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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04845204
Other study ID # GO 15/77-22
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date January 1, 2015
Est. completion date January 1, 2017

Study information

Verified date April 2021
Source Hacettepe University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Surgical techniques and treatment methods of the arthroplasty have been improved and the results after total knee arthroplasty (TKA) are generally good. However, some patients have suboptimal postoperative results with respect to pain and physical functioning and may not be satisfied with the results of their TKA. Psychological symptoms were found to be associated with these suboptimal results. The aim of the present study is to determine weather relaxation techniques had beneficial effects on pain, sleeping quality, functional status and physiological symptoms in TKA patients during their hospital stay.


Recruitment information / eligibility

Status Completed
Enrollment 50
Est. completion date January 1, 2017
Est. primary completion date January 1, 2016
Accepts healthy volunteers No
Gender Female
Age group 55 Years to 75 Years
Eligibility Inclusion Criteria: - primary knee osteoarthritis, Female Patients who are scheduled for unilateral Total Knee Arthroplasty surgery, were included in the study. Exclusion Criteria: - having a previous knee or hip surgery or fracture, diagnosis of rheumatoid arthritis, severe obesity (BMI>40 kg/m2), sensory and motor disorders in the operated limb, inability to understand pain assessment.

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Relaxation Treatment
Relaxation Group recieve progressive muscle relaxation exercises additional to the standard exercises. The relaxation exercises are applied two times a day till the discharge day starting on the postoperative day one. Progressive muscle relaxation included the relaxing of different muscle groups along with deep breathing. The maximal contraction period consist of the contraction of muscle groups around ankle, calf, knee, hip, lumbar, thoracic and cervical regions, shoulder, arm, forearm for 5 s and continued with a relaxation period for 30 s while focusing on breathing. These two periods ware repeated for each muscle groups and lasted approximately 30 min
Standard Exercises
The physiotherapy protocol is applied under the supervision of the same physiotherapist within a progressive manner immediately after surgery. Continued passive range of motion is applied twice a day starting with 45º of knee flexion range of motion and increased gradually as tolerated. All patients performed same isometric, isotonic and active exercises. Patients were instructed to bear weight as tolerated on the postoperative day 1

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Hacettepe University

References & Publications (2)

Koken M, Guclu B. The Effects of Total Knee Arthroplasty on Sleep Quality. Malays Orthop J. 2019 Jul;13(2):11-14. doi: 10.5704/MOJ.1907.002. — View Citation

Schache MB, McClelland JA, Webster KE. Does the addition of hip strengthening exercises improve outcomes following total knee arthroplasty? A study protocol for a randomized trial. BMC Musculoskelet Disord. 2016 Jun 13;17:259. doi: 10.1186/s12891-016-1104-x. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Pain Level Change Visual analog scale Mean change from Postoperative day 1 to day 4 recorded
Secondary Sleep Quality Change Visual analog scale Mean change from Postoperative day 1 to day 4 recorded
Secondary Functional Outcomes Change Timed Up and Go Mean change from Postoperative day4 to 6 weeks following surgery recorded
Secondary Functional Outcomes Change Western Ontario McMaster Universities Osteoarthritis Index (WOMAC) Mean change from Postoperative day4 to 6 weeks following surgery recorded
Secondary Knee Range of Motion Change Flexion and Extension Mean change from Postoperative day4 to 6 weeks following surgery recorded
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