Wearable Technological Device Applied to Patients with Chronic Pain

Hacettepe University

Status: Completed

Conditions: Musculoskeletal Pain; Chronic Pain; Neck Pain; Low Back Pain

Treatments: Device: Exopulse Molli-Suit (Wearable Technological Device)

Study type: Interventional

Funder types: Other

Identifiers

NCT06345430

2023-14

Details and patient eligibility

About

Within the scope of this research, a single session of Wearable Technological Device (Exopulse Molli-Suit) will be applied to patients with chronic back and neck pain. The results will be evaluated acutely, after 24 hours, after 1 week and after 1 month.

Full description

After initial evaluations, patients received a single session for 1 hour. Exopulse Mollii Suit will be applied. The stimulation level of the electrodes will be determined by the automatically by the system in accordance with the level of pain they indicate for their parts, individually tailored to the person.

will be created. Patients will wear the Exopulse Mollii Suit, which is suitable for their body size, Hacettepe University Physics They will dress in the room allocated for them at the Faculty of Treatment and Rehabilitation. After each use The hygiene of Exopulse Mollii Suits has been evaluated at Hacettepe University Faculty of Physical Therapy and Rehabilitation in this will be provided with the help of a special device included in the scope. Initial assessments will be made immediately will be repeated three more times: after the intervention, 24 hours after the intervention and 4 weeks after the intervention.

All data will be collected face-to-face from patients using the instruments mentioned above.

Enrollment: 40 patients

Sex: All

Ages: 20 to 65 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Being between the ages of 20-65
• Pain intensity should be at least 5 according to a numeric scale (low back pain and neck pain)
• no pain for at least 6 months (healthy people)

Exclusion criteria

• Malignant condition,
• People with systemic diseases such as neurological, psychological, cardiovascular, rheumatologic diseases and loss of function due to these diseases,
• History of previous surgery on the spine and upper extremities, including the cervical and lumbar region,
• Fractures in the spine and upper extremities, including the cervical and lumbar region, with a history of inflammation,
• Acute infection,
• Attending another rehabilitation program,
• Refused to participate in the study and did not give written informed consent

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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40 participants in 1 patient group

Exopulse Molli Suit Interventipn

Experimental group

Description:

After initial evaluations, patients received a single session for 1 hour. Exopulse Mollii Suit will be applied. The stimulation level of the electrodes will be determined by the automatically by the system in accordance with the level of pain they indicate for their parts, individually tailored to the person. will be created. Patients will wear the Exopulse Mollii Suit, which is suitable for their body size, Hacettepe University Physics They will dress in the room reserved for them at the Faculty of Treatment and Rehabilitation.

Treatment:

Device: Exopulse Molli-Suit (Wearable Technological Device)