Central SensitisationNCT06553118
Evaluation of the Effect of Central Sensitivity on Pain and Functional Status After Total Knee Joint Replacement Surgery
An observational study of Central Sensitisation and Postoperative Pain, run by Istanbul University.
Trial summary
The study is a prospective observational study designed to determine the effects of central sensitization on pain and functional status of patients before and after total knee joint replacement surgery. Read more about this study
- Who is it for?
- Ages 60 to 75 years
- Conditions the study is for
- Central Sensitisation, Postoperative Pain, Arthritis
- What is being tested?
- Total knee arthroplasty
- Type of treatment
- Surgery or procedure
- How many people
- 80 participants
- Where
- No sites listed yet
- Study dates
- 12 Aug 2024to 12 Feb 2026
- 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 60 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The study population consists of patients who were planned to have total knee arthroplasty for primary knee osteoarthritis
Who may be able to join
- Diagnosis of primary knee osteoarthritis
- Planning for total joint replacement surgery for the knee
- Being between the ages of 60-75
Who cannot join
- Having secondary knee osteoarthritis
- Planning for knee total joint prosthesis revision
- Having uncontrolled systemic disease (such as diabetes mellitus, hypertension, thyroid disease)
- Having neuromuscular disease
- Having a body mass index over 40
Trial locations and contacts
No sites are listed yet.
About this study
The study is a prospective observational study designed to determine the effects of central sensitization on pain and functional status of patients before and after total knee joint replacement surgery.
The aim of this study is to evaluate whether there is a difference in preoperative and postoperative pain and functional status between patients with and without central sensitization with knee osteoarthritis.
When the literature was reviewed, it was seen that central sensitization was one of the important mechanisms that caused pain in knee osteoarthritis, and it was determined that this had negative consequences in terms of postoperative pain and improvement in functional status. In this study, the effect of central sensitization on the results will be investigated by evaluating pain and functional status before and after knee total joint prosthesis in two groups of knee osteoarthritis patients, with and without central sensitization, and by comparing the groups.
- Conditions
- Central Sensitisation, Postoperative Pain, Arthritis
- Being tested
- Total knee arthroplasty
- Medical subject headings
- Pain, Postoperative, Arthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Total knee arthroplastyProcedure or surgery
Patients already admitted for total knee arthroplasty for knee osteoarthritis will have the procedure as planned
| Study group | Role | What they receive |
|---|---|---|
| Central Sensitization Group | Patients with central sensitization Receives: Procedure: Total knee arthroplasty | |
| Non-sensitized Group | Patients without central sensitization Receives: Procedure: Total knee arthroplasty |
What is being measured
The primary outcome is the main question the study is designed to answer.
Knee pain
Knee pain will be assessed with numerical rating scale, where the patients rate their pain on a scale from 0 to 10 where 0 means no pain and 10 means the most severe pain they can imagine.
Measured: Preoperative, 1 month postoperative and 3 months postoperative
Secondary outcomes (1)
Functional Status
Functionality of the patients will be assessed with WOMAC (Western Ontario and McMaster Universities Osteoarthritis Index). Responses are typically rated on a scale from 0 (none) to 4 (extreme). Higher scores indicate greater impairment.
Measured: Preoperative, 1 month postoperative and 3 months postoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2024
- Study start12 Aug 2024 (estimated)
- Primary completion12 Aug 2025 (estimated)
- Study completion12 Feb 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Central SensitisationStudies of the same condition, open and under way.
- More trials run by Istanbul 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Istanbul University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fatma Merih Akpınar, Istanbul University
- Investigators
- Fatma Merih Akpınar, Principal investigator, Istanbul Faculty of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06553118
- Sponsor's protocol ID
- 2024/1010
- Status last verified
- Aug 2024
- First submitted
- 10 Aug 2024
- Last updated
- 15 Aug 2024
- 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 15 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Effect of Central Sensitivity on Pain and Functional Status After Total Knee Joint Replacement Surgery
- ClinicalTrials.gov ID
- NCT06553118
- Acronym / sponsor ID
- 2024/1010
- Conditions
- Central Sensitisation, Postoperative Pain, Arthritis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Istanbul UniversityUniversity, hospital or other
- Study start
- 12 Aug 2024 (estimated)
- Primary completion
- 12 Aug 2025 (estimated)
- Study completion
- 12 Feb 2026 (estimated)
- First posted
- 14 Aug 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.
The study is a prospective observational study designed to determine the effects of central sensitization on pain and functional status of patients before and after total knee joint replacement surgery.
The aim of this study is to evaluate whether there is a difference in preoperative and postoperative pain and functional status between patients with and without central sensitization with knee osteoarthritis.
When the literature was reviewed, it was seen that central sensitization was one of the important mechanisms that caused pain in knee osteoarthritis, and it was determined that this had negative consequences in terms of postoperative pain and improvement in functional status. In this study, the effect of central sensitization on the results will be investigated by evaluating pain and functional status before and after knee total joint prosthesis in two groups of knee osteoarthritis patients, with and without central sensitization, and by comparing the groups.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Central Sensitization Group | – | Procedure: Total knee arthroplastyPatients with central sensitization |
| Non-sensitized Group | – | Procedure: Total knee arthroplastyPatients without central sensitization |
Who may qualify
- Ages
- 60 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population consists of patients who were planned to have total knee arthroplasty for primary knee osteoarthritis
Key inclusion criteria (3 listed)
- Diagnosis of primary knee osteoarthritis
- Planning for total joint replacement surgery for the knee
- Being between the ages of 60-75
Key exclusion criteria (5 listed)
- Having secondary knee osteoarthritis
- Planning for knee total joint prosthesis revision
- Having uncontrolled systemic disease (such as diabetes mellitus, hypertension, thyroid disease)
- Having neuromuscular disease
- Having a body mass index over 40
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 |
|---|---|---|
| Total knee arthroplastyPatients already admitted for total knee arthroplasty for knee osteoarthritis will have the procedure as planned | Procedure or surgery | Central Sensitization Group, Non-sensitized Group |
Primary outcome
Knee pain
Time frame: Preoperative, 1 month postoperative and 3 months postoperative
Knee pain will be assessed with numerical rating scale, where the patients rate their pain on a scale from 0 to 10 where 0 means no pain and 10 means the most severe pain they can imagine.
1 secondary outcome
Functional Status
Time frame: Preoperative, 1 month postoperative and 3 months postoperative
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Aug 2024.
- 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.
Fatma Merih Akpınar principal investigator
Istanbul Faculty of Medicine
Questions about this trial
What is this clinical trial studying?
An observational study of Central Sensitisation and Postoperative Pain, run by Istanbul 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 3 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 15 Aug 2024. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Fatma Merih Akpınar (+905333558843, merihcaliskan@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Knee pain (time frame: Preoperative, 1 month postoperative and 3 months postoperative). 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 15 Aug 2024.