Low Back PainNCT05215093
The Direct-Physio Trial
A study testing Direct access physiotherapy for acute low back pain in people with Low Back Pain and Physiotherapy, run by Hasselt University at 1 site in Belgium.
Trial summary
Previous research showed that direct access to physiotherapy, and the associated early physiotherapeutic treatment of patients with low back pain (LBP), results in improved clinical outcomes, as well as reduced health-related costs. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Low Back Pain, Physiotherapy
- What is being tested?
- Direct access physiotherapy for acute low back pain
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteBelgium
- Study dates
- 1 Dec 2022to 1 Sep 2026
- 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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with non-specific acute LBP defined as (based on Nicol et al. 2020):
- pain between the 12th rib and buttocks
- associated or not with non-dominant leg pain
- looking for LBP care for the first time in case of first episode, OR for the first time for the current episode in case of recurrent or persistent LBP
- lasting > 24 hours and < 6 weeks
- with an average pain intensity during the past 24 hours of ≥ 3 on an 11-point Numerical Pain Rating Scale
- with an Oswestry Disability Index score (version 2.1a) of at least 20% (Denteneer et al. 2018).
- Patients aged between 18 and 65 years
Who cannot join
- Recent lumbar surgery (< 1 year)
- Pregnancy
- History of (any) treatment for the current pain episode
- Red flags suggesting specific LBP (e.g. resulting from infection or neoplasm, cauda equina), based on the Belgian Health Care Knowledge Center (KCE, BEL) who published evidence-based guidelines to manage LBP and radicular pain (Van Wambeke et al. 2017), leads to exclusion from treatment within the study.
- Generalized musculoskeletal pain (based on fibromyalgia criteria) (Galvez-Sánchez and Reyes del Paso 2020).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Direct Access to Physiotherapy for Acute Low Back Pain: a Pragmatic Pilot Trial
Previous research showed that direct access to physiotherapy, and the associated early physiotherapeutic treatment of patients with low back pain (LBP), results in improved clinical outcomes, as well as reduced health-related costs. However, despite these results, the effectiveness of direct access to physiotherapy and its impact on costs has never been investigated in Belgium. Therefore, the goal of this study is to compare the (cost-)effectiveness of direct access to physiotherapy compared to usual care by the general practitioner (GP) for patients with acute LBP.
In this study, 600 patients with acute LBP (lasting >24 hours and <6 weeks) will be divided into two groups (Dutch-speaking: n=2x150; French-speaking n= 2x150). One group will receive treatment through direct access to the physiotherapist, without prescription by a GP. The other group will follow the traditional care pathway through the GP. Th effects on pain, disability and cost-effectiveness will be analysed using questionnaires obtained before and at the end of treatment, after 3 months, after one and after two years. Primary outcomes include pain and disability. Secondary outcomes include clinical outcomes, beliefs related to LBP, quality of life, patient satisfaction, but also direct health care costs, health care resource use, as well as absenteeism and productivity loss.
The results of this study will answer the question whether direct access to physiotherapy is (cost)effective for acute LBP. In the long term, these results might be used to optimize the care pathway in Belgium for patients with acute low back pain.
- Conditions
- Low Back Pain, Physiotherapy
- Being tested
- Direct access physiotherapy for acute low back pain, Usual care for acute low back pain
- Keywords
- Direct access
- Medical subject headings
- Low Back Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Direct access physiotherapy for acute low back painOther
Interventions include physiotherapeutic treatment, without prescription of the general practitioner, for low back pain according to current biopsychosocial national (KCE - Belgium) and international (NICE) guidelines.
Usual care for acute low back painOther
Interventions include standard of care by the general practitioner for low back pain according to current biopsychosocial national (KCE - Belgium) and international (NICE) guidelines.
| Study group | Role | What they receive |
|---|---|---|
| Direct physiotherapy pathway | Experimental | People with acute low back pain will directly go to a physiotherapist, who will treat the patient without prescription of the general practitioner. Receives: Other: Direct access physiotherapy for acute low back pain |
| Usual care pathway | Active comparator | People with low back pain will receive usual care by the general practitioner (with or without referral to physiotherapy). Receives: Other: Usual care for acute low back pain |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in pain intensity
Numeric Rating Scale
Measured: Immediately before, during the first 6 weeks and immediately after intervention and at 3 months, 1 and 2 years after enrollment
Changes in pain location and extent
Pain Diagram of Margolis
Measured: Immediately before, during the first 6 weeks and immediately after intervention and at 3 months, 1 and 2 years after enrollment
Changes in disability
Oswestry Disability Index
Measured: Immediately before, during the first 6 weeks and immediately after intervention and at 3 months, 1 and 2 years after enrollment
Secondary outcomes (5)
Cost-effectiveness of the provided treatment (direct physiotherapy access vs usual care for acute low back pain)
Costs of low back pain and its treatment in terms of medical and societal costs
Measured: Up to 2 years after enrollment
Changes in beliefs and cognitions related to low back
Back Pain Attitude Questionnaire (Back-PAQ)
Measured: Immediately before, during the first 6 weeks and immediately after intervention and at 3 months, 1 and 2 years after enrollment
Changes in patient satisfaction
Measured: Immediately before, during the first 6 weeks and immediately after intervention and at 3 months, 1 and 2 years after enrollment
Changes in quality of life
EQ-5D
Measured: Immediately before, during the first 6 weeks and immediately after intervention and at 3 months, 1 and 2 years after enrollment
Amount of / coping with flare-ups during follow-up
Measured: Immediately before, during the first 6 weeks and immediately after intervention and at 3 months, 1 and 2 years after enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2022
- Study start1 Dec 2022
- Primary completion1 Sep 2026
- Study completion1 Sep 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Low Back 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hasselt University
- Sponsor type
- University, hospital or other
- Collaborators
- KU Leuven, Universiteit Antwerpen, Université Catholique de Louvain, Axxon - the Belgian physiotherapy professional association, Riziv-Inami - National Institute for the Sickness and Invalidity Insurance
- Responsible party
- Principal investigator, Lotte Janssens, Hasselt University
- Investigators
- Lotte Janssens, PhD, Principal investigator, UHasselt
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05215093
- Sponsor's protocol ID
- CME2021/066
- Status last verified
- Sep 2026
- First submitted
- 13 Dec 2021
- Last updated
- 17 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 17 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Direct Access to Physiotherapy for Acute Low Back Pain: a Pragmatic Pilot Trial
- ClinicalTrials.gov ID
- NCT05215093
- Acronym / sponsor ID
- CME2021/066
- Conditions
- Low Back Pain, Physiotherapy
- Keywords
- Direct access
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Hasselt UniversityUniversity, hospital or other
- Collaborators
- KU Leuven, Universiteit Antwerpen, Université Catholique de Louvain, Axxon - the Belgian physiotherapy professional association, Riziv-Inami - National Institute for the Sickness and Invalidity Insurance
- Study start
- 1 Dec 2022 (actual)
- Primary completion
- 1 Sep 2026 (actual)
- Study completion
- 1 Sep 2026 (actual)
- First posted
- 31 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.
Previous research showed that direct access to physiotherapy, and the associated early physiotherapeutic treatment of patients with low back pain (LBP), results in improved clinical outcomes, as well as reduced health-related costs. However, despite these results, the effectiveness of direct access to physiotherapy and its impact on costs has never been investigated in Belgium. Therefore, the goal of this study is to compare the (cost-)effectiveness of direct access to physiotherapy compared to usual care by the general practitioner (GP) for patients with acute LBP.
In this study, 600 patients with acute LBP (lasting >24 hours and <6 weeks) will be divided into two groups (Dutch-speaking: n=2x150; French-speaking n= 2x150). One group will receive treatment through direct access to the physiotherapist, without prescription by a GP. The other group will follow the traditional care pathway through the GP. Th effects on pain, disability and cost-effectiveness will be analysed using questionnaires obtained before and at the end of treatment, after 3 months, after one and after two years. Primary outcomes include pain and disability. Secondary outcomes include clinical outcomes, beliefs related to LBP, quality of life, patient satisfaction, but also direct health care costs, health care resource use, as well as absenteeism and productivity loss.
The results of this study will answer the question whether direct access to physiotherapy is (cost)effective for acute LBP. In the long term, these results might be used to optimize the care pathway in Belgium for patients with acute low back pain.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Direct physiotherapy pathway | Experimental | Other: Direct access physiotherapy for acute low back painPeople with acute low back pain will directly go to a physiotherapist, who will treat the patient without prescription of the general practitioner. |
| Usual care pathway | Active comparator | Other: Usual care for acute low back painPeople with low back pain will receive usual care by the general practitioner (with or without referral to physiotherapy). |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Patients with non-specific acute LBP defined as (based on Nicol et al. 2020):
- looking for LBP care for the first time in case of first episode, OR for the first time for the current episode in case of recurrent or persistent LBP
- lasting > 24 hours and < 6 weeks
- with an average pain intensity during the past 24 hours of ≥ 3 on an 11-point Numerical Pain Rating Scale
- with an Oswestry Disability Index score (version 2.1a) of at least 20% (Denteneer et al. 2018).
Key exclusion criteria (5 listed)
- Recent lumbar surgery (< 1 year)
- Pregnancy
- History of (any) treatment for the current pain episode
- Red flags suggesting specific LBP (e.g. resulting from infection or neoplasm, cauda equina), based on the Belgian Health Care Knowledge Center (KCE, BEL) who published evidence-based guidelines to manage LBP and radicular pain (Van Wambeke et al. 2017), leads to exclusion from treatment within the study.
- Generalized musculoskeletal pain (based on fibromyalgia criteria) (Galvez-Sánchez and Reyes del Paso 2020).
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 |
|---|---|---|
| Direct access physiotherapy for acute low back painInterventions include physiotherapeutic treatment, without prescription of the general practitioner, for low back pain according to current biopsychosocial national (KCE - Belgium) and international (NICE) guidelines. | Other | Direct physiotherapy pathway |
| Usual care for acute low back painInterventions include standard of care by the general practitioner for low back pain according to current biopsychosocial national (KCE - Belgium) and international (NICE) guidelines. | Other | Usual care pathway |
Primary outcome
Changes in pain intensity
Time frame: Immediately before, during the first 6 weeks and immediately after intervention and at 3 months, 1 and 2 years after enrollment
Numeric Rating Scale
Changes in pain location and extent
Time frame: Immediately before, during the first 6 weeks and immediately after intervention and at 3 months, 1 and 2 years after enrollment
Pain Diagram of Margolis
Changes in disability
Time frame: Immediately before, during the first 6 weeks and immediately after intervention and at 3 months, 1 and 2 years after enrollment
Oswestry Disability Index
5 secondary outcomes
Cost-effectiveness of the provided treatment (direct physiotherapy access vs usual care for acute low back pain)
Time frame: Up to 2 years after enrollment
Changes in beliefs and cognitions related to low back
Time frame: Immediately before, during the first 6 weeks and immediately after intervention and at 3 months, 1 and 2 years after enrollment
Changes in patient satisfaction
Time frame: Immediately before, during the first 6 weeks and immediately after intervention and at 3 months, 1 and 2 years after enrollment
Changes in quality of life
Time frame: Immediately before, during the first 6 weeks and immediately after intervention and at 3 months, 1 and 2 years after enrollment
Amount of / coping with flare-ups during follow-up
Time frame: Immediately before, during the first 6 weeks and immediately after intervention and at 3 months, 1 and 2 years after enrollment
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 17 Sep 2026.
- Individual participant dataSharing planned: Undecided
Related trials for Low Back Pain
Recruiting
Comparing Myofascial Exercise and Trigger Point Therapy for Non-Specific Low Back Pain
Non-specific Low Back Pain
Active, not recruiting
Integrated Feldenkrais Method With and Without DNS for Chronic Low Back Pain in Females
Chronic Low Back Pain (CLBP)
Not yet recruiting
Effects of Spinal Mobilization With and Without Clinical Pilates in Patients With Lumbar Disc Herniationc Herniation
Disc Herniation
Not yet recruitingObservational study
SERENITY Study of Chronic Pain Interference in Adults
Chronic Low Back Pain, Spinal Cord Injury
Recruiting
Ultrasound-guided Percutaneous Electrical Stimulation for Gluteus Muscle Dysfunction After Low Back Pain Episode
Low Back Pain, Functional Motor Disorder
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.
Lotte Janssens, PhD principal investigator
UHasselt
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Direct access physiotherapy for acute low back pain in people with Low Back Pain and Physiotherapy, run by Hasselt University at 1 site in Belgium.
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 8 inclusion and 5 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 17 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. 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?
Changes in pain intensity (time frame: Immediately before, during the first 6 weeks and immediately after intervention and at 3 months, 1 and 2 years after enrollment). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 17 Sep 2026.