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Clinical Trials/NCT06345430
NCT06345430
Completed
N/A

Clinical and Functional Effects of Wearable Technological Device Applied to Patients with Chronic Pain

Hacettepe University1 site in 1 country40 target enrollmentDecember 18, 2023

Overview

Phase
N/A
Intervention
Not specified
Conditions
Neck Pain
Sponsor
Hacettepe University
Enrollment
40
Locations
1
Primary Endpoint
Pain Severity
Status
Completed
Last Updated
last year

Overview

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.

Registry
clinicaltrials.gov
Start Date
December 18, 2023
End Date
June 30, 2024
Last Updated
last year
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Ozlem Ulger

Professor

Hacettepe University

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

Outcomes

Primary Outcomes

Pain Severity

Time Frame: bBefore the intervention, immediately after the intervention, after 24 hours, after 1 week and up to 1 month after the intervention. 5 times

Numeric Pain Scale will be used. On a 10 cm horizontal straight line (0: no pain, 10: most severe pain), the patient will be asked to mark the relevant place according to the severity of the pain. Using a ruler, the distance between point 0 and the marked place will be measured to determine the intensity of the pain.

Secondary Outcomes

  • back performance test(Before the intervention, after 24 hours, after 1 week and up to 1 month after the intervention. 4 times)
  • Disability Level(Before the intervention, after 24 hours, after 1 week and up to 1 month after the intervention. 4 times)
  • Sustained Overhead Work Test(Before the intervention, after 24 hours, after 1 week and up to 1 month after the intervention. 4 times)
  • Sleep Qaulity(Before the intervention, after 24 hours, after 1 week and up to 1 month after the intervention. 4 times)
  • Body Composition Analysis(before intervention, 1 times)
  • Lifting object overhead test(Before the intervention, after 24 hours, after 1 week and up to 1 month after the intervention. 4 times)
  • Repetitive Reach Test(Before the intervention, after 24 hours, after 1 week and up to 1 month after the intervention. 4 times)

Study Sites (1)

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