Neck PainNCT07159724
Turkish Version of the Usefulness, Satisfaction, and Ease of Use Questionnaire (USE): Reliability and Validity
An observational study of Neck Pain and Low Back Pain, run by Hacettepe University.
Trial summary
In recent years, numerous technological products and devices have been developed in rehabilitation through advances in biomedical technology. These innovations support traditional rehabilitation services, offering more effective treatment methods and improving patients' adherence and participation. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Neck Pain, Low Back Pain, Biomedical Technology
- What is being tested?
- back up, mollii-suit, compex, tens
- Type of treatment
- Medical device
- How many people
- 220 participants
- Where
- No sites listed yet
- Study dates
- 26 Aug 2025to 30 Sep 2025
- How long will I take part?
- 3 Days
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: patients with low back pain and neck pain
Who may be able to join
- Presence of back or neck pain lasting at least 3 months
- Use of a supportive biomedical device in a rehabilitation program
- Literacy
- Age between 18 and 65
- Willingness to participate in the study on a voluntary basis
Who cannot join
- 1. Malignant condition 2. Pregnancy 3. Loss of function due to neurological or systemic disease 4. Having undergone surgery in the last 6 months 5. Acute infection 6. Unhealed fracture 7. Withdrawal from any phase of the study 8. Light sensitivity
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
Özlem Ülger, PT, PhD contact
About this study
Official title: Cross-cultural Adaptation, Reliability and Validity of the Turkish Version of the Usefulness, Satisfaction, and Ease of Use Questionnaire (USE) in Individuals With Back and Neck Pain
In recent years, numerous technological products and devices have been developed in rehabilitation through advances in biomedical technology. These innovations support traditional rehabilitation services, offering more effective treatment methods and improving patients' adherence and participation. Increased compliance in treatment positively influences functional status, quality of life, and satisfaction. However, the diversity of biomedical products and the varying strength of their scientific foundations make it critical to evaluate them in terms of benefit, patient compliance, and usability. In physiotherapy and rehabilitation, objective tools for this purpose remain limited, which hinders accurate assessment of product effectiveness and the identification of improvements. Uncertainty regarding usability and ease of use may also result in inefficient utilization of resources.
Questionnaires provide cost-effective tools to capture users' opinions, reflecting strengths and weaknesses of a product without the need for measurement devices. The Usefulness, Satisfaction, and Ease of Use (USE) Questionnaire, developed by Arnold Lund in 2001, is a comprehensive 30-item scale scored on a 7-point Likert system. It evaluates usefulness, ease of use, ease of learning, and satisfaction, with items applicable across different products and services such as software, hardware, applications, or user support materials. Its multidimensional structure allows for the evaluation of usability in physiotherapy and rehabilitation technologies as well as in broader fields including robotics, social networking sites, diagnostic tools, and virtual reality.
Read more
Despite its wide use internationally, no validated Turkish version of the USE Questionnaire exists. Establishing a culturally adapted, valid, and reliable Turkish version will address this gap and provide clinicians and researchers with a standardized tool for usability assessment.
The aim of this study is to investigate the validity and reliability of the Turkish version of the USE Questionnaire.
Read the detailed description
This study will be carried out at Hacettepe University, Faculty of Physical Therapy and Rehabilitation, Spine Health Unit. Individuals who apply to the rehabilitation program and use biomedical devices will be included. Inclusion criteria are: presence of back or neck pain for at least three months, use of a supportive biomedical device in the rehabilitation program, literacy, age between 18-65 years, and voluntary participation with written informed consent. Exclusion criteria include malignancy, pregnancy, neurological or systemic disease causing functional loss, surgery within the last six months, acute infection, unhealed fracture, or withdrawal of consent at any stage.
The cross-cultural adaptation of the Usefulness, Satisfaction and Ease of Use (USE) Questionnaire will be conducted according to established guidelines. Permission has been obtained from the original author. Two bilingual translators (a physiotherapist with a PhD and a linguist from Hacettepe University School of Foreign Languages) will independently translate the questionnaire into Turkish. Their translations will be reviewed by an expert committee consisting of three health professionals and three linguists. Back-translation into English will be performed by two native English speakers. Following review and consensus, a pre-final Turkish version will be created. The pre-test phase will include 10 individuals with back or neck pain who used biomedical devices in rehabilitation. Comprehensibility, clarity, and time to complete the questionnaire will be evaluated. Items that are unclear will be revised or removed.
A total of 150-300 participants will be recruited, following the recommendation of 5-10 participants per item for validation studies. Data collection will include demographic information (age, sex, weight, height, occupation, education, diagnosis), the Turkish USE Questionnaire, Neck Disability Index, Oswestry Disability Index, Quebec User Evaluation of Satisfaction with Assistive Technology, and Numeric Pain Rating Scale. Device-related usefulness, learning, and ease of use will be evaluated using Visual Analog Scales. The USE Questionnaire will be administered twice, with a three-day interval, to assess test-retest reliability.
Statistical analyses will be performed using IBM SPSS. Construct validity will be examined using factor analysis and correlations with established scales. Internal consistency will be assessed by Cronbach's alpha coefficient, and test-retest reliability will be evaluated using intraclass correlation coefficients. These methodological steps will ensure the scientific rigor, validity, and reliability of the Turkish version of the USE Questionnaire. The adapted instrument is expected to provide a standardized and reliable tool to evaluate usability of biomedical devices and technologies in physiotherapy and rehabilitation settings, filling an important gap in the Turkish literature.
- Conditions
- Neck Pain, Low Back Pain, Biomedical Technology, Validation
- Being tested
- back up, mollii-suit, compex, tens
- Keywords
- Musculoskeletal Pain, validaiton, medical device, evaluation
- Medical subject headings
- Neck Pain, Low Back Pain, Musculoskeletal Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
back up, mollii-suit, compex, tensDevice
In order to be included in this study, individuals must have undergone at least one session of treatment with a biomedical device.
In the validity and reliability study of the Turkish version of the questionnaire, permission was first obtained from the questionnaire's author via e-mail. The Usefulness, Satisfaction and Ease of Use Questionnaire (USE) was translated from English into Turkish by two independent translators: one was a physiotherapist with a doctoral degree, and the other a faculty member at Hacettepe University School of Foreign Languages. Both translators were native Turkish speakers, fluent in English, and had no personal or professional interaction with each other. They evaluated the original questionnaire in terms of meaning and grammar to produce the Turkish version of the Usefulness, Satisfaction and Ease of Use Questionnaire (USE).
The independently translated Turkish versions of the questionnaire were then reviewed by an expert panel to reach consensus. This exp
| Study group | Role | What they receive |
|---|---|---|
| People with low back and neck pain | Participants will be adults aged 18-65 years who have experienced low back or neck pain for at least 3 months and have undergone rehabilitation including at least one biomedical device (e.g., Back Up, Mollii Suit, Compex, or TENS). Eligible individuals must be literate and willing to provide informed consent. Exclusion criteria include malignancy, pregnancy, neurological or systemic disease causing functional loss, recent surgery within the last 6 months, acute infection, unhealed fracture, or withdrawal of consent. Receives: Device: back up, mollii-suit, compex, tens |
What is being measured
The primary outcome is the main question the study is designed to answer.
Neck Disability Index
It was developed by Vernon and colleagues as a neck version of the Oswestry Back Pain Scale. The Turkish version was developed by Aslan and colleagues. The Neck Disability Questionnaire consists of a total of 10 questions related to pain, personal care, concentration, work, driving, and sleeping. Each question is scored on a scale of 0 to 5. The total score is evaluated out of 50.
Measured: Baseline (Day 1)
Usefulness, Satisfaction, and Ease of Use Questionnaire
Developed by Arnold Lund in 2001, the Usefulness, Satisfaction, and Ease of Use Questionnaire (USE) is a comprehensive tool consisting of 30 items that assess various dimensions of usability. The questionnaire is scored on a 7-point Likert scale (1 = "Strongly Disagree"; 7 = "Strongly Agree") and includes a "None" option.
Measured: Baseline (Day 1) and 3 days after initial assessment
Oswestry Disability Index
Developed by Fairbank et al. to assess the level of functional loss in individuals with back pain. The Turkish version was developed by Yakut et al. The scale consists of 10 questions related to pain intensity, self-care, lifting and carrying, walking, sitting, standing, sleeping, degree of pain change, travel, and social life. Each question is scored on a scale of 0 to 5. The total score is evaluated out of 100.
Measured: Baseline (Day 1)
Quebec Assistive Technology User Satisfaction Survey
The Quebec Assistive Technology User Satisfaction Evaluation (Q-YTKMD) Questionnaire is a standardized questionnaire widely used to assess the satisfaction of individuals who use various assistive devices. The Q-YTKMD Questionnaire contains 12 items that inquire about satisfaction with assistive devices (8 items) and services (4 items). The validity and reliability of the Turkish version of the Q-YTKMD Survey have been established.
Measured: Baseline (Day 1)
Secondary outcomes (4)
Evaluation of the Benefit Level of Biomedical Devices
The benefit participants derive from the biomedical device used in the rehabilitation program process will be evaluated using the Visual Analog Scale (VAS). In the literature, the VAS has been used to assess the level of benefit provided by a product or service. Participants are asked to mark the level of benefit they have received on a horizontal line 10 cm long on a plane. The scale is marked as follows: "0: not beneficial at all" and "10: very beneficial." Scoring is based on measuring the level marked by the participant on the plane with a ruler.
Measured: Baseline (Day 1)
Assessment of the Ease of Learning Biomedical Devices
GAS will be used to assess the ease of learning related to biomedical devices used in the rehabilitation program process. Participants are asked to mark their responses on a scale from "0: not easy to learn at all" to "10: very easy to learn." Scoring is based on measuring the level marked by the participant on a ruler.
Measured: Baseline (Day 1)
Evaluation of the Ease of Use of Biomedical Devices
GAS will be used to evaluate the ease of use of biomedical devices used in the rehabilitation program process by participants. GAS has been used in the literature to evaluate the ease of use of a product or service . Participants are asked to mark their response on a scale from "0: not easy to use at all" to "10: very easy to use." The scoring is based on measuring the level marked by the participant on a ruler.
Measured: Baseline (Day 1)
Pain Severity Assessment
Participants' pain intensity will be assessed using the Numerical Pain Scale (NAS). The NAS is a unidimensional measure that uses 11 numbers (ranging from 0 to 10) to measure pain intensity. The patient is asked to rate their pain on the scale, with 0 indicating no pain and 10 indicating the worst (unbearable) pain.
Measured: Baseline (Day 1)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Sep 2025
- Study start26 Aug 2025 (estimated)
- Primary completion1 Sep 2025 (estimated)
- Study completion30 Sep 2025 (estimated)
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
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 220 participants (estimated)
- Target duration
- 3 Days
Sponsor and investigators
- Lead sponsor
- Hacettepe University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, ABDURAHİM ASLIYÜCE, Hacettepe University
- Investigators
- Özlem Ülger, PT, PhD, Principal investigator, Hacettepe University, Faculty of Physical Therapy and Rehabilitation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07159724
- Sponsor's protocol ID
- FTREK24/39
- Status last verified
- Aug 2025
- First submitted
- 25 Aug 2025
- Last updated
- 8 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 8 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cross-cultural Adaptation, Reliability and Validity of the Turkish Version of the Usefulness, Satisfaction, and Ease of Use Questionnaire (USE) in Individuals With Back and Neck Pain
- ClinicalTrials.gov ID
- NCT07159724
- Acronym / sponsor ID
- FTREK24/39
- Conditions
- Neck Pain, Low Back Pain, Biomedical Technology, Validation
- Keywords
- Musculoskeletal Pain, validaiton, medical device, evaluation
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 220 participants (estimated)
- Lead sponsor
- Hacettepe UniversityUniversity, hospital or other
- Study start
- 26 Aug 2025 (estimated)
- Primary completion
- 1 Sep 2025 (estimated)
- Study completion
- 30 Sep 2025 (estimated)
- First posted
- 8 Sep 2025 (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.
In recent years, numerous technological products and devices have been developed in rehabilitation through advances in biomedical technology. These innovations support traditional rehabilitation services, offering more effective treatment methods and improving patients' adherence and participation. Increased compliance in treatment positively influences functional status, quality of life, and satisfaction. However, the diversity of biomedical products and the varying strength of their scientific foundations make it critical to evaluate them in terms of benefit, patient compliance, and usability. In physiotherapy and rehabilitation, objective tools for this purpose remain limited, which hinders accurate assessment of product effectiveness and the identification of improvements. Uncertainty regarding usability and ease of use may also result in inefficient utilization of resources.
Questionnaires provide cost-effective tools to capture users' opinions, reflecting strengths and weaknesses of a product without the need for measurement devices. The Usefulness, Satisfaction, and Ease of Use (USE) Questionnaire, developed by Arnold Lund in 2001, is a comprehensive 30-item scale scored on a 7-point Likert system. It evaluates usefulness, ease of use, ease of learning, and satisfaction, with items applicable across different products and services such as software, hardware, applications, or user support materials. Its multidimensional structure allows for the evaluation of usability in physiotherapy and rehabilitation technologies as well as in broader fields including robotics, social networking sites, diagnostic tools, and virtual reality.
Despite its wide use internationally, no validated Turkish version of the USE Questionnaire exists. Establishing a culturally adapted, valid, and reliable Turkish version will address this gap and provide clinicians and researchers with a standardized tool for usability assessment.
The aim of this study is to investigate the validity and reliability of the Turkish version of the USE Questionnaire.
Detailed description
This study will be carried out at Hacettepe University, Faculty of Physical Therapy and Rehabilitation, Spine Health Unit. Individuals who apply to the rehabilitation program and use biomedical devices will be included. Inclusion criteria are: presence of back or neck pain for at least three months, use of a supportive biomedical device in the rehabilitation program, literacy, age between 18-65 years, and voluntary participation with written informed consent. Exclusion criteria include malignancy, pregnancy, neurological or systemic disease causing functional loss, surgery within the last six months, acute infection, unhealed fracture, or withdrawal of consent at any stage.
The cross-cultural adaptation of the Usefulness, Satisfaction and Ease of Use (USE) Questionnaire will be conducted according to established guidelines. Permission has been obtained from the original author. Two bilingual translators (a physiotherapist with a PhD and a linguist from Hacettepe University School of Foreign Languages) will independently translate the questionnaire into Turkish. Their translations will be reviewed by an expert committee consisting of three health professionals and three linguists. Back-translation into English will be performed by two native English speakers. Following review and consensus, a pre-final Turkish version will be created. The pre-test phase will include 10 individuals with back or neck pain who used biomedical devices in rehabilitation. Comprehensibility, clarity, and time to complete the questionnaire will be evaluated. Items that are unclear will be revised or removed.
A total of 150-300 participants will be recruited, following the recommendation of 5-10 participants per item for validation studies. Data collection will include demographic information (age, sex, weight, height, occupation, education, diagnosis), the Turkish USE Questionnaire, Neck Disability Index, Oswestry Disability Index, Quebec User Evaluation of Satisfaction with Assistive Technology, and Numeric Pain Rating Scale. Device-related usefulness, learning, and ease of use will be evaluated using Visual Analog Scales. The USE Questionnaire will be administered twice, with a three-day interval, to assess test-retest reliability.
Statistical analyses will be performed using IBM SPSS. Construct validity will be examined using factor analysis and correlations with established scales. Internal consistency will be assessed by Cronbach's alpha coefficient, and test-retest reliability will be evaluated using intraclass correlation coefficients. These methodological steps will ensure the scientific rigor, validity, and reliability of the Turkish version of the USE Questionnaire. The adapted instrument is expected to provide a standardized and reliable tool to evaluate usability of biomedical devices and technologies in physiotherapy and rehabilitation settings, filling an important gap in the Turkish literature.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Target follow-up
- 3 Days
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| People with low back and neck pain | – | Device: back up, mollii-suit, compex, tensParticipants will be adults aged 18-65 years who have experienced low back or neck pain for at least 3 months and have undergone rehabilitation including at least one biomedical device (e.g., Back Up, Mollii Suit, Compex, or TENS). Eligible individuals must be literate and willing to provide informed consent. Exclusion criteria include malignancy, pregnancy, neurological or systemic disease causing functional loss, recent surgery within the last 6 months, acute infection, unhealed fracture, or withdrawal of consent. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients with low back pain and neck pain
Key inclusion criteria (5 listed)
- Presence of back or neck pain lasting at least 3 months
- Use of a supportive biomedical device in a rehabilitation program
- Literacy
- Age between 18 and 65
- Willingness to participate in the study on a voluntary basis
Key exclusion criteria (1 listed)
- 1. Malignant condition 2. Pregnancy 3. Loss of function due to neurological or systemic disease 4. Having undergone surgery in the last 6 months 5. Acute infection 6. Unhealed fracture 7. Withdrawal from any phase of the study 8. Light sensitivity
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 |
|---|---|---|
| back up, mollii-suit, compex, tensIn order to be included in this study, individuals must have undergone at least one session of treatment with a biomedical device. In the validity and reliability study of the Turkish version of the questionnaire, permission was first obtained from the questionnaire's author via e-mail. The Usefulness, Satisfaction and Ease of Use Questionnaire (USE) was translated from English into Turkish by two independent translators: one was a physiotherapist with a doctoral degree, and the other a faculty member at Hacettepe University School of Foreign Languages. Both translators were native Turkish speakers, fluent in English, and had no personal or professional interaction with each other. They evaluated the original questionnaire in terms of meaning and grammar to produce the Turkish version of the Usefulness, Satisfaction and Ease of Use Questionnaire (USE). The independently translated Turkish versions of the questionnaire were then reviewed by an expert panel to reach consensus. This exp | Device | People with low back and neck pain |
Primary outcome
Neck Disability Index
Time frame: Baseline (Day 1)
It was developed by Vernon and colleagues as a neck version of the Oswestry Back Pain Scale. The Turkish version was developed by Aslan and colleagues. The Neck Disability Questionnaire consists of a total of 10 questions related to pain, personal care, concentration, work, driving, and sleeping. Each question is scored on a scale of 0 to 5. The total score is evaluated out of 50.
Usefulness, Satisfaction, and Ease of Use Questionnaire
Time frame: Baseline (Day 1) and 3 days after initial assessment
Developed by Arnold Lund in 2001, the Usefulness, Satisfaction, and Ease of Use Questionnaire (USE) is a comprehensive tool consisting of 30 items that assess various dimensions of usability. The questionnaire is scored on a 7-point Likert scale (1 = "Strongly Disagree"; 7 = "Strongly Agree") and includes a "None" option.
Oswestry Disability Index
Time frame: Baseline (Day 1)
Developed by Fairbank et al. to assess the level of functional loss in individuals with back pain. The Turkish version was developed by Yakut et al. The scale consists of 10 questions related to pain intensity, self-care, lifting and carrying, walking, sitting, standing, sleeping, degree of pain change, travel, and social life. Each question is scored on a scale of 0 to 5. The total score is evaluated out of 100.
Quebec Assistive Technology User Satisfaction Survey
Time frame: Baseline (Day 1)
The Quebec Assistive Technology User Satisfaction Evaluation (Q-YTKMD) Questionnaire is a standardized questionnaire widely used to assess the satisfaction of individuals who use various assistive devices. The Q-YTKMD Questionnaire contains 12 items that inquire about satisfaction with assistive devices (8 items) and services (4 items). The validity and reliability of the Turkish version of the Q-YTKMD Survey have been established.
4 secondary outcomes
Evaluation of the Benefit Level of Biomedical Devices
Time frame: Baseline (Day 1)
Assessment of the Ease of Learning Biomedical Devices
Time frame: Baseline (Day 1)
Evaluation of the Ease of Use of Biomedical Devices
Time frame: Baseline (Day 1)
Pain Severity Assessment
Time frame: Baseline (Day 1)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Sep 2025.
- Individual participant dataSharing planned: Undecided
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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.
Özlem Ülger, PT, PhD contact
Özlem Ülger, PT, PhD principal investigator
Hacettepe University, Faculty of Physical Therapy and Rehabilitation
Questions about this trial
What is this clinical trial studying?
An observational study of Neck Pain and Low Back Pain, run by Hacettepe University.
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 5 inclusion and 1 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: opening soon, as of the sponsor's last update on 8 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Abdurahim Aslıyüce, PT, PhD cand (+905422476991, fzt.abdurahim.asliyuce@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Neck Disability Index (time frame: Baseline (Day 1)). The study lists 4 primary outcomes in all. 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 8 Sep 2025.