Using a Robot to Treat Non-specific Low Back Pain

NCT04882748 | Completed

• 1 other identifier: FRS-ADAMO-01
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

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.

Conditions

Non-specific Low Back Pain

Keywords

back pain; massage; robot

Outcome Measures

Primary Outcomes (2)

• 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.

  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).

  Through study completion. An average of 6 months.

Study Arms (2)

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.

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.

Other: ADAMO

Interventions

ADAMO OTHER

Physical therapy provided with or without the help of a robot

Control; Robot massage

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Patients suffering non-specific low back pain

You may not qualify if:

• 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

Sponsors & Collaborators

• Fundacion Rioja Salud: lead
• Hospital San Pedro de Logroño: collaborator

Study Sites (1)

CIBIR

Logroño, La Rioja, 26006, Spain

Location

Related Publications (1)

• 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.

  PMID: 34594197 RESULT

Related Links

• Robot description

MeSH Terms

Conditions

Back Pain

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Eduardo Mirpuri, PhD

  CIBIR

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The Oswestry disability index (ODI) will be performed by an independent physician blind to the treatment.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: April 29, 2021
• First Posted: May 12, 2021
• Study Start: September 1, 2020
• Primary Completion: May 20, 2021
• Study Completion: May 25, 2021
• Last Updated: October 25, 2021

Record last verified: 2021-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: The data will be published together with the actual publication.
• Access Criteria: Everyone will be able to access all data.

Locations

ES (1)