Osteoarthritis, KneeNCT05928351
Pain Neuroscience Education in Patients With Total Knee Arthroplasty
A study testing Pain Neuroscience Education and Standard Physiotherapy Program (SPP) in people with Osteoarthritis, Knee, run by Ahi Evran University Education and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
The aim of Pain Neuroscience Education (PNE) is to explain to patients the biological and physiological processes involved in a pain experience and, more importantly, defocus the issues associated with the anatomical structures. Read more about this study
- Who is it for?
- Ages 40 to 80 years
- Conditions the study is for
- Osteoarthritis, Knee
- What is being tested?
- Pain Neuroscience Education and Standard Physiotherapy Program (SPP)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jun 2023to 1 Dec 2023
- 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 40 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Having a body mass index between 19-40 kg/m2,
- Having had a unilateral TKA,
- Knee pain score to be 4 and above daily according to the visual analog scale,
- Ability to read, speak and understand Turkish.
Who cannot join
- Prosthesis disorders requiring re-surgery,
- Having visual, auditory and cognitive impairment,
- Secondary TKA such as rheumatoid arthritis,
- Acute pain,
- Pregnancy, drug and alcohol use,
- Having bilateral TKA,
- Not volunteering to participate in the study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Investigation of the Efficacy of Neuroscience Pain Education in Patients With Total Knee Arthroplasty
The aim of Pain Neuroscience Education (PNE) is to explain to patients the biological and physiological processes involved in a pain experience and, more importantly, defocus the issues associated with the anatomical structures. PNE provides compelling evidence in reducing pain, disability, pain catastrophization, and limited physical movement in musculoskeletal problems. Knee osteoarthritis (KOA) is a very common painful musculoskeletal problem, especially in people over 50 years old, and lead to decrease in knee range of motion. Despite costly arthroscopic surgeries and long-term physiotherapy treatments, poor outcomes are common. The lack of satisfactory results suggests that some practices should be revised. Although PNE could be useful as an intervention, to our knowledge, there is no randomized controlled trial in the literature investigating the effects of PNE in patients with a KOA. Therefore, we aimed to examine the effectiveness of PNE on clinical outcomes in patients with KOA.
- Conditions
- Osteoarthritis, Knee
- Being tested
- Pain Neuroscience Education, Standard Physiotherapy Program (SPP)
- Keywords
- pain neuroscience education, knee, osteoarthritis
- Medical subject headings
- Osteoarthritis, Knee, Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pain Neuroscience EducationOther
The experimental group will follow a PNE protocol based on previous procedure for 6 weeks in addition to the standard physiotherapy program (SPP) in postoperative period.
Each PNE session will take 45-60 min. PNE will be conducted in line with international guidelines and covered the neurophysiology of pain, transition from acute to chronic pain, and the nervous system ability to modulate the pain experience.
Standard Physiotherapy Program (SPP)Other
The control group will follow a SPP. The 45-minute-long treatment sessions will be held 5 days per week. The treatment program will be organized in 3 periods as 0-2 weeks, 3-4 weeks and 5-6 weeks. The overall treatment program will include scar massage, patellar mobilization, coldpack, ankle pump, quadriceps and hamstring strengthening, hip range of motion, hip strengthening exercises, squat, ascending and descending stairs, walking training. All exercises will be 10 repetitions x 2 sets.
| Study group | Role | What they receive |
|---|---|---|
| PNE Group | Experimental | Pain Neuroscience Education + Standard Physiotherapy Program Receives: Other: Pain Neuroscience Education; Other: Standard Physiotherapy Program (SPP) |
| Control Group | Active comparator | Standard Physiotherapy Program Receives: Other: Standard Physiotherapy Program (SPP) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain severity
Visual Analogue Scale (0-10, higher means worse)
Measured: Baseline
Pain severity change is being assessed
Visual Analogue Scale (0-10, higher means worse)
Measured: 6 week
Pain and Function
Knee Injury and Osteoarthritis Outcome Score (0-100, higher means better)
Measured: Baseline
Pain and Function change are being assessed
Knee Injury and Osteoarthritis Outcome Score (0-100, higher means better)
Measured: 6 week
Pain and Function
Western Ontario and McMaster Universities Arthritis Index (0-96, higher means worse)
Measured: Baseline
Pain and Function change are being assessed
Western Ontario and McMaster Universities Arthritis Index (0-96, higher means worse)
Measured: 6 week
Secondary outcomes (10)
Pain Catastrophizing
Pain Catastrophizing Scale (0-52, higher means worse)
Measured: Baseline
Pain Catastrophizing change is being assessed
Pain Catastrophizing Scale (0-52, higher means worse)
Measured: 6 week
Kinesiophobia
Tampa Scale of Kinesiophobia (17-68, higher means worse)
Measured: Baseline
Kinesiophobia change is being assessed
Tampa Scale of Kinesiophobia (17-68, higher means worse)
Measured: 6 week
Level of quality of life
Short Form-12 (0-100, higher means better)
Measured: Baseline
Level of quality of life change is being assessed
Short Form-12 (0-100, higher means better)
Measured: 6 week
Anxiety and Depression
Hospital Anxiety Depression Scale (0-21, higher means worse)
Measured: Baseline
Anxiety and Depression change is being assessed
Hospital Anxiety Depression Scale (0-21, higher means worse)
Measured: 6 week
Physical Function
40 meter walking test (in seconds, less is better)
Measured: Baseline
Physical Function change is being assessed
40 meter walking test (in seconds, less is better)
Measured: 6 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jul 2023
- Study start1 Jun 2023
- Primary completion1 Nov 2023
- Study completion1 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Osteoarthritis, 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
- Model description
- Randomized
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ahi Evran University Education and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Abdulhamit Tayfur, Ahi Evran University Education and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05928351
- Sponsor's protocol ID
- 2023/605
- Status last verified
- Jan 2024
- First submitted
- 15 Jun 2023
- Last updated
- 17 Jan 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Louw A, Diener I, Butler DS, Puentedura EJ. The effect of neuroscience education on pain, disability, anxiety, and stress in chronic musculoskeletal pain. Arch Phys Med Rehabil. 2011 Dec;92(12):2041-56. doi: 10.1016/j.apmr.2011.07.198.
PubMed 22133255Louw A PT, PhD, Zimney K PT, DPT, Reed J PT, DPT, Landers M PT, DPT, PhD, Puentedura EJ PT, DPT, PhD. Immediate preoperative outcomes of pain neuroscience education for patients undergoing total knee arthroplasty: A case series. Physiother Theory Pract. 2019 Jun;35(6):543-553. doi: 10.1080/09593985.2018.1455120. Epub 2018 Mar 28.
PubMed 29589782Tayfur A, Ozyurt F, Kodak MI, Cakmak MF, Ozsoy G, Cigdem Karacay B, Ozsoy I, Basat HC, Kararti C. The efficacy of pain neuroscience education in patients after total knee arthroplasty: a single blind randomized controlled trial. Physiother Theory Pract. 2025 Dec;41(12):2513-2523. doi: 10.1080/09593985.2025.2526025. Epub 2025 Jul 1.
PubMed 40590360
Study at a glance
From the registry record, last updated by the sponsor on 17 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of the Efficacy of Neuroscience Pain Education in Patients With Total Knee Arthroplasty
- ClinicalTrials.gov ID
- NCT05928351
- Acronym / sponsor ID
- 2023/605
- Conditions
- Osteoarthritis, Knee
- Keywords
- pain neuroscience education, knee, osteoarthritis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- Ahi Evran University Education and Research HospitalUniversity, hospital or other
- Study start
- 1 Jun 2023 (actual)
- Primary completion
- 1 Nov 2023 (actual)
- Study completion
- 1 Dec 2023 (actual)
- First posted
- 3 Jul 2023 (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 aim of Pain Neuroscience Education (PNE) is to explain to patients the biological and physiological processes involved in a pain experience and, more importantly, defocus the issues associated with the anatomical structures. PNE provides compelling evidence in reducing pain, disability, pain catastrophization, and limited physical movement in musculoskeletal problems. Knee osteoarthritis (KOA) is a very common painful musculoskeletal problem, especially in people over 50 years old, and lead to decrease in knee range of motion. Despite costly arthroscopic surgeries and long-term physiotherapy treatments, poor outcomes are common. The lack of satisfactory results suggests that some practices should be revised. Although PNE could be useful as an intervention, to our knowledge, there is no randomized controlled trial in the literature investigating the effects of PNE in patients with a KOA. Therefore, we aimed to examine the effectiveness of PNE on clinical outcomes in patients with KOA.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized
| Arm | Type | Receives |
|---|---|---|
| PNE Group | Experimental | Other: Pain Neuroscience Education, Other: Standard Physiotherapy Program (SPP)Pain Neuroscience Education + Standard Physiotherapy Program |
| Control Group | Active comparator | Other: Standard Physiotherapy Program (SPP)Standard Physiotherapy Program |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Having a body mass index between 19-40 kg/m2,
- Having had a unilateral TKA,
- Knee pain score to be 4 and above daily according to the visual analog scale,
- Ability to read, speak and understand Turkish.
Key exclusion criteria (7 listed)
- Prosthesis disorders requiring re-surgery,
- Having visual, auditory and cognitive impairment,
- Secondary TKA such as rheumatoid arthritis,
- Acute pain,
- Pregnancy, drug and alcohol use,
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 |
|---|---|---|
| Pain Neuroscience EducationThe experimental group will follow a PNE protocol based on previous procedure for 6 weeks in addition to the standard physiotherapy program (SPP) in postoperative period. Each PNE session will take 45-60 min. PNE will be conducted in line with international guidelines and covered the neurophysiology of pain, transition from acute to chronic pain, and the nervous system ability to modulate the pain experience. | Other | PNE Group |
| Standard Physiotherapy Program (SPP)The control group will follow a SPP. The 45-minute-long treatment sessions will be held 5 days per week. The treatment program will be organized in 3 periods as 0-2 weeks, 3-4 weeks and 5-6 weeks. The overall treatment program will include scar massage, patellar mobilization, coldpack, ankle pump, quadriceps and hamstring strengthening, hip range of motion, hip strengthening exercises, squat, ascending and descending stairs, walking training. All exercises will be 10 repetitions x 2 sets. | Other | Control Group, PNE Group |
Primary outcome
Pain severity
Time frame: Baseline
Visual Analogue Scale (0-10, higher means worse)
Pain severity change is being assessed
Time frame: 6 week
Visual Analogue Scale (0-10, higher means worse)
Pain and Function
Time frame: Baseline
Knee Injury and Osteoarthritis Outcome Score (0-100, higher means better)
Pain and Function change are being assessed
Time frame: 6 week
Knee Injury and Osteoarthritis Outcome Score (0-100, higher means better)
Pain and Function
Time frame: Baseline
Western Ontario and McMaster Universities Arthritis Index (0-96, higher means worse)
Pain and Function change are being assessed
Time frame: 6 week
Western Ontario and McMaster Universities Arthritis Index (0-96, higher means worse)
10 secondary outcomes
Pain Catastrophizing
Time frame: Baseline
Pain Catastrophizing change is being assessed
Time frame: 6 week
Kinesiophobia
Time frame: Baseline
Kinesiophobia change is being assessed
Time frame: 6 week
Level of quality of life
Time frame: Baseline
Level of quality of life change is being assessed
Time frame: 6 week
Anxiety and Depression
Time frame: Baseline
Anxiety and Depression change is being assessed
Time frame: 6 week
Physical Function
Time frame: Baseline
Physical Function change is being assessed
Time frame: 6 week
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 17 Jan 2024.
- Background: PubMed 22133255Louw A, Diener I, Butler DS, Puentedura EJ. The effect of neuroscience education on pain, disability, anxiety, and stress in chronic musculoskeletal pain. Arch Phys Med Rehabil. 2011 Dec;92(12):2041-56. doi: 10.1016/j.apmr.2011.07.198.
- Background: PubMed 29589782Louw A PT, PhD, Zimney K PT, DPT, Reed J PT, DPT, Landers M PT, DPT, PhD, Puentedura EJ PT, DPT, PhD. Immediate preoperative outcomes of pain neuroscience education for patients undergoing total knee arthroplasty: A case series. Physiother Theory Pract. 2019 Jun;35(6):543-553. doi: 10.1080/09593985.2018.1455120. Epub 2018 Mar 28.
- Derived from this study: PubMed 40590360Tayfur A, Ozyurt F, Kodak MI, Cakmak MF, Ozsoy G, Cigdem Karacay B, Ozsoy I, Basat HC, Kararti C. The efficacy of pain neuroscience education in patients after total knee arthroplasty: a single blind randomized controlled trial. Physiother Theory Pract. 2025 Dec;41(12):2513-2523. doi: 10.1080/09593985.2025.2526025. Epub 2025 Jul 1.
- 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.
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 Pain Neuroscience Education and Standard Physiotherapy Program (SPP) in people with Osteoarthritis, Knee, run by Ahi Evran University 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 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 17 Jan 2024. 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 (time frame: Baseline). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05928351, which also lists 3 linked publications.
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 17 Jan 2024.