Effect of Foot Massage on Pain and Analgesic Consumption in Total Knee Prosthesis

NCT07126340 | Recruiting

• 1 other identifier: Alev Keskin
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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). 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.

Conditions

Knee Osteoarthritis

Keywords

Cold Therapy; Total Knee Arthroplasty; Postoperative Pain; Foot Massage; Analgesic Consumption

Outcome Measures

Primary Outcomes (2)

• 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.

  One minute

• Brief Pain

  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).

  Five minutes

Secondary Outcomes (1)

• Newcastle Nursing Satisfaction Scale

  Ten minutes

Study Arms (2)

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.

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.

Other: Cold Application

Interventions

Foot Massage and Cold Application OTHER

The patient will receive both cold application and foot massage after total knee arthroplasty.

Effect of Foot Massage and Cold Application on Postoperative Pain

Cold Application OTHER

After total knee arthroplasty, the patient will receive routine cold application.

Effect of Cold Application on Postoperative Pain

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Presence of any intellectual disability or psychiatric disorder
• History of diabetes
• Presence of neurological or cerebrovascular disease
• Diagnosis of deep vein thrombosis

Sponsors & Collaborators

• Alev Keskin: lead

Study Sites (1)

Çukurova Üniversitesi

Adana, University, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Osteoarthritis, Knee; Pain, Postoperative

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: RN, MSc Nurse

Study Record Dates

• First Submitted: April 26, 2025
• First Posted: August 17, 2025
• Study Start: August 18, 2025
• Primary Completion: May 31, 2026
• Study Completion: June 1, 2026
• Last Updated: June 9, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)