Central SensitizationNCT07883824
Aquatic Exercise in Patients With Knee Osteoarthritis
A study testing Standard physical therapy and Hydrotherapy in people with Central Sensitization and Knee Osteoarthristis, run by Kirsehir Ahi Evran Universitesi at 1 site in Turkey (Türkiye).
Trial summary
The effect of aquatic exercise on central sensitization in patients with knee osteoarthritis are not fully known in the studies conducted to date. The aim of this study is to examine the effect of aquatic exercise on central sensitization and functional parameters in patients with knee osteoarthritis. Read more about this study
- Who is it for?
- Ages 40 to 65 years
- Conditions the study is for
- Central Sensitization, Knee Osteoarthristis, Aquatic
- What is being tested?
- Standard physical therapy and Hydrotherapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jun 2026to 1 Feb 2027
- Phase
- Interventional
- 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 40 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults aged 40-65
- Individuals diagnosed with knee osteoarthritis
- Individuals with no cognitive impairments
- Volunteers for the study
Who cannot join
- Individuals who have undergone knee surgery
- Individuals presenting with signs such as fracture, malignancy, or infection
- Pregnancy
- Individuals with cognitive impairments who are unable to express themselves.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Kirsehir Ahi Evran University, Kırşehir, Merkez 40100
Kırşehir, Merkez, 40000
Mensure ASLAN, +90 386 280 42 24, mensure.aa@outlook.com
About this study
Official title: The Effect of Aquatic Exercise on Central Sensitization and Functional Parameters in Patients With Knee Osteoarthritis: a Randomized Controlled Trial
The effect of aquatic exercise on central sensitization in patients with knee osteoarthritis are not fully known in the studies conducted to date. The aim of this study is to examine the effect of aquatic exercise on central sensitization and functional parameters in patients with knee osteoarthritis.
- Conditions
- Central Sensitization, Knee Osteoarthristis, Aquatic
- Being tested
- Standard physical therapy, Hydrotherapy
- Keywords
- balance, quality of life, depression, central sensitization, knee osteoarthritis, aquatic exercise
- Medical subject headings
- Depression, Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard physical therapyOther
Standard physical conventional therapy exercises for knee osteoarthritis.
HydrotherapyOther
Hydrotherapy (pool therapy) sessions tailored to standard physiotherapy for knee osteoarthritis.
| Study group | Role | What they receive |
|---|---|---|
| Standard physical group | Active comparator | Participants receive standard physical therapy sessions for knee osteoarthritis for 8 weeks, each session is 60minutes. Receives: Other: Standard physical therapy |
| Standard physical group and hydrotherapy | Experimental | • Participants receive standard physical therapy sessions combined with hydrotherapy (pool therapy) sessions for knee osteoarthritis for 8 weeks, each session is 60 minutes. Receives: Other: Standard physical therapy; Other: Hydrotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Central Sensitization
The Central Sensitization Inventory is a valid tool for assessing psychological and sensory factors associated with central pain sensitivity in patients with knee osteoarthritis. The Central Sensitization Inventory demonstrates moderate reliability in patients who have developed central sensitization due to knee osteoarthritis. Part A consists of 25 items that assess an individual's symptoms of central sensitization; it is scored using a 4-point Likert scale. Part B assesses whether the patient has received a diagnosis of another condition within the family of central sensitization syndromes from a physician. A high score indicates severe central sensitization.Number of Items: Section A of the scale, which is included in the assessment, consists of 25 items. Item Scoring: Each item uses a 5-point Likert-type scale, ranging from 0 to 4 points (0 = Never, 1 = Rarely, 2 = Sometimes, 3 = Often, 4 = Always). Minimum Score: 0; Maximum Score: 100
Measured: 8 weeks
Secondary outcomes (7)
Visual Analog Scale
Participants' pain intensity will be assessed. Pain intensity is indicated on a 10 cm straight line with anchor points representing "no pain" and "worst pain imaginable." The distance between the starting point and the point marked by the patient is measured in centimeters. An increase in this distance signifies an increase in pain intensity. This is an assessment method, ranging from 0 to 10 (or 0-100 mm), used to measure the severity of subjective symptoms-most commonly pain. A score of 0 indicates no pain; 1-3, mild pain; 4-6, moderate pain; 7-9, severe pain; and 10, unbearable, extreme pain.
Measured: 8 weeks
Knee Injury and Osteoarthritis Outcome Score
Knee-related quality of life scales for patients with knee osteoarthritis are tools used to assess pain, function, and activities of daily living. They comprise 42 items across five distinct subscales. A higher total score indicates extremely severe pain in the knee, restricted movement, and loss of function. Scores range from 0 points to 100 points.
Measured: 8 weeks
Algometer
Central sensitization is assessed by measuring the Pressure Pain Threshold (PPT). Pressure will be applied to the quadriceps muscle using an algometer until the patient perceives pain. The procedure will be performed three times at 20-second intervals, and the average value will be calculated. Subsequently, the patient will immerse their foot and ankle in cold water (1-4°C) for 60-120 seconds. Following this, the PPT will be measured again at the same point on the quadriceps muscle using the algometer, and the total score will be calculated. A high score indicates that central sensitization is not present. An algometer is a physical device that provides objective measurements. Consequently, the results obtained from the device are not scores, but rather values expressed in units of applied pressure. A low score, on the other hand, shows that central sensitization is present.
Measured: 8 weeks
SF-36 Quality of Life Scale (36-Item Short Form Health Survey)
It measures an individual's quality of life. The questionnaire consists of 36 items and 8 sub-parameters (physical functioning, bodily pain, limitations due to physical problems, emotional well-being, social functioning, energy/fatigue, and general health perception). A high score on the SF-36 questionnaire indicates that the patient's health-related quality of life is very good. Based on the data obtained from the survey, scores ranging from 0 to 100 are calculated separately for 8 distinct sub-dimensions and for the 2 main components into which these dimensions are grouped.
Measured: 8 weeks
Biodex Balance Scale
Patients' static balance will be measured using the Biodex Balance System®. Patients will be asked to maintain a balanced standing position on the static platform. The anteroposterior index, mediolateral index, and overall index will be evaluated with eyes open and eyes closed. Each position will be tested three times, and the average value will be recorded. For dynamic balance, level two of the 8-level resistance scale (1 = least stable, 8 = most stable) will be used.
Measured: 8 weeks
Beck Depression Inventory
It is widely used to assess the severity of depression in patients. It is a questionnaire consisting of 21 items. The questionnaire has a total score ranging from 0 to 63 points. A high total score indicates a high level of depression severity.
Measured: 8 weeks
Mini-Mental State Examination
The Mini-Mental test, which measures cognitive functions quickly and in a standardized manner, will be administered in the clinical setting; memory, attention, language, and visuospatial skills are assessed. The total score for the 11 items across these five domains ranges from 0 to 30. A high score in the assessment indicates normal mental functions, while a low score points to cognitive impairment or dementia.
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Oct 2026
- Study start1 Jun 2026
- Primary completion1 Dec 2026 (estimated)
- Study completion1 Feb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Central SensitizationStudies of the same condition, open and under way.
- More trials run by Kirsehir Ahi Evran UniversitesiThe 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kirsehir Ahi Evran Universitesi
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mensure Aslan, Kirsehir Ahi Evran Universitesi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07883824
- Sponsor's protocol ID
- 2026/81
- Status last verified
- Oct 2026
- First submitted
- 13 Oct 2026
- Last updated
- 4 Nov 2026
- Results posted
- No
- Data monitoring committee
- Yes
- 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 4 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Aquatic Exercise on Central Sensitization and Functional Parameters in Patients With Knee Osteoarthritis: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07883824
- Acronym / sponsor ID
- 2026/81
- Conditions
- Central Sensitization, Knee Osteoarthristis, Aquatic
- Keywords
- balance, quality of life, depression, central sensitization, knee osteoarthritis, aquatic exercise
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Kirsehir Ahi Evran UniversitesiUniversity, hospital or other
- Study start
- 1 Jun 2026 (actual)
- Primary completion
- 1 Dec 2026 (estimated)
- Study completion
- 1 Feb 2027 (estimated)
- First posted
- 20 Oct 2026 (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 effect of aquatic exercise on central sensitization in patients with knee osteoarthritis are not fully known in the studies conducted to date. The aim of this study is to examine the effect of aquatic exercise on central sensitization and functional parameters in patients with knee osteoarthritis.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard physical group | Active comparator | Other: Standard physical therapyParticipants receive standard physical therapy sessions for knee osteoarthritis for 8 weeks, each session is 60minutes. |
| Standard physical group and hydrotherapy | Experimental | Other: Standard physical therapy, Other: Hydrotherapy• Participants receive standard physical therapy sessions combined with hydrotherapy (pool therapy) sessions for knee osteoarthritis for 8 weeks, each session is 60 minutes. |
Who may qualify
- Ages
- 40 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Adults aged 40-65
- Individuals diagnosed with knee osteoarthritis
- Individuals with no cognitive impairments
- Volunteers for the study
Key exclusion criteria (4 listed)
- Individuals who have undergone knee surgery
- Individuals presenting with signs such as fracture, malignancy, or infection
- Pregnancy
- Individuals with cognitive impairments who are unable to express themselves.
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 |
|---|---|---|
| Standard physical therapyStandard physical conventional therapy exercises for knee osteoarthritis. | Other | Standard physical group, Standard physical group and hydrotherapy |
| HydrotherapyHydrotherapy (pool therapy) sessions tailored to standard physiotherapy for knee osteoarthritis. | Other | Standard physical group and hydrotherapy |
Primary outcome
Central Sensitization
Time frame: 8 weeks
The Central Sensitization Inventory is a valid tool for assessing psychological and sensory factors associated with central pain sensitivity in patients with knee osteoarthritis. The Central Sensitization Inventory demonstrates moderate reliability in patients who have developed central sensitization due to knee osteoarthritis. Part A consists of 25 items that assess an individual's symptoms of central sensitization; it is scored using a 4-point Likert scale. Part B assesses whether the patient has received a diagnosis of another condition within the family of central sensitization syndromes from a physician. A high score indicates severe central sensitization.Number of Items: Section A of the scale, which is included in the assessment, consists of 25 items. Item Scoring: Each item uses a 5-point Likert-type scale, ranging from 0 to 4 points (0 = Never, 1 = Rarely, 2 = Sometimes, 3 = Often, 4 = Always). Minimum Score: 0; Maximum Score: 100
7 secondary outcomes
Visual Analog Scale
Time frame: 8 weeks
Knee Injury and Osteoarthritis Outcome Score
Time frame: 8 weeks
Algometer
Time frame: 8 weeks
SF-36 Quality of Life Scale (36-Item Short Form Health Survey)
Time frame: 8 weeks
Biodex Balance Scale
Time frame: 8 weeks
Beck Depression Inventory
Time frame: 8 weeks
Mini-Mental State Examination
Time frame: 8 weeks
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 4 Nov 2026.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Standard physical therapy and Hydrotherapy in people with Central Sensitization and Knee Osteoarthristis, run by Kirsehir Ahi Evran Universitesi 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 4 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: looking for participants now, as of the sponsor's last update on 4 Nov 2026. 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?
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 Mensure Aslan (90 386 280 50 31, mensure.aa@outlook.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Central Sensitization (time frame: 8 weeks). 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 4 Nov 2026.