Low Back Pain, RecurrentPhase 2NCT06306742
Open-label Placebo in Manual Therapy
A Phase 2 study testing Osteopathic manipulative treatment in people with Low Back Pain, Recurrent, run by Studio Osteopatico Busto Arsizio at 1 site in Italy.
Trial summary
to investigate the effects of placebo in patients affected by low-back pain. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Low Back Pain, Recurrent
- What is being tested?
- Osteopathic manipulative treatment
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 31 participants
- Where
- 1 siteItaly
- Study dates
- 26 Feb 2024to 18 Jun 2025
- Phase
- Phase 2
- 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
- Adult patients (+18 years) who complain of chronic non-specific low back pain for at least 3 months with or without pain exacerbations at the time of recruitment, will be included.
- -Patients will need to have a diagnosis of low back pain made by a physician
Who cannot join
- pathologies such as ankylosing spondylitis, infections, fractures, tumors or metastases.
- Pregnant women
- patients with previous spinal surgery or undergoing cortisone therapy in the 6 months prior to the trial
- diseases that may affect the interpretation of results such as fibromyalgia
- patients currently being treated by other specialists or other manual therapists
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Open-label Placebo in Manual Therapies: a Pilot Study.
to investigate the effects of placebo in patients affected by low-back pain.
- Conditions
- Low Back Pain, Recurrent
- Being tested
- Open-label placebo, Osteopathic manipulative treatment
- Keywords
- Placebo, Placebo effect, Open-label trial
- 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.
Open-label placeboOther
Light pressure manual therapy
Osteopathic manipulative treatmentOther
Manual therapy
| Study group | Role | What they receive |
|---|---|---|
| OMT | Active comparator | Participants will receive manual treatments. The treatment will include soft-tissue, joint mobilization techniques of the lumbar and sacral region. The treatment will also include the approach of the abdomen and lower limb with the same type of techniques.
Four treatments will be provided at 1, 2, 4 and 8 weeks. Receives: Other: Osteopathic manipulative treatment |
| Open-label placebo | Experimental | This group will receive an open-label placebo. The manual treatment will be performed in the same areas of the active comparator but using a very light pressure. Additionally, before the start of the treatment, Four treatments will be provided at 1, 2, 4 and 8 weeks. Receives: Other: Open-label placebo |
| Waiting list | No intervention | Participants will receive no treatment. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Numeric Rating Scale
a verbal determination of a pain level on a scale from 0 to 10, in which 0 represents no pain and 10 represents excruciating pain.
Measured: Change from baseline of numeric rating scale at week 2, 4 and 8.
Adverse effects
Number and types of adverse effects occurred after intervention
Measured: through study completion (8 weeks)
Secondary outcomes (3)
Change in measures of Von Frey filaments
Changes in pressure measures
Measured: from baseline at week 2,4 and 8.
Changes in algometer measurements
Changes in pressure with algometer
Measured: from baseline at week 2, 4 and 8
Use of analgesics
Usage (Yes/no), number and type of analgesics used
Measured: The week before the scheduled visit.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2024
- Study start26 Feb 2024
- Primary completion18 Jun 2025
- Study completion18 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Low Back Pain, RecurrentStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- Studio Osteopatico Busto Arsizio
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Carolina Lavazza, Studio Osteopatico Busto Arsizio
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06306742
- Sponsor's protocol ID
- ct9874
- Status last verified
- Mar 2024
- First submitted
- 29 Feb 2024
- Last updated
- 11 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Open-label Placebo in Manual Therapies: a Pilot Study.
- ClinicalTrials.gov ID
- NCT06306742
- Acronym / sponsor ID
- ct9874
- Conditions
- Low Back Pain, Recurrent
- Keywords
- Placebo, Placebo effect, Open-label trial
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- Studio Osteopatico Busto ArsizioUniversity, hospital or other
- Study start
- 26 Feb 2024 (actual)
- Primary completion
- 18 Jun 2025 (actual)
- Study completion
- 18 Jun 2025 (actual)
- First posted
- 12 Mar 2024 (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.
to investigate the effects of placebo in patients affected by low-back pain.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| OMT | Active comparator | Other: Osteopathic manipulative treatmentParticipants will receive manual treatments. The treatment will include soft-tissue, joint mobilization techniques of the lumbar and sacral region. The treatment will also include the approach of the abdomen and lower limb with the same type of techniques. Four treatments will be provided at 1, 2, 4 and 8 weeks. |
| Open-label placebo | Experimental | Other: Open-label placeboThis group will receive an open-label placebo. The manual treatment will be performed in the same areas of the active comparator but using a very light pressure. Additionally, before the start of the treatment, Four treatments will be provided at 1, 2, 4 and 8 weeks. |
| Waiting list | No intervention | –Participants will receive no treatment. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Adult patients (+18 years) who complain of chronic non-specific low back pain for at least 3 months with or without pain exacerbations at the time of recruitment, will be included.
- -Patients will need to have a diagnosis of low back pain made by a physician
Key exclusion criteria (5 listed)
- pathologies such as ankylosing spondylitis, infections, fractures, tumors or metastases.
- Pregnant women
- patients with previous spinal surgery or undergoing cortisone therapy in the 6 months prior to the trial
- diseases that may affect the interpretation of results such as fibromyalgia
- patients currently being treated by other specialists or other manual therapists
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 |
|---|---|---|
| Open-label placeboLight pressure manual therapy | Other | Open-label placebo |
| Osteopathic manipulative treatmentManual therapy | Other | OMT |
Primary outcome
Change in Numeric Rating Scale
Time frame: Change from baseline of numeric rating scale at week 2, 4 and 8.
a verbal determination of a pain level on a scale from 0 to 10, in which 0 represents no pain and 10 represents excruciating pain.
Adverse effects
Time frame: through study completion (8 weeks)
Number and types of adverse effects occurred after intervention
3 secondary outcomes
Change in measures of Von Frey filaments
Time frame: from baseline at week 2,4 and 8.
Changes in algometer measurements
Time frame: from baseline at week 2, 4 and 8
Use of analgesics
Time frame: The week before the scheduled visit.
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 11 Aug 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Osteopathic manipulative treatment in people with Low Back Pain, Recurrent, run by Studio Osteopatico Busto Arsizio at 1 site in Italy.
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 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 11 Aug 2025. 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 Italy. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Change in Numeric Rating Scale (time frame: Change from baseline of numeric rating scale at week 2, 4 and 8.). 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?
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 11 Aug 2025.