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Comparison of TENS current, Ultrasound and exercise with/without Tecar therapy on muscle haematoma, pain, pain pressure threshold and quality of life in Hamstring muscle strain injury

Protocol summary

Study aim
Comparison of TENS current, Ultrasound and exercise with/without Tecar therapy on muscle haematoma, pain, pain threshold and quality of life in Hamstring muscle strain injury
Design
Randomized , Single blind , Sham controlled clinical trials with parallel group design of 32 patients enrolled and follow up for 1 and 2 months
Settings and conduct
After assessment of area of hamstring muscle haematoma (bleeding), intensity of pain, pain pressure threshold and quality of life (based on SF-36 questionnaire), patients will be divided into two treatment and control groups randomly. Patients will be treated in Physiotherapy clinic of Rehabilitation faculty of Shahid Beheshti University of Medical Science.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Age 18-40, Afflicted to structural hamstring muscle strain injuries ( indirect muscle injuries), Existence of muscle haematoma which is confirmed by imaging test, Patients with pain intensity of more than 3, in Visual Analog Scale, Absence of history of surgery or metal implantation in lower limb, especially in posterior area of hip and thigh, Not using Analgesic and Anticoagulant drugs, Exclusion criteria: Pregnancy, Existence of tumor or malignant tissue, Having electronic implanted device such as pace maker, Open infected wounds, Treated with radiotherapy in last 6 month, Cardiovascular disorders, Tuberculosis, Unreliable patients,
Intervention groups
Treatment group 1: patients were treated with TENS current, Ultrasound, Exercise and real Tecar therapy. Treatment group 2 (control): patients were treated with TENS current, Ultrasound, Exercise and sham Tecar therapy.
Main outcome variables
Area size of muscle haematoma, intensity of pain ( based on Visual Analog Scale), intensity of pain pressure threshold and quality of life ( based on SF-36 questionnaire)

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20191022045187N1
Registration date: 2019-12-27, 1398/10/06
Registration timing: registered_while_recruiting

Last update: 2019-12-27, 1398/10/06
Update count: 0
Registration date
2019-12-27, 1398/10/06
Registrant information
Name
Seyed Ali Adabi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 3624 7842
Email address
aliadabi_pt@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-04-09, 1398/01/20
Expected recruitment end date
2020-03-10, 1398/12/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of TENS current, Ultrasound and exercise with/without Tecar therapy on muscle haematoma, pain, pain pressure threshold and quality of life in Hamstring muscle strain injury
Public title
The effect of Tecar therapy on haematoma caused by hamstring muscle strain
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age 18-40 Structural hamstring muscle strain injuries ( indirect muscle injuries) Existence of muscle haematoma which is confirmed by imaging test Patients with pain intensity of more than 3, in Visual Analog Scale Absence of history of surgery or metal implantation in lower limb, especially in posterior area of hip and thigh Not using Analgesic and Anticoagulant drugs
Exclusion criteria:
Pregnancy Existence of tumor or malignant tissue Having electronic implanted device such as pace maker Open infected wounds Treated with radiotherapy in last 6 month Cardiovascular disorders Tuberclosis Unreliable patients
Age
From 18 years old to 40 years old
Gender
Both
Phase
3
Groups that have been masked
  • Participant
Sample size
Target sample size: 32
Randomization (investigator's opinion)
Randomized
Randomization description
Simple Randomization: Patients will be assigned a number according to the order of selection and will be divided into two treatment groups by sortition. The first pulled out number would be assigned to the treatment group 1 and the subsequent numbers would be assigned treatment group 2, respectively. Stratified randomization is based on gender and Body Mass Index (BMI).
Blinding (investigator's opinion)
Single blinded
Blinding description
Only the Participants of the Study will be blinded. Patients would be assigned in two groups randomly. Difference of two groups is in intensity of Tecar therapy(High frequency electromagnetic currents), as in control group , Sham therapy (with zero intensity) would be applied and intensity of device in treatment group would be 20-30 percent. Patients will not be aware of intensity of Tecar device
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Shahid Beheshti University of Medical Science
Street address
3rd Floor, Medical Faculty, Next to the Taleghani hospital, Evin, Shahid Chamran highway
City
Tehran
Province
Tehran
Postal code
1985717434
Approval date
2019-01-15, 1397/10/25
Ethics committee reference number
IR.SBMU.RETECH.REC.1397.855

Health conditions studied

1

Description of health condition studied
Muscle Strain Injury
ICD-10 code
S76.311A
ICD-10 code description
Strain of muscle, fascia and tendon of the posterior muscle group at thigh level

Primary outcomes

1

Description
Area size of muscle haematoma
Timepoint
Before intervention, After 10 treatment sessions, After 1 and 2 month follow up
Method of measurement
Ultrasonography imaging

Secondary outcomes

1

Description
Pain intensity
Timepoint
Before intervention, After 10 treatment sessions, After 1 and 2 month follow up
Method of measurement
Based on Visual Analog Scale

2

Description
Pain Pressure Threshold
Timepoint
Before intervention, After 10 treatment sessions, After 1 and 2 month follow up
Method of measurement
By using Algometer device

3

Description
Quality of life
Timepoint
Before intervention, After 10 treatment sessions, After 1 and 2 month follow up
Method of measurement
Using SF-36 questionnaire

Intervention groups

1

Description
Intervention group: Patients in this group receive Capacitive Tecar therapy ( High frequency electromagnetic currents), with intensity of 20-30 percent for 15 minutes in injury site of hamstring muscle ( Posterior area of thigh), then they are treated with 25 minutes of TENS ( AN analgesic electric currents with frequency of 120 Hz) , after that patients receive 3-5 minutes of Pulsed Ultrasound therapy with duty cycle of 50-80 percent . After 5 treatment sessions, Isometric and stretching hamstring muscle exercises will be added to the treatment program ( treatment program includes 10 sessions in which 4 sessions would be in first week and 6 sessions in second and third week too).
Category
Rehabilitation

2

Description
Control group: Patients in this group are treated with 25 minutes of TENS ( AN analgesic electric currents with frequency of 120 Hz) , after that patients receive 3-5 minutes of Pulsed Ultrasound therapy with duty cycle of 50-80 percent. Capacitive Tecar therapy ( High frequency electromagnetic currents) in this group will be used as Sham therapy (with zero intensity) for 15 minutes in injury site of hamstring muscle ( Posterior area of thigh). After 5 treatment sessions, Isometric and stretching hamstring muscle exercises will be added to the treatment program ( treatment program includes 10 sessions in which 4 sessions would be in first week and 6 sessions in second and third week too).
Category
Rehabilitation

Recruitment centers

1

Recruitment center
Name of recruitment center
Physiotherapy clinic of School of Rehabilitation of Shahid Beheshti University of Mediacl science
Full name of responsible person
Seyed Ali Adabi
Street address
No.4, Honarmand alley , Shahid beheshti Ave, Varamin Town , Tehran
City
Varamin
Province
Tehran
Postal code
3371843433
Phone
+98 21 3624 7842
Email
aliadabi_msc@yahoo.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Afshin Zarghi
Street address
3rd Floor, Medical Faculty, Next to the Taleghani hospital, Evin, Shahid Chamran highway
City
Tehran
Province
Tehran
Postal code
1985717434
Phone
+98 21 2243 9780
Email
zarghi@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Shahid Beheshti University of Medical Science
Proportion provided by this source
1
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic

Person responsible for general inquiries

Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Seyed Ali Adabi
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Physiotherapy
Street address
No.4, Honarmand alley , Shahid beheshti Ave, Varamin Town , Tehran
City
Varamin
Province
Tehran
Postal code
3371843433
Phone
+98 21 3624 7842
Email
aliadabi_msc@yahoo.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Khosro Khademi-Kalantari
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Physiotherapy
Street address
School of Rehabilitation of Shahid Beheshti University of Medical Science, Damavand Ave, Emam Hossein Sq
City
Tehran
Province
Tehran
Postal code
1616913111
Phone
+98 21 7756 1721
Email
k_khademi@sbmu.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Seyed Ali Adabi
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Physiotherapy
Street address
No.4, Honarmand alley , Shahid beheshti Ave, Varamin Town , Tehran
City
Varamin
Province
Tehran
Postal code
3371843433
Phone
+98 21 3624 7842
Email
aliadabi_msc@yahoo.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
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