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Comparison effect of oral & intramuscular injection of methocarbamol and placebo on muscle strain

Protocol summary

Summary
The aim of this study was to explore the effect of oral & intramuscular injection of methocarbamol in comparison to placebo on muscle strain. This study was a clinical trial that was performed between June 2008 to March 2010. The 120 patients with diagnosis of muscle strain with duration of less than 2 weeks were classified by random allocation (3 blocks) into 3 groups with equal numbers. The demographic information and pain intensity (measured by visual analogue scale) were evaluated before start of treatment. The first group (33 cases) received oral methocarbamol( 2 tab (1000mg), q4h, for 3 days, then 3 tab, q8h, for 4 days) and naproxen (1 tab (500mg), q12 h for 7 days). The second group (38cases) received 1 ampule (1000mg) methocarbamol on buttocks and naproxen (1 tab (500mg), q12 h for 7 days). The third group (35 cases) received placebo (1 tab, q12h) and naproxen (1 tab (500mg), q12 h) for 7 days. The pain intensity and rate of recovery was evaluated after end of treatment. Data were analyzed using SPSS software

General information

Acronym
IRCT registration information
IRCT registration number: IRCT138904014238N1
Registration date: 2010-10-11, 1389/07/19
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2010-10-11, 1389/07/19
Registrant information
Name
Parviz Yazdanpanah
Name of organization / entity
Yasuj University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 74 1223 1005
Email address
pyazdanpanah@yums.ac.ir
Recruitment status
Recruitment complete
Funding source
Yasuj University of Medical Science
Expected recruitment start date
2008-01-03, 1386/10/13
Expected recruitment end date
2009-12-31, 1388/10/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison effect of oral & intramuscular injection of methocarbamol and placebo on muscle strain
Public title
Effect of oral & intramuscular injection of methocarbamol and placebo on muscle strain
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion: Onset of pain (acute pain,<2week), No history of trauma Exclusion: Radiculopathy, Fracture, Infection, Ligament sprain, Malignancy, Diabetes Mellitus, Thyroid disease, Underlying disease, Rheumatic disease, Myopathy, Motor Neuron disease, Neuropathy
Age
From 20 years old to 65 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 105
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Yasuj University of Medical Sciences
Street address
Montazeri street
City
Yasuj
Postal code
75919-94799
Approval date
2007-11-20, 1386/08/29
Ethics committee reference number
9/29/8/86

Health conditions studied

1

Description of health condition studied
Muscle strain
ICD-10 code
M60-M79
ICD-10 code description
M62.6

Primary outcomes

1

Description
Pain
Timepoint
In start of treatment and 7-10 days later
Method of measurement
Visual analogue scale

Secondary outcomes

empty

Intervention groups

1

Description
Conventional treatment (Napoxen, 500 mg, q12h,for 7 days) + Placebo(1 tablet, q12h, for 7 days)
Category
Placebo

2

Description
Methocarbamol, Intramuscular, 1 Ampule, 1000 milligram intramuscular in two buttocks + Conventional treatment Naproxen (1 tablet, 500mg, q12h, for 7days)
Category
Treatment - Drugs

3

Description
Oral Methocarbamol 2 tablet (1000 Milligram, q4h) for 3 days, then 2 tablet (q8h) for 4th days + Conventional treatment Naproxen (1 tablet, 500mg, q12h, for 7days)
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
S. Mofateh clinic
Full name of responsible person
Dr Parviz Yazdanpanah
Street address
S. Montazeri street, S. Mofateh clinic
City
Yasuj

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Yasuj University of Medical Sciences
Full name of responsible person
Dr Parviz Yazdanpanah
Street address
S. Montazeri street, S. Mofateh clinic
City
Yasuj
Grant name
بودجه معاونت پزوهشی 10506
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Yasuj 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
Yasuj medical College
Full name of responsible person
Ruhallah Hossini
Position
General Physician
Other areas of specialty/work
Street address
Yasuj Medical College
City
Yasuj
Postal code
75917-94856
Phone
+98 74 1222 8212
Fax
+98 74 1223 1005
Email
sa_jahanara@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Yasuj University of Medical Sciences
Full name of responsible person
Parviz Yazdanpanah
Position
Assistant professor of Physical Medicine & Rehabilitation
Other areas of specialty/work
Street address
Yasuj, Beheshti hospital
City
Yasuj
Postal code
75917-94856
Phone
+98 74 1223 1005
Fax
+98 74 1223 1005
Email
pyazdanpanah@yums.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Yasuj Medical College
Full name of responsible person
Shirali Kharamine
Position
Assistant Professor of clinical Psycology
Other areas of specialty/work
Street address
Yasuj University of Medical Sciences
City
Yasuj
Postal code
75917-94856
Phone
+98 74 1223 1005
Fax
+98 74 1223 2470
Email
sapootang@yahoo.com
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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