Wearable Technological Device Applied to Patients with Chronic Pain

NCT06345430 | Completed

• 1 other identifier: 2023-14
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Neck Pain; Low Back Pain; Chronic Pain; Musculoskeletal Pain

Outcome Measures

Primary Outcomes (1)

• Pain Severity

  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.

  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 (7)

• Sleep Qaulity

  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

• Repetitive Reach Test

  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

Study Arms (1)

Exopulse Molli Suit Interventipn

EXPERIMENTAL

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.

Device: Exopulse Molli-Suit (Wearable Technological Device)

Interventions

Exopulse Molli-Suit (Wearable Technological Device) DEVICE

After initial evaluations, patients will receive Exopulse Mollii Suit in a single session for 1 hour. The stimulation level of the electrodes will be automatically generated by the system in accordance with the pain level specified by the patients for their body parts before the application.

Exopulse Molli Suit Interventipn

Eligibility Criteria

• Age: 20 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Hacettepe University: lead

Study Sites (1)

Yasemin Özel Aslıyüce

Yenimahalle, Ankara, 06100, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Neck Pain; Low Back Pain; Chronic Pain; Musculoskeletal Pain

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Back Pain; Muscular Diseases; Musculoskeletal Diseases

Study Officials

• Özlem Ö Ülger, Proff

  Hacettepe Üniversity

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: November 16, 2023
• First Posted: April 3, 2024
• Study Start: December 18, 2023
• Primary Completion: April 15, 2024
• Study Completion: June 30, 2024
• Last Updated: January 20, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)