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Musculoskeletal InjuriesNCT02089022

Analysis of Neuromuscular Responses and the Balance After the Application of Physiotherapy Resources

A study testing Physiotherapy resources in people with Musculoskeletal Injuries and Cryotherapy Effect, run by University of Sao Paulo at 1 site in Brazil.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 18 to 30 years, women onlyHealthy volunteers can take part
What is being tested?
Physiotherapy resources
Could I receive a placebo?
No, everyone receives an active treatment
How many people
21 participants
Where
1 siteBrazil
Study dates
Jan 2011to Dec 2012
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 30 years
  • Women only
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • woman
  • healthy
  • young
  • sedentary

Who cannot join

  • sensory changes
  • history of fractures in the lower limbs
  • being in the menstrual period
  • diabetes Mellitus
  • Bone, muscle and/or neural diseases

Trial locations and contacts

1 site in 1 country.

Brazil1 site

  • Rehabilitation Center HCRP, FMRP-USP

    Ribeirão Preto, São Paulo, 14048-900

Other trials in Brazil

About this study

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.

Read the 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.

Being tested
Physiotherapy resources
Keywords
Ice, Heat, Ground reaction forces, Electromyography, Lower Limb, Center of pressure

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Physiotherapy resourcesOther

    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.

Study groups in NCT02089022
Study groupRoleWhat they receive
Physiotherapy resourcesExperimentalThe 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
Receives: Other: Physiotherapy resources

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

    Measured: We evaluated 22 volunteers in a period of one year and 6 months

  2. 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

    Measured: We evaluated 22 volunteers in a period of one year and 6 months

Secondary outcomes (1)

  1. 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.

    Measured: We evaluated 22 volunteers in a period of one year and 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Mar 2014 (estimated)
  2. Study startJan 2011
  3. Primary completionJun 2012
  4. Study completionDec 2012

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
21 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02089022
Sponsor's protocol ID
HCRP 12788/2011
Status last verified
Mar 2014
First submitted
10 Mar 2014
Last updated
17 Mar 2014
Results posted
No
Data monitoring committee
Yes

Publications

  • 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.

    PubMed 17224445

  • 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.

    PubMed 8420520

  • 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.

    PubMed 20855981

  • 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.

    PubMed 17275093

  • 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.

    PubMed 17401291

  • 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.

    PubMed 18093299

  • 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.

    PubMed 16423539

  • 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.

    PubMed 8224055

  • 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.

    PubMed 12208913

  • 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.

    PubMed 19830450

  • 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.

    PubMed 16698285

  • 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.

    PubMed 15016793

  • 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.

    PubMed 16948498

  • 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.

    PubMed 17147078

  • 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.

    PubMed 19627693

Questions about this trial

What is this clinical trial studying?

A study testing Physiotherapy resources in people with Musculoskeletal Injuries and Cryotherapy Effect, run by University of Sao Paulo at 1 site in Brazil.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 17 Mar 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02089022, which also lists 32 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Mar 2014.

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