Wearable Technological Device Applied to Patients With Chronic Pain

Chronic Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06345430
• Other study ID #: 2023-14
• Status: Completed
• Phase: N/A
• Start date: November 18, 2023
• Est. completion date: January 30, 2024

Study information

• Verified date: March 2024
• Source: Hacettepe University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: January 30, 2024
• Est. primary completion date: January 15, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Chronic Pain
• Low Back Pain
• Musculoskeletal Pain
• Neck Pain

Intervention

Device:
• Exopulse Molli-Suit (Wearable Technological 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.

Locations

Country	Name	City	State
Turkey	Yasemin Özel Asliyüce	Yeni?mahalle	Ankara

Sponsors (1)

Lead Sponsor	Collaborator
Hacettepe University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Sleep Qaulity	In this evaluation, the Pittsburg Sleep Quality Index, which was developed by Buysse et al. (Buysse et al., 1989), and validated and reliably validated in Turkish by Agargün et al. will be used (Agargün et al., 1996). The index is presented in the appendix.	Before the intervention, after 24 hours, after 1 week and up to 1 month after the intervention. 4 times
Secondary	Disability Level	Oswestry Disability Index will be used for individuals with low back pain and Neck Disability Index for individuals with neck pain. The Turkish validity and reliability of the Oswestry Disability Index developed by Fairbank et al. (Fairbank & Pynsent, 2000) was demonstrated by Yakut et al. (Yakut et al., 2004) (internal consistency coefficient: 0.91). The Turkish validity and reliability of the Neck Disability Index developed by Vernon and Mior (Vernon & Mior, 1991) was demonstrated by Aslan et al. (Aslan et al., 2008) (internal consistency coefficient: 0.97).	Before the intervention, after 24 hours, after 1 week and up to 1 month after the intervention. 4 times
Secondary	Repetitive Reach Test	This test assesses the speed and coordination of the upper extremity in repetitive tasks. The time spent transferring 30 marbles (14 diameters) between two bowls placed at a distance determined by the arm opening is recorded in the sitting position. This test consists of four different subtasks, two-sided for the two upper extremities (right hand-left to the right, left hand-left to the right, right hand-right to the left, left hand-right to the left). Test-retest reliability in healthy subjects is weak	Before the intervention, after 24 hours, after 1 week and up to 1 month after the intervention. 4 times
Secondary	Body Composition Analysis	Body Mass Index (BMI), muscular and fat body weights will be assessed with the TANITA BC420SMA (Tanita Corp, Tokyo, Japan). TANITA is a medically approved and reliable measuring device. It determines body composition by utilizing changes in bioelectric resistance (Jebb et al., 2000).	before intervention, 1 times
Secondary	Lifting object overhead test	Lifitng object Overhead Test:This test is used to evaluate the functional strength of the upper extremity muscles. During the test, the participant takes the weight from a table 80 cm high and is asked to lift it up to the head five times within 90 seconds and return to the original position. It starts with the lightest weight determined and progresses step by step towards the heaviest. Initial and maximum weight were 10-60 kg and 6-30 kg in males and females, respectively. Increases are made in 4-5 kg (Gross & Battie´, 2002). The criteria for termination of the test are reaching maximum weight, pain, or the individual's desire to terminate. Test-retest reliability in healthy subjects is high	Before the intervention, after 24 hours, after 1 week and up to 1 month after the intervention. 4 times
Secondary	Sustained Overhead Work Test	This test assesses postural tolerance capacity. The test is performed in the standing position with 1 kg cuff weights tied to the participant's arms. He was asked to manipulate the nuts and bolts as long as he can with the arms at forehead height and the time is recorded.	Before the intervention, after 24 hours, after 1 week and up to 1 month after the intervention. 4 times
Secondary	back performance test	evaluates the effectiveness of each activity that includes 5 different activities (socks test, gathering test, righting test, fingertip-floor test, carrying test). The Back Performance Scale test is scored between 0-15 points. An increase in score indicates a poor result	Before the intervention, after 24 hours, after 1 week and up to 1 month after the intervention. 4 times