An interventional study of ADAMO in Non-specific Low Back Pain, sponsored by Fundacion Rioja Salud. Completed at 1 site in Spain. Open to participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2021-10-25.
Sponsored by Fundacion Rioja Salud · Not applicable, Interventional, and Treatment
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.
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.
2,373 studies on the registry are indexed under Back Pain; 284 are open to participants now.
This study's enrollment of 44 is below the median of 60 across 1,941 interventional studies indexed under Back Pain.
Browse Back Pain studies →Fundacion Rioja Salud is the lead sponsor of 2 studies on the registry; none are open to participants now.
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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
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
Physical therapy provided with or without the help of a robot
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.
Time frame: 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).
Time frame: Through study completion. An average of 6 months.
Plan to share: 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.
Supporting information: Study protocol, Sap, Icf
This study is completed, as verified in Oct 2021. You cannot join it, but the record below documents what was studied.
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Fundacion Rioja Salud