- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02089022
Analysis of Neuromuscular Responses and the Balance After the Application of Physiotherapy Resources
March 13, 2014 updated by: Thiago Batista Muniz, University of Sao Paulo
The aim of this study was to evaluate the effect of ice and shortwave diathermy in different regions of lower limb neuromuscular response and balance.
Study Overview
Status
Completed
Intervention / Treatment
Detailed Description
Applying ice and shortwave diathermy was performed separately (on different days) in the foot, ankle and calf.
To assess the neuromuscular response was evaluated electromyographic activity of the rectus femorals, biceps femorals, gastrocnemius and tibialis anterior.
To assess the effect of applications on balance, through a force platform was evaluated oscillation of the center of pressure as well as ground reaction forces.
Study Type
Interventional
Enrollment (Actual)
21
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
São Paulo
-
Ribeirão Preto, São Paulo, Brazil, 14048-900
- Rehabilitation Center HCRP, FMRP-USP
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 30 years (Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
Female
Description
Inclusion Criteria:
- woman
- healthy
- young
- sedentary
Exclusion Criteria:
- sensory changes
- history of fractures in the lower limbs
- being in the menstrual period
- diabetes Mellitus
- Bone, muscle and/or neural diseases
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Physiotherapy resources
The goal of applying ice and shortwave diathermy to the calf, ankle and sole of the foot was to verify the effect of this resources at the neuromuscular response of the lower limb and postural balance
|
The application of ice has been accomplished by means of a plastic bag containing 1.5 kg of crushed ice.
The duration of the application was 30 minutes.
The use of shortwave diathermy was performed by means of rectangular electrodes having a duration of 20 minutes.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Analysis of neuromuscular responses after the application of physiotherapy resources
Time Frame: We evaluated 22 volunteers in a period of one year and 6 months
|
To evaluate the neuromuscular response, we used the median frequency of the electromyographic variables and root mean square
|
We evaluated 22 volunteers in a period of one year and 6 months
|
|
Analysis of body balance after the application of physiotherapy
Time Frame: We evaluated 22 volunteers in a period of one year and 6 months
|
To evaluate postural balance used the variables: maximum displacement of the center of pressure, speed of displacement of the center of pressure and ground reaction forces as an impulse and braking
|
We evaluated 22 volunteers in a period of one year and 6 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Pain assessment during application of ice and shortwave diathermy
Time Frame: We evaluated 22 volunteers in a period of one year and 6 months
|
To evaluate the pain during the application of the studied features we use the McGill questionnaire.
|
We evaluated 22 volunteers in a period of one year and 6 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Thiago B Muniz, Master, University of Sao Paulo
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Garrett CL, Draper DO, Knight KL. Heat distribution in the lower leg from pulsed short-wave diathermy and ultrasound treatments. J Athl Train. 2000 Jan;35(1):50-5.
- Deal DN, Tipton J, Rosencrance E, Curl WW, Smith TL. Ice reduces edema. A study of microvascular permeability in rats. J Bone Joint Surg Am. 2002 Sep;84(9):1573-8.
- Algafly AA, George KP. The effect of cryotherapy on nerve conduction velocity, pain threshold and pain tolerance. Br J Sports Med. 2007 Jun;41(6):365-9; discussion 369. doi: 10.1136/bjsm.2006.031237. Epub 2007 Jan 15.
- Arsenault AB, Belanger AY, Durand MJ, De Serres SJ, Fortin L, Kemp F. Effects of TENS and topical skin anesthesia on soleus H-reflex and the concomitant influence of skin/muscle temperature. Arch Phys Med Rehabil. 1993 Jan;74(1):48-53.
- Beaulieu M, Allard P, Simoneau M, Dalleau G, Hazime FA, Rivard CH. Relationship between oscillations about the vertical axis and center of pressure displacements in single and double leg upright stance. Am J Phys Med Rehabil. 2010 Oct;89(10):809-16. doi: 10.1097/PHM.0b013e3181f1b4af.
- Beck TW, Housh TJ, Mielke M, Cramer JT, Weir JP, Malek MH, Johnson GO. The influence of electrode placement over the innervation zone on electromyographic amplitude and mean power frequency versus isokinetic torque relationships. J Neurosci Methods. 2007 May 15;162(1-2):72-83. doi: 10.1016/j.jneumeth.2006.12.009. Epub 2006 Dec 28.
- Belaid D, Rougier P, Lamotte D, Cantaloube S, Duchamp J, Dierick F. [Clinical and posturographic comparison of patients with recent total hip arthroplasty]. Rev Chir Orthop Reparatrice Appar Mot. 2007 Apr;93(2):171-80. doi: 10.1016/s0035-1040(07)90221-4. French.
- Bleakley CM, O'Connor S, Tully MA, Rocke LG, Macauley DC, McDonough SM. The PRICE study (Protection Rest Ice Compression Elevation): design of a randomised controlled trial comparing standard versus cryokinetic ice applications in the management of acute ankle sprain [ISRCTN13903946]. BMC Musculoskelet Disord. 2007 Dec 19;8:125. doi: 10.1186/1471-2474-8-125.
- Bolgla LA, Uhl TL. Reliability of electromyographic normalization methods for evaluating the hip musculature. J Electromyogr Kinesiol. 2007 Feb;17(1):102-11. doi: 10.1016/j.jelekin.2005.11.007. Epub 2006 Jan 19.
- Collins JJ, De Luca CJ. Open-loop and closed-loop control of posture: a random-walk analysis of center-of-pressure trajectories. Exp Brain Res. 1993;95(2):308-18. doi: 10.1007/BF00229788.
- Dewhurst S, Macaluso A, Gizzi L, Felici F, Farina D, De Vito G. Effects of altered muscle temperature on neuromuscular properties in young and older women. Eur J Appl Physiol. 2010 Feb;108(3):451-8. doi: 10.1007/s00421-009-1245-9. Epub 2009 Oct 15.
- Dewhurst S, Riches PE, De Vito G. Moderate alterations in lower limbs muscle temperature do not affect postural stability during quiet standing in both young and older women. J Electromyogr Kinesiol. 2007 Jun;17(3):292-8. doi: 10.1016/j.jelekin.2006.03.002. Epub 2006 May 15.
- Farina D, Merletti R, Enoka RM. The extraction of neural strategies from the surface EMG. J Appl Physiol (1985). 2004 Apr;96(4):1486-95. doi: 10.1152/japplphysiol.01070.2003.
- Faryniarz DA, Bhargava M, Lajam C, Attia ET, Hannafin JA. Quantitation of estrogen receptors and relaxin binding in human anterior cruciate ligament fibroblasts. In Vitro Cell Dev Biol Anim. 2006 Jul-Aug;42(7):176-81. doi: 10.1290/0512089.1.
- Guirro RR, Forti F, Bigaton DR. Proposal for electrical insulation of the electromyographic signal acquisition module. Electromyogr Clin Neurophysiol. 2006 Nov;46(6):355-63.
- Janwantanakul P. The effect of quantity of ice and size of contact area on ice pack/skin interface temperature. Physiotherapy. 2009 Jun;95(2):120-5. doi: 10.1016/j.physio.2009.01.004. Epub 2009 Mar 21.
- Kernozek TW, Greany JF, Anderson DR, Van Heel D, Youngdahl RL, Benesh BG, Durall CJ. The effect of immersion cryotherapy on medial-lateral postural sway variability in individuals with a lateral ankle sprain. Physiother Res Int. 2008 Jun;13(2):107-18. doi: 10.1002/pri.393.
- Kurca E, Drobny M. Four quantitative EMG methods and theirs individual parameter diagnostic value. Electromyogr Clin Neurophysiol. 2000 Dec;40(8):451-8.
- Li S, Kukulka CG, Rogers MW, Brunt D, Bishop M. Sural nerve evoked responses in human hip and ankle muscles while standing. Neurosci Lett. 2004 Jul 1;364(2):59-62. doi: 10.1016/j.neulet.2004.01.084.
- Lu G, Brittain JS, Holland P, Yianni J, Green AL, Stein JF, Aziz TZ, Wang S. Removing ECG noise from surface EMG signals using adaptive filtering. Neurosci Lett. 2009 Oct 2;462(1):14-9. doi: 10.1016/j.neulet.2009.06.063. Epub 2009 Jun 25.
- Melnyk M, Faist M, Claes L, Friemert B. Therapeutic cooling: no effect on hamstring reflexes and knee stability. Med Sci Sports Exerc. 2006 Jul;38(7):1329-34. doi: 10.1249/01.mss.0000227635.86285.3b.
- Norcross MF, Blackburn JT, Goerger BM. Reliability and interpretation of single leg stance and maximum voluntary isometric contraction methods of electromyography normalization. J Electromyogr Kinesiol. 2010 Jun;20(3):420-5. doi: 10.1016/j.jelekin.2009.08.003. Epub 2009 Sep 9.
- Piedrahita H, Oksa J, Rintamaki H, Malm C. Effect of local leg cooling on upper limb trajectories and muscle function and whole body dynamic balance. Eur J Appl Physiol. 2009 Feb;105(3):429-38. doi: 10.1007/s00421-008-0920-6. Epub 2008 Nov 12.
- Seigle B, Ramdani S, Bernard PL. Dynamical structure of center of pressure fluctuations in elderly people. Gait Posture. 2009 Aug;30(2):223-6. doi: 10.1016/j.gaitpost.2009.05.005. Epub 2009 Jun 2.
- Vuillerme N, Sporbert C, Pinsault N. Postural adaptation to unilateral hip muscle fatigue during human bipedal standing. Gait Posture. 2009 Jul;30(1):122-5. doi: 10.1016/j.gaitpost.2009.03.004. Epub 2009 Apr 28.
- Rattanachaiyanont M, Kuptniratsaikul V. No additional benefit of shortwave diathermy over exercise program for knee osteoarthritis in peri-/post-menopausal women: an equivalence trial. Osteoarthritis Cartilage. 2008 Jul;16(7):823-8. doi: 10.1016/j.joca.2007.10.013. Epub 2008 Feb 21.
- Saeki Y. Effect of local application of cold or heat for relief of pricking pain. Nurs Health Sci. 2002 Sep;4(3):97-105. doi: 10.1046/j.1442-2018.2002.00112.x.
- Rutkove SB, Kothari MJ, Shefner JM. Nerve, muscle, and neuromuscular junction electrophysiology at high temperature. Muscle Nerve. 1997 Apr;20(4):431-6. doi: 10.1002/(sici)1097-4598(199704)20:43.0.co;2-b.
- Kiernan MC, Cikurel K, Bostock H. Effects of temperature on the excitability properties of human motor axons. Brain. 2001 Apr;124(Pt 4):816-25. doi: 10.1093/brain/124.4.816.
- Dioszeghy P, Stalberg E. Changes in motor and sensory nerve conduction parameters with temperature in normal and diseased nerve. Electroencephalogr Clin Neurophysiol. 1992 Aug;85(4):229-35. doi: 10.1016/0168-5597(92)90110-w.
- Nurse MA, Nigg BM. The effect of changes in foot sensation on plantar pressure and muscle activity. Clin Biomech (Bristol, Avon). 2001 Nov;16(9):719-27. doi: 10.1016/s0268-0033(01)00090-0.
- Muniz TB, Moraes R, Guirro RR. Lower limb ice application alters ground reaction force during gait initiation. Braz J Phys Ther. 2015 Mar-Apr;19(2):114-21. doi: 10.1590/bjpt-rbf.2014.0080. Epub 2015 Apr 27.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2011
Primary Completion (Actual)
June 1, 2012
Study Completion (Actual)
December 1, 2012
Study Registration Dates
First Submitted
March 10, 2014
First Submitted That Met QC Criteria
March 13, 2014
First Posted (Estimate)
March 17, 2014
Study Record Updates
Last Update Posted (Estimate)
March 17, 2014
Last Update Submitted That Met QC Criteria
March 13, 2014
Last Verified
March 1, 2014
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- HCRP 12788/2011
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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