Neck PainNCT06345430
Wearable Technological Device Applied to Patients with Chronic Pain
A study testing Exopulse Molli-Suit (Wearable Technological Device) in people with Neck Pain and Low Back Pain, run by Hacettepe University at 1 site in Turkey (Türkiye).
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. Read more about this study
- Who is it for?
- Ages 20 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Neck Pain, Low Back Pain, Chronic Pain
- What is being tested?
- Exopulse Molli-Suit (Wearable Technological Device)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 18 Dec 2023to 30 Jun 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Yasemin Özel Aslıyüce
Yenimahalle, Ankara, 06100
About this study
Official title: Clinical and Functional Effects of Wearable Technological Device Applied to Patients with Chronic Pain
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.
Read the 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.
- Conditions
- Neck Pain, Low Back Pain, Chronic Pain, Musculoskeletal Pain
- Being tested
- Exopulse Molli-Suit (Wearable Technological Device)
- Medical subject headings
- Neck Pain, Low Back Pain, Chronic Pain, Musculoskeletal Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Exopulse Molli-Suit (Wearable Technological Device) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
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.
Measured: Before the intervention, after 24 hours, after 1 week and up to 1 month after the intervention. 4 times
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).
Measured: Before the intervention, after 24 hours, after 1 week and up to 1 month after the intervention. 4 times
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
Measured: Before the intervention, after 24 hours, after 1 week and up to 1 month after the intervention. 4 times
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).
Measured: before intervention, 1 times
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 \& 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
Measured: Before the intervention, after 24 hours, after 1 week and up to 1 month after the intervention. 4 times
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.
Measured: Before the intervention, after 24 hours, after 1 week and up to 1 month after the intervention. 4 times
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
Measured: Before the intervention, after 24 hours, after 1 week and up to 1 month after the intervention. 4 times
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Apr 2024
- Study start18 Dec 2023
- Primary completion15 Apr 2024
- Study completion30 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neck PainStudies of the same condition, open and under way.
- More trials run by Hacettepe UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hacettepe University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ozlem Ulger, Hacettepe University
- Investigators
- Özlem Ö Ülger, Proff, Study director, Hacettepe Üniversity
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06345430
- Sponsor's protocol ID
- 2023-14
- Status last verified
- Jan 2025
- First submitted
- 16 Nov 2023
- Last updated
- 20 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical and Functional Effects of Wearable Technological Device Applied to Patients with Chronic Pain
- ClinicalTrials.gov ID
- NCT06345430
- Acronym / sponsor ID
- 2023-14
- Conditions
- Neck Pain, Low Back Pain, Chronic Pain, Musculoskeletal Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Hacettepe UniversityUniversity, hospital or other
- Study start
- 18 Dec 2023 (actual)
- Primary completion
- 15 Apr 2024 (actual)
- Study completion
- 30 Jun 2024 (actual)
- First posted
- 3 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Exopulse Molli Suit Interventipn | Experimental | Device: Exopulse Molli-Suit (Wearable Technological Device)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. |
Who may qualify
- Ages
- 20 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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)
Key exclusion criteria (7 listed)
- 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,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Device | Exopulse Molli Suit Interventipn |
Primary outcome
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.
7 secondary outcomes
Sleep Qaulity
Time frame: 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
Repetitive Reach Test
Time frame: 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
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
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
back performance test
Time frame: Before the intervention, after 24 hours, after 1 week and up to 1 month after the intervention. 4 times
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jan 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Özlem Ö Ülger, Proff study director
Hacettepe Üniversity
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exopulse Molli-Suit (Wearable Technological Device) in people with Neck Pain and Low Back Pain, run by Hacettepe University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jan 2025.