Knee OsteoarthritisNCT07126340
Effect of Foot Massage on Pain and Analgesic Consumption in Total Knee Prosthesis
A study testing Foot Massage and Cold Application and Cold Application in people with Knee Osteoarthritis, run by Alev Keskin at 1 site in Turkey (Türkiye).
Trial summary
This randomized controlled trial aims to examine the effects of foot massage combined with cold application on postoperative pain, patient satisfaction, and analgesic consumption in individuals undergoing Total Knee Arthroplasty (TKA). Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Knee Osteoarthritis
- What is being tested?
- Foot Massage and Cold Application and Cold Application
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 18 Aug 2025to 26 Jun 2026
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Being 18 years or older
- Ability to speak Turkish
- No visual or hearing impairment
- No cognitive disability
- Undergoing unilateral knee replacement surgery
- Volunteering to participate in the study
- Being performed by the same doctor
- Patients who received regional anesthesia (spinal or epidural) during surgery
Who cannot join
- Presence of any intellectual disability or psychiatric disorder
- History of diabetes
- Presence of neurological or cerebrovascular disease
- Diagnosis of deep vein thrombosis
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Foot Massage on Pain, Satisfaction, and Analgesic Consumption in Patients Undergoing Total Knee Arthroplasty
This randomized controlled trial aims to examine the effects of foot massage combined with cold application on postoperative pain, patient satisfaction, and analgesic consumption in individuals undergoing Total Knee Arthroplasty (TKA). The study will be conducted in the Orthopedics and Traumatology Department of Çukurova University Balcalı Hospital, which includes an 18-bed orthopedic unit.
Eligible patients will be randomly assigned to either the intervention group or the control group.
Read more
- Intervention group: Patients will receive both cold application and foot massage. Cold therapy will be administered for 20 minutes every 2 hours for the first 48 hours postoperatively. Foot massage will be performed twice daily (morning and evening) for two days following drain removal, using standardized massage techniques.
- Control group: Patients will receive only cold application following the same schedule and procedure as the intervention group.
Data will be collected using the Patient Information Form, the Short Form of the Brief Pain Inventory, the Numeric Rating Scale, and the Newcastle Satisfaction with Nursing Care Scale. Statistical analyses will be conducted using SPSS, and findings will be interpreted at a 95% confidence level (p < 0.05).
Ethical approval has been granted by the Çukurova University Non-Interventional Clinical Research Ethics Committee. Institutional permission will be obtained prior to data collection. Participation will be voluntary, and all data will be treated confidentially.
- Conditions
- Knee Osteoarthritis
- Being tested
- Foot Massage and Cold Application, Cold Application
- Keywords
- Cold Therapy, Total Knee Arthroplasty, Postoperative Pain, Foot Massage, Analgesic Consumption
- Medical subject headings
- Osteoarthritis, Knee, Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Foot Massage and Cold ApplicationOther
The patient will receive both cold application and foot massage after total knee arthroplasty.
Cold ApplicationOther
After total knee arthroplasty, the patient will receive routine cold application.
| Study group | Role | What they receive |
|---|---|---|
| Effect of Foot Massage and Cold Application on Postoperative Pain | Active comparator | The cold application protocol will be initiated upon the patient's arrival at the clinic after surgery. Cold therapy will be applied for 20 minutes every two hours and will continue for 48 hours postoperatively. In addition to cold therapy, patients will receive foot massage performed according to a standard technique. The massage will include effleurage (stroking and gliding), petrissage (kneading), and friction maneuvers. Vaseline will be used during the massage to minimize skin friction and facilitate smooth hand movements. Receives: Other: Foot Massage and Cold Application |
| Effect of Cold Application on Postoperative Pain | Active comparator | The cold application protocol will be started from the moment the patient comes to the clinic after surgery. Cold application will be done for 20 minutes and every 2 hours. This application will be continued for the patient for 48 hours from the postoperative period. Receives: Other: Cold Application |
What is being measured
The primary outcome is the main question the study is designed to answer.
Numeric Rating Scale,
The patient is asked to choose the number that best reflects the pain intensity, 0=no pain, 10= equal to the worst (unbearable) pain.
Measured: One minute
Brief Pain Inventory
The inhibition of individuals' daily living activities due to pain experienced in the last 24 hours is similarly assessed using a numerical scale (0 = not affected at all, 10 = completely affected).
Measured: Five minutes
Secondary outcomes (1)
Newcastle Satisfaction with Nursing Care Scale
The evaluation of all the items marked on the scale is converted to 100 after the pu moments are collected and made over 0-100 points. The fact that the total score is 100 indicates that all dimensions of nursing care are satisfied.
Measured: Ten minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Aug 2025
- Study start18 Aug 2025
- Primary completion31 May 2026
- Study completion26 Jun 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Knee OsteoarthritisStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alev Keskin
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Alev Keskin, Cukurova University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07126340
- Sponsor's protocol ID
- Alev Keskin
- Status last verified
- Sep 2026
- First submitted
- 26 Apr 2025
- Last updated
- 30 Sep 2026
- Results posted
- 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 30 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Foot Massage on Pain, Satisfaction, and Analgesic Consumption in Patients Undergoing Total Knee Arthroplasty
- ClinicalTrials.gov ID
- NCT07126340
- Acronym / sponsor ID
- Alev Keskin
- Conditions
- Knee Osteoarthritis
- Keywords
- Cold Therapy, Total Knee Arthroplasty, Postoperative Pain, Foot Massage, Analgesic Consumption
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Alev KeskinUniversity, hospital or other
- Study start
- 18 Aug 2025 (actual)
- Primary completion
- 31 May 2026 (actual)
- Study completion
- 26 Jun 2026 (actual)
- First posted
- 17 Aug 2025 (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.
This randomized controlled trial aims to examine the effects of foot massage combined with cold application on postoperative pain, patient satisfaction, and analgesic consumption in individuals undergoing Total Knee Arthroplasty (TKA). The study will be conducted in the Orthopedics and Traumatology Department of Çukurova University Balcalı Hospital, which includes an 18-bed orthopedic unit.
Eligible patients will be randomly assigned to either the intervention group or the control group.
- Intervention group: Patients will receive both cold application and foot massage. Cold therapy will be administered for 20 minutes every 2 hours for the first 48 hours postoperatively. Foot massage will be performed twice daily (morning and evening) for two days following drain removal, using standardized massage techniques.
- Control group: Patients will receive only cold application following the same schedule and procedure as the intervention group.
Data will be collected using the Patient Information Form, the Short Form of the Brief Pain Inventory, the Numeric Rating Scale, and the Newcastle Satisfaction with Nursing Care Scale. Statistical analyses will be conducted using SPSS, and findings will be interpreted at a 95% confidence level (p < 0.05).
Ethical approval has been granted by the Çukurova University Non-Interventional Clinical Research Ethics Committee. Institutional permission will be obtained prior to data collection. Participation will be voluntary, and all data will be treated confidentially.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Effect of Foot Massage and Cold Application on Postoperative Pain | Active comparator | Other: Foot Massage and Cold ApplicationThe cold application protocol will be initiated upon the patient's arrival at the clinic after surgery. Cold therapy will be applied for 20 minutes every two hours and will continue for 48 hours postoperatively. In addition to cold therapy, patients will receive foot massage performed according to a standard technique. The massage will include effleurage (stroking and gliding), petrissage (kneading), and friction maneuvers. Vaseline will be used during the massage to minimize skin friction and facilitate smooth hand movements. |
| Effect of Cold Application on Postoperative Pain | Active comparator | Other: Cold ApplicationThe cold application protocol will be started from the moment the patient comes to the clinic after surgery. Cold application will be done for 20 minutes and every 2 hours. This application will be continued for the patient for 48 hours from the postoperative period. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Being 18 years or older
- Ability to speak Turkish
- No visual or hearing impairment
- No cognitive disability
- Undergoing unilateral knee replacement surgery
Key exclusion criteria (4 listed)
- Presence of any intellectual disability or psychiatric disorder
- History of diabetes
- Presence of neurological or cerebrovascular disease
- Diagnosis of deep vein thrombosis
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 |
|---|---|---|
| Foot Massage and Cold ApplicationThe patient will receive both cold application and foot massage after total knee arthroplasty. | Other | Effect of Foot Massage and Cold Application on Postoperative Pain |
| Cold ApplicationAfter total knee arthroplasty, the patient will receive routine cold application. | Other | Effect of Cold Application on Postoperative Pain |
Primary outcome
Numeric Rating Scale,
Time frame: One minute
The patient is asked to choose the number that best reflects the pain intensity, 0=no pain, 10= equal to the worst (unbearable) pain.
Brief Pain Inventory
Time frame: Five minutes
The inhibition of individuals' daily living activities due to pain experienced in the last 24 hours is similarly assessed using a numerical scale (0 = not affected at all, 10 = completely affected).
1 secondary outcome
Newcastle Satisfaction with Nursing Care Scale
Time frame: Ten minutes
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 30 Sep 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. 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 Foot Massage and Cold Application and Cold Application in people with Knee Osteoarthritis, run by Alev Keskin 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 8 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 30 Sep 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?
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?
Numeric Rating Scale, (time frame: One minute). The study lists 2 primary outcomes in all. 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 30 Sep 2026.