The effect of combination of extracorporeal shock wave therapy (ESWT) and muscle energy technique (MET) on active trigger point in upper trapezius muscle
the effectiveness of combination of extracorporeal shock wave therapy and muscle energy technique on active trigger points in upper trapezious muscle.
Design
54 participants will be divided in three groups, randomly. Randomization will performed using sealed, filled envelopes describing the treatment groups. We prepare three envelopes, in each of which one of the three methods is written. Each participant will choose one of the envelop and will divide in each treatment group.
Settings and conduct
The patients with active upper trapezious trigger points in the physiotherapy clinic of school of Rehabilitation will evaluate and will be divide in three groups. Group A will receive only MET while group B will receive only ESWT and group C will receive combination of MET and ESWT. In the end of treatment sessions, evaluations will be down, again.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
- Age between 18-40 years.
- Presence of a palpable taut band in upper trapezius muscle.
- Presence of a nodule in upper trapezius muscle.
- Presence of 1 to 3 trigger point in one side.
- Iron or calcium deficiency
Exclusion criteria:
- Diagnosed fibromyalgia
- Cervical radiculopathy
- Facial neuralgia
- Coagulation alteration
- Cancer
- History of cervical or shoulder surgery
- History of deep vein thrombosis
- History of myopathy
- Aspirin intake during the last 3 days
Intervention groups
1. Group A- treatment with only MET .
2. Group B - treatment with only ESWT .
3. Group C - treatment with combination of MET and ESWT .
Main outcome variables
• Visual analog scale VAS.
. pain pressure threshould
• neck range of motion
• Neck disability index (NDI)
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20130121012210N8
Registration date:2021-03-09, 1399/12/19
Registration timing:prospective
Last update:2021-03-09, 1399/12/19
Update count:0
Registration date
2021-03-09, 1399/12/19
Registrant information
Name
Azadeh Shadmehr
Name of organization / entity
Teharn University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 7752 8468
Email address
shadmehr@tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-04-21, 1400/02/01
Expected recruitment end date
2021-07-23, 1400/05/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of combination of extracorporeal shock wave therapy (ESWT) and muscle energy technique (MET) on active trigger point in upper trapezius muscle
Public title
The effect of combination of shock wave therapy and muscle energy technique on neck pain
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age between 18-40 years.
Presence of a palpable taut band in upper trapezius muscle.
Presence of a nodule in upper trapezius muscle.
Presence of 1 to 3 trigger point in one side.
Exclusion criteria:
Diagnosed fibromyalgia
Cervical radiculopathy
Facial neuralgia
History of cervical or shoulder surgery
History of deep vein thrombosis
History of myopathy
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:
54
Randomization (investigator's opinion)
Randomized
Randomization description
The patients will randomly assign into 3 groups of only MET , only ESWT and combination of MET and ESWT . Randomization will performed using sealed, randomly filled envelopes describing the treatment groups. We prepare three envelopes, in each of which one of the three methods is written.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Tehran University of Medical Sciences
Street address
school of Rehabilitation, Piche Shemiran, Enghelab street
City
Tehran
Province
Tehran
Postal code
1148965111
Approval date
2020-12-19, 1399/09/29
Ethics committee reference number
IR.TUMS.MEDICINE.REC.1399.917
Health conditions studied
1
Description of health condition studied
Activetrigger points in upper trapezuis muscle
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
•Pain
Timepoint
before and after 1 week of intervention
Method of measurement
• visual analog scale
2
Description
Pain pressure threshold
Timepoint
before and after 1 week of intervention
Method of measurement
Algometer
3
Description
• Active neck range of motion
Timepoint
before and after 1 week of intervention
Method of measurement
Digital goniometer
4
Description
neck function
Timepoint
before and after 1 week of intervention
Method of measurement
neck disability index questionnaire (NDI)
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group A- only Muscle energy techniques- in this group muscle energy technique will apply on the upper trapezious. ّFirst upper trapezious will put in stretch position and then its antagonist muscle is down 10 seconds isometric contraction.after 20 seconds relaxation,upper trapezious will be stretched again. This technique will do 3 times in 3 sessions.
Category
Rehabilitation
2
Description
Intervention group B: only shock wave- shock wave prob will put on active trigger points of the upper trapezious and mechanical stimulation with 2000 Bar pressure will apply for one minutes. his technique will do 3 times in 3 sessions.
Category
Rehabilitation
3
Description
Intervention group C: Combination of Muscle energy techniques and shock wave- Muscle energy technique will apply on the upper trapezious. ّFirst upper trapezious will put in stretch position and then its antagonist muscle is down 10 seconds isometric contraction.after 20 seconds relaxation,upper trapezious will be stretched again. Then shock wave prob will put on active trigger points of the upper trapezious and mechanical stimulation with 2000 Bar pressure will apply for one minutes.This technique will do 3 times in 3 sessions.
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
School of Rehabilitation, Tehran University of Medical Sciences
Full name of responsible person
Azadeh Shadmehr
Street address
Piche Shemiran, Enghelab Street
City
Tehran
Province
Tehran
Postal code
1148965111
Phone
+98 21 7752 8468
Email
shadmehr@tums.ac.ir
Web page address
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Ahmad Esmaielzadeh
Street address
ًInternational Campous, Qods Stree, Engelab street
City
Tehran
Province
Tehran
Postal code
1148965111
Phone
+98 21 7752 8468
Email
ic-research@tums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
Sponsor: country of origin
Country of origin
IR
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Azadeh Shadmehr
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Physiotherapy
Street address
School of Rehabilitation, Piche Shemiran, Engelab street
City
Tehran
Province
Tehran
Postal code
1148965111
Phone
+98 21 7752 8468
Email
Shadmehr@tums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Azadeh Shadmehr
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Physiotherapy
Street address
School of Rehabilitation, Piche Shemiran, Engelab street
City
Tehran
Province
Tehran
Postal code
1148965111
Phone
+98 21 7752 8468
Email
Shadmehr@tums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Azadeh Shadmehr
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Physiotherapy
Street address
School of Rehabilitation, Piche Shemiran, Englab street
City
Tehran
Province
Tehran
Postal code
1148965111
Phone
+98 21 7752 8468
Email
Shadmehr@tums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD