Analysis of the Effects on Human Tissues After Application of Therapeutic Modalities.

NCT03414346 | Completed DMC

• 1 other identifier: 1771454
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

Brief Summary

As a therapeutic modality, cryotherapy is highly used for soft tissue damage control during acute and subacute stages. Cryotherapy is able to reduce pain, inflammatory condition, muscle spasm, nerve conduction, metabolic rate, edema formation and to prevent secondary hypoxic injury. These effects are due to the heat conduction, passing from tissue to different cryotherapy modalities, leading to tissue temperature reduction. The diversity of cryotherapy modalities in clinical practice, like crushed-ice packs, frozen food, gel packs and wetted ice packs, are widely explored by studies. To achieve anesthesia by cryotherapy it's settled that the skin temperature must reach 13,6 degrees celsius (ºC). Ice packs are the most effective modality of cryotherapy when placed directly on the skin, this effectiveness is accentuated when ice packs are associated with water. To improve the contact area the pack must be wrapped. Even though wetted ice packs are the most effective modality, there are few studies approaching it. There aren't studies analyzing an ideal percentage of water to ice in this modality either. Also, it isn't observed if the amount of water interferes on the conduction of the heat from the skin to the ice pack, and in rewarming time. Besides neither of the studies measures the amount of pain during cryotherapy application, and if there was any difference between wetted ice packs, and ice packs isolated. Therefore, the purpose of this study is to analyze the most effective cryotherapy modality for reducing skin temperature, rewarming time, and the amount of discomfort during the application.

Conditions

Humans; Young Adults; Health

Keywords

Cryotherapy; Skin temperature; Physical therapy modalities; Physical therapy; Thermography; Pain measurement

Outcome Measures

Primary Outcomes (1)

• The most effective cryotherapy modality

  Evaluation of the most effective percentage of water and ice, as a cryotherapy modality, in attenuating skin temperature. It will be evaluated in three visits, 24 hours apart each.

  3 days

Secondary Outcomes (2)

• Rewarming after ice application.

  3 days

• Recurrence of pain.

  3 days

Study Arms (3)

Exclusively ice pack:

EXPERIMENTAL

Ice pack application: 500 grams of crushed ice.

Other: Exclusively ice pack

Ice pack added 10% of water:

EXPERIMENTAL

Wetted ice pack application: 500 grams of crushed ice added to 50 mL of water at room temperature.

Other: Ice pack added 10% of water

Ice pack added 100% of water:

EXPERIMENTAL

Wetted ice pack application: 500 grams of crushed ice added to 500 mL of water at room temperature.

Other: Ice pack added 100% of water

Interventions

Exclusively ice pack OTHER

Each subject will receive an experimental intervention of exclusively 500 grams of crushed ice. The intervention will last 20 minutes, and the order of application, expressed in % of water X ice, will be according to the randomization (realized in the first day). The pack will be wrapped in a band for improvement of the contac area. The subject will be asked to mark his pain level on the visual analogue scale (no pain score of 0 and pain as bad as it could be score of 10) every minute until the total time of the intervention.

Exclusively ice pack:

Ice pack added 10% of water OTHER

Each subject will receive an experimental intervention of ice pack added to 50 mL of water. The intervention will last 20 minutes, and the order of application, expressed in % of water X ice, will be according to the randomization (realized in the first day). The pack will be wrapped in a band for improvement of the contac area. The subject will be asked to mark his pain level on the visual analogue scale (no pain score of 0 and pain as bad as it could be score of 10) every minute until the total time of the intervention.

Ice pack added 10% of water:

Ice pack added 100% of water OTHER

Each subject will receive an experimental intervention of ice pack added to 500 mL of water. The intervention will last 20 minutes, and the order of application, expressed in % of water X ice, will be according to the randomization (realized in the first day). The pack will be wrapped in a band for improvement of the contac area. The subject will be asked to mark his pain level on the visual analogue scale (no pain score of 0 and pain as bad as it could be score of 10) every minute until the total time of the intervention.

Ice pack added 100% of water:

Eligibility Criteria

• Age: 20 Years - 40 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• No orthopedic injury in three months prior to the study;
• A minimum of 18 years of age, and a maximum of 40 years;
• Female;
• Must agree not to practice exercise the day before the study and not ingest caffeine, alcohol, or foods one hour before intervention.

You may not qualify if:

• Cold hypersensitivity and urticaria;
• Cold hyposensitivity;
• Raynaud's phenomenon diagnosed;
• Any thigh open wound;
• Muscular or neurological disease;
• Diabetes diagnosed;
• Cigarette smokers.

Sponsors & Collaborators

• Alessandro Haupenthal: lead
• Santa Catarina Federal University: collaborator

Study Sites (1)

Santa Catarina Federal University

Araranguá, Santa Catarina, 88.906-072, Brazil

Location

Related Publications (10)

• Belitsky RB, Odam SJ, Hubley-Kozey C. Evaluation of the effectiveness of wet ice, dry ice, and cryogenic packs in reducing skin temperature. Phys Ther. 1987 Jul;67(7):1080-4. doi: 10.1093/ptj/67.7.1080.

  PMID: 3602101 BACKGROUND

• Chesterton LS, Foster NE, Ross L. Skin temperature response to cryotherapy. Arch Phys Med Rehabil. 2002 Apr;83(4):543-9. doi: 10.1053/apmr.2002.30926.

  PMID: 11932859 BACKGROUND

• Dykstra JH, Hill HM, Miller MG, Cheatham CC, Michael TJ, Baker RJ. Comparisons of cubed ice, crushed ice, and wetted ice on intramuscular and surface temperature changes. J Athl Train. 2009 Mar-Apr;44(2):136-41. doi: 10.4085/1062-6050-44.2.136.

  PMID: 19295957 BACKGROUND

• Enwemeka CS, Allen C, Avila P, Bina J, Konrade J, Munns S. Soft tissue thermodynamics before, during, and after cold pack therapy. Med Sci Sports Exerc. 2002 Jan;34(1):45-50. doi: 10.1097/00005768-200201000-00008.

  PMID: 11782646 BACKGROUND

• Faul F, Erdfelder E, Lang AG, Buchner A. G*Power 3: a flexible statistical power analysis program for the social, behavioral, and biomedical sciences. Behav Res Methods. 2007 May;39(2):175-91. doi: 10.3758/bf03193146.

  PMID: 17695343 BACKGROUND

• Herrera E, Sandoval MC, Camargo DM, Salvini TF. Effect of walking and resting after three cryotherapy modalities on the recovery of sensory and motor nerve conduction velocity in healthy subjects. Rev Bras Fisioter. 2011 May-Jun;15(3):233-40. doi: 10.1590/s1413-35552011000300010.

  PMID: 21829988 BACKGROUND

• Jutte LS, Merrick MA, Ingersoll CD, Edwards JE. The relationship between intramuscular temperature, skin temperature, and adipose thickness during cryotherapy and rewarming. Arch Phys Med Rehabil. 2001 Jun;82(6):845-50. doi: 10.1053/apmr.2001.23195.

  PMID: 11387593 BACKGROUND

• Kanlayanaphotporn R, Janwantanakul P. Comparison of skin surface temperature during the application of various cryotherapy modalities. Arch Phys Med Rehabil. 2005 Jul;86(7):1411-5. doi: 10.1016/j.apmr.2004.11.034.

  PMID: 16003673 BACKGROUND

• Oosterveld FG, Rasker JJ, Jacobs JW, Overmars HJ. The effect of local heat and cold therapy on the intraarticular and skin surface temperature of the knee. Arthritis Rheum. 1992 Feb;35(2):146-51. doi: 10.1002/art.1780350204.

  PMID: 1734903 BACKGROUND

• de Estefani D, Ruschel C, Beninca IL, Dos Santos Haupenthal DP, de Avelar NCP, Haupenthal A. Volume of water added to crushed ice affects the efficacy of cryotherapy: a randomised, single-blind, crossover trial. Physiotherapy. 2020 Jun;107:81-87. doi: 10.1016/j.physio.2019.12.005. Epub 2019 Dec 16.

  PMID: 32026839 DERIVED

MeSH Terms

Interventions

Water

Intervention Hierarchy (Ancestors)

Hydroxides; Alkalies; Inorganic Chemicals; Anions; Ions; Electrolytes; Oxides; Oxygen Compounds

Study Officials

• Alessandro Haupenthal, Doctorate

  Santa Catarina Federal University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Model Details: A randomized single blind, crossover experimental study.

Study Record Dates

• First Submitted: October 31, 2017
• First Posted: January 29, 2018
• Study Start: May 11, 2017
• Primary Completion: June 30, 2018
• Study Completion: June 30, 2018
• Last Updated: February 26, 2019

Record last verified: 2019-02

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)