None listed
Conditions
Brief summary
Introduction: physiotherapy has a great role in the recovery of patients who undergone total knee replacement surgery. Therapeutic exercise and other techniques are used to recover the range of motion and the function of the knee. However, frequently many patients still refer pain and function limitation after physiotherapy treatment. Technological advances in physical medicine have made possible new therapeutic tools to reduce pain and accelerate tissue recovery, being one of them the monopolar dielectric diathermy by radiofrequency. This tool could be useful to reduce complications as pain an function limitation in these patients, so the objective of this study is to check the efficacy of the monopolar dielectric diathermy treatment in the improvement of pain and knee function in patients who have undertaken surgery for total knee replacement. Material and methods: a randomized clinical trial will be carried out with 60 patients who will be allocated randomly in three groups of treatment (intervention, placebo and control). Patients will receive 10 sessions of treatment along two weeks from Monday to Friday (20 minutes of diathermy and 30 of exercise the intervention group, 20 minutes of sham diathermy and 30 of exercise the placebo group, 30 minutes of exercise the control group). Pain will be measured by VAS, function by WOMAC, "Five times sit to stand" test and TUG test and quality of life by SF-12. A follow up after two weeks from the last session of treatment will be done.
Interventions
Once participants are adequately informed and have signed the informed consent, they will be evaluated face to face by a physiotherapist with more than 10 years of experience on knee replacement rehabilitation. VAS scale for pain, SF-12 questionnaire for quality of life, WOMAC knee function scale, "Five times sit to stand" and "TUG test" for knee function will be used in this evaluation.
After that, patients will be randomized in three groups of treatment:
a) Intervention group: this particip
Once participants are adequately informed and have signed the informed consent, they will be evaluated face to face by a physiotherapist with more than 10 years of experience on knee replacement rehabilitation. VAS scale for pain, SF-12 questionnaire for quality of life, WOMAC knee function scale, "Five times sit to stand" and "TUG test" for knee function will be used in this evaluation. After that, patients will be randomized in three groups of treatment: a) Intervention group: this participants will receive 10 sessions of 20 minutes of monopolar dielectric diathermy with emission of 840kHz modulated in 140Hz, intensity of 30V and pulsed at 70% (device name: DCD®; manufacturer: Biotronic Advance Develops®) and 30 minutes of knee strength exercises, daily from Monday to Friday along two weeks. b) Placebo group: this participants will receive sham diathermy by using a similar device that turns on the light of the applicator but do not give any emission. In addition, they will also receive 30 minutes of knee strength exercises, both interventions daily from Monday to Friday along two weeks. c) Control group: this participants will only receive 30 minutes of knee strength exercises daily from Monday to Friday along two weeks. The knee strength exercises will consist on 10 minutes of active knee flexion and extension until the end of available range of motion without pain, 10 minutes of walking on flat land and 10 minutes of knee extension from sitting with a five kilos dumbbell placed at the foot. All the interventions will be carried face to face by a different physiotherapist from the one of the evaluations, with also a minimum of ten years of experienced on knee replacement rehabilitation. The intervention will be allocated at the Physiotherapy Room of the Hospital of Jaen. After the last session of treatment, participants will be re-evaluated by the same first physiotherapist and a follow up will be carried out two weeks after the re-evaluation by using the same questionnaires that at the beginning and the end of treatment evaluation. All the data will be note down in a registry sheet, which will be encoded to assure the anonymity of the participant. These sheets will be exported to digital archive, useful to its statistical treatment by another investigator different from the physiotherapist that carried out the intervention or evaluation.
Sponsors
Universidad de Jaén
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
60 Years to No maximum
Healthy volunteers
No
Inclusion criteria
-Participants that underwent surgery of total knee replacement in one knee in the last two weeks. -Age: 60 years or more
Exclusion criteria
-Cognitive alterations, cardiovascular disease or metabolic diseased uncontrolled at the moment of study. -Receiving any other physiotherapy treatment at the moment of the study -Having or being suffering cancer or any tumor. -Thermal sensitivity alterations -Leg deformation or osteomuscular disease
Outcome results
None listed