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PainPainSMARTNCT06187428

The PainSMART Research Program: Evaluating a Pain Education Strategy for Patients Seeking Primary Care Physiotherapy

A study testing PainSMART-strategy and Usual physiotherapy management in people with Pain and Pain Acute, run by Kajsa Johansson at 6 sites in Sweden.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The goal of this clinical trial is to test the PainSMART-strategy in a population of patients seeking primary care physiotherapy for pain related to muscles, joints and bones, so called musculoskeletal pain. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Pain, Pain Acute, Pain, Chronic
What is being tested?
PainSMART-strategy and Usual physiotherapy management
Could I receive a placebo?
No, everyone receives an active treatment
How many people
494 participants
Where
6 sitesSweden
Study dates
22 Jan 2024to 10 Mar 2025
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

  • Patients who, via telephone or online text-based triage, are judged to have benign MSKP and are booked for an initial physiotherapy consultation at one of the five participating physiotherapy departments
  • Adult patients (18 years or older)

Who cannot join

  • Patients who are judged to require urgent medical examination due to suspected serious pathology (red flags)
  • Patients who are booked to an initial physiotherapy consultation on the same day as, or the day directly following triage.
  • Patients referred for physiotherapy following consultation with a tertiary care practitioner (e.g. orthopaedic surgeon, rheumatologist, neurologist)
  • Patients who cannot communicate in Swedish to the equivalent of a 12-year-old native speaker (as judged by the triaging physiotherapist)
  • Patients who, through visual impairments, are unable to complete the necessary questionnaires for the study
  • Patients who are booked for an initial consultation with a physiotherapist who has not consented to taking part in the study

Trial locations and contacts

6 sites in 1 country.

6 sites in 1 country

Sweden6 sites

  • Rehab Finspång, Primary Care Physiotherapy department

    Finspång, Östergötland County, 612 25

  • Rörelse och Hälsa, Primary Care Physiotherapy department

    Linköping, Östergötland County, 581 85

  • Linköping University

    Linköping, Östergötland County, 58183

  • Rehab Väst, Primary Care Physiotherapy department

    Motala, Östergötland County, 581 85

  • Rehab Öst, Primary Care Physiotherapy department

    Norrköping, Östergötland County, 612 25

  • Bra Liv VC Tranås, Primary Care Physiotherapy department

    Svärtinge, Jönköping County, 60580

Other trials in Sweden

About this study

Official title: The PainSMART Project: A Research Program on Effectiveness, Mechanisms of Effect and Patient-practitioner Experiences of the PainSMART-strategy as an Adjunct to Usual Primary Care Physiotherapy Management for Musculoskeletal Pain

The goal of this clinical trial is to test the PainSMART-strategy in a population of patients seeking primary care physiotherapy for pain related to muscles, joints and bones, so called musculoskeletal pain. The PainSMART-strategy consists of a digital educational film (entitled Be PainSMART:er) and a discussion based on the film at the initial physiotherapy consultation.

The main questions this clinical trial aims to answer are:

Read more
  1. Can the PainSMART-strategy update knowledge and beliefs about pain and aid early stage self-management of pain for participants seeking primary care physiotherapy with benign musculoskeletal pain?
  2. Can the PainSMART-strategy improve evaluations of the initial physiotherapy consultation for both the patient and physiotherapist?

Participating patients will be randomised into two groups. One group (intervention group) will receive the PainSMART-strategy as an adjunct to the current physiotherapy care pathway for musculoskeletal pain. The other group (control group) will follow the current physiotherapy care pathway. The two groups will be followed and compared over three months. Self-report questionnaires and data from central healthcare registers will be collected during and after the three-month period to analyse what effects the PainSMART-strategy can have on the following health outcomes:

  • Pain levels
  • Beliefs that one can remain active despite pain
  • Knowledge about pain
  • Worry about the seriousness of the pain
  • Expectations regarding recovery
  • Use of pain self-management strategies
  • Levels of physical activity
  • Absence from work due to pain
  • Number of referrals made for scans or x-rays, or to a specialist, for pain
  • Number of healthcare visits and direct costs incurred for pain during the trial period.

Participating patients (both groups) and physiotherapists will also complete questionnaires to evaluate the effect of the PainSMART-strategy on the initial physiotherapy consultation.

The final 30 to 40 participating patients in the study will also have their initial consultation with the physiotherapist audio recorded in order to enable analysis of any potential influence of the PainSMART-strategy on communication around pain during the consultation.

Read the detailed description

For more detailed information about the study see the attached study protocol and the attached statistical analysis plan.

Being tested
PainSMART-strategy, Usual physiotherapy management
Keywords
pain, education, pain self efficacy, digitalisation, primary care
Medical subject headings
Pain, Acute Pain, Chronic Pain, Anxiety Disorders, Communication

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PainSMART-strategyOther

    Be PainSMART:er is a seven minute long film developed by the research group based on modern pain science and previous qualitative studies.

    The film is divided into three sections:

    Section 1- Educates that MSKP is a complex protective system that does not reflect the anatomical state of the body and provides reassurance that MSKP is rarely caused by serious pathology.

    Section 2- Provides advice on active MSKP coping, such as encouraging work despite some pain, in an attempt to reconceptualise the belief that a painful body part needs to be rested.

    Section 3- Aims to prepare patients for a biopsychosocial physiotherapy consultation by encouraging them to reflect on the film's messages.

    In addition to the film, the questions posed to the participant at the initial consultation aim to facilitate the discussion around the film and MSKP reflections. Management subsequent to the initial consultation will follow usual management.

  • Usual physiotherapy managementOther

    Patients randomised to the control group follow usual MSKP physiotherapy management. Specifically, patients first contact their physiotherapy department online or via telephone and are triaged by a certified physiotherapist and are booked for an initial physiotherapy consultation. After triage, study information and the consent to participate, patients in the control group receive online data collection questionnaires identical to those of the intervention group at baseline and prior to the consultation, excluding the film and the questions linked to the film. The initial consultation will take place as usual according to the preferences of the physiotherapist. The physiotherapist will pose one question at start of the consultation to acknowledge the completion of control group questionnaires. Management subsequent to the initial consultation will follow usual management.

Study groups in NCT06187428
Study groupRoleWhat they receive
PainSMART-strategy (intervention) groupExperimentalPatients eligible for inclusion first contact the physiotherapy department and are triaged by a physiotherapist and booked for an initial physiotherapy consultation. After triage, study information and the consent to participate, patients randomised to the intervention group receive the PainSMART-strategy as an adjunct to usual MSKP physiotherapy management. The strategy includes; exposure to the film 'Be PainSMART:er' at baseline, together with ratings of the clarity of the film's key-messages, a second film exposure prior to the initial consultation and three questions related to the film at the initial consultation. Baseline data collection will occur prior to first exposure to the film. The film is available exclusively via the questionnaires via Region Östergötland's Quick channel. Therefore it is not shareable or available via online searching.
Receives: Other: PainSMART-strategy
Usual physiotherapy management (control) groupActive comparatorPatient participants randomised to the control group will follow the usual physiotherapy management pathway at the physiotherapy departments participating in the study.
Receives: Other: Usual physiotherapy management

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Mean change from baseline and proportion of responders in self-reported Pain Self-efficacy measured using the Pain Self-efficacy questionnaire 10 (PSEQ-10) (within- and between group changes)

    Pain self-efficacy will be measured using the PSEQ-10 (Nicholas, 2007). The PSEQ-10 is a self-reported ten item scale scored as a total (0-60) with a higher score indicating greater pain self-efficacy (higher score = better outcome). The PSEQ-10 includes ten statements where patients are asked to rate, from zero to six, how confident they are that they can do certain things despite their pain.

    Change = Baseline score compared to score 24-72 hours prior to the initial physiotherapy consultation, 24 hours post-initial physiotherapy consultation (primary outcome point 1) and again at three months post-baseline (primary outcome point 2).

    Secondary analyses of within and between-group differences in proportion of responders will be conducted based on the study specific minimal clinical important difference (MCID) for primary outcomes at primary outcome time points. The MCID will be calculated for the whole cohort using an anchor method based on Global rating of change scores.

    Measured: The PSEQ-10 will be collected at baseline, 24-72 hours prior to the initial physiotherapy consultation, 24 hours post-initial physiotherapy consultation and again at three months post-baseline

  2. Mean change from baseline and proportion of responders in self-reported Pain Intensity measured using numerical rating scale (NRS) (within- and between group changes)

    Self-reported average pain intensity (primary outcome), worst pain intensity and best pain intensity in the previous 24 hours will be measured using three separate Numerical Rating Scales (NRS) (0-10; 0 = no pain to 10 = worst imaginable pain). NRS rating related to the past 24 hours has been chosen to avoid overlap of the ratings at the separate data collection time points.

    Change = Baseline score compared to score 24-72 hours prior to the initial physiotherapy consultation, 24 hours post-initial physiotherapy consultation (primary outcome point 1) and again at three months post-baseline (primary outcome point 2).

    Secondary analyses of within and between-group differences in proportion of responders will be conducted based on the study specific minimal clinical important difference (MCID) for primary outcomes at primary outcome time points. The MCID will be calculated for the whole cohort using an anchor method based on Global rating of change scores.

    Measured: NRS will be collected at baseline, 24-72 hours prior to the initial physiotherapy consultation, 24 hours post-initial physiotherapy consultation and again at three months post-baseline

Secondary outcomes (12)

  1. Mean change from baseline in self-reported Musculoskeletal pain illness perceptions measured using the Brief Illness Perception Questionnaire (BIPQ) (within- and between group changes)

    The BIPQ has nine questions, eight use an 11-point NRS with anchor statements. Question 9 is a free text question where participants list the three most important factors they believed cause their MSKP (Broadbent et al., 2006).

    Change = Baseline score compared to score 24-72 hours prior to the initial physiotherapy consultation, 24 hours post-initial consultation and again at three months post-baseline.

    BIPQ will be analysed as recommended by Broadbent et al (2015): As individual items and as total score (max 80). The total score gives an impression of the patient's perception of the threat level of their MSKP, with a higher score reflecting a higher threat (lower item or total score=better outcome). The causal item question will be collected at baseline, immediately following the baseline exposure to the film and again at 24 hours post-initial consultation. The causal item question will be analysed by grouping of answers into categories.

    Measured: BIPQ will be collected at baseline, repeated directly after first exposure to the film, 24-72 hours prior to the initial physiotherapy consultation, 24 hours post-initial physiotherapy consultation and again at three months post-baseline

  2. Mean change from baseline in self-reported level of reassurance as to the benign nature of MSKP will be measured using a single numerical rating scale (Reassurance NRS) (within- and between group changes)

    Self-reported level of reassurance about the seriousness of MSKP will be measured using a reassurance NRS with an eleven-point scale (0-10). The reassurance NRS asks the participant how certain they are that there is not a serious condition causing their MSKP. A higher score indicates greater assurance. This question has been adapted from the original research by Sox et al. (1981) and has been previously used in research on acute LBP (Deyo et al., 1987).

    Change =Baseline score compared to score 24-72 hours prior to the initial physiotherapy consultation, 24 hours post-initial physiotherapy consultation and again at three months post-baseline.

    Measured: Reassurance NRS will be collected at baseline, 24-72 hours prior to the initial physiotherapy consultation, 24 hours post-initial physiotherapy consultation and again at three months post-baseline.

  3. Mean change from baseline in self-reported traditional musculoskeletal pain coping strategies and psychological flexibility measured using the Brief Pain Coping Inventory 2 (BPCI-2) (within- and between group changes)

    The BPCI-2 is a 19-item questionnaire, where participants are asked to report on how many days in the last week they adopted certain pain management strategies (0-7 days; Vowles et al., 2014). The BPCI-2 is scored as a total score (0-133) and also contains two sub-scales which measure traditional pain coping strategies (max 56) and psychological flexibility (max 77; with 4 reverse scored items). Higher total or sub-scale scores indicate more adaptive coping (Vowles et al., 2014).

    Change = Baseline score compared to score 24-72 hours prior to the initial physiotherapy consultation, 24 hours post-initial physiotherapy consultation and again at three months post-baseline.

    Measured: BPCI-2 will be collected at baseline, 24-72 hours prior to the initial physiotherapy consultation, 24 hours post-initial physiotherapy consultation and again at three months post-baseline.

  4. Mean change in self-reported levels of physical activity measured using three screening questions developed for the Swedish national board of health and welfare (within- and between group changes)

    The three questions ask the participants how many minutes in the last week they have performed activity that makes the breathless, how many minutes they have been otherwise physically active, for example house work or gardening, and how many hours they usually sit during a day (not including sleeping) (Kallings, 2014).

    Change = Within and between group mean change in the scores over time from baseline to follow-up three months post-baseline (all time points). Scores on question regarding "Moderate to intensive exercise" and "Other physical activity beside exercise" will also be converted to activity minutes per week < 150min/w or ≥ 150min/w.

    Measured: Physical activity will be collected at baseline, 24-72 hours prior to the initial physiotherapy consultation, 24 hours post-initial physiotherapy consultation and again at three months post-baseline.

  5. Mean self-reported global rating of change measured using a global rating of change scale (GRoCs) measured at three time points (analysed for both within- and between group changes)

    Global Rating of Change will be measured using a single item GRoCs scored on an 11-point scale. The 11-point scale is scored from minus five to plus five, anchored by the terms very much worse (minus five), unchanged (zero) and completely recovered (plus five) in accordance with the recommendation made by Kamper et al. (2009). The score is based on the time period from when the participant first contacted their physiotherapy department and were triaged to 24-48 hours prior to the initial physiotherapy consultation and again at three months post-baseline.

    The score will be dichotomized into improved (1-5) and unchanged/worse (-5-0).

    Measured: GRoCs will be collected at three time points; first 24-72 hours prior to the initial physiotherapy consultation, 24 hours post-initial physiotherapy consultation and again at three months post-baseline

  6. Change in type and frequency of self-reported analgesic medication use (within and between group changes)

    Self-reported analgesic medication use (type and consumption) for the presenting MSKP complaint will be collected via two questions. The first question establishes analgesic consumption and consumption frequency quantified via one question with response options: Yes, on a regular basis; Yes, sometimes; or No. The type of analgesics taken for MSKP is established via one question with six response options: 1. Paracetamol, 2. NSAID, 3. Opioids, 4. Gabapentinoids/Tricyclic antidepressants/Serotonin-norepinephrine reuptake inhibitors 5. Don't know 6. Other.

    Change = Baseline consumption (type \& regularity) compared to score 24-72 hours prior to the initial physiotherapy consultation, 24 hours post-initial physiotherapy consultation and again at three months post-baseline. Analgesic type will be grouped into 3 groups for analysis:

    1. Paracetamol, 2. NSAID, 3. Opioids/gabapentinoids/Tricyclic antidepressants/Serotonin-norepinephrine reuptake inhibitors.

    Measured: will be collected at baseline, 24-72 hours prior to the initial physiotherapy consultation, 24 hours post-initial physiotherapy consultation and again at three months post-baseline.

  7. Total days of Sickness absence for each group (intervention and control) from baseline to three months post-baseline (between group difference)

    Data on sickness certification will be collected for each participating patient via the Swedish social security database (Försäkringskassan) following completion of patient and physiotherapist outcome measure data collection. In addition the participants will self-rapport if they are currently on sick leave for their presenting MSKP complaint at the time of baseline data collection, 24-72 hours prior to the initial physiotherapy consultation, 24 hours post-initial physiotherapy consultation and again at the three month post-baseline data collection.

    Measured: Total aggregated days (for all participants in each group) from baseline to three months post-baseline

  8. Total number of referrals for diagnostic imaging for each group (intervention and control) from baseline to three months post-baseline (between group differences)

    Data will be collected for each participating patient via regional healthcare databases (Rebus Vård, Region Östergötland \& Region Jönköpings län) following completion of patient and physiotherapist outcome measure data collection. The number of referrals made for diagnostic imaging for musculoskeletal diagnoses for each participant made during the time that elapses between baseline and three months post-baseline will be collected.

    Measured: Total aggregated referrals (for all participants in each group) made between baseline and three months post-baseline

  9. Total number of referrals to tertiary/specialist care for musculoskeletal pain for each group (intervention and control) from baseline to three months post-baseline (between group differences)

    Data will be collected for each participating patient via regional healthcare databases (Rebus Vård, Region Östergötland \& Region Jönköpings län) following completion of patient and physiotherapist outcome measure data collection. The number of referrals made to tertiary/specialist care for musculoskeletal diagnoses for each participant made during the time that elapses between baseline and three months post-baseline will be collected.

    Measured: Total aggregated referrals (for all participants in each group) made between baseline and three months post-baseline

  10. Total number of healthcare consultations attended for musculoskeletal pain for each group (intervention and control) from baseline to three months post-baseline (between group differences)

    Data will be collected for each participating patient via regional healthcare databases (Rebus Vård, Region Östergötland \& Region Jönköpings län) following completion of patient and physiotherapy outcome measure data collection. The number of healthcare appointments attended for musculoskeletal diagnoses for each participant during the time that elapses between baseline and three months post-baseline will be collected. Patients will also self-report if they have attended healthcare consultations for their MSKP presenting complaint with healthcare practitioners who are not the physiotherapist involved in the trial.

    Measured: Total aggregated healthcare consultations attended (for all participants in each group) between baseline and three months post-baseline

  11. Direct healthcare costs per patient

    Direct costs per patient for healthcare during the MSKP study period will be collected from the central healthcare database. A comparison will be made between the intervention and control groups to establish if the PainSMART-strategy can improve health outcomes and the effectiveness of the physiotherapy management pathway.

    Measured: Total aggregated direct healthcare costs (for all participants in each group) between baseline and three months post-baseline

  12. One-off screening at baseline with the Örebro Musculoskeletal pain screening questionnaire

    The Örebro Musculoskeletal pain screening questionnaire (ÖMPSQ) is a ten item questionnaire which assesses five constructs; self-perceived function, pain experience, distress, fear-avoidance beliefs and return to work expectancy (Linton et al., 2011). The ÖMPSQ was developed in a primary care setting and the questionnaire is scored from 0-100 where a higher score indicates higher risk for future work related disability (Linton et al., 2011).

    Measured: Baseline only

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Jan 2024
  2. Study start22 Jan 2024
  3. Primary completion10 Mar 2025
  4. Study completion10 Mar 2025

Resources

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
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Two-arm parallel randomised assignment to intervention (PainSMART) group or control (usual management) group
Masking
Double blind
Who is masked
Participant, Outcomes assessor
Enrolment
494 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06187428
Sponsor's protocol ID
Dnr 2023-05968-01
Other IDs
Primary care rehabilitation, Primary care rehabilitation
Acronym
PainSMART
Status last verified
Jun 2025
First submitted
15 Dec 2023
Last updated
12 Jun 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: Individual patient data will be shared pseudonymised upon reasonable request after study completion and after finalising relevant research program publications. This will include background data, patient reported outcome measure data and patient and physiotherapist experience measure data.

Publications

  • Försäkringskassan (2023, June 20) Statistical database. Statistics related to illness. https://www.forsakringskassan.se/statistik-och-analys/statistikdatabas#!/sjuk/sjp-antal-mottagare-nettodagar-belopp

  • Kallings, L. (2014). Validering av Socialstyrelsens screeningfrågor om fysisk aktivitet. The Swedish National Board of Health and Welfare. https://www.socialstyrelsen.se/globalassets/sharepoint-dokument/dokument-webb/nationella-riktlinjer/levnadsvanor-validering-av-indikatorfragor-till-patienter-om-fysisk-aktivitet.pdf

  • Moseley, G. L., & Butler, D. S. (2017). Explain Pain Supercharged. NOI Group, Australia.

  • Broadbent E, Wilkes C, Koschwanez H, Weinman J, Norton S, Petrie KJ. A systematic review and meta-analysis of the Brief Illness Perception Questionnaire. Psychol Health. 2015;30(11):1361-85. doi: 10.1080/08870446.2015.1070851. Epub 2015 Aug 26.

    PubMed 26181764

  • Caneiro JP, Bunzli S, O'Sullivan P. Beliefs about the body and pain: the critical role in musculoskeletal pain management. Braz J Phys Ther. 2021 Jan-Feb;25(1):17-29. doi: 10.1016/j.bjpt.2020.06.003. Epub 2020 Jun 20.

    PubMed 32616375

  • Chiarotto A, Vanti C, Cedraschi C, Ferrari S, de Lima E Sa Resende F, Ostelo RW, Pillastrini P. Responsiveness and Minimal Important Change of the Pain Self-Efficacy Questionnaire and Short Forms in Patients With Chronic Low Back Pain. J Pain. 2016 Jun;17(6):707-18. doi: 10.1016/j.jpain.2016.02.012. Epub 2016 Mar 11.

    PubMed 26975193

  • Deyo RA, Diehl AK, Rosenthal M. Reducing roentgenography use. Can patient expectations be altered? Arch Intern Med. 1987 Jan;147(1):141-5. doi: 10.1001/archinte.147.1.141.

    PubMed 2948466

  • Dube MO, Langevin P, Roy JS. Measurement properties of the Pain Self-Efficacy Questionnaire in populations with musculoskeletal disorders: a systematic review. Pain Rep. 2021 Dec 21;6(4):e972. doi: 10.1097/PR9.0000000000000972. eCollection 2021 Nov-Dec.

    PubMed 34963996

  • Emilsson M, Berndtsson I, Gustafsson PA, Horne R, Marteinsdottir I. Reliability and validation of Swedish translation of Beliefs about Medication Specific (BMQ-Specific) and Brief Illness Perception Questionnaire (B-IPQ) for use in adolescents with attention-deficit hyperactivity disorder. Nord J Psychiatry. 2020 Feb;74(2):89-95. doi: 10.1080/08039488.2019.1674376. Epub 2019 Oct 9.

    PubMed 31596161

  • Finucane LM, Downie A, Mercer C, Greenhalgh SM, Boissonnault WG, Pool-Goudzwaard AL, Beneciuk JM, Leech RL, Selfe J. International Framework for Red Flags for Potential Serious Spinal Pathologies. J Orthop Sports Phys Ther. 2020 Jul;50(7):350-372. doi: 10.2519/jospt.2020.9971. Epub 2020 May 21.

    PubMed 32438853

  • Jensen MP, Turner JA, Romano JM, Fisher LD. Comparative reliability and validity of chronic pain intensity measures. Pain. 1999 Nov;83(2):157-62. doi: 10.1016/s0304-3959(99)00101-3.

    PubMed 10534586

  • Kamper SJ, Maher CG, Mackay G. Global rating of change scales: a review of strengths and weaknesses and considerations for design. J Man Manip Ther. 2009;17(3):163-70. doi: 10.1179/jmt.2009.17.3.163.

    PubMed 20046623

  • Leventhal H, Phillips LA, Burns E. The Common-Sense Model of Self-Regulation (CSM): a dynamic framework for understanding illness self-management. J Behav Med. 2016 Dec;39(6):935-946. doi: 10.1007/s10865-016-9782-2. Epub 2016 Aug 11.

    PubMed 27515801

  • Linton SJ, Nicholas M, MacDonald S. Development of a short form of the Orebro Musculoskeletal Pain Screening Questionnaire. Spine (Phila Pa 1976). 2011 Oct 15;36(22):1891-5. doi: 10.1097/BRS.0b013e3181f8f775.

    PubMed 21192286

  • Nicholas MK. The pain self-efficacy questionnaire: Taking pain into account. Eur J Pain. 2007 Feb;11(2):153-63. doi: 10.1016/j.ejpain.2005.12.008. Epub 2006 Jan 30.

    PubMed 16446108

Questions about this trial

What is this clinical trial studying?

A study testing PainSMART-strategy and Usual physiotherapy management in people with Pain and Pain Acute, run by Kajsa Johansson at 6 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 2 inclusion and 6 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 12 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 6 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?

Mean change from baseline and proportion of responders in self-reported Pain Self-efficacy measured using the Pain Self-efficacy questionnaire 10 (PSEQ-10) (within- and between group changes) (time frame: The PSEQ-10 will be collected at baseline, 24-72 hours prior to the initial physiotherapy consultation, 24 hours post-initial physiotherapy consultation and again at three months post-baseline). 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 NCT06187428, which also lists 28 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 12 Jun 2025.

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