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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02089022
Other study ID # HCRP 12788/2011
Secondary ID
Status Completed
Phase N/A
First received March 10, 2014
Last updated March 13, 2014
Start date January 2011
Est. completion date December 2012

Study information

Verified date March 2014
Source University of Sao Paulo
Contact n/a
Is FDA regulated No
Health authority Brazil: National Committee of Ethics in Research
Study type Interventional

Clinical Trial Summary

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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 21
Est. completion date December 2012
Est. primary completion date June 2012
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 18 Years to 30 Years
Eligibility 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 Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention


Related Conditions & MeSH terms


Intervention

Other:
Physiotherapy resources
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.

Locations

Country Name City State
Brazil Rehabilitation Center HCRP, FMRP-USP Ribeirão Preto São Paulo

Sponsors (3)

Lead Sponsor Collaborator
University of Sao Paulo Conselho Nacional de Desenvolvimento Científico e Tecnológico, Fundação de Amparo à Pesquisa do Estado de São Paulo

Country where clinical trial is conducted

Brazil, 

References & Publications (31)

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. Epub 2007 Jan 15. — View Citation

Arsenault AB, Bélanger 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. — View Citation

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. — View Citation

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. Epub 2006 Dec 28. — View Citation

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. French. — View Citation

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. — View Citation

Bolgla LA, Uhl TL. Reliability of electromyographic normalization methods for evaluating the hip musculature. J Electromyogr Kinesiol. 2007 Feb;17(1):102-11. Epub 2006 Jan 19. — View Citation

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. — View Citation

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-A(9):1573-8. — View Citation

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. — View Citation

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. Epub 2006 May 15. — View Citation

Dioszeghy P, Stålberg 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. — View Citation

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. Review. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Kurca E, Drobný M. Four quantitative EMG methods and theirs individual parameter diagnostic value. Electromyogr Clin Neurophysiol. 2000 Dec;40(8):451-8. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Piedrahita H, Oksa J, Rintamäki 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. — View Citation

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. — View Citation

Rutkove SB, Kothari MJ, Shefner JM. Nerve, muscle, and neuromuscular junction electrophysiology at high temperature. Muscle Nerve. 1997 Apr;20(4):431-6. — View Citation

Saeki Y. Effect of local application of cold or heat for relief of pricking pain. Nurs Health Sci. 2002 Sep;4(3):97-105. — View Citation

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. — View Citation

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. — View Citation

* Note: There are 31 references in allClick here to view all references

Outcome

Type Measure Description Time frame Safety issue
Primary Analysis of neuromuscular responses after the application of physiotherapy resources 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 Yes
Primary Analysis of body balance after the application of physiotherapy 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 Yes
Secondary Pain assessment during application of ice and shortwave diathermy 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 Yes
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