Clinical trial NCT04038918: The Effectiveness of Progressive Relaxation Exercises
Official title: The Effectiveness of Relaxation Exercises on Pain, Functional Outcomes and Muscle Strength in Patients With Total Knee Arthroplasty: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Functional Outcomes
Muscle Strength
Keywords: Total knee arthroplasty
progressive muscle relaxation exercise
pain
functional outcomes
muscle strength
Lead sponsor: Dokuz Eylul University
Sponsor class: OTHER
First posted: 2019-07-31
Enrollment: 106
Sex: ALL
Minimum age (years): 30
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: The purpose of this study is to investigate the effectiveness of progressive muscle relaxation (PMR) exercise on pain, functional outcomes and muscle strength in patients with TKA. Seventy patients with TKA are going to randomly assigned to intervention group and control group.

Detailed description: Total knee arthroplasty (TKA) is applied in end-stage osteoarthritis to reduce pain, improve functional ability, and provide greater health related quality of life. However, evidence showed that presence of severe pain, impaired functional outcomes and reduced muscle strength continue up to 6 to 12 month after surgery. Relaxation techniques such as progressive muscle relaxation exercise and rhythmic breathing have long been used in treating postoperative pain and for various health-related purposes. Although the number of studies that include relaxation techniques in treating postoperative pain is increasing, there isn't any study that investigate the effectiveness of progressive muscle relaxation exercise on pain, functional outcomes and muscle strength in patients with TKA.

The aim is to investigate the effectiveness of progressive muscle relaxation (PMR) exercise on pain, functional outcomes and muscle strength in patients with TKA.

Eligibility criteria: Inclusion Criteria:

* 30 years older above
* Preoperative diagnosis have to be knee osteoarthritis
* Have a primary total knee arthroplasty
* Able to understand Turkish instructions
* Willing and able to attend study

Exclusion Criteria:

* Revision total knee arthroplasty
* Unable to understand verbal and written instructions
* Having previously orthopaedic or neurological disorder that causes gait disturbance

Primary outcomes:
measure: The Numeric Pain Rating Scale
timeFrame: Postoperative three months
measure: Iowa Level of Assistance Scale
timeFrame: Postoperative three months
measure: Hospital for Special Surgery Knee Score
timeFrame: Postoperative three months
measure: 10 meter walk speed test
timeFrame: Postoperative three months
measure: Timed Up and Go (TUG)
timeFrame: Postoperative three months
measure: Muscle Strength
timeFrame: Postoperative three months
Secondary outcomes:
measure: Range of Motion
timeFrame: Postoperative three months
measure: The Hospital Anxiety and Depression Scale (HADS)
timeFrame: Postoperative three months
measure: Tampa Scale for Kinesiophobia (TSK)
timeFrame: Postoperative three months
measure: 12-Item Short Form Survey
timeFrame: Postoperative three months
Other outcomes:
Locations:
city: İzmir
country: Turkey
facility: Dokuz Eylul University
Study officials:
References:
citation: Kurtz S, Ong K, Lau E, Mowat F, Halpern M. Projections of primary and revision hip and knee arthroplasty in the United States from 2005 to 2030. J Bone Joint Surg Am. 2007 Apr;89(4):780-5. doi: 10.2106/JBJS.F.00222.
citation: Mizner RL, Petterson SC, Stevens JE, Vandenborne K, Snyder-Mackler L. Early quadriceps strength loss after total knee arthroplasty. The contributions of muscle atrophy and failure of voluntary muscle activation. J Bone Joint Surg Am. 2005 May;87(5):1047-53. doi: 10.2106/JBJS.D.01992.
citation: Baker PN, van der Meulen JH, Lewsey J, Gregg PJ; National Joint Registry for England and Wales. The role of pain and function in determining patient satisfaction after total knee replacement. Data from the National Joint Registry for England and Wales. J Bone Joint Surg Br. 2007 Jul;89(7):893-900. doi: 10.1302/0301-620X.89B7.19091.
citation: Bernatzky G, Presch M, Anderson M, Panksepp J. Emotional foundations of music as a non-pharmacological pain management tool in modern medicine. Neurosci Biobehav Rev. 2011 Oct;35(9):1989-99. doi: 10.1016/j.neubiorev.2011.06.005. Epub 2011 Jun 16.
citation: Baird CL, Sands L. A pilot study of the effectiveness of guided imagery with progressive muscle relaxation to reduce chronic pain and mobility difficulties of osteoarthritis. Pain Manag Nurs. 2004 Sep;5(3):97-104. doi: 10.1016/j.pmn.2004.01.003.