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Using a Robot to Treat Non-specific Low Back Pain

Using a Robot to Treat Non-specific Low Back Pain: a Two-arm, Single-blinded, Randomized Controlled Trial

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04882748
Acronym
ADAMO
Enrollment
44
Registered
2021-05-12
Start date
2020-09-01
Completion date
2021-05-25
Last updated
2021-10-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Non-specific Low Back Pain

Keywords

back pain, massage, robot

Brief 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). 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.

Interventions

OTHERADAMO

Physical therapy provided with or without the help of a robot

Sponsors

Hospital San Pedro de Logroño
CollaboratorOTHER
Fundacion Rioja Salud
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Masking description

The Oswestry disability index (ODI) will be performed by an independent physician blind to the treatment.

Intervention 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.

Eligibility

Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No

Inclusion criteria

* Patients suffering non-specific low back pain

Exclusion criteria

* 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

Design outcomes

Primary

MeasureTime frameDescription
Patient disability as tested by the Oswestry disability index (ODI).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).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).

Countries

Spain

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 14, 2026