Comparison Between the Effects of Intramuscular Injection of Ozone and Lidocain on Pain, Range of Motion and Functional Score of Patients with Myofascial Pain Syndrome
Objectives: Comparison between ozone and lidocaine intramuscular injection in symptom improving of patients with myofascial pain syndrome (MPS)
Design: A double blinded randomized clinical trial on MPS patients referred to physical medicine and rehabilitation (PMR) clinic
Setting and conduct: In this study conducted in 2015, patients referred to Shahid Modarres Hospital clinic with suspension of MPS were consecutively recruited.
Participants including major eligibility criteria: Among all patients referring to our clinic 62 subjects with confirmed diagnosis of MPS were included.
Intervention: Patients randomly categorized into three groups of dry needling (DN), Lidocaine injection (WN: Wet Needling) and ozone injection (OI).
Main outcome measures: visual analogue scale (VAS), point pressure threshold (PPT), ROM of the neck and function of the patient were evaluated before and one month after the treatment.
Keywords: Myofascial pain syndrome, trigger point, dry needling, wet needling, ozone injection
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016042113442N10
Registration date:2016-09-01, 1395/06/11
Registration timing:retrospective
Last update:
Update count:0
Registration date
2016-09-01, 1395/06/11
Registrant information
Name
Seyed Ahmad Raeissadat
Name of organization / entity
Modares Hospital
Country
Iran (Islamic Republic of)
Phone
+98 21 2273 1112
Email address
a_raeissadat@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Shahid Beheshti University of Medical Sciences
Expected recruitment start date
2016-02-20, 1394/12/01
Expected recruitment end date
2016-06-21, 1395/04/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison Between the Effects of Intramuscular Injection of Ozone and Lidocain on Pain, Range of Motion and Functional Score of Patients with Myofascial Pain Syndrome
Public title
The Effects of Intramuscular Ozone Injection in Patients with Myofascial Pain Syndrome
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion Criteria:
25-60 years old؛ Presence of active trigger points in the upper trapezius muscles؛ Unilateral pain؛ More than 3 months pain
Exclusion Criteria:
Cognitive disorders؛ History of radiculopathy, trauma or previous surgery in neck؛ Previous treatment of trigger points with needling during last 6 months؛ Past medical history of fibromyalgia, RA, hypothyroidism and DM
Age
From 25 years old to 60 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
62
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Shahid Beheshti Univeraity of Medical Sciences, Medical Ethics Committee
Street address
Shahid Beheshti Univeraity of Medical Sciences, Velenjak St, Tehran
City
Tehran
Postal code
Approval date
2016-01-31, 1394/11/11
Ethics committee reference number
IR.SBMU.SM.REC.1394.168
Health conditions studied
1
Description of health condition studied
Myofascial Pain Syndrome
ICD-10 code
M79.1
ICD-10 code description
Myalgia (excl. myositis)
Primary outcomes
1
Description
Pain
Timepoint
0- 4 weeks
Method of measurement
visual analogue scale (VAS), point pressure threshold (PPT)
2
Description
Range of Motion
Timepoint
0- 4 weeks
Method of measurement
Goniometer
Secondary outcomes
1
Description
Functional Score
Timepoint
0-4 weeks
Method of measurement
Neck Disability Index (NDI) questionnaire
Intervention groups
1
Description
Ozone Injection In Trigger Points
Category
Treatment - Drugs
2
Description
Wet Needling (Lidocaine)
Category
Treatment - Drugs
3
Description
Dry Needling (Without Drug)
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid Modarres Hospital, Shahid Beheshti Univeraity of Medical Sciences
Full name of responsible person
Fatemeh Sadeghi
Street address
Shahid Modarres Hospital, Kaj Square, Saadat Abad street, Tehran
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Vice chancellor for research, Seyed Ahmad Raeissadat
Street address
Physical Medicine and Rehabilitation Departement, Shahid Modarres Hospital, Kaj Square, Saadat Abad, Tehran
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahid Beheshti 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
Shahid Beheshti Univeraity of Medical Sciences
Full name of responsible person
Fatemeh Sadeghi
Position
Assistant in physical medicine and rehabilitation
Other areas of specialty/work
Street address
Shahid Modarres Hospital, Kaj square, Saadat Abad street, Tehran
City
Tehran
Postal code
Phone
+98 21 2273 1112
Fax
Email
sadeghi_fsv@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahid Beheshti Univeraity of Medical Sciences
Full name of responsible person
Seyed Ahmad Raeissadat
Position
Associate Professor
Other areas of specialty/work
Street address
Shahid Modarres Hospital, Kaj Square, Saadat Abad street, Tahran
City
Tehran
Postal code
Phone
+98 21 2207 4090
Fax
Email
a_raeissadat@sbmu.ac.ir
Web page address
Person responsible for updating data
Contact
Sharing plan
Deidentified Individual Participant Data Set (IPD)