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Cryotherapy EffectNCT05355584

Acute Effects of Cryotherapy Duration in Healthy Individuals

A study testing Cryotherapy application in people with Cryotherapy Effect, run by Burcu Camcıoğlu Yılmaz at 1 site in Turkey (Türkiye).

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 study will investigate the acute effects of cryotherapy duration on shoulder muscle strength, flexibility, endurance and dynamic balance in healthy individuals. Read more about this study

Who is it for?
Ages 18 to 25 yearsHealthy volunteers can take part
Conditions the study is for
Cryotherapy Effect
What is being tested?
Cryotherapy application
Could I receive a placebo?
No, everyone receives an active treatment
How many people
75 participants
Where
1 siteTurkey (Türkiye)
Study dates
20 May 2022to 31 Oct 2022
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 25 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • Individuals between the ages of 18-25 who volunteer to participate in the study
  • No upper extremity orthopedic problems
  • No history of shoulder injury or surgery in the past two years
  • Absence of Raynaud's disease or cold intolerance

Who cannot join

  • Having a history of shoulder injury or surgery
  • Cervical or thoracic spine disorders
  • People with any neurological disorder or known balance/proprioceptive deficits
  • Decreased sensation or decreased blood flow
  • Have Raynaud's disease or any cold intolerance

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site

  • Muğla Sıtkı Koçman University Training and Research Hospital

    Muğla, Menteşe, 48000

Other trials in Turkey (Türkiye)

About this study

Official title: Acute Effects of Cryotherapy Duration on Muscle Strength, Flexibility, Endurance and Balance in Healthy Individuals

The study will investigate the acute effects of cryotherapy duration on shoulder muscle strength, flexibility, endurance and dynamic balance in healthy individuals.

Read the detailed description

Cryotherapy is a practice that induces therapeutic effects by reducing tissue temperature to produce an analgesic effect. Cryotherapy application methods vary from simple ice packs and cold water immersion to whole body cryotherapy methods. The purpose of cryotherapy treatment is to reduce tissue damage, muscle spasm, edema and pain and to provide a faster rehabilitation process after injury. It is also used as a recovery technique after high-intensity training in different sports branches. Despite the proven benefits of cryotherapy according to the literature, discussions continue about its effect on some parameters and there is no consensus on the duration of cryotherapy application. In addition, although there are studies on the effects of cryotherapy on the lower extremities, studies for the upper extremity are limited and the results of these studies are inconsistent. In the literature, no study was found that evaluated the effect of cryotherapy application time on shoulder muscle strength, endurance, flexibility and balance. Therefore, in this study, the acute effects of cryotherapy duration on shoulder muscle strength, flexibility, endurance and dynamic balance in healthy individuals will be investigated and the optimum duration of cryotherapy on these parameters will be determined. In addition, the results of the research will contribute to the planned rehabilitation and exercise program.

Being tested
Cryotherapy application
Keywords
Cryotherapy, Muscle strength, Flexibility, Endurance, Balance, Healthy people, Cold pack, Shoulder

What participants receive

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

  • Cryotherapy applicationOther

    The temperature sense test was applied on the dominant side shoulder of the participants against the risk of sensory loss or decreased sensation. In order to test cold intolerance, a cold pack was placed on the forearm of the individuals. After waiting 2-3 minutes, the region was evaluated. Individuals meeting the inclusion criteria were assigned to the groups according to the randomization list created by the computer. Then, the participants' shoulder isometric muscle strength, shoulder flexibility, shoulder endurance and shoulder balance was evaluated. Except for shoulder endurance, all measurements were repeated three times, with a 30-second rest period between each repetition. A 2-3-minute rest period was given after each test. Then, the cold pack was wrapped in a thin and wet cloth on the shoulders of the participants. The treated area was checked every 5 minutes and the participants were asked to say when they felt any unusual symptoms.

Study groups in NCT05355584
Study groupRoleWhat they receive
10-minute Cryotherapy ApplicationActive comparatorA cold application will be made on the shoulder for 10 minutes. Before and after the application, individuals will be evaluated in terms of muscle strength, flexibility, endurance and balance. The values before and after the application will be compared.
Receives: Other: Cryotherapy application
15-minute Cryotherapy ApplicationActive comparatorA cold application will be made on the shoulder for 15 minutes. Before and after the application, individuals will be evaluated in terms of muscle strength, flexibility, endurance and balance. The values before and after the application will be compared.
Receives: Other: Cryotherapy application
20-minute Cryotherapy ApplicationActive comparatorA cold application will be made on the shoulder for 20 minutes. Before and after the application, individuals will be evaluated in terms of muscle strength, flexibility, endurance and balance. The values before and after the application will be compared.
Receives: Other: Cryotherapy application

What is being measured

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

  1. Change in Shoulder Muscle Strength

    Isometric strength of shoulder flexors, extensors, abductors, adductors, internal and external rotators will be measured with a hand dynamometer and recorded in kg. Each muscle group will be tested in three repetitions according to the procedures described by Kendall et al. The average of the three scores will be used for analysis.

    Measured: Just before and within 5 minutes after cryotherapy cryotherapy

  2. Change in Shoulder Flexibility

    It will be evaluated with the Back Scratch Test. In this test, while in a standing position, the person's fingers are extended (stretched) and the arm is rotated outward with the palm facing the back, towards the ground over the shoulder and while doing this, the other arm is internally rotated, with the palm facing forward and the fingers extended. The distance between the middle fingers of both hands will be measured. If the middle fingers do not touch, the distance between them is recorded as (-) in cm, if the middle fingers touch end to end, the value is (0), if the middle finger crosses the other, the distance between the middle finger is recorded as (+) in cm. Keith et al. reported that the test had a high reliability coefficient (left hand, rxy=0.77 and right hand rxy=0.75).

    Measured: Just before and within 10 minutes after cryotherapy

  3. Change in Shoulder Functional Balance

    The Y Balance Test kit will be used in the medial, superolateral and inferolateral directions with an angle of 135-135-90 degrees between them. While the dominant hand on the test kit is in the push-up position with the hand at the junction of the angles, the farthest point that the participants can reach with the fingertip of the other hand. and the distance he can reach will be measured in cm.

    Measured: Just before and within 10 minutes after cryotherapy

  4. Change in Shoulder Muscle Endurance

    Modified Push-up Test will be used. In the test, individuals are positioned face down on the mat with their knees and elbows flexed. The participant will be asked to push his torso backwards by extending his elbows without disturbing the flexion of the knees. The number of correct moves in 30 seconds will be recorded.

    Measured: Just before and within 15 minutes after cryotherapy

Secondary outcomes (2)

  1. Temperature Sensation

    The test will be performed on the shoulder with eyes closed, by putting hot water (40-45 degrees) in one of two glass tubes of equal diameter and cold water (5-10 degrees) in the other. Then, these tubes will be touched to the person and the person will be asked to tell which is hot and which is cold.

    Measured: Before cryotherapy

  2. Cold Intolerance

    There are four types of symptoms in cold intolerance: pain/discomfort, stiffness, dysesthesia (numbness or tingling), and discoloration. In order to test cold intolerance, cold application will be made on the forearm of the individuals and waited for 2-3 minutes.

    Measured: Before cryotherapy

Timeline

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

  1. First posted2 May 2022
  2. Study start20 May 2022
  3. Primary completion31 Oct 2022
  4. Study completion31 Oct 2022

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
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Individuals aged 18-25 years who volunteer to participate in the study will be included in this study and randomly assigned to 3 groups. After the demographic information of the volunteers is obtained and their dominant upper extremities are determined, the shoulder isometric muscle strength will be measured with a hand dynamometer. The back scratch test will be used to evaluate the shoulder flexibility of the participants, the modified push-up test will be used to evaluate the endurance, and the upper extremity Y balance test will be used to evaluate the shoulder dynamic balance. Then, cryotherapy will be applied on the shoulder for 10 minutes in Group 1, 15 minutes in Group 2 and 20 minutes in Group 3.After the application, the same measurements will be repeated and the values before and after the application will be compared.
Masking
Single blind
Who is masked
Participant
Enrolment
75 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05355584
Sponsor's protocol ID
KPR2
Status last verified
Oct 2022
First submitted
20 Apr 2022
Last updated
1 Nov 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

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

  • Swenson C, Sward L, Karlsson J. Cryotherapy in sports medicine. Scand J Med Sci Sports. 1996 Aug;6(4):193-200. doi: 10.1111/j.1600-0838.1996.tb00090.x.

    PubMed 8896090

  • Bleakley C, McDonough S, MacAuley D. The use of ice in the treatment of acute soft-tissue injury: a systematic review of randomized controlled trials. Am J Sports Med. 2004 Jan-Feb;32(1):251-61. doi: 10.1177/0363546503260757.

    PubMed 14754753

  • Costello JT, Baker PR, Minett GM, Bieuzen F, Stewart IB, Bleakley C. Whole-body cryotherapy (extreme cold air exposure) for preventing and treating muscle soreness after exercise in adults. Cochrane Database Syst Rev. 2015 Sep 18;2015(9):CD010789. doi: 10.1002/14651858.CD010789.pub2.

    PubMed 26383887

  • Bleakley CM, Costello JT, Glasgow PD. Should athletes return to sport after applying ice? A systematic review of the effect of local cooling on functional performance. Sports Med. 2012 Jan 1;42(1):69-87. doi: 10.2165/11595970-000000000-00000.

    PubMed 22121908

  • Rowsell GJ, Coutts AJ, Reaburn P, Hill-Haas S. Effect of post-match cold-water immersion on subsequent match running performance in junior soccer players during tournament play. J Sports Sci. 2011 Jan;29(1):1-6. doi: 10.1080/02640414.2010.512640.

    PubMed 21077001

  • Wilcock IM, Cronin JB, Hing WA. Water immersion: does it enhance recovery from exercise? Int J Sports Physiol Perform. 2006 Sep;1(3):195-206. doi: 10.1123/ijspp.1.3.195.

    PubMed 19116434

  • Keith NR, Clark DO, Stump TE, Miller DK, Callahan CM. Validity and reliability of the Self-Reported Physical Fitness (SRFit) survey. J Phys Act Health. 2014 May;11(4):853-9. doi: 10.1123/jpah.2012-0264. Epub 2013 May 10.

    PubMed 23676451

  • Gorman PP, Butler RJ, Plisky PJ, Kiesel KB. Upper Quarter Y Balance Test: reliability and performance comparison between genders in active adults. J Strength Cond Res. 2012 Nov;26(11):3043-8. doi: 10.1519/JSC.0b013e3182472fdb.

    PubMed 22228174

  • Borms D, Maenhout A, Cools AM. Upper Quadrant Field Tests and Isokinetic Upper Limb Strength in Overhead Athletes. J Athl Train. 2016 Oct;51(10):789-796. doi: 10.4085/1062-6050-51.12.06. Epub 2016 Nov 11.

    PubMed 27834503

  • Campbell DA, Kay SP. What is cold intolerance? J Hand Surg Br. 1998 Feb;23(1):3-5. doi: 10.1016/s0266-7681(98)80207-6.

    PubMed 9571469

  • Yildiz FB, Camcioglu Yilmaz B. Acute effects of cryotherapy duration on upper extremity muscle strength, flexibility, endurance, and balance: a randomized trial. BMC Sports Sci Med Rehabil. 2026 Jul 3. doi: 10.1186/s13102-026-01850-2. Online ahead of print.

    PubMed 42400060

Questions about this trial

What is this clinical trial studying?

A study testing Cryotherapy application in people with Cryotherapy Effect, run by Burcu Camcıoğlu Yılmaz at 1 site in Turkey (Türkiye).

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 1 Nov 2022. 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 Turkey (Türkiye). 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?

Change in Shoulder Muscle Strength (time frame: Just before and within 5 minutes after cryotherapy cryotherapy). The study lists 4 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 NCT05355584, which also lists 12 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 1 Nov 2022.

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