Non-specific Low Back PainADAMONCT04882748
Using a Robot to Treat Non-specific Low Back Pain
A study testing ADAMO in people with Non-specific Low Back Pain, run by Fundacion Rioja Salud at 1 site in Spain.
Trial summary
Non-specific low back pain (NSLBP) is a musculoskeletal syndrome whose main characteristic is the pain, which is focalized in the lumbar area of the spine, which cannot be attributed to a known cause (traumatism, systemic diseases, nerve root compression, etc). Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Non-specific Low Back Pain
- What is being tested?
- ADAMO
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 1 siteSpain
- Study dates
- 1 Sep 2020to 25 May 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 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Patients suffering non-specific low back pain
Who cannot join
- Age <18 or >60 years Pregnant women Impossibility to stay in a prone position Serious systemic pathologies Patients with treatments that may interfere with the study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Using a Robot to Treat Non-specific Low Back Pain: a Two-arm, Single-blinded, Randomized Controlled Trial
Non-specific low back pain (NSLBP) is a musculoskeletal syndrome whose main characteristic is the pain, which is focalized in the lumbar area of the spine, which cannot be attributed to a known cause (traumatism, systemic diseases, nerve root compression, etc). The treatment includes massage and rehabilitation techniques. Here the investigators want to test whether a robot (ADAMO) may help in improving current physiotherapy exercises in reducing back pain. NSLBP patients will be randomly assigned to two arms (robot versus control) and they will receive 10 massage sessions. Pain evaluation will be performed with the visual analogue scale (VAS) and the Oswestry disability index (ODI). The ODI will be performed by an independent physician blind to the treatment.
Read the detailed description
Low back pain is defined as a musculoskeletal syndrome, or group of symptoms, whose main characteristic is the pain, which is focalized in the lumbar area of the spine. The diagnosis is rather easy since symptoms are very evident. When this pain cannot be attributed to a known cause (traumatism, systemic diseases, nerve root compression, etc), it is called non-specific low back pain (NSLBP), which may represent 90-95% of all cases of back pain.
The treatment for this pathology has been collected in several clinical practice guidelines, with little differences among them. All of them recommend: i) maintaining physical activity as far as the pain allows; ii) pharmacological treatment (analgesics, non-steroidal anti-inflammatories, muscle relaxants); and iii) non-pharmacological measures (local heat, cognitive-behavior therapy, spinal manipulation, rehabilitation programs). Rehabilitation therapy, including different exercises, such as extensions, back workshops, and aquatic exercises, among others, provides excellent results in managing chronic back pain. In addition, physiotherapeutic massage constitutes the most common practice to treat back pain and is very effective in the short term, although it may not address the underlying causes.
The main problem in reporting and measuring physiotherapeutic massage practices is that the massage is applied by different therapists, with different strength and intensity, which may vary from session to session. The use of massaging robotic devices should solve all these problems and several prototypes are already available.
In this study, the efficiency of the new ADAMO robot system (https://adamorobot.com/) will be tested. ADAMO bases its operation on a computer program that controls the manipulator robot, which, and by means of cameras installed at its end, must find in each session the points of treatment in the patient previously defined by the health professional and apply the air at the necessary pressure. This pressure is generated by means of a compressed air nozzle integrated in a handpiece installed at the end of the robot.
Forty-four patients suffering from NSLBP will be recruited after signing the informed consent and randomly assigned to one of two experimental arms: robot or control for 10 sessions. Pain evaluation will be performed with the Oswestry disability index (ODI), which will be applied before starting and at the end of the treatment, and the visual analogue scale (VAS) which will be applied after each session. The ODI will be performed by an independent physician blind to the treatment. Statistical analysis will be performed to compare both treatments.
- Conditions
- Non-specific Low Back Pain
- Being tested
- ADAMO
- Keywords
- back pain, massage, robot
- Medical subject headings
- Back Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ADAMOOther
Physical therapy provided with or without the help of a robot
| Study group | Role | What they receive |
|---|---|---|
| Control | Active comparator | In the control arm, patients were laid down on the robot platform. Physiotherapists identified the trigger points and the robot was connected, providing the expected noise and vibration, but the air pressure was not applied. Thermotherapy and rehabilitation exercises were provided, as is the standard treatment for NSLBP at the Rehabilitation Service. Receives: Other: ADAMO |
| Robot massage | Experimental | In the robot arm, a physiotherapist with more than 15 years of experience identified the trigger points in the patient, programmed the robot, and applied robot-controlled air pressure massage for 10 minutes. The ADAMO robot applies an air current to the trigger points on the back of the patient, guided by cameras and computer programs (https://adamorobot.com/). Thermotherapy and rehabilitation exercises were also applied. Receives: Other: ADAMO |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient disability as tested by the Oswestry disability index (ODI).
The ODI will be recorded before starting and at the end of the treatment. The Oswestry disability index (ODI) is a questionnaire which gives a subjective percentage score of level of function (disability) in activities of daily living in those rehabilitating from low back pain. Possible scores go from 0 to 50, being 0 no pain and 50 the highest possible pain.
Measured: Through study completion. An average of 6 months.
Perceived pain as tested by the visual analogue scale (VAS).
The VAS will be recorded after every session. The visual analogue scale (VAS) is a unidimensional measure of pain intensity. The patient is presented with a horizontal line of face pictograms. The patient marks on the line the point that they feel represents their perception of their current state, which may rank from 0 (best, no pain) to 10 (worst pain).
Measured: Through study completion. An average of 6 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2021
- Study start1 Sep 2020
- Primary completion20 May 2021
- Study completion25 May 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Non-specific 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
- Model description
- Forty-four patients suffering from NSLBP will be recruited after signing the informed consent and randomly assigned to one of two experimental arms: physical therapy with or without the help of a robot for 10 sessions. Pain evaluation will be performed with the Oswestry disability index (ODI), which will be applied before starting and at the end of the treatment, and the visual analogue scale (VAS) which will be applied after each session. The ODI will be performed by an independent physician blind to the treatment. Statistical analysis will be performed to compare both treatments.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fundacion Rioja Salud
- Sponsor type
- University, hospital or other
- Collaborators
- Hospital San Pedro de Logroño
- Responsible party
- Sponsor
- Investigators
- Eduardo Mirpuri, PhD, Study director, CIBIR
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04882748
- Sponsor's protocol ID
- FRS-ADAMO-01
- Acronym
- ADAMO
- Status last verified
- Oct 2021
- First submitted
- 29 Apr 2021
- Last updated
- 25 Oct 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All results from the study will be published in a specialized journal, including the study protocol, statistical Analysis, informed consent form, and a table with all raw data.
Publications
Marin-Mendez H, Marin-Novoa P, Jimenez-Marin S, Isidoro-Garijo I, Ramos-Martinez M, Bobadilla M, Mirpuri E, Martinez A. Using a Robot to Treat Non-specific Low Back Pain: Results From a Two-Arm, Single-Blinded, Randomized Controlled Trial. Front Neurorobot. 2021 Sep 14;15:715632. doi: 10.3389/fnbot.2021.715632. eCollection 2021.
PubMed 34594197
Study at a glance
From the registry record, last updated by the sponsor on 25 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Using a Robot to Treat Non-specific Low Back Pain: a Two-arm, Single-blinded, Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04882748
- Acronym / sponsor ID
- ADAMO / FRS-ADAMO-01
- Conditions
- Non-specific Low Back Pain
- Keywords
- back pain, massage, robot
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- Fundacion Rioja SaludUniversity, hospital or other
- Collaborators
- Hospital San Pedro de Logroño
- Study start
- 1 Sep 2020 (actual)
- Primary completion
- 20 May 2021 (actual)
- Study completion
- 25 May 2021 (actual)
- First posted
- 12 May 2021 (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.
Non-specific low back pain (NSLBP) is a musculoskeletal syndrome whose main characteristic is the pain, which is focalized in the lumbar area of the spine, which cannot be attributed to a known cause (traumatism, systemic diseases, nerve root compression, etc). The treatment includes massage and rehabilitation techniques. Here the investigators want to test whether a robot (ADAMO) may help in improving current physiotherapy exercises in reducing back pain. NSLBP patients will be randomly assigned to two arms (robot versus control) and they will receive 10 massage sessions. Pain evaluation will be performed with the visual analogue scale (VAS) and the Oswestry disability index (ODI). The ODI will be performed by an independent physician blind to the treatment.
Detailed description
Low back pain is defined as a musculoskeletal syndrome, or group of symptoms, whose main characteristic is the pain, which is focalized in the lumbar area of the spine. The diagnosis is rather easy since symptoms are very evident. When this pain cannot be attributed to a known cause (traumatism, systemic diseases, nerve root compression, etc), it is called non-specific low back pain (NSLBP), which may represent 90-95% of all cases of back pain.
The treatment for this pathology has been collected in several clinical practice guidelines, with little differences among them. All of them recommend: i) maintaining physical activity as far as the pain allows; ii) pharmacological treatment (analgesics, non-steroidal anti-inflammatories, muscle relaxants); and iii) non-pharmacological measures (local heat, cognitive-behavior therapy, spinal manipulation, rehabilitation programs). Rehabilitation therapy, including different exercises, such as extensions, back workshops, and aquatic exercises, among others, provides excellent results in managing chronic back pain. In addition, physiotherapeutic massage constitutes the most common practice to treat back pain and is very effective in the short term, although it may not address the underlying causes.
The main problem in reporting and measuring physiotherapeutic massage practices is that the massage is applied by different therapists, with different strength and intensity, which may vary from session to session. The use of massaging robotic devices should solve all these problems and several prototypes are already available.
In this study, the efficiency of the new ADAMO robot system (https://adamorobot.com/) will be tested. ADAMO bases its operation on a computer program that controls the manipulator robot, which, and by means of cameras installed at its end, must find in each session the points of treatment in the patient previously defined by the health professional and apply the air at the necessary pressure. This pressure is generated by means of a compressed air nozzle integrated in a handpiece installed at the end of the robot.
Forty-four patients suffering from NSLBP will be recruited after signing the informed consent and randomly assigned to one of two experimental arms: robot or control for 10 sessions. Pain evaluation will be performed with the Oswestry disability index (ODI), which will be applied before starting and at the end of the treatment, and the visual analogue scale (VAS) which will be applied after each session. The ODI will be performed by an independent physician blind to the treatment. Statistical analysis will be performed to compare both treatments.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Forty-four patients suffering from NSLBP will be recruited after signing the informed consent and randomly assigned to one of two experimental arms: physical therapy with or without the help of a robot for 10 sessions. Pain evaluation will be performed with the Oswestry disability index (ODI), which will be applied before starting and at the end of the treatment, and the visual analogue scale (VAS) which will be applied after each session. The ODI will be performed by an independent physician blind to the treatment. Statistical analysis will be performed to compare both treatments.
| Arm | Type | Receives |
|---|---|---|
| Control | Active comparator | Other: ADAMOIn the control arm, patients were laid down on the robot platform. Physiotherapists identified the trigger points and the robot was connected, providing the expected noise and vibration, but the air pressure was not applied. Thermotherapy and rehabilitation exercises were provided, as is the standard treatment for NSLBP at the Rehabilitation Service. |
| Robot massage | Experimental | Other: ADAMOIn the robot arm, a physiotherapist with more than 15 years of experience identified the trigger points in the patient, programmed the robot, and applied robot-controlled air pressure massage for 10 minutes. The ADAMO robot applies an air current to the trigger points on the back of the patient, guided by cameras and computer programs (https://adamorobot.com/). Thermotherapy and rehabilitation exercises were also applied. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Patients suffering non-specific low back pain
Key exclusion criteria (1 listed)
- Age <18 or >60 years Pregnant women Impossibility to stay in a prone position Serious systemic pathologies Patients with treatments that may interfere with the study
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 |
|---|---|---|
| ADAMOPhysical therapy provided with or without the help of a robot | Other | Control, Robot massage |
Primary outcome
Patient disability as tested by the Oswestry disability index (ODI).
Time frame: Through study completion. An average of 6 months.
The ODI will be recorded before starting and at the end of the treatment. The Oswestry disability index (ODI) is a questionnaire which gives a subjective percentage score of level of function (disability) in activities of daily living in those rehabilitating from low back pain. Possible scores go from 0 to 50, being 0 no pain and 50 the highest possible pain.
Perceived pain as tested by the visual analogue scale (VAS).
Time frame: Through study completion. An average of 6 months.
The VAS will be recorded after every session. The visual analogue scale (VAS) is a unidimensional measure of pain intensity. The patient is presented with a horizontal line of face pictograms. The patient marks on the line the point that they feel represents their perception of their current state, which may rank from 0 (best, no pain) to 10 (worst pain).
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 25 Oct 2021.
- Results publication: PubMed 34594197Marin-Mendez H, Marin-Novoa P, Jimenez-Marin S, Isidoro-Garijo I, Ramos-Martinez M, Bobadilla M, Mirpuri E, Martinez A. Using a Robot to Treat Non-specific Low Back Pain: Results From a Two-Arm, Single-Blinded, Randomized Controlled Trial. Front Neurorobot. 2021 Sep 14;15:715632. doi: 10.3389/fnbot.2021.715632. eCollection 2021.
- Robot descriptionLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. All results from the study will be published in a specialized journal, including the study protocol, statistical Analysis, informed consent form, and a table with all raw data.
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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.
Eduardo Mirpuri, PhD study director
CIBIR
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ADAMO in people with Non-specific Low Back Pain, run by Fundacion Rioja Salud at 1 site in Spain.
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 1 inclusion and 1 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 25 Oct 2021. 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 Spain. 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?
Patient disability as tested by the Oswestry disability index (ODI). (time frame: Through study completion. An average of 6 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?
On the ClinicalTrials.gov record for NCT04882748, which also lists 1 linked publication.
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 25 Oct 2021.