Relaxation Treatment in Total Knee Arthroplasty

Effects of Progressive Muscle Relaxation Techniques on Pain, Sleeping Quality and Functional Levels After Total Knee Arthroplasty

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.

Study Overview

• Status: Completed
• Conditions: Exercise; Total Knee Arthroplasty; Relaxation; Joint
• Intervention / Treatment: Other: Standard Exercises; Other: Relaxation Treatment

• Study Type: Interventional
• Enrollment (Actual): 50
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 55 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Relaxation Treatment; Relaxation treatment (RT) is applied additional to standard physiotherapy treatment. RT includes 8 sessions (2 times a day, for four days after surgery) of relaxation exercises.	Other: 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; Other Names: Relaxation Treatment
Active Comparator: Standard Exercises; Standard postoperative rehabilitation program is applied to Control Group. Knee-based exercises were undertaken in supine (active- assisted knee flexion using a bandage, inner range quadriceps contractions, and straight-leg raises), seated (active-assisted knee flexion using the contralateral limb and inner range quadriceps contractions), and standing (hip and knee flexion, active hamstring curls, lunges on a step, hamstring stretches) postures.	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; Other Names: Standard Exercises

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain Level Change	Visual analog scale	Mean change from Postoperative day 1 to day 4 recorded

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Hacettepe University

Publications and helpful links

General Publications

• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2015
• Primary Completion (Actual): January 1, 2016
• Study Completion (Actual): January 1, 2017

Study Registration Dates

• First Submitted: April 6, 2021
• First Submitted That Met QC Criteria: April 10, 2021
• First Posted (Actual): April 14, 2021

Study Record Updates

• Last Update Posted (Actual): April 14, 2021
• Last Update Submitted That Met QC Criteria: April 10, 2021
• Last Verified: April 1, 2021

More Information

Terms related to this study

• Other Study ID Numbers: GO 15/77-22

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No