NCT05355584

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
75

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started May 2022

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 20, 2022

Completed
12 days until next milestone

First Posted

Study publicly available on registry

May 2, 2022

Completed
18 days until next milestone

Study Start

First participant enrolled

May 20, 2022

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 31, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 31, 2022

Completed
Last Updated

November 1, 2022

Status Verified

October 1, 2022

Enrollment Period

5 months

First QC Date

April 20, 2022

Last Update Submit

October 31, 2022

Conditions

Keywords

CryotherapyMuscle strengthFlexibilityEnduranceBalanceHealthy peopleCold packShoulder

Outcome Measures

Primary Outcomes (4)

  • 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.

    Just before and within 5 minutes after cryotherapy cryotherapy

  • 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).

    Just before and within 10 minutes after cryotherapy

  • 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.

    Just before and within 10 minutes after cryotherapy

  • 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.

    Just before and within 15 minutes after cryotherapy

Secondary Outcomes (2)

  • Temperature Sensation

    Before cryotherapy

  • Cold Intolerance

    Before cryotherapy

Study Arms (3)

10-minute Cryotherapy Application

ACTIVE COMPARATOR

A 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.

Other: Cryotherapy application

15-minute Cryotherapy Application

ACTIVE COMPARATOR

A 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.

Other: Cryotherapy application

20-minute Cryotherapy Application

ACTIVE COMPARATOR

A 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.

Other: Cryotherapy application

Interventions

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.

10-minute Cryotherapy Application15-minute Cryotherapy Application20-minute Cryotherapy Application

Eligibility Criteria

Age18 Years - 25 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Muğla Sıtkı Koçman University Training and Research Hospital

Muğla, Menteşe, 48000, Turkey (Türkiye)

Location

Related Publications (11)

  • 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.

    PMID: 17224445BACKGROUND
  • 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.

    PMID: 8896090BACKGROUND
  • 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.

    PMID: 14754753BACKGROUND
  • 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.

    PMID: 26383887BACKGROUND
  • 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.

    PMID: 22121908BACKGROUND
  • 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.

    PMID: 21077001BACKGROUND
  • 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.

    PMID: 19116434BACKGROUND
  • 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.

  • 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.

  • 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.

  • 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.

Study Officials

  • Burcu Camcıoğlu Yılmaz, PT,PhD

    Muğla Sıtkı Koçman University

    STUDY DIRECTOR
  • Ferhan Beril Yıldız, MSc. Student

    Muğla Sıtkı Koçman University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
PT, PhD

Study Record Dates

First Submitted

April 20, 2022

First Posted

May 2, 2022

Study Start

May 20, 2022

Primary Completion

October 31, 2022

Study Completion

October 31, 2022

Last Updated

November 1, 2022

Record last verified: 2022-10

Data Sharing

IPD Sharing
Will not share

Locations