part is a self-assessment of quality of life across five dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression, with each dimension rated on five levels of severity. The second part is a rating using a visual analogue scale (VAS) from 0 to 100, where 0 represents the worst imaginable health and 100 represents the best imaginable health (EuroQol Research Foundation, n.d.).
Measured: 6 months
Quality of life measured with EuroQol Dimensions - 5 Levels (EQ-5D-5L) at 12 months
The EQ-5D-5L is a health-related quality of life instrument consisting of two parts. The first part is a self-assessment of quality of life across five dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression, with each dimension rated on five levels of severity. The second part is a rating using a visual analogue scale (VAS) from 0 to 100, where 0 represents the worst imaginable health and 100 represents the best imaginable health (EuroQol Research Foundation, n.d.).
Measured: 12 months
Work Ability Index (WAI) at Baseline
Self-rated work ability will be measured with WAI. Questionnaire consisting of a total 10 questions of seven items, sometimes only one question is used. The index addresses demand of work, the worker's health status and resources (Illmarinen, 2007; Svenska WAI-nätverket, n.d.).
Measured: Baseline
Work Ability Index (WAI) at 6 weeks
Self-rated work ability will be measured with WAI. Questionnaire consisting of a total 10 questions of seven items, sometimes only one question is used. The index addresses demand of work, the worker's health status and resources (Illmarinen, 2007; Svenska WAI-nätverket, n.d.).
Measured: 6 weeks
Work Ability Index (WAI) at 3 months
Self-rated work ability will be measured with WAI. Questionnaire consisting of a total 10 questions of seven items, sometimes only one question is used. The index addresses demand of work, the worker's health status and resources (Illmarinen, 2007; Svenska WAI-nätverket, n.d.).
Measured: 3 months
Work Ability Index (WAI) at 6 months
Self-rated work ability will be measured with WAI. Questionnaire consisting of a total 10 questions of seven items, sometimes only one question is used. The index addresses demand of work, the worker's health status and resources (Illmarinen, 2007; Svenska WAI-nätverket, n.d.).
Measured: 6 months
Work Ability Index (WAI) at 12 months
Self-rated work ability will be measured with WAI. Questionnaire consisting of a total 10 questions of seven items, sometimes only one question is used. The index addresses demand of work, the worker's health status and resources (Illmarinen, 2007; Svenska WAI-nätverket, n.d.).
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2026
- Study start1 Oct 2026 (estimated)
- Primary completion31 Dec 2028 (estimated)
- Study completion31 Dec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (33)Papers the sponsor has linked to this study.
- Other trials for Musculoskeletal DiseasesStudies 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 208 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Vastra Gotaland Region
- Sponsor type
- Other government
- Collaborators
- The Swedish Research Council
- Responsible party
- Sponsor
- Investigators
- Elvira Lange, PhD, Principal investigator, Vastra Gotaland Region
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07788651
- Sponsor's protocol ID
- VIPP
- Other IDs
- 2025-07915, 2025
- Acronym
- VIPP
- Status last verified
- Aug 2026
- First submitted
- 10 Aug 2026
- Last updated
- 26 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual participant data (IPD) will not be publicly shared due to restrictions under the EU General data Protection Regulation (GDPR). However anonymised data may be made available upon reasonable request, provided the request complies with GDPR and Swedish data protection regulations.
Publications
Abbott JH, Schmitt J. Minimum important differences for the patient-specific functional scale, 4 region-specific outcome measures, and the numeric pain rating scale. J Orthop Sports Phys Ther. 2014 Aug;44(8):560-4. doi: 10.2519/jospt.2014.5248. Epub 2014 May 14.
PubMed 24828475Artandi MK, Stewart RW. The Outpatient Physical Examination. Med Clin North Am. 2018 May;102(3):465-473. doi: 10.1016/j.mcna.2017.12.008. Epub 2018 Mar 12.
PubMed 29650068Bernhardsson S, Larsson A, Bergenheim A, Ho-Henriksson CM, Ekhammar A, Lange E, Larsson MEH, Nordeman L, Samsson KS, Bornhoft L. Digital physiotherapy assessment vs conventional face-to-face physiotherapy assessment of patients with musculoskeletal disorders: A systematic review. PLoS One. 2023 Mar 21;18(3):e0283013. doi: 10.1371/journal.pone.0283013. eCollection 2023.
PubMed 36943857Bornhoft L, Larsson ME, Nordeman L, Eggertsen R, Thorn J. Health effects of direct triaging to physiotherapists in primary care for patients with musculoskeletal disorders: a pragmatic randomized controlled trial. Ther Adv Musculoskelet Dis. 2019 Feb 15;11:1759720X19827504. doi: 10.1177/1759720X19827504. eCollection 2019.
PubMed 30800175Bornhoft L, Thorn J, Svensson M, Nordeman L, Eggertsen R, Larsson MEH. More cost-effective management of patients with musculoskeletal disorders in primary care after direct triaging to physiotherapists for initial assessment compared to initial general practitioner assessment. BMC Musculoskelet Disord. 2019 May 1;20(1):186. doi: 10.1186/s12891-019-2553-9.
PubMed 31043169Cieza A, Causey K, Kamenov K, Hanson SW, Chatterji S, Vos T. Global estimates of the need for rehabilitation based on the Global Burden of Disease study 2019: a systematic analysis for the Global Burden of Disease Study 2019. Lancet. 2021 Dec 19;396(10267):2006-2017. doi: 10.1016/S0140-6736(20)32340-0. Epub 2020 Dec 1.
PubMed 33275908De Sire, A., & Invernizzi, M. (2021). Musculoskeletal rehabilitation: State-of-the-art. Applied Sciences, 11(14), 6243. https://doi.org/10.3390/app11146243
Di, W., Nie, Y., Chua, B. L., Chye, S., & Teo, T. (2023). Developing a single-item general self-efficacy measure. Journal of Psychoeducational Assessment, 41(6). https://doi.org/10.21203/rs.3.rs-342642/v1
EuroQol Research Foundation. (n.d.). EQ-5D-5L. Retrieved April 20, 2026, from https://euroqol.org/information-and-support/euroqol-instruments/eq-5d-5l/
Fernando, M., & Lange, E. (2025). New ways of working as a physiotherapist in the digital era: A qualitative study. Physiotherapy Practice and Research, 46(2), 103-110.
FHVmetodik. (n.d.). Svenska WAI-nätverket. Retrieved April 20, 2026, from https://fhvmetodik.se/arbetsmiljo-sam/kartlaggning-arbetsformaga/arbetsformaga/wai/svenska-wai-natverket/
Gerlinger C, Schmelter T. Determining the non-inferiority margin for patient reported outcomes. Pharm Stat. 2011 Sep-Oct;10(5):410-3. doi: 10.1002/pst.507. Epub 2011 Sep 19.
PubMed 21932298Hjermstad MJ, Fayers PM, Haugen DF, Caraceni A, Hanks GW, Loge JH, Fainsinger R, Aass N, Kaasa S; European Palliative Care Research Collaborative (EPCRC). Studies comparing Numerical Rating Scales, Verbal Rating Scales, and Visual Analogue Scales for assessment of pain intensity in adults: a systematic literature review. J Pain Symptom Manage. 2011 Jun;41(6):1073-93. doi: 10.1016/j.jpainsymman.2010.08.016.
PubMed 21621130Horn KK, Jennings S, Richardson G, Vliet DV, Hefford C, Abbott JH. The patient-specific functional scale: psychometrics, clinimetrics, and application as a clinical outcome measure. J Orthop Sports Phys Ther. 2012 Jan;42(1):30-42. doi: 10.2519/jospt.2012.3727. Epub 2011 Oct 25.
PubMed 22031594Hurst H, Bolton J. Assessing the clinical significance of change scores recorded on subjective outcome measures. J Manipulative Physiol Ther. 2004 Jan;27(1):26-35. doi: 10.1016/j.jmpt.2003.11.003.
PubMed 14739871
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Video-based First-contact Consultation With a Physiotherapist in Primary Care for Patients With Musculoskeletal Symptoms
- ClinicalTrials.gov ID
- NCT07788651
- Acronym / sponsor ID
- VIPP / VIPP
- Conditions
- Musculoskeletal Diseases
- Keywords
- Remote Consultation, Physical Therapy Modalities, Digital Health, Telemedicine
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 208 participants (estimated)
- Lead sponsor
- Vastra Gotaland RegionOther government
- Collaborators
- The Swedish Research Council
- Study start
- 1 Oct 2026 (estimated)
- Primary completion
- 31 Dec 2028 (estimated)
- Study completion
- 31 Dec 2030 (estimated)
- First posted
- 26 Aug 2026 (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.
This study aims to evaluate the effects and implications of using video-based first-contact consultation in primary care physiotherapy, compared with traditional in-person consultation for musculoskeletal symptoms. The participants with musculoskeletal symptoms will receive either a video-based first contact physiotherapy consultation or an in-person first-contact physiotherapy consultation and will be followed for up to two years. The project addresses clinical effectiveness, healthcare utilisation, cost-effectiveness, and carbon footprint, according to the following specific aims.
Objectives
- To evaluate whether a video-based first-contact consultation with a physiotherapist is not clinically inferior to an in-person first-contact consultation, using the Patient-Specific Functional Scale (PSFS) as the primary outcome measure and multiple secondary outcomes assessed over time.
- To analyse healthcare utilisation in primary and specialist care at 12 and 24 months following a video-based first-contact consultation, compared with an in-person first contact consultation.
- To evaluate whether a video-based first-contact consultation with a physiotherapist is cost-effective from a healthcare perspective and in terms of environmental impact compared with an in-person first contact consultation.
Detailed description
Background The digitalisation of health care has accelerated in recent years, driven by the World Health Organisation's Global Strategy on Digital Health. Musculoskeletal conditions include diseases and disorders affecting the joints, bones, muscles and related connective tissues. These conditions can affect multiple body areas or systems. Furthermore, the conditions are often characterised by pain and limitations in mobility and activities of daily living. Globally, musculoskeletal conditions are estimated to affect 1.7 billion people. Musculoskeletal conditions represent approximately two-thirds of all adults requiring rehabilitation. Physiotherapy plays a central role in the management and rehabilitation of musculoskeletal conditions. When provided as first-line primary care, physiotherapy has proven both efficient and cost-effective . Furthermore, video-based physiotherapy has been associated with improved attendance and adherence, factors that are critical for treatment effectiveness.
Video-based assessment in physiotherapy has been shown to be partially valid and reliable, but the methods remain poorly standardised, and the use of approaches and technical tools varies considerably. Overall, the evidence is limited, and existing descriptions are insufficient to support implementation in clinical practice. The transition to video-based care is described as a paradigm shift, and the profession expresses uncertainty regarding its effectiveness.
Despite the promising potential of digital health encounters, several challenges remain. A substantial proportion of patients initially assessed via video subsequently require in-person visits. Moreover, the therapeutic relationship may be affected by the video-based format. Taken together, these factors highlight an urgent need for robust, long-term evaluations of video-based first-contact physiotherapy.
Methods Study design A pragmatic randomised controlled trial (RCT) with a non-inferiority design will be conducted. The study will evaluate whether a video-based first-contact consultation with a physiotherapy yields outcomes that are not clinically inferior to those of a standard in-person first-contact physiotherapy consultation in primary care. The study will be reported in accordance with the CONSORT 2010 Statement for non-inferiority trials.
A non-inferiority analysis will be conducted, as the study aims to determine whether video-based first-contact physiotherapy consultation is not clinically inferior to an in-person first-contact physiotherapy. The analysis will use a predefined margin (∆) based on both statistical considerations and clinical judgement. The minimal clinically important difference and change for the PSFS was considered to define the non-inferiority margin. Previous literature reports that the minimal clinically important change for the PSFS ranges from approximately 1.3 and 2.3 points, depending on the diagnostic area. To ensure that any potential difference between groups is not clinically relevant, the non-inferiority margin has been set at ∆ = 1.5 points, which is also consistent with previous research in digital physiotherapy. The standard deviation (SD) will be set to 2, based on previous studies .
Sample size calculations based on the primary outcome variable PSFS, with ∆ = 1.5, indicate that 78 participants per group are required to achieve 80% statistical power with a one-sided alpha of 2.5%. Assuming a 25 % dropout rate, 104 participants will be included in each group, for a total of 208 participants.
Participant Selection and Recruitment Participants aged 18 years or older with musculoskeletal symptoms will be recruited. The study will be conducted at approximately six regional primary care rehabilitation units in Region Västra Götaland, Sweden, representing both geographic and demographic variation.
Potential participants will be identified through advertisement via social media, through posters and telephone. Potential participants will be screened to ensure that they meet the inclusion and exclusion criteria. They will receive written participant information digitally, will have the opportunity to ask questions, and will be offered verbal information. Informed consent will be obtained digitally.
Participants will be stratified by age, randomised, and scheduled for the type of consultation (video or in-person) corresponding to their allocated group with participating physiotherapist. All collected data will be handled in accordance with the principal investigator's data management procedures and applicable legislation.
Procedures The video-based first-contact consultation and the in-person first-contact consultation will be conducted within routine care. Participating physiotherapists will undergo approximately five hours of training in a structured model for conducting video-based physiotherapeutic assessments.
Participants will complete digital questionnaires before the first consultation, immediately after the first consultation, and at 6 weeks, 3 months, 6 months, and 12 months. The estimated time required to complete the digital questionnaires is approximately 10-20 minutes. Medical records and registry data will be collected in 6, 12 and 24 months.
Statistical Analysis The analyses will be conducted using IBM SPSS Statistics for Windows, (IBM Corp., Armonk, NY, USA). Descriptive statistics will be presented as means, standard deviations, and medians for continuous variables, and as frequencies for categorical variables.
Comparisons of improvement levels will be conducted using regression models, controlling for potential confounders (e.g., age, gender, trust). Comparisons of proportions showing improvement will be performed using a two-proportion Z-test. Exploratory analyses will be conducted to identify predictors of outcomes within the video consultation group.
For the health economic analysis, QALYs will be calculated from EQ-5D-5L data, and cost data will be obtained from healthcare registers and patient records. Incremental cost-effectiveness ratios (ICERs) will be calculated, with uncertainty analyses performed using bootstrapping and cost-effectiveness acceptability curves.
Estimates of carbon dioxide emissions will be performed from a life-cycle perspective, based on patient travel and estimates from the Swedish Transport Administration, healthcare utilisation based on estimates from the National Health Service in England, and the use of digital technology.
Comparisons between groups and over time will be conducted using appropriate parametric or non-parametric tests and regression models, depending on the characteristics of the data. Matched analyses will be applied where relevant.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Video-based first-contact physiotherapy | Experimental | Other: Video-based first-contact physiotherapy consultationParticipants receive a video-based first-contact physiotherapy consultation. Following the first-contact consultation, participants will receive standard individualised physiotherapy treatment which falls outside the scope of the study. |
| Traditional in-person first-contact physiotherapy | Active comparator | Other: In-person first-contact physiotherapy consultationParticipants receive an in-person physiotherapy consultation at a primary care rehabilitation clinic. Following the first-contact consultation, participants will receive standard individualised physiotherapy treatment which falls outside the scope of the study. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age 18 years or older.
- Musculoskeletal complaints.
- Sufficient linguistic and cognitive ability to read, understand, and complete a web-based application form and provide informed consent in Swedish.
- Willing to attend the clinic in person.
Key exclusion criteria (2 listed)
- Ongoing treatment for the current condition with planned follow-up by a physiotherapist.
- Lack of access to technology capable of supporting video consultations (e.g., smartphone, computer, or tablet).
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 |
|---|---|---|
| Video-based first-contact physiotherapy consultationParticipants receive a video-based first-contact physiotherapy consultation. Following the assessment, individualised standard physiotherapy treatment is provided as needed. During the video-based assessment, participants will be in a setting of their choice and will meet a physiotherapist via video. The physiotherapists will be trained in a structured model for conducting video-based physiotherapeutic assessments. The rehabilitation clinic's standard platform for real-time audio and video healthcare visits will be used. The estimated time will be approximately 30-45 minutes. | Other | Video-based first-contact physiotherapy |
| In-person first-contact physiotherapy consultationParticipants receive an in-person physiotherapy consultation at a primary care rehabilitation clinic. Following the assessment, individualised standard physiotherapy treatment is provided as needed. The traditional in-person consultation will be conducted at a rehabilitation clinic within the public healthcare system in Region Västra Götaland. The estimated time will be approximately 30-45 minutes. | Other | Traditional in-person first-contact physiotherapy |
Primary outcome
Patient-Specific Functional Scale (PSFS) at 6 weeks
Time frame: 6 weeks
Evaluates treatment outcomes by having the patient identify three activities limited by their condition and rate them on a scale from 0 to 10, where 0 = "unable to perform activity" and 10 = "able to perform activity at the same level as before injury or problem" (Stratford et al., 1995).
23 secondary outcomes
Patient-Specific Functional Scale (PSFS) at baseline
Time frame: Baseline
Patient-Specific Functional Scale (PSFS) at 3 months
Time frame: 3 months
Patient-Specific Functional Scale (PSFS) at 6 months
Time frame: 6 months
Patient-Specific Functional Scale (PSFS) at 12 months
Time frame: 12 months
Pain intensity using Numeric Rating Scale (NRS) at baseline
Time frame: Baseline
Pain intensity using Numeric Rating Scale (NRS) at 6 weeks
Time frame: 6 weeks
Pain intensity using Numeric Rating Scale (NRS) at 3 months
Time frame: 3 months
Pain intensity using Numeric Rating Scale (NRS) at 6 months
Time frame: 6 months
Pain intensity using Numeric Rating Scale (NRS) at 12 months
Time frame: 12 months
Patient's Global Impression of Change (PGIC) at 6 weeks
Time frame: 6 weeks
Patient's Global Impression of Change (PGIC) at 3 months
Time frame: 3 months
Perceived quality of care, Quality from the Patient's Perspective (QPP) at day 1
Time frame: Day 1
Perceived quality of care, Quality from the Patient's Perspective (QPP) at 6 weeks
Time frame: 6 weeks
Quality of life measured with EuroQol Dimensions - 5 Levels (EQ-5D-5L) at Baseline
Time frame: Baseline
Quality of life measured with EuroQol Dimensions - 5 Levels (EQ-5D-5L) at 6 weeks
Time frame: 6 weeks
Quality of life measured with EuroQol Dimensions - 5 Levels (EQ-5D-5L) at 3 months
Time frame: 3 months
Quality of life measured with EuroQol Dimensions - 5 Levels (EQ-5D-5L) at 6 months
Time frame: 6 months
Quality of life measured with EuroQol Dimensions - 5 Levels (EQ-5D-5L) at 12 months
Time frame: 12 months
Work Ability Index (WAI) at Baseline
Time frame: Baseline
Work Ability Index (WAI) at 6 weeks
Time frame: 6 weeks
Work Ability Index (WAI) at 3 months
Time frame: 3 months
Work Ability Index (WAI) at 6 months
Time frame: 6 months
Work Ability Index (WAI) at 12 months
Time frame: 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Aug 2026.
- Background: PubMed 24828475Abbott JH, Schmitt J. Minimum important differences for the patient-specific functional scale, 4 region-specific outcome measures, and the numeric pain rating scale. J Orthop Sports Phys Ther. 2014 Aug;44(8):560-4. doi: 10.2519/jospt.2014.5248. Epub 2014 May 14.
- Background: PubMed 29650068Artandi MK, Stewart RW. The Outpatient Physical Examination. Med Clin North Am. 2018 May;102(3):465-473. doi: 10.1016/j.mcna.2017.12.008. Epub 2018 Mar 12.
- Background: PubMed 36943857Bernhardsson S, Larsson A, Bergenheim A, Ho-Henriksson CM, Ekhammar A, Lange E, Larsson MEH, Nordeman L, Samsson KS, Bornhoft L. Digital physiotherapy assessment vs conventional face-to-face physiotherapy assessment of patients with musculoskeletal disorders: A systematic review. PLoS One. 2023 Mar 21;18(3):e0283013. doi: 10.1371/journal.pone.0283013. eCollection 2023.
- Background: PubMed 30800175Bornhoft L, Larsson ME, Nordeman L, Eggertsen R, Thorn J. Health effects of direct triaging to physiotherapists in primary care for patients with musculoskeletal disorders: a pragmatic randomized controlled trial. Ther Adv Musculoskelet Dis. 2019 Feb 15;11:1759720X19827504. doi: 10.1177/1759720X19827504. eCollection 2019.
- Background: PubMed 31043169Bornhoft L, Thorn J, Svensson M, Nordeman L, Eggertsen R, Larsson MEH. More cost-effective management of patients with musculoskeletal disorders in primary care after direct triaging to physiotherapists for initial assessment compared to initial general practitioner assessment. BMC Musculoskelet Disord. 2019 May 1;20(1):186. doi: 10.1186/s12891-019-2553-9.
- Background: PubMed 33275908Cieza A, Causey K, Kamenov K, Hanson SW, Chatterji S, Vos T. Global estimates of the need for rehabilitation based on the Global Burden of Disease study 2019: a systematic analysis for the Global Burden of Disease Study 2019. Lancet. 2021 Dec 19;396(10267):2006-2017. doi: 10.1016/S0140-6736(20)32340-0. Epub 2020 Dec 1.
- BackgroundDe Sire, A., & Invernizzi, M. (2021). Musculoskeletal rehabilitation: State-of-the-art. Applied Sciences, 11(14), 6243. https://doi.org/10.3390/app11146243
- BackgroundDi, W., Nie, Y., Chua, B. L., Chye, S., & Teo, T. (2023). Developing a single-item general self-efficacy measure. Journal of Psychoeducational Assessment, 41(6). https://doi.org/10.21203/rs.3.rs-342642/v1
- BackgroundEuroQol Research Foundation. (n.d.). EQ-5D-5L. Retrieved April 20, 2026, from https://euroqol.org/information-and-support/euroqol-instruments/eq-5d-5l/
- BackgroundFernando, M., & Lange, E. (2025). New ways of working as a physiotherapist in the digital era: A qualitative study. Physiotherapy Practice and Research, 46(2), 103-110.
- BackgroundFHVmetodik. (n.d.). Svenska WAI-nätverket. Retrieved April 20, 2026, from https://fhvmetodik.se/arbetsmiljo-sam/kartlaggning-arbetsformaga/arbetsformaga/wai/svenska-wai-natverket/
- Background: PubMed 21932298Gerlinger C, Schmelter T. Determining the non-inferiority margin for patient reported outcomes. Pharm Stat. 2011 Sep-Oct;10(5):410-3. doi: 10.1002/pst.507. Epub 2011 Sep 19.
- Individual participant dataSharing planned: Yes. Individual participant data (IPD) will not be publicly shared due to restrictions under the EU General data Protection Regulation (GDPR). However anonymised data may be made available upon reasonable request, provided the request complies with GDPR and Swedish data protection regulations.
Related trials for Musculoskeletal Diseases
Enrolling by invitationPhase 2
Extension Study of Infigratinib in Children With Achondroplasia (ACH)
Achondroplasia
RecruitingPhase 3
A Study of MACI in Patients Aged 17 to 65 Years With Symptomatic Chondral or Osteochondral Defects of the Ankle
Chondral Defect, Articular Cartilage Defect
Recruiting
Effect of a Constipation Prevention Checklist in Hip Surgery Patients
Constipation, Perioperative Nursing
RecruitingPhase 2/3
Study to Evaluate the Efficacy and Safety of BMN 333 Versus Vosoritide in Children With Achondroplasia
Achondroplasia
Recruiting
Activity Post Spinal Surgery Engagement Trial
Spinal Surgery for Lumbar Spinal Stenosis (LSS)
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.
Elvira Lange, PhD principal investigator
Vastra Gotaland Region
Questions about this trial
What is this clinical trial studying?
A study testing Video-based first-contact physiotherapy consultation and In-person first-contact physiotherapy consultation in people with Musculoskeletal Diseases, run by Vastra Gotaland Region.
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 4 inclusion and 2 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: opening soon, as of the sponsor's last update on 26 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Elvira Lange, PhD (+46 764-95 61 23, elvira.m.lange@vgregion.se), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient-Specific Functional Scale (PSFS) at 6 weeks (time frame: 6 weeks). 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 NCT07788651, which also lists 33 linked publications.
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 26 Aug 2026; AzTrials last refreshed its copy on 27 Oct 2026.