Clincosm LogoSign in Get a demo

Relaxation Treatment in Total Knee Arthroplasty

Sponsor
Hacettepe University (Other)
Overall Status
Completed
CT.gov ID
NCT04845204
Collaborator
(none)
50
Enrollment
2
Arms
24
Actual Duration (Months)

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
  • Other: Relaxation Treatment
  • Other: Standard Exercises
 N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
50 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Participant)
Primary Purpose:
Treatment
Official Title:
Effects of Progressive Muscle Relaxation Techniques on Pain, Sleeping Quality and Functional Levels After Total Knee Arthroplasty
Actual Study Start Date :
Jan 1, 2015
Actual Primary Completion Date :
Jan 1, 2016
Actual Study Completion Date :
Jan 1, 2017

Arms and Interventions

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 45ยบ 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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Pain Level Change [Mean change from Postoperative day 1 to day 4 recorded]

      Visual analog scale

    Secondary Outcome Measures

    1. Sleep Quality Change [Mean change from Postoperative day 1 to day 4 recorded]

      Visual analog scale

    2. Functional Outcomes Change [Mean change from Postoperative day4 to 6 weeks following surgery recorded]

      Timed Up and Go

    3. Functional Outcomes Change [Mean change from Postoperative day4 to 6 weeks following surgery recorded]

      Western Ontario McMaster Universities Osteoarthritis Index (WOMAC)

    4. Knee Range of Motion Change [Mean change from Postoperative day4 to 6 weeks following surgery recorded]

      Flexion and Extension

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    55 Years to 75 Years
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    No
    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.

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Hacettepe University

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    HANDE GUNEY, Associate Professor, Hacettepe University
    ClinicalTrials.gov Identifier:
    NCT04845204
    Other Study ID Numbers:
    • GO 15/77-22
    First Posted:
    Apr 14, 2021
    Last Update Posted:
    Apr 14, 2021
    Last Verified:
    Apr 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No

    Study Results

    No Results Posted as of Apr 14, 2021