Osteo Arthritis KneeNCT04308967
Central Sensitization in Knee Osteoarthritis
A study testing balance exercises in people with Osteo Arthritis Knee and Central Sensitisation, run by Cukurova University at 1 site in Turkey (Türkiye).
Trial summary
The stimuli that activate nociceptors cause the dorsal horn of the spinal cord neurons to be sensitive to low-intensive afferent stimuli by decreasing the excitation threshold in patients with osteoarthritis. Although painful stimuli disappear, this situation causes pain to continue and a decrease in quality of life. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Osteo Arthritis Knee, Central Sensitisation
- What is being tested?
- balance exercises
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 20 Mar 2020to 30 Apr 2021
- Phase
- Interventional
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Being diagnosed with primary knee osteoarthritis according to American College of Rheumatology criteria,
- To be stage 2-3-4 knee osteoarthritis according to Kellgren Lawrence radiological staging,
- To be with a central sensitization score of over 40 according to the CSI,
- To be able to fill the scales and accept to participate in the study.
Who cannot join
- Being diagnosed with secondary osteoarthritis or inflammatory rheumatic disease,
- Having cognitive impairment,
- To have been treated with physiotherapy, with an intra articular injection or with a surgery from the knee within a maximum of six months
- Having various diseases that may adversely affect performing balance exercises,
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Cukurova University, Faculty of Medicine, Physical Medicine and Rehabilitation Clinic
Adana, 01100
About this study
Official title: Effects of Balance Exercises on Central Sensitization in Patients With Knee Osteoarthritis
The stimuli that activate nociceptors cause the dorsal horn of the spinal cord neurons to be sensitive to low-intensive afferent stimuli by decreasing the excitation threshold in patients with osteoarthritis. Although painful stimuli disappear, this situation causes pain to continue and a decrease in quality of life. Therefore, central sensitization should be considered and treated in patients with osteoarthritis. Although various pharmacological and electrophysiological agents are used in the treatment of central sensitization, adequate efficacy is not provided in patients with osteoarthritis. The aim of this study is to investigate the effects of balance exercises on central sensitization in patients with knee osteoarthritis.
- Conditions
- Osteo Arthritis Knee, Central Sensitisation
- Being tested
- balance exercises
- Keywords
- central sensitisation, osteoarthritis, balance exercises
- Medical subject headings
- Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
balance exercisesOther
Three-stage progressive balance exercises will be applied.
| Study group | Role | What they receive |
|---|---|---|
| Balance exercises and information | Experimental | Balance exercises six weeks and three days in a week and information about central sensitisation. Receives: Other: balance exercises |
| Information | No intervention | Information about central sensitisation. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Central Sensitization Inventory (CSI)
CSI consists of 2 parts as A and B. Part A contains 25 items associated with central sensitization symptoms, and the person is asked to score each item between 0 (never) and 4 (always) and total score ranges from 0-100. It is accepted that there is central sensitization in individuals over 40 points. Part B consists of 10 diseases. In this section, it is questioned whether she was diagnosed one or more of these 10 diseases. If any of these diseases exist, the person is excluded from the study.
Measured: Before intervention, change in CSI scores at sixth week, change in CSI scores at 3 months.
Secondary outcomes (3)
Berg Balance Scale (BBS)
In this scale, the patient is asked to perform 14 different activities. Every activity is scored between 0 (the worst)- 4 (the best) and a maximum of 56 points can be obtained.There is a correct proportion between the height of the score obtained and the balance.
Measured: Before intervention, change in BBS scores at sixth week, change in BBS scores at 3 months.
Western Ontario ve McMaster University Osteoarthritis Index (WOMAC)
It consists of three sections as pain, stiffness and physical function and a total of 24 questions and scoring for each question as 0 = none, 1 = mild, 2 = medium, 3 = severe, 4 = very severe. Total WOMAC rate increases as pain, stiffness and physical function deterioration increase
Measured: Before intervention, change in WOMAC scores at sixth week, change in WOMAC scores at 3 months.
Y Balance Test
Y Balance Test was used to assess the dynamic balance. This test is inexpensive and easy to transport which can be administered by therapists with different expertise and has been shown to have high reliability. In this test, patient exerts an effort to reach maximum distance in three different directions with the one leg while standing on the other leg.
Measured: Before intervention, change in Y balance test scores at sixth week, change in Y balance test scores at 3 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Mar 2020
- Study start20 Mar 2020
- Primary completion20 Apr 2021
- Study completion30 Apr 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Osteo Arthritis KneeStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cukurova University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Emre Tirasci, Cukurova University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04308967
- Sponsor's protocol ID
- 96/17
- Status last verified
- Oct 2022
- First submitted
- 12 Mar 2020
- Last updated
- 12 Oct 2022
- 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 12 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Balance Exercises on Central Sensitization in Patients With Knee Osteoarthritis
- ClinicalTrials.gov ID
- NCT04308967
- Acronym / sponsor ID
- 96/17
- Conditions
- Osteo Arthritis Knee, Central Sensitisation
- Keywords
- central sensitisation, osteoarthritis, balance exercises
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Cukurova UniversityUniversity, hospital or other
- Study start
- 20 Mar 2020 (actual)
- Primary completion
- 20 Apr 2021 (actual)
- Study completion
- 30 Apr 2021 (actual)
- First posted
- 16 Mar 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.
The stimuli that activate nociceptors cause the dorsal horn of the spinal cord neurons to be sensitive to low-intensive afferent stimuli by decreasing the excitation threshold in patients with osteoarthritis. Although painful stimuli disappear, this situation causes pain to continue and a decrease in quality of life. Therefore, central sensitization should be considered and treated in patients with osteoarthritis. Although various pharmacological and electrophysiological agents are used in the treatment of central sensitization, adequate efficacy is not provided in patients with osteoarthritis. The aim of this study is to investigate the effects of balance exercises on central sensitization in patients with knee osteoarthritis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Balance exercises and information | Experimental | Other: balance exercisesBalance exercises six weeks and three days in a week and information about central sensitisation. |
| Information | No intervention | –Information about central sensitisation. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Being diagnosed with primary knee osteoarthritis according to American College of Rheumatology criteria,
- To be stage 2-3-4 knee osteoarthritis according to Kellgren Lawrence radiological staging,
- To be with a central sensitization score of over 40 according to the CSI,
- To be able to fill the scales and accept to participate in the study.
Key exclusion criteria (4 listed)
- Being diagnosed with secondary osteoarthritis or inflammatory rheumatic disease,
- Having cognitive impairment,
- To have been treated with physiotherapy, with an intra articular injection or with a surgery from the knee within a maximum of six months
- Having various diseases that may adversely affect performing balance exercises,
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 |
|---|---|---|
| balance exercisesThree-stage progressive balance exercises will be applied. | Other | Balance exercises and information |
Primary outcome
Central Sensitization Inventory (CSI)
Time frame: Before intervention, change in CSI scores at sixth week, change in CSI scores at 3 months.
CSI consists of 2 parts as A and B. Part A contains 25 items associated with central sensitization symptoms, and the person is asked to score each item between 0 (never) and 4 (always) and total score ranges from 0-100. It is accepted that there is central sensitization in individuals over 40 points. Part B consists of 10 diseases. In this section, it is questioned whether she was diagnosed one or more of these 10 diseases. If any of these diseases exist, the person is excluded from the study.
3 secondary outcomes
Berg Balance Scale (BBS)
Time frame: Before intervention, change in BBS scores at sixth week, change in BBS scores at 3 months.
Western Ontario ve McMaster University Osteoarthritis Index (WOMAC)
Time frame: Before intervention, change in WOMAC scores at sixth week, change in WOMAC scores at 3 months.
Y Balance Test
Time frame: Before intervention, change in Y balance test scores at sixth week, change in Y balance test scores at 3 months.
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 12 Oct 2022.
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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?
A study testing balance exercises in people with Osteo Arthritis Knee and Central Sensitisation, run by Cukurova 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 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: finished, as of the sponsor's last update on 12 Oct 2022. 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?
Central Sensitization Inventory (CSI) (time frame: Before intervention, change in CSI scores at sixth week, change in CSI scores at 3 months.). 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 12 Oct 2022.