(1) Objectives: The aim of the present study is compare the effects of cryostretching and cryotherapy on pain, range of motion and functional status in athletes with acute hamstring muscle strain.(2) Design: This is a randomized clinical trial on 37 athletes with acute hamstring muscle strain which will be divided to two groups (cryotherapy and cryostretch group) randomly. The patients will not aware about her/his group. (3) Setting and conduct: a) The patients will be divided to two groups randomly. Both treatment regimens will be augmented by a daily home treatment program for five consecutive days. In the cryotherapy group ice bag will wrap around injured location for 20 minutes in prone position. In cryostretch group, participants will perform static stretch of hamstring muscle hold for 30 seconds after 20 minutes cold application. Pain will be measured based on visual analog scale (VAS), knee range of motion during active and passive knee extension test will be measured using inclinometer and functional status will be measured using the Persian version of Lower Extremity Functional Scale (LEFS). Pre-treatment and post-treatment assessments will be performed on day 1 and day 6. The variables will be compared between groups. (4) Participants: Athletes with acute hamstring strain.
Inclusion criteria: Elite male or female athlete between 18-40 years؛ Athletes with acute first or second degree strain of hamstring؛ Participants will be visited in sports physical therapy clinic within 72 hours after injury؛ Participants have no hypersensitivity or cold intolerance؛ No history of lower limb injury such as fracture or injury that required surgery within the past 6 months ؛Participants agree not to take NSAID medication during the study.
Exclusion criteria: If the patient dose not complete the treatment program and missing the sessions. The patient will stop his/her program any time he/she wants.(5) Intervention: Cryotherapy and cryostretch for 5 sessions.(6) Variables: The main variables are pain, active and passive knee extension ROM and functional status.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016030726957N1
Registration date:2016-06-19, 1395/03/30
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2016-06-19, 1395/03/30
Registrant information
Name
Leyla Sefiddashti
Name of organization / entity
Department of Physiotherapy
Country
Iran (Islamic Republic of)
Phone
+98 21 7753 4133
Email address
l-sefiddashti@razi.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research of Tehran University of Medical Sciences
Expected recruitment start date
2016-04-29, 1395/02/10
Expected recruitment end date
2016-08-31, 1395/06/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effects of cryotherapy and cryostretch on clinical and functional outcomes in athletes with acute hamstring muscle strain
Public title
The effect of stretching exercise and cryotherapy in hamstring strain management
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: The athletes participate in sports activity for at least two years and three times per week for a minimum of 2 hours each time؛ Male or female athlete between 18-40 years old؛ Athletes with acute first or second degree strain of hamstring; Pain evoked by resisted prone knee flexion and passive tension testing using؛ Participants are visited in sports physical therapy clinic within 72 hours after injury؛ Participants had no hypersensitivity or cold intolerance؛ participant had no sign of complete muscle disruption؛ no history of lower limb injury such as fracture or injury that required surgery within the past 6 months؛ No history of malignant or neurologic disease؛ No clinical finding showing radiculopathy؛ No hip flexor muscle shortness (as diagnose by Thomas test )؛ Participants agree not to take NSAID medication or receive any other form of treatment during the study.
Exclusion criteria: If the patient dose not complete the treatment program and missing the sessions. The patient will stop his/her program any time he/she wants.
Age
From 18 years old to 40 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
37
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Randomization will performe using random number table.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Tehran University of Medical Sciences
Street address
6th floor, Central orzanization of Tehran university of Medical Science, Keshavarz Blvd
City
Tehran
Postal code
Approval date
2016-04-17, 1395/01/29
Ethics committee reference number
IR.TUMS.REC.1395.2411
Health conditions studied
1
Description of health condition studied
muscle strain
ICD-10 code
M62.6
ICD-10 code description
Muscle strain
Primary outcomes
1
Description
Pain
Timepoint
On day 1 (before first treatment session) and day 6 (after fifth treatment session)
Method of measurement
Visual Analog Scale (VAS)
2
Description
Active and passive knee extension range of motion
Timepoint
On day 1 (before first treatment session) and day 6 (after fifth treatment session)
Method of measurement
Knee extension test using inclinometer
3
Description
Functional status level
Timepoint
on day 1 (before first treatment session) and day 6 (after fifth treatment session)
Method of measurement
Lower Extremity Functional Scale (LEFS)
Secondary outcomes
1
Description
_
Timepoint
_
Method of measurement
_
Intervention groups
1
Description
Superficial cooling by ice bag composed of crushed ice for intervention group(cryotherapy) 2
Category
Rehabilitation
2
Description
Static stretching exercise of hamstring for intervention group(cryostretch) 1
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
Sport Physicaltherapy Center
Full name of responsible person
Nastaran Ghotbi
Street address
No 204, Floor 2, Asemane Sardar Building, Sardar Jangal St
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research,Tehran University of Medical Sciences
Full name of responsible person
Masud Yunesian, Vice chancellor for research
Street address
6th floor, Central organization of Tehran University of Medical Sciences, Keshavarz Blvd
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research,Tehran University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
School of Rehabilitation Sciences, Tehran University of Medical Sciences
Full name of responsible person
Nastaran Ghotbi
Position
PT, PhD in Physiotherapy, Associated Professor, Tehran University of Medical Sciences
Other areas of specialty/work
Street address
Physiotherapy department, School of Rehabilitation Sciences, Pich-e-Shemiran, Enghelab St
City
Tehran
Postal code
Phone
+98 21 7753 3939
Fax
+98 21 7753 4133
Email
nghotbi@sina.tums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
School of Rehabilitation Sciences, Tehran University of Medical Sciences
Full name of responsible person
Nastaran Ghotbi
Position
PT, PhD in Physiotherapy, Associated Professor
Other areas of specialty/work
Street address
Physiotherapy department, School of Rehabilitation Sciences, Pich-e-Shemiran, Enghelab St
City
Tehran
Postal code
Phone
+98 21 7753 5132
Fax
+98 21 7753 4133
Email
nghotbi@sina.tums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Department of Physical therapy, School of Rehabilitation, Tehran University of Medical Sciences.
Full name of responsible person
Nastaran Ghotbi
Position
PT, PhD in Physiotherapy, Associated Professor
Other areas of specialty/work
Street address
Physiotherapy department, School of Rehabilitation Sciences, Pich-e-Shemiran, Enghelab St
City
Tehran
Postal code
Phone
+98 21 7753 3939
Fax
Email
nghotbi@sina.tums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)