Clinical trial NCT06345430: Wearable Technological Device Applied to Patients with Chronic Pain
Official title: Clinical and Functional Effects of Wearable Technological Device Applied to Patients with Chronic Pain
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Neck Pain
Low Back Pain
Chronic Pain
Musculoskeletal Pain
Lead sponsor: Hacettepe University
Sponsor class: OTHER
First posted: 2024-04-03
Enrollment: 40
Sex: ALL
Minimum age (years): 20
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Pain Severity
timeFrame: bBefore the intervention, immediately after the intervention, after 24 hours, after 1 week and up to 1 month after the intervention. 5 times
Secondary outcomes:
measure: Sleep Qaulity
timeFrame: Before the intervention, after 24 hours, after 1 week and up to 1 month after the intervention. 4 times
measure: Disability Level
timeFrame: Before the intervention, after 24 hours, after 1 week and up to 1 month after the intervention. 4 times
measure: Repetitive Reach Test
timeFrame: Before the intervention, after 24 hours, after 1 week and up to 1 month after the intervention. 4 times
measure: Body Composition Analysis
timeFrame: before intervention, 1 times
measure: Lifting object overhead test
timeFrame: Before the intervention, after 24 hours, after 1 week and up to 1 month after the intervention. 4 times
measure: Sustained Overhead Work Test
timeFrame: Before the intervention, after 24 hours, after 1 week and up to 1 month after the intervention. 4 times
measure: back performance test
timeFrame: Before the intervention, after 24 hours, after 1 week and up to 1 month after the intervention. 4 times
Other outcomes:
Locations:
city: Yeni̇mahalle
country: Turkey
facility: Yasemin Özel Aslıyüce
state: Ankara
Study officials:
affiliation: Hacettepe Üniversity
name: Özlem Ö Ülger, Proff
role: STUDY_DIRECTOR
References: