Neuropathic PainNCT04674631
The Effect of Neuropathic Pain in Patients With Combat-related Extremity Injury
An observational study of Neuropathic Pain, run by Gaziler Physical Medicine and Rehabilitation Education and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
It has been suggested that veterans with chronic pain might be at increased risk for the development of depression, anxiety and post-traumatic stress disorder. To date, most of the published studies have focused on chronic pain as a whole, and there are limited studies examining association of neuropathic pain with… Read more about this study
- Who is it for?
- Ages 18 to 65 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Neuropathic Pain
- What is being tested?
- The effect of neuropathic pain on quality of life, depression and sleep quality
- How many people
- 98 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jul 2020to 1 Nov 2021
- Phase
- Observational
- 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 18 to 65 years
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Study population: A total of 98 patients with combat-related extremity injury
Who may be able to join
- Patients between the ages of 18-65 years who had previous history of combat-related extremity injury
Who cannot join
- Previous history of the cervical or lumbosacral radiculopathy, any known rheumatic disease or neurologic or endocrine disorders, excessive alcohol consumption and vitamin B12 deficiency
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Neuropathic Pain on Quality of Life, Depression and Sleep in Patients With Combat-related Extremity Injury
It has been suggested that veterans with chronic pain might be at increased risk for the development of depression, anxiety and post-traumatic stress disorder. To date, most of the published studies have focused on chronic pain as a whole, and there are limited studies examining association of neuropathic pain with psychological comorbidity and quality of life.Combat related extremity injury significantly influences the patients' quality of life and psychological state. In this context, the purpose of this study is to illustrate to what extent neuropathic pain influences the quality of life, depression level and sleep quality of patients with combat-related extremity injury.
Read the detailed description
A total of 120 patients with combat-related extremity injury and 60 age and BMI-matched healthy controls will be participated in this cross-sectional study. The presence of neuropathic pain will be evaluated using Leeds assessment of neuropathic symptoms and signs (LANSS) questionnaire. The impact of pain on health-related quality of life will be assessed using the 36-Item Short Form Survey (SF-36). Beck Depression Scale (BDS) will be used to evaluate depression status of the patients. Quality of sleep will be assessed using the Pittsburgh Sleep Quality Index (PSQI).
- Conditions
- Neuropathic Pain
- Being tested
- The effect of neuropathic pain on quality of life, depression and sleep quality
- Medical subject headings
- Neuralgia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The effect of neuropathic pain on quality of life, depression and sleep qualityOther
The effect of neuropathic pain on quality of life, depression and sleep quality
| Study group | Role | What they receive |
|---|---|---|
| Case group 1 | 52 patients with score of 12 or more on Leeds assessment of neuropathic symptoms and signs (LANSS) questionnaire will be included in the neuropathic pain group. Receives: Other: The effect of neuropathic pain on quality of life, depression and sleep quality | |
| Case group 2 | 46 patients with scores less than 12 on LANSS will be included in the group without neuropathic pain. Receives: Other: The effect of neuropathic pain on quality of life, depression and sleep quality |
What is being measured
The primary outcome is the main question the study is designed to answer.
Short Form Survey (SF-36)
The impact of pain on health-related quality of life will be assessed using the 36-Item Short Form Survey (SF-36). The validity and reliability of the Turkish version of SF-36 has been illustrated. SF-36 is a common questionnaire for the evaluation of quality of life, and it includes a total of 36 items in eight separate scales (physical functioning, general health, physical role, bodily pain, vitality, social functioning, mental health and emotional role). Each subscale is scored between 0 and 100, and high scores indicate better quality of life
Measured: through study completion, an average of one and a half months
Beck Depression Scale (BDS)
Beck Depression Scale (BDS) will be used to evaluate depression status of the patients. Beck Depression Scale, which is a 21-item self report rating inventory, measures characteristic symptoms and attitudes of depression. The scale is scored between 0 and 63. The cut-off point considered is 17. Higher scores reflect more severe depression.
Measured: through study completion, an average of one and a half months
Pittsburgh Sleep Quality Index (PSQI)
Quality of sleep will be assessed using the Pittsburgh Sleep Quality Index (PSQI), which assesses the individual's self-reported quality of sleep during the last month [9]. This 19-item index evaluates seven components of quality of sleep: subjective quality of sleep, sleep duration, sleep latency, sleep disturbances, sleep efficiency, drug use for sleep, and daytime dysfunction. A total PSQI score (range, 0-21) is the total of particular scores from the seven components. A score of ≥6 is considered to indicate poor quality of sleep. The Turkish validation of PSQI was performed.
Measured: through study completion, an average of one and a half months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2020
- Study start1 Jul 2020
- Primary completion1 Nov 2021
- Study completion1 Nov 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neuropathic PainStudies of the same condition, open and under way.
- 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
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 98 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gaziler Physical Medicine and Rehabilitation Education and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yasin Demir, Gaziler Physical Medicine and Rehabilitation Education and Research Hospital
- Investigators
- Merve Orucu Atar, MD, Principal investigator, Gaziler PMR, Training and Research Hospital, Department of PMR
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04674631
- Sponsor's protocol ID
- 8
- Status last verified
- Nov 2021
- First submitted
- 14 Dec 2020
- Last updated
- 2 Dec 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Neuropathic Pain on Quality of Life, Depression and Sleep in Patients With Combat-related Extremity Injury
- ClinicalTrials.gov ID
- NCT04674631
- Acronym / sponsor ID
- 8
- Conditions
- Neuropathic Pain
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 98 participants (actual)
- Lead sponsor
- Gaziler Physical Medicine and Rehabilitation Education and Research HospitalUniversity, hospital or other
- Study start
- 1 Jul 2020 (actual)
- Primary completion
- 1 Nov 2021 (actual)
- Study completion
- 1 Nov 2021 (actual)
- First posted
- 19 Dec 2020 (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.
It has been suggested that veterans with chronic pain might be at increased risk for the development of depression, anxiety and post-traumatic stress disorder. To date, most of the published studies have focused on chronic pain as a whole, and there are limited studies examining association of neuropathic pain with psychological comorbidity and quality of life.Combat related extremity injury significantly influences the patients' quality of life and psychological state. In this context, the purpose of this study is to illustrate to what extent neuropathic pain influences the quality of life, depression level and sleep quality of patients with combat-related extremity injury.
Detailed description
A total of 120 patients with combat-related extremity injury and 60 age and BMI-matched healthy controls will be participated in this cross-sectional study. The presence of neuropathic pain will be evaluated using Leeds assessment of neuropathic symptoms and signs (LANSS) questionnaire. The impact of pain on health-related quality of life will be assessed using the 36-Item Short Form Survey (SF-36). Beck Depression Scale (BDS) will be used to evaluate depression status of the patients. Quality of sleep will be assessed using the Pittsburgh Sleep Quality Index (PSQI).
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Case group 1 | – | Other: The effect of neuropathic pain on quality of life, depression and sleep quality52 patients with score of 12 or more on Leeds assessment of neuropathic symptoms and signs (LANSS) questionnaire will be included in the neuropathic pain group. |
| Case group 2 | – | Other: The effect of neuropathic pain on quality of life, depression and sleep quality46 patients with scores less than 12 on LANSS will be included in the group without neuropathic pain. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- A total of 98 patients with combat-related extremity injury
Key inclusion criteria (1 listed)
- Patients between the ages of 18-65 years who had previous history of combat-related extremity injury
Key exclusion criteria (1 listed)
- Previous history of the cervical or lumbosacral radiculopathy, any known rheumatic disease or neurologic or endocrine disorders, excessive alcohol consumption and vitamin B12 deficiency
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 |
|---|---|---|
| The effect of neuropathic pain on quality of life, depression and sleep qualityThe effect of neuropathic pain on quality of life, depression and sleep quality | Other | Case group 1, Case group 2 |
Primary outcome
Short Form Survey (SF-36)
Time frame: through study completion, an average of one and a half months
The impact of pain on health-related quality of life will be assessed using the 36-Item Short Form Survey (SF-36). The validity and reliability of the Turkish version of SF-36 has been illustrated. SF-36 is a common questionnaire for the evaluation of quality of life, and it includes a total of 36 items in eight separate scales (physical functioning, general health, physical role, bodily pain, vitality, social functioning, mental health and emotional role). Each subscale is scored between 0 and 100, and high scores indicate better quality of life
Beck Depression Scale (BDS)
Time frame: through study completion, an average of one and a half months
Beck Depression Scale (BDS) will be used to evaluate depression status of the patients. Beck Depression Scale, which is a 21-item self report rating inventory, measures characteristic symptoms and attitudes of depression. The scale is scored between 0 and 63. The cut-off point considered is 17. Higher scores reflect more severe depression.
Pittsburgh Sleep Quality Index (PSQI)
Time frame: through study completion, an average of one and a half months
Quality of sleep will be assessed using the Pittsburgh Sleep Quality Index (PSQI), which assesses the individual's self-reported quality of sleep during the last month [9]. This 19-item index evaluates seven components of quality of sleep: subjective quality of sleep, sleep duration, sleep latency, sleep disturbances, sleep efficiency, drug use for sleep, and daytime dysfunction. A total PSQI score (range, 0-21) is the total of particular scores from the seven components. A score of ≥6 is considered to indicate poor quality of sleep. The Turkish validation of PSQI was performed.
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 2 Dec 2021.
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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.
Merve Orucu Atar, MD principal investigator
Gaziler PMR, Training and Research Hospital, Department of PMR
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Neuropathic Pain, run by Gaziler Physical Medicine and Rehabilitation Education and Research Hospital 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 1 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: finished, as of the sponsor's last update on 2 Dec 2021. 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?
Short Form Survey (SF-36) (time frame: through study completion, an average of one and a half months). The study lists 3 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 2 Dec 2021.