Condition category
Musculoskeletal Diseases
Date applied
05/05/2020
Date assigned
13/05/2020
Last edited
13/05/2020
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Delayed-onset muscle soreness (DOMS) is the most common clinical manifestation after intense muscle exercise for both professionals and amateur athletes. Despite the extensive research that has been performed in order to determine its origin and effective treatment, there is currently no clear scientific proof. On this basis, this research effort is primarily designed to investigate the effects of three different methods of physiotherapy to restore the delayed muscle pain.

Who can participate?
Healthy college athletes, participating in amateur sports, with no injury at the lower extremities in the last 6 months.

What does the study involve?
Participants will be randomly allocated to receive athletic massage, cold water immersion, both or neither of these, following a brief period of intense activity designed to produce DOMS. Measurements including a blood test will be taken before and after exercise up to 72 hours.

What are the possible benefits and risks of participating?
The benefits of participation include the possibilities of evaluating the effect of an individual fatigue program on each participant evaluated at any time and the effects of the evaluated treatment on them.
The risk is small and includes the prolongation of some symptoms of DOMS such as pain and tenderness for more than 2-3 days.

Where is the study run from?
University of Patras (Greece)

When is the study starting and how long is it expected to run for?
January 2020 to May 2020

Who is funding the study?
Investigator initiated and funded

Who is the main contact?
Dr Konsstantinos Fousekis, kfousekis@upatras.gr

Trial website

Contact information

Type

Scientific

Primary contact

Dr Konsstantinos Fousekis

ORCID ID

http://orcid.org/0000-0003-1451-6529

Contact details

Andreou Londou 46
Egio
25100
Greece
+30 6936767679
kfousekis@upatras.gr

Additional identifiers

EudraCT number

Nil known

ClinicalTrials.gov number

Nil known

Protocol/serial number

05052020

Study information

Scientific title

The effect of cold water immersion, athletic massage and their combination on delayed onset muscle soreness symptoms in amateur athletes

Acronym

DOMS

Study hypothesis

This research effort is primarily designed to investigate the effects of three different methods of physiotherapy to restore delayed muscle pain.

Ethics approval

Approved 25/06/2019, Ethics committee of the University of Patras (Psaron 6, Egio PC 25100, Greece; +30 26910 22058; orthopatras@yahoo.gr), ref: 23-25/06/2019

Study design

Interventional randomized controlled study

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Other

Trial type

Treatment

Patient information sheet

No participant information sheet available

Condition

Delayed onset muscle soreness (DOMS)

Intervention

Male amateur athletes will randomly be assigned by computer, to four equal groups (three intervention and one control)

The interventions consist of athletic massage, cold water immersion and the combination of these two.

All subjects perform a plyometric exercise consisted of consecutive drop jumps (5 sets of 20 drop jumps) according to the protocol of Nosaka and Miyama (2004), aiming at producing delayed onset muscle soreness (DOMS). The examination and evaluation of DOMS will be based on acceptable markers such as exercise intensity (BORG) and muscle pain (VAS), upper thigh (CUT) and medial circumference (CMT), femoral rectal perimeter, with (PFRC) ) and without (PFR) contraction, knee flexion range of motion (ROM), maximal quadriceps isometric (MQI) and serum creatine phosphokinase (CPK) levels.The control of the above parameters will be assessed in 5 conditions (at baseline, immediately after plyometric exercise, 24, 48 and 72 hours after the exercise). Control in blood serum was performed before exercise and then 24, 48, 72 hours after it.

Ιmmersion in ice water: Athletes will be immersed in a container with ice water 10 ± 1oC for 10 minutes. The water level will reach up to the anterior superior iliac spine (Ascensao et al, 2011; Goodall and Howatson, 2008; Sellwood, 2007). The water temperature will be controlled with a liquid thermometer.

Sports massage: Applying aggressive massage to athletes for 20 minutes, 10 minutes for each lower limb. The massage process will initially be 1 minute of gentle massage on the entire quadriceps and then application of athletic aggressive massage for 1 minute on the vastus lateralis, 1 minute on the right femur and 1 minute on the vastus medialis. The series will be repeated once again and in the remaining two minutes there will be an application of 1 minute of sports massage on the entire quadriceps and finally 1 minute of relaxing massage. The massage will be done slowly but with increased intensity so that it also affects the deep tissues (Nosaka et al., 2005; Hart et al., 2005; Jönhagen et al., 2004).

Intervention type

Behavioural

Phase

Drug names

Primary outcome measure

The examination and evaluation of DOMS will be based on:
1. Exercise intensity (BORG)
2. Muscle pain (VAS)
3. Upper thigh (CUT) and medial circumference (CMT)
4. Femoral rectal perimeter, with (PFRC) and without (PFR) contraction
5. Knee flexion range of motion (ROM)
6. Maximal quadriceps isometric (MQI)
7. Serum creatine phosphokinase (CPK) levels
Assessed in 5 conditions (at baseline, immediately after plyometric exercise, 24, 48 and 72 hours after the exercise). Control in blood serum was performed before exercise and then 24, 48, 72 hours after it.

Secondary outcome measures

None

Overall trial start date

10/01/2020

Overall trial end date

30/05/2020

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

1. Healthy college athletes
2. Participating in amateur sports
3. No injury at the lower extremities the last 6 months

Participant type

Healthy volunteer

Age group

Mixed

Gender

Male

Target number of participants

60

Participant exclusion criteria

Does not meet inclusion criteria

Recruitment start date

10/05/2020

Recruitment end date

20/05/2020

Locations

Countries of recruitment

Greece

Trial participating centre

University of Patras
Psaron 6
Egio
25100
Greece

Sponsor information

Organisation

University of Patras

Sponsor details

Psaron 6
Egio
25100
Greece
+30 6936767679
msctherex@upatras.gr

Sponsor type

University/education

Website

http://www.upatras.gr/

Funders

Funder type

Other

Funder name

Investigator initiated and funded

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Planned publication in a high-impact peer-reviewed journal.

IPD sharing statement:
All data generated or analysed during this study will be included in the subsequent results publication.

Intention to publish date

20/06/2020

Participant level data

Other

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes

11/05/2020: Trial’s existence confirmed by University of Patras.