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Using a Robot to Treat Non-specific Low Back Pain

NCT ID: NCT04882748

Last Updated: 2021-10-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

44 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-09-01

Study Completion Date

2021-05-25

Brief Summary

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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

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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

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Non-specific Low Back Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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 Study Purpose

TREATMENT

Blinding Strategy

SINGLE

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

Study Groups

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Control

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.

Group Type ACTIVE_COMPARATOR

ADAMO

Intervention Type OTHER

Physical therapy provided with or without the help of a robot

Robot massage

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.

Group Type EXPERIMENTAL

ADAMO

Intervention Type OTHER

Physical therapy provided with or without the help of a robot

Interventions

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ADAMO

Physical therapy provided with or without the help of a robot

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hospital San Pedro de Logroño

OTHER

Sponsor Role collaborator

Fundacion Rioja Salud

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Eduardo Mirpuri, PhD

Role: STUDY_DIRECTOR

CIBIR

Locations

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CIBIR

Logroño, La Rioja, Spain

Site Status

Countries

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Spain

References

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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.

Reference Type RESULT
PMID: 34594197 (View on PubMed)

Study Documents

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Document Type: Individual Participant Data Set

View Document

Related Links

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https://adamorobot.com/

Robot description

Other Identifiers

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FRS-ADAMO-01

Identifier Type: -

Identifier Source: org_study_id