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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT00797875
Other study ID # 200803064R
Secondary ID
Status Not yet recruiting
Phase N/A
First received November 24, 2008
Last updated November 24, 2008
Start date December 2008
Est. completion date December 2008

Study information

Verified date November 2008
Source National Taiwan University Hospital
Contact Shiun-Jeng Lin
Phone 0939803219
Email seanjeng2000@yahoo.com.tw
Is FDA regulated No
Health authority Taiwan: Department of Health
Study type Interventional

Clinical Trial Summary

To investigate immediate and short term effects on angle of knee flexion, intensity of pain, strength of the knee extensor, and function of the lower extremity by using PNF stretching technique in patients with total knee arthroplasty.

hypothesis:TKA patients may increase ROM after PNF stretching


Description:

Proprioceptive neuromuscular facilitation(PNF) is defined as a treatment method that promotes or hastens the response of the neuromuscular mechanism through stimulation of proprioceptors within the related muscles or joints. PNF stretching technique is a therapeutic technique using the PNF concept to the related muslces either to increase neuro-inhibition mechanism for releasing muscle spasm and elongating muscle length, or to increase neuro-excitation mechanism for enhancing muscle strength. Improvement in range of motion using PNF stretching technique has been reported superior to other techniques in previous literature, but those studies have only been done in healthy adults. Less is known in the effect of PNF stretching on improvement in joint restriction. Range of motion limitation usually disturbed the patients with total knee arthroplasty. PNF stretching techniques has been used frequently for patients with total knee arthroplasty in clinical practice to increase range of motion effectively and reduced knee pain during exercise. However there is no evidence-based research in such a technique for patients with total knee arthroplasty. This research project, therefore, will explore application of PNF stretch in changes of knee flexion, pain, muscle strength, and function of the lower extremity following total knee arthroplasty.

Purposes: To investigate immediate and short term effects on angle of knee flexion, intensity of pain, strength of the knee extensor, and function of the lower extremity by using PNF stretching technique in patients with total knee arthroplasty.

Method: Sixty patients who received total knee arthroplasty in National Taiwan University Hospital will be recruited in this study. They will be allocated randomly into either experimental or control groups. Conventional physical therapy will be given to all participants. Besides, the experimental group will assume PNF stretching technique from the third post-operative day to the day of discharge. This technique will be executed by the same physical therapist, including 5 trials of isometric knee extension for 6 s, followed by active knee flexion to the maximum range immediately, and holding for 10s. The rest interval will be 10 s. For the control group, passive stretch technique with the same treatment time will be given, instead. All participants will be asked to do home exercises after discharged from the hospital. The outcome measures will be given before and after the first session treatment on the same day, on the day of discharge, and one month after the operation. The variables measured will be (1) knee flexion angle measured with a universal goniometer, (2) maximum voluntary isometric strength of the knee extensor measured with a hand-held dynamometer, (3) pain score using pain visual analog scale, (4) function performance of the lower extremity measured with timed up and go test, (5) Knee Injury and Osteoarthritis Outcome Score (KOOS) to record 5 dimensions including the symptoms, stiffness, pain, difficulties in knee functions and/or daily activities, limitations in sports or recreational participation, and quality of life.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 60
Est. completion date December 2008
Est. primary completion date December 2008
Accepts healthy volunteers No
Gender Both
Age group N/A and older
Eligibility Inclusion Criteria:

- OA knee

- primary unilateral TKA

Exclusion Criteria:

- knee flexion>110 or thigh girth > 55 cm

- poor cognition

- CNS or PNS neuromuscular disease

- received operation in recent 3 months

- joint infection and loosening

- revision total knee arthroplasty

- complication during follow up

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Procedure:
PNF stretching
PNF stretching x 5 repetitions and continue 3 days
passive stretching
passive stretching x 5 repetitions continue 3 days

Locations

Country Name City State
Taiwan National Taiwan University Hospital Taipei

Sponsors (1)

Lead Sponsor Collaborator
National Taiwan University Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type Measure Description Time frame Safety issue
Primary knee flexion angle baseline and follow up No
Secondary VAS pain score baseline and follow up No
Secondary knee extensor strength baseline and follow up No
Secondary time up and go test time baseline and follow up No
Secondary KOOS score baseline and follow up No
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