Grand Hôpital de Charleroi
Charleroi, Hainaut, 6060, Belgium
Location status: Recruiting
NCT Number: NCT06718348
The study will include patients suffering from nonspecific mechanical low back pain for more than 6 weeks. Two groups will be compared. A Control group and an Experimental group with the exoskeleton JAPET.W
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Request Info18 year and older
All sexes
Interventional
Not applicable
Charleroi, Hainaut, 6060, Belgium
Location status: Recruiting
The study will include patients suffering from nonspecific mechanical low back pain for more than 6 weeks. The study will consist of two groups: a control group (Group CTRL) and an experimental group (Group EXP). Participants will be categorized into two categories: "workers," patients on temporary work leave due to low back pain, and "non-workers," patients unable to work due to this condition after exhausting all available therapeutic solutions.
Monitoring period (30 physiotherapy sessions): evaluations will be conducted at sessions 1, 15 and 30, on the two groups. Evaluation session 3 months after the end of the physiotherapy sessions.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Phsysiotherapy sessions with the support of the Exoskeleton JAPET.W
Time frame: Up to six months
VAS scale for pain (o -no pain to 10 - pain as bad as it could possibly be) : rate of the patients who had at least -20 points/100 on the VAS for pain
Time frame: Up to six months
Assessment of analgesic use in the two groups at the first and last session
Time frame: Up to six months
Mobility assessment with the french version of Oswestry Disablility Index. The scale goes from 0 - no pain to 5 - worse.
Time frame: Up to six months
Comparison of the difference in TAMPA scale. This scale goes to 1-strongly disagree to 4-strongly agree with the proposal
Time frame: Up to six months
Assessment in quality of life with EQ-5D-5L. The scale goes to 1-totally able to carry out the activity up to 5-totally unable to do so.
Time frame: Up to six months
Assessment of the Anxiety level with Hospital Anxiety Depression Scale. This scale ranges from 0-no anxiety to 3-totally anxious.
Time frame: Up to six months
Rate of patients who had at least one device related adverse event during the clinical investigation.
Contact information is provided by the study sponsor or research team.
Grand Hôpital de Charleroi
Other
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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