- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06345430
Wearable Technological Device Applied to Patients With Chronic Pain
Clinical and Functional Effects of Wearable Technological Device Applied to Patients With Chronic Pain
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Ankara
-
Yeni̇mahalle, Ankara, Turkey, 06100
- Yasemin Özel Aslıyüce
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Exopulse Molli Suit Interventipn
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. |
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
bBefore the intervention, immediately after the intervention, after 24 hours, after 1 week and up to 1 month after the intervention. 5 times
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Sleep Qaulity
Time Frame: Before the intervention, after 24 hours, after 1 week and up to 1 month after the intervention. 4 times
|
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 Ağargün et al. will be used (Ağargün 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
|
Disability Level
Time Frame: Before the intervention, after 24 hours, after 1 week and up to 1 month after the intervention. 4 times
|
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
|
Repetitive Reach Test
Time Frame: Before the intervention, after 24 hours, after 1 week and up to 1 month after the intervention. 4 times
|
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
|
Body Composition Analysis
Time Frame: before intervention, 1 times
|
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
|
Lifting object overhead test
Time Frame: Before the intervention, after 24 hours, after 1 week and up to 1 month after the intervention. 4 times
|
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 & Battié, 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
|
Sustained Overhead Work Test
Time Frame: Before the intervention, after 24 hours, after 1 week and up to 1 month after the intervention. 4 times
|
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
|
back performance test
Time Frame: Before the intervention, after 24 hours, after 1 week and up to 1 month after the intervention. 4 times
|
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
|
Collaborators and Investigators
Sponsor
Investigators
- Study Director: Özlem Ö Ülger, Proff, Hacettepe University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2023-14
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Low Back Pain
-
Dow University of Health SciencesRecruitingLow Back Pain | Chronic Low-back Pain | Low Back Pain, Mechanical | Mechanical Low Back Pain | Pain, Chronic | Pain, Back | Lower Back Pain Chronic | CLBP - Chronic Low Back PainPakistan
-
Faculdade de Ciências Médicas da Santa Casa de...CompletedLow Back Pain, Mechanical | Low Back Pain, Postural | Lower Back Pain Chronic | Low Back Pain, Posterior CompartmentBrazil
-
University School of Physical Education in WroclawCompletedLow Back Pain | Low Back Pain, Mechanical | Low Back Pain, PosturalPoland
-
Texas Woman's UniversityTexas Physical Therapy AssociationCompletedLow Back Pain | Chronic Low Back Pain | Subacute Low Back PainUnited States
-
University of ParmaKing's College London; Helmholtz Zentrum München; GENOS; Ip Research Consulting... and other collaboratorsUnknownChronic Low Back Pain | Acute Low Back PainUnited States, Australia, Belgium, Croatia, Italy, United Kingdom
-
Ache Laboratorios Farmaceuticos S.A.Unknown
-
Palmer College of ChiropracticDepartment of Health and Human ServicesCompletedChronic Low Back Pain | Subacute Low Back PainUnited States
-
Universität Duisburg-EssenSiemens-BetriebskrankenkasseCompletedChronic Low Back Pain | Recurrent Low Back Pain
-
Karolinska InstitutetCompletedChronic Low Back Pain | Recurrent Low Back Pain | Persistent Low Back PainSweden
-
Apsen Farmaceutica S.A.CompletedLow Back Pain | Low Back Pain, Mechanical | Acute Low Back PainBrazil