Protocol summary

Summary
This single blind Randomized Clinical Trial was designed to compare the effects of Scaphoid and Hamate mobilization in patients with mild to moderate Carpal Tunnel Syndrome. A total of forty patients will be randomly assigned into 2 groups,control group and treatment group. control group will receive only splint, treatment group will receive splint with Scaphoid and Hamate mobilization. Both groups will use cock up splint for CTS for 8 weeks. Pain visual analog scale (VAS), (BQ-SYMPT) Bostone/Levine symptom severity scale and Bostone/Levine functional status scale(BQ-FUNC) and EDX studys will be assessed before intervention and 8 weeks after the intervention

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2015120125317N1
Registration date: 2016-01-11, 1394/10/21
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2016-01-11, 1394/10/21
Registrant information
Name
Vida Dinarvand
Name of organization / entity
University of Social Welfare and Rehabilitation Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 2235 3581
Email address
vi.dinarvand@uswr.ac.ir
Recruitment status
Recruitment complete
Funding source
modarres hospital
Expected recruitment start date
2015-12-22, 1394/10/01
Expected recruitment end date
2016-02-20, 1394/12/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Study of the effects of Scaphoid and Hamate mobilization in patients with mild to moderate carpal tunnel syndrome
Public title
the effects of Scaphoid and Hamate mobilization in patients with carpal tunnel syndrome
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion Criteria: patient with mild and moderate CTS confirmed by the presence of 1 or more of the following standard electrophysiological criteria:1- prolonged distal motor latency (DML) (abnormal ≥4.2 ms)of Median nerve and 2) prolonged antidromic distal sensory latency (DSL) to the third digit (abnormal >3.6 ms. Exclusion criteria:Pregnancy; Severe degree CTS; Background metabolic diseases such as: Diabetes mellitus; Hypothyroidism; Rheumatoid arthritis; Previous history of Corticosteroid injection in Carpal Tunnel; Severe atrophy of Thener muscles; cervical radiculopathy or significant polyneuropathy; Unwillingness to participate in the present study;
Age
From 37 years old to 60 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 40
Randomization (investigator's opinion)
Randomized
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
University of Social Welfare and Rehabilitation Sciences
Street address
Daneshjoo Blvd, Evin, Tehran
City
Tehran
Postal code
Approval date
2015-01-06, 1393/10/16
Ethics committee reference number
uswr.rec.1393.213

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
pain
Timepoint
0, 8 weeks after treatment
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

2

Description
Symptome Severity(pain and paresthesia)
Timepoint
0, 8 weeks after treatment
Method of measurement
Bostone/levine Symptome Severity Scale Questionnaire

3

Description
Functional Status
Timepoint
0, 8 weeks after treatment
Method of measurement
Bostone/levine Functional Status Scale Questionnare

4

Description
Distal Sensory Peak Latency(SNAP) of median nerve
Timepoint
0, 8 weeks after treatment
Method of measurement
EDX Indexes

5

Description
Distal Motor Onset Latency(CMAP) of median nerve
Timepoint
0, 8 weeks after treatment
Method of measurement
EDX indexes

Secondary outcomes

empty

Intervention groups

1

Description
Intervention Group: Mobilization of Scaphoid and Hamate and Splint
Category
Treatment - Other

2

Description
Control Group: Splint
Category
Treatment - Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Shahid Modarres Hospital of Tehran
Full name of responsible person
Seyed Ahmad Raeissadat
Street address
City
Tehran

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Shahid Moderres Hospital of Tehran
Full name of responsible person
Seyed Ahmad Raeissadat
Street address
Shahid Modarres hospital, Kaj square, Saadat abad street 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 Moderres Hospital of Tehran
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
University of Social Welfare and Rehabilitations Sciences
Full name of responsible person
Vida Dinarvand
Position
MSc Student of Physiotherapy
Other areas of specialty/work
Street address
Daneshjoo Blvd, Evin, Tehran
City
Tehran
Postal code
Phone
+98 21 2235 3581
Fax
Email
vi.dinarvand@uswr.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
University of Social Welfare and Rehabilitation Sciences
Full name of responsible person
Iraj Abdollahi
Position
Associate Professor of Physiotherapy
Other areas of specialty/work
Street address
Daneshjoo Blvd, Evin, Tehran
City
Tehran
Postal code
Phone
+98 21 2218 0039
Fax
Email
irajabdollahi@hotmail.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
University of Social Welfare and Rehabilitation Sciences
Full name of responsible person
Vida Dinarvand
Position
MSc Student of Physiotherapy
Other areas of specialty/work
Street address
Daneshjoo Blvd, Evin, Tehran
City
Postal code
Phone
00
Fax
Email
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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