The concurrence of upper limb myofascial pain syndrome with carpal tunnel syndrome and the effects of dry needling on the reduction of pain and improving function of these patients
(1) Objective: The aim of this study is to evaluate concurrence of upper limb myofascial pain syndrome with carpal tunnel syndrome and the effects of dry needling on the reduction of symptoms. (2) Design: In this study, 50 patients with mild to moderate carpal tunnel syndrome (CTS) which their condition was confirmed using EMG-NCV were included in the study after qualifying the inclusion and exclusion criteria and obtaining the informed consent. (3) Setting and conduct: Patients will be randomly divided to groups of 25. For randomization. We will use computerized randomization with Excel software. Inclusion criteria are having mild to moderate CTS and willingness to participate in the study. Exclusion criteria are any history of local injection or surgery related to CTS, radiculopathy, coexisting disease (rheumatoid arthritis, osteoarthritis, diabetes, and hypothyroidism) and severe CTS. (4) Interventions: In control group, wristbands, Nonsteroidal anti-inflammatory drugs and Gabapentin tablet (300 mg daily) will be administered. In intervention group, besides all these, dry needling on trigger points of bracioradialis muscle will be performed. (5) Main outcome measures: Patients' pain and functional status will be evaluated before, one week and sex weeks after intervention.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201602051292N4
Registration date:2016-03-07, 1394/12/17
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2016-03-07, 1394/12/17
Registrant information
Name
Vahideh Toopchizadeh
Name of organization / entity
Tabriz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 984113335625
Email address
toopchi@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Tabriz University of Medical Sciences
Expected recruitment start date
2016-02-03, 1394/11/14
Expected recruitment end date
2016-06-03, 1395/03/14
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The concurrence of upper limb myofascial pain syndrome with carpal tunnel syndrome and the effects of dry needling on the reduction of pain and improving function of these patients
Public title
Effects of needling on the reduction of upper limb's pain
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: having mild to moderate CTS; willingness to participate in the study.
Exclusion criteria: any history of local injection or surgery related to CTS; radiculopathy; coexisting disease (rheumatoid arthritis, osteoarthritis, diabetes, and hypothyroidism); severe CTS.
Age
From 18 years old to 65 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
50
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Single 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 Tabriz University of Medical Sciences
Street address
Ethics committee، Tabriz University of Medical Sciences, Golgasht Street, Azadi Street, Tabriz
City
Tabriz
Postal code
Approval date
2016-01-04, 1394/10/14
Ethics committee reference number
TBZMED.REC.1394.877
Health conditions studied
1
Description of health condition studied
Carpal tunnel syndrome
ICD-10 code
G56.0
ICD-10 code description
Carpal tunnel syndrome
Primary outcomes
1
Description
Patients' pain
Timepoint
Before, one and sex weeks after intervention
Method of measurement
Using visual analogue scale
Secondary outcomes
1
Description
Patient' functional status
Timepoint
Before, one and six weeks after intervention
Method of measurement
Using Boston questionnare
Intervention groups
1
Description
In control group, wristbands, Nonsteroidal anti-inflammatory drugs and Gabapentin tablet (300 mg daily) will be administered.
Category
Treatment - Other
2
Description
In intervention group besides using wristbands, Nonsteroidal anti-inflammatory drugs and Gabapentin tablet (300 mg daily), dry needling of bracioradialis muscle' trigger points will be performed.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Reza Hospital
Full name of responsible person
Dr. Shima Karimnia
Street address
Department of Physical Medicine and Rehabilitaion, Imam Reza Hospital, Daneshgah Square, Tabriz
City
Tabriz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research, Tabriz University of Medical Sciences
Full name of responsible person
Dr. Hasan Soleymanpour
Street address
Vice chancellor for research, Tabriz University of Medical Sciences, Daneshgah square, Tabriz Tabriz
City
Tabriz
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, Tabriz 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
Tabriz University of Medical Sciences
Full name of responsible person
Dr. Shima Karimnia
Position
Physical medicine and rehabilitation resident
Other areas of specialty/work
Street address
Department of Physical Medicine and Rehabilitaion, Imam Reza Hospital, Daneshgah Square, Tabriz
City
Tabriz
Postal code
Phone
+98 41 3334 1317
Fax
Email
shimakna@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Dr. Vahideh Toopchizadeh
Position
Physical Medicine and Rehabilitation
Other areas of specialty/work
Street address
Research ministry, second central building, Tabriz University of Medical Sciences, Golgasht street
City
Tabriz
Postal code
Phone
+98 41 3337 3954
Fax
Email
toopchi@tbzmed.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Dr. Shima Karimnia
Position
Physical medicine and rehabilitation resident
Other areas of specialty/work
Street address
Department of Physical Medicine and Rehabilitaion, Imam Reza Hospital, Daneshgah Square, Tabriz
City
Tabriz
Postal code
Phone
+98 41 3334 1317
Fax
Email
shimakna@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)