Effects of single Platelet-Rich Plasma local injection on pain, symptom severity, functional state and electrodiagnostic findings in women with mild and moderate Carpal Tunnel Syndrome, A clinical trial
Objectives: This study is designed to indicate the short term effects of Platelet-Rich Plasma (PRP) injection on VAS score, symptom severity and functional status based on Boston questionnaire and electrodiagnostic findings of women with idiopathic mild and moderate Carpal Tunnel Syndrome (CTS). Study Design: This study is a non-blind randomized clinical trial. Randomization will be done by computer generated random numbers. Setting and conduct:A total of 41 patients will be randomly assigned to two groups of control, only using a wrist splint, and PRP that received wrist splints along with a single local injection of in the carpal tunnel.
Participants: Participants are women referring to the physical medicine and rehabilitation clinics at Shahid Modarres Hospital during 2016 with a diagnosis of mild and moderate idiopathic CTS aged 20 to 65 without any comorbidities such as thyroid disease or diabetes mellitus. Interventions: Both groups will use the same prefabricated hand wrist splint for CTS along with PRP group will be treated with a single injection of 1 ml of PRP plus 0.5 ml lidocaine 1% in the carpal tunnel. outcome measures: At the beginning and 10 weeks after the intervention, outcome measures which are Pain visual analog scale (VAS), (BQ-SYMPT) Boston/Levine symptom severity scale and Boston/Levine functional status scale (BQ-FUNC), median nerve sensory peak latency and median nerve will be assessed.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2017041513442N13
Registration date:2017-06-19, 1396/03/29
Registration timing:retrospective
Last update:
Update count:0
Registration date
2017-06-19, 1396/03/29
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
Physical Medicine and Rehabilitation Department
Expected recruitment start date
2017-02-22, 1395/12/04
Expected recruitment end date
2017-04-30, 1396/02/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effects of single Platelet-Rich Plasma local injection on pain, symptom severity, functional state and electrodiagnostic findings in women with mild and moderate Carpal Tunnel Syndrome, A clinical trial
Public title
Effects of Platelet-Rich Plasma local injection in treatment of women with mild and moderate carpal tunnel syndrome
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: patient with mild and moderate CTS confirmed by the presence of one or more of the following standard electrophysiological criteria: 1- prolonged distal motor latency (DML) (abnormal response is more than 4.2 millisecond) of Median nerve and 2- prolonged antidromic distal sensory latency (DSL) to the third digit (abnormal response is more than 3.6 millisecond); Exclusion criteria: Pregnancy; Severe degree CTS; Background metabolic diseases such as: diabetes mellitus; hypothyroidism; rheumatoid arthritis; Previous history of corticosteroid injection in Carpal Tunnel Syndrome; Severe atrophy of thenar muscles; cervical radiculopathy or significant polyneuropathy; Unwillingness to participate in the present study; patient younger than 20 or older than 65 years old; history or presence of cancer or malignant disorders; presence of immunosuppressive, autoimmune and platelet disorders; treatment with anticoagulant and anti-platelet medications 10 days before injection; use of NSAIDs 2 days before injection; use of systemic corticosteroids 2 weeks before PRP injections; hemoglobin measures of less than 12 g/dl and platelet counts of less than 150,000 per micro liter
Age
From 20 years old to 65 years old
Gender
Female
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
41
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
randomization via computer generated random numbers
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee Of Shahid Beheshti University Of Medical Sciences
Street address
Shahid Beheshti University of Medical Siences, Next to Taleghani Hospital, Yaman Street, Chamran Highway Tehran Iran, Islamic Republic Of Iran
City
Tehran
Postal code
Approval date
2016-11-05, 1395/08/15
Ethics committee reference number
IR.SBMU.MSP.REC.1395.382
Health conditions studied
1
Description of health condition studied
carpal tunnel syndrome
ICD-10 code
G56.0
ICD-10 code description
Mononeuropathies of upper limb
Primary outcomes
1
Description
pain
Timepoint
at the beginning and after 10 weeks of injection or 10 weeks after starting using splint
Method of measurement
Visual Analog Scale, that is from 0-10 and zero (0) means that you did not have any pain and ten (10) means that you had the worst pain imaginable
Secondary outcomes
1
Description
median CMAP distal latency
Timepoint
at the beginning and after 10 weeks of injection or 10 weeks after starting using splint
Method of measurement
Electrodiagnostic study
2
Description
symptom severity
Timepoint
at the beginning and after 10 weeks of injection or 10 weeks after starting using splint
Method of measurement
Boston/Levine symptome severity scale
3
Description
median SNAP peak latency
Timepoint
at the beginning and after 10 weeks of injection or 10 weeks after starting using splint
Method of measurement
Electrodiagnostic study
4
Description
Functional Status
Timepoint
at the beginning and after 10 weeks of injection or 10 weeks after starting using splint
Method of measurement
boston questionaire
Intervention groups
1
Description
Single injection of 1 ml of PRP with 0.5 ml lidocain 1% in carpal tunnel and prefabricated hand wrist splint in neutral position for CTS
Category
Treatment - Drugs
2
Description
Prefabricated hand wrist splint in neutral position for CTS
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid Modarres Hospital, Shahid Beheshti Univeraity of Medical Sciences
Full name of responsible person
Seyed Ahmad Raeissadat
Street address
Shahid Modarres Hospital, Kaj Square, Saadat Abad street, Tehran
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research,Shahid Beheshti University of Medical Sciences
Full name of responsible person
Seyed Ahmad Raeissadat
Street address
Shahid Beheshti University of Medical siences, next to Taleghani Hospital, yaman street, Chamran Highway
City
Tehran
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,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
Leila Bagherzadeh
Position
Resident 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
leila_bagherzade@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 2273 1112
Fax
Email
a_raeissadat@sbmu.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Shahid Beheshti Univeraity of Medical Sciences
Full name of responsible person
Leila Bagherzadeh
Position
Resident 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
leila_bagherzade@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)