Low Back PainNCT04277039
Effects of Osteopathic Treatment With Cognitive Training on Low Back Pain
A study testing osteopathic treatment + cognitive training and osteopathic treatment in people with Low Back Pain, run by Come Collaboration at 3 sites in Italy.
Trial summary
The objective of this study is to verify whether the combined approach (osteopathic manipulative treatment -OMT- and cognitive training -CT) is more effective in the long term than the individual approaches (OMT or CT) in patients with chronic lumbar pain, evaluating the Numeric Rating Scale (NRS) and the… Read more about this study
- Who is it for?
- Ages 30 to 65 years
- Conditions the study is for
- Low Back Pain
- What is being tested?
- osteopathic treatment + cognitive training and osteopathic treatment
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 216 participants
- Where
- 3 sitesItaly
- Study dates
- 1 Mar 2020to 30 Jun 2021
- 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 30 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- aged between 30 and 65 y
- diagnosis of aspecific chronic low back pain
- minimum of 3 on the NRS score
Who cannot join
- Neuropathic pain or chronic widespread pain
- Low back spinal surgery in the last three years
- Low back spinal surgery to osteoporosis and/or traumatic fractures
- Rheumatic disease
- Pregnancy or having a baby in the last 12 months
- Painful disease in evidence through RX, MRI or CT in the last 6 months (listesis, moderate arthrosis, severe, algodystrophy etc.).
- The subjects have not to be treated with physical or manual therapies or psychotherapy in the last 6 months
Trial locations and contacts
3 sites in 1 country.
Italy3 sites
Orthoplus
Bolzano, Trentino-Alto Adige, 39100
Andrea Ghedina, 0471976433, ghedinaosteopatia@gmail.com
Niguarda hospital
Milan, Lombardy, 20161
Stefano Uberti, 3492624521, stefano.uberti@isoi.it
Santa Lucia Foundation
Rome, Lazio, 00179
Marco Tramontano, 0651501420, m.tramontano@hsantalucia.it
About this study
Official title: Effects of Osteopathic Treatment in Combination With Cognitive Training on Low Back Pain Patients: a Randomised Sham-controlled Trial
The objective of this study is to verify whether the combined approach (osteopathic manipulative treatment -OMT- and cognitive training -CT) is more effective in the long term than the individual approaches (OMT or CT) in patients with chronic lumbar pain, evaluating the Numeric Rating Scale (NRS) and the Rolland-Morris Disability Questionnaire (RMDQ) questionnaire
- Conditions
- Low Back Pain
- Being tested
- osteopathic treatment + cognitive training, osteopathic treatment, usual care
- Keywords
- osteopathic manipulative treatment, cognitive therapy, chronic low back pain, pain, disability
- Medical subject headings
- Low Back Pain, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
osteopathic treatment + cognitive trainingOther
This intervention is a combination of manipulative osteopathic treatment and cognitive training to be administered each week for a 12-week study period
osteopathic treatmentOther
manual treatment using osteopathic procedure. 8 sessions for a 12 week study period
usual careOther
administration of non-steroid inflammatory drug according to international guidelines
| Study group | Role | What they receive |
|---|---|---|
| OMT+CT | Experimental | It consists of 8 sessions of osteopathic treatment and two 20-min sessions of cognitive training per week per 2 months Receives: Other: osteopathic treatment + cognitive training |
| osteopathic treatment | Active comparator | It consists of 8 sessions of osteopathic treatment throughout the 2-month study period Receives: Other: osteopathic treatment |
| usual care | Other | patients will continue the routine care as established by international guidelines Receives: Other: usual care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in NRS at 3 months
Change from Baseline Numeric Rating Scale (NRS) of Pain at 3 months. NRS values range from 0-10, where 10 means highest pain and 0 no pain
Measured: 3 months
Change in RMDQ at 3 months
Change from Baseline Rolland Morris Disability Questionnaire (RMDQ) at 3 months. Each question is worth one point so scores can range from 0 (no disability) to 24 (severe disability)
Measured: 3 months
Secondary outcomes (12)
Changes in CSI
Baseline changes in Central Sensitization index (CSI). CSI values ranges from 0 to 100. A score of more than 40 indicates the presence of central sensitisation.
Measured: 1 month - 3 month - 6 month
Changes in Oswestry
Baseline changes in Oswestry Low Back Pain Disability Questionnaire. The questionnaire range is from 0 to 100. Zero is equated with no disability and 100 is the maximum disability possible
Measured: 1 month - 3 month - 6 month
BPQ
Baseline Changes in Body Perception Questionnaire
Measured: 1 month - 3 month - 6 month
Changes in DASS-21
Baseline changes in Depression Anxiety Stress Scales-21. The scale ranges from 0 to 36, where 36 indicates severe depression, anxiety and stress
Measured: 1 month - 3 month - 6 month
Changes in SF-36
Baseline changes in the Short Form-36. The questionnaire is a health survey ranging from 0 to 100. The lower the score the more disability.
Measured: 1 month - 3 month - 6 month
Rate of AER
Number of participants with Adverse Events Reporting (AER) calculated by the rates
Measured: 1 month - 3 month - 6 month
Changes in SCWT
Baseline changes in Stroop Color and Word Test. Word, color, and color-word T-Scores of 40 or less are considered "low." Word, color, and color-word T-Scores above 40 or are considered "normal."
Measured: 1 month - 3 month - 6 month
TMT
Trail Making Test
Measured: 1 month - 3 month - 6 month
Change in NRS at 1 month
Change from Baseline Numeric Rating Scale (NRS) of Pain at 1 month. NRS values range from 0-10, where 10 means highest pain and 0 no pain
Measured: 1 month
Change in NRS at 6 months
Change from Baseline Numeric Rating Scale (NRS) of Pain at 6 months. NRS values range from 0-10, where 10 means highest pain and 0 no pain
Measured: 6 months
Change in RMDQ at 1 month
Change from Baseline Rolland Morris Disability Questionnaire (RMDQ) at 1 month. Each question is worth one point so scores can range from 0 (no disability) to 24 (severe disability)
Measured: 1 month
Change in RMDQ at 6 months
Change from Baseline Rolland Morris Disability Questionnaire (RMDQ) at 6 months. Each question is worth one point so scores can range from 0 (no disability) to 24 (severe disability)
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2020
- Study start1 Mar 2020 (estimated)
- Primary completion30 Mar 2021 (estimated)
- Study completion30 Jun 2021 (estimated)
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
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 216 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Come Collaboration
- Sponsor type
- University, hospital or other
- Collaborators
- Hospital General Universitario Santa Lucia, Niguarda Hospital, Orthoplus
- Responsible party
- Sponsor
- Investigators
- Francesco Cerritelli, PhD, Study chair, Come Collaboration
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04277039
- Sponsor's protocol ID
- COME-01-20
- Status last verified
- Feb 2020
- First submitted
- 14 Feb 2020
- Last updated
- 20 Feb 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: available upon request
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Osteopathic Treatment in Combination With Cognitive Training on Low Back Pain Patients: a Randomised Sham-controlled Trial
- ClinicalTrials.gov ID
- NCT04277039
- Acronym / sponsor ID
- COME-01-20
- Conditions
- Low Back Pain
- Keywords
- osteopathic manipulative treatment, cognitive therapy, chronic low back pain, pain, disability
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 216 participants (estimated)
- Lead sponsor
- Come CollaborationUniversity, hospital or other
- Collaborators
- Hospital General Universitario Santa Lucia, Niguarda Hospital, Orthoplus
- Study start
- 1 Mar 2020 (estimated)
- Primary completion
- 30 Mar 2021 (estimated)
- Study completion
- 30 Jun 2021 (estimated)
- First posted
- 20 Feb 2020 (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.
The objective of this study is to verify whether the combined approach (osteopathic manipulative treatment -OMT- and cognitive training -CT) is more effective in the long term than the individual approaches (OMT or CT) in patients with chronic lumbar pain, evaluating the Numeric Rating Scale (NRS) and the Rolland-Morris Disability Questionnaire (RMDQ) questionnaire
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| OMT+CT | Experimental | Other: osteopathic treatment + cognitive trainingIt consists of 8 sessions of osteopathic treatment and two 20-min sessions of cognitive training per week per 2 months |
| osteopathic treatment | Active comparator | Other: osteopathic treatmentIt consists of 8 sessions of osteopathic treatment throughout the 2-month study period |
| usual care | Other | Other: usual carepatients will continue the routine care as established by international guidelines |
Who may qualify
- Ages
- 30 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- aged between 30 and 65 y
- diagnosis of aspecific chronic low back pain
- minimum of 3 on the NRS score
Key exclusion criteria (7 listed)
- Neuropathic pain or chronic widespread pain
- Low back spinal surgery in the last three years
- Low back spinal surgery to osteoporosis and/or traumatic fractures
- Rheumatic disease
- Pregnancy or having a baby in the last 12 months
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 |
|---|---|---|
| osteopathic treatment + cognitive trainingThis intervention is a combination of manipulative osteopathic treatment and cognitive training to be administered each week for a 12-week study period | Other | OMT+CT |
| osteopathic treatmentmanual treatment using osteopathic procedure. 8 sessions for a 12 week study period | Other | osteopathic treatment |
| usual careadministration of non-steroid inflammatory drug according to international guidelines | Other | usual care |
Primary outcome
Change in NRS at 3 months
Time frame: 3 months
Change from Baseline Numeric Rating Scale (NRS) of Pain at 3 months. NRS values range from 0-10, where 10 means highest pain and 0 no pain
Change in RMDQ at 3 months
Time frame: 3 months
Change from Baseline Rolland Morris Disability Questionnaire (RMDQ) at 3 months. Each question is worth one point so scores can range from 0 (no disability) to 24 (severe disability)
12 secondary outcomes
Changes in CSI
Time frame: 1 month - 3 month - 6 month
Changes in Oswestry
Time frame: 1 month - 3 month - 6 month
BPQ
Time frame: 1 month - 3 month - 6 month
Changes in DASS-21
Time frame: 1 month - 3 month - 6 month
Changes in SF-36
Time frame: 1 month - 3 month - 6 month
Rate of AER
Time frame: 1 month - 3 month - 6 month
Changes in SCWT
Time frame: 1 month - 3 month - 6 month
TMT
Time frame: 1 month - 3 month - 6 month
Change in NRS at 1 month
Time frame: 1 month
Change in NRS at 6 months
Time frame: 6 months
Change in RMDQ at 1 month
Time frame: 1 month
Change in RMDQ at 6 months
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Feb 2020.
- Individual participant dataSharing planned: No. available upon request
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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.
Francesco Cerritelli, PhD study chair
Come Collaboration
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing osteopathic treatment + cognitive training and osteopathic treatment in people with Low Back Pain, run by Come Collaboration at 3 sites 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 3 inclusion and 7 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: status not confirmed, as of the sponsor's last update on 20 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Francesco Cerritelli, PhD (+393394332801, francesco.cerritelli@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in NRS at 3 months (time frame: 3 months). 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 20 Feb 2020.