Neck PainNCT05212870
Investıgatıon Of The Effect Of The Pandemıc Process In Indıvıduals Wıth Chronıc Low Back And Neck Paın
An observational study of Neck Pain and Low Back Pain, run by Hacettepe University at 1 site in Turkey (Türkiye).
Trial summary
There are a limited number of studies examining the difficulty of reaching treatment related to the pandemic process and the general effects of the process in patients with chronic low back and neck pain. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Neck Pain, Low Back Pain, Cognitive Level
- What is being tested?
- assessment of cognitive level, pain catastrophe, physical activity level and quality of life
- How many people
- 84 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 22 Nov 2021to 15 Dec 2022
- 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 60 years
- All sexes
- No healthy volunteers
- Adult
Study population: Patients with chronic low back and neck pain
Who may be able to join
- Those between the ages of 18-60,
- Having low back or neck pain lasting longer than 3 months,
- Having a history of Covid-19 (At least 6 weeks-post acute),
- Individuals with chronic low back and neck pain without a history of Covid-19 will be included.
Who cannot join
- Those with an active diagnosis of Covid-19
- Having a rheumatological disease,
- Broken etc. severe deformity that may lead to nerve injury,
- Having a history of spinal surgery,
- Having neurological disease in addition to spinal pathology,
- Having problems such as cancer, diabetes, dementia, organic brain dysfunction,
- Illiterate individuals will not be included.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Investıgatıon Of The Effect Of The Pandemıc Process On Cognıtıve Level, Paın Catastrophızatıon, Physıcal Actıvıty Level And Qualıty Of Lıfe In Indıvıduals Wıth Chronıc Low Back And Neck Paın
There are a limited number of studies examining the difficulty of reaching treatment related to the pandemic process and the general effects of the process in patients with chronic low back and neck pain. However, no study has been found that compares the effects of individuals actively carrying and not carrying the Covid-19 virus. For this reason, the aim of the study is to examine the effects of the pandemic process on the cognitive level, pain catastrophization, physical activity level and quality of life in individuals with chronic low back and neck pain.
- Conditions
- Neck Pain, Low Back Pain, Cognitive Level, COVID-19 Pandemic
- Being tested
- assessment of cognitive level, pain catastrophe, physical activity level and quality of life
- Medical subject headings
- Neck Pain, Low Back Pain, COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
assessment of cognitive level, pain catastrophe, physical activity level and quality of lifeOther
assessment of cognitive level, pain catastrophe, physical activity level and quality of life
| Study group | Role | What they receive |
|---|---|---|
| Low back and neck pain group with experience of Covid-19 | Not described Receives: Other: assessment of cognitive level, pain catastrophe, physical activity level and quality of life | |
| Low back and neck pain group without experience of Covid-19 | Not described Receives: Other: assessment of cognitive level, pain catastrophe, physical activity level and quality of life |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain Severity Assessment- Visual Analog Sacle
VAS indicates the level of pain that the person is currently experiencing with a vertical line on a plane. The pain felt by the person is marked as "0: I do not feel any pain", "10: I feel very severe pain". Scoring is based on measuring the vertical marking of the participant for pain marked on the plane with a ruler. The validity and reliability study of the scale was done by Price et al. made by
Measured: through study completion, an average of 1 year
Secondary outcomes (4)
Assessment of Cognitive Level: Montreal Cognitive Assessment Scale (MOCA)
The scale consists of 11 questions in total. The score range is 0-30. Below 21 points is interpreted as cognitive disability for the Turkish population. Turkish validity and reliability study was conducted by Selekler et al. made by
Measured: 5 minutes, through study completion, an average of 1 year
Evaluation of Pain Catastrophization Level: Pain Catastrophization Scale
There are 13 questions in total on this scale. The questions are aimed at questioning the feelings and thoughts of individuals during pain. Each question scores between 0 and 4. A score of 30 and above indicates the presence of pain catastrophization. The validity and reliability study of the Turkish version of the scale was conducted by Süren et al. made by.
Measured: 5 minutes, through study completion, an average of 1 year
Assessment of Physical Activity Level: International Physical Activity Questionnaire (UFAA)-Short Form
It was developed by Craig, Marshall, Sjostrom, Bauman, and Booth (2003) by conducting validity and reliability studies of individuals in 12 different countries. The questionnaire is a valid tool developed to determine the physical activity levels of individuals between the ages of 18-65. There are eight versions of the questionnaire, which was adapted into Turkish by Öztürk (2005). It has been developed as four short and four long forms. The short form "last 7 days" was used in this study. The short form (7 questions) provides information about time spent walking, moderate-to-vigorous and vigorous activities. The time spent sitting is considered as a separate question. It is classified as low, medium and high level by calculating the activity level of the person in terms of METs according to the duration, frequency and intensity level of the movement.
Measured: 5 minutes, through study completion, an average of 1 year
Quality of Life Assessment: SF-36
SF-36 is a 36-item scale that evaluates the health status of a person with 8 sub-items (physical function, role limitations, social function, mental health, vitality, pain, general health). Each sub-item is scored separately between 0-100. As the score approaches 100, it indicates good health. Turkish validity and reliability study, Koçyiğit et al. (1999).
Measured: 5 minutes, through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2022
- Study start22 Nov 2021
- Primary completion15 Oct 2022
- Study completion15 Dec 2022
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
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 84 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hacettepe University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ozlem Ulger, Hacettepe University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05212870
- Sponsor's protocol ID
- 16969557-1040
- Status last verified
- Aug 2022
- First submitted
- 8 Oct 2021
- Last updated
- 21 Nov 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investıgatıon Of The Effect Of The Pandemıc Process On Cognıtıve Level, Paın Catastrophızatıon, Physıcal Actıvıty Level And Qualıty Of Lıfe In Indıvıduals Wıth Chronıc Low Back And Neck Paın
- ClinicalTrials.gov ID
- NCT05212870
- Acronym / sponsor ID
- 16969557-1040
- Conditions
- Neck Pain, Low Back Pain, Cognitive Level, COVID-19 Pandemic
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 84 participants (actual)
- Lead sponsor
- Hacettepe UniversityUniversity, hospital or other
- Study start
- 22 Nov 2021 (actual)
- Primary completion
- 15 Oct 2022 (actual)
- Study completion
- 15 Dec 2022 (actual)
- First posted
- 28 Jan 2022 (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.
There are a limited number of studies examining the difficulty of reaching treatment related to the pandemic process and the general effects of the process in patients with chronic low back and neck pain. However, no study has been found that compares the effects of individuals actively carrying and not carrying the Covid-19 virus. For this reason, the aim of the study is to examine the effects of the pandemic process on the cognitive level, pain catastrophization, physical activity level and quality of life in individuals with chronic low back and neck pain.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Low back and neck pain group with experience of Covid-19 | – | Other: assessment of cognitive level, pain catastrophe, physical activity level and quality of life |
| Low back and neck pain group without experience of Covid-19 | – | Other: assessment of cognitive level, pain catastrophe, physical activity level and quality of life |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Patients with chronic low back and neck pain
Key inclusion criteria (4 listed)
- Those between the ages of 18-60,
- Having low back or neck pain lasting longer than 3 months,
- Having a history of Covid-19 (At least 6 weeks-post acute),
- Individuals with chronic low back and neck pain without a history of Covid-19 will be included.
Key exclusion criteria (7 listed)
- Those with an active diagnosis of Covid-19
- Having a rheumatological disease,
- Broken etc. severe deformity that may lead to nerve injury,
- Having a history of spinal surgery,
- Having neurological disease in addition to spinal pathology,
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 |
|---|---|---|
| assessment of cognitive level, pain catastrophe, physical activity level and quality of lifeassessment of cognitive level, pain catastrophe, physical activity level and quality of life | Other | Low back and neck pain group with experience of Covid-19, Low back and neck pain group without experience of Covid-19 |
Primary outcome
Pain Severity Assessment- Visual Analog Sacle
Time frame: through study completion, an average of 1 year
VAS indicates the level of pain that the person is currently experiencing with a vertical line on a plane. The pain felt by the person is marked as "0: I do not feel any pain", "10: I feel very severe pain". Scoring is based on measuring the vertical marking of the participant for pain marked on the plane with a ruler. The validity and reliability study of the scale was done by Price et al. made by
4 secondary outcomes
Assessment of Cognitive Level: Montreal Cognitive Assessment Scale (MOCA)
Time frame: 5 minutes, through study completion, an average of 1 year
Evaluation of Pain Catastrophization Level: Pain Catastrophization Scale
Time frame: 5 minutes, through study completion, an average of 1 year
Assessment of Physical Activity Level: International Physical Activity Questionnaire (UFAA)-Short Form
Time frame: 5 minutes, through study completion, an average of 1 year
Quality of Life Assessment: SF-36
Time frame: 5 minutes, through study completion, an average of 1 year
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 21 Nov 2023.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 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 4 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 21 Nov 2023. 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 Assessment- Visual Analog Sacle (time frame: through study completion, an average of 1 year). 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 21 Nov 2023.