Clinical trial NCT04882748: Using a Robot to Treat Non-specific Low Back Pain
Official title: Using a Robot to Treat Non-specific Low Back Pain: a Two-arm, Single-blinded, Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Non-specific Low Back Pain
Keywords: back pain
massage
robot
Lead sponsor: Fundacion Rioja Salud
Sponsor class: OTHER
Collaborators: name: Hospital San Pedro de Logroño
First posted: 2021-05-12
Enrollment: 44
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Patient disability as tested by the Oswestry disability index (ODI).
timeFrame: Through study completion. An average of 6 months.
measure: Perceived pain as tested by the visual analogue scale (VAS).
timeFrame: Through study completion. An average of 6 months.
Secondary outcomes:
Other outcomes:
Locations:
city: Logroño
country: Spain
facility: CIBIR
state: La Rioja
Study officials:
affiliation: CIBIR
name: Eduardo Mirpuri, PhD
role: STUDY_DIRECTOR
References:
citation: 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.