1. Home
  2. Approved trials
  3. » فارسی

The effect of rehabilitation interventions based on the patient's condition, on the sensation, function and pain of patients with carpal tunnel syndrome after surgery

Protocol summary

Summary
This study is performed to evaluate the effect of rehabilitation process after surgery for carpal tunnel syndrome on function, sensation and pain. this clinical trial has been done in Iran Hand Rehabilitation Center in Tehran, on 30 patients undergoing median nerve release surgery, the intervention and control groups were divided into two groups by random cards.The intervention group receives rehabilitation treatment (the early motion), depending on the patient's condition. This rehabilitation process, depending on the patient's condition may include these items : scar reduction techniques , standard techniques to control edema, stretching exercises,range of motion exercises for involved and uninvolved joints, nerve and tendon gliding exercises, light and tolerable activities of daily living and tolerable tasks and activities related to patient's job and the control group (dressing) receives no intervention. Inclusion criteria was as fallows : patients with idiopathic CTS and people without a history of trauma and wrist injuries or previous surgery, exclusion criteria was injury or trauma during intervention, the Double Crush Syndrome and certain diseases such as rheumatoid arthritis, autoimmune and metabolic disorders. patients were evaluated for pain,sensation, function and power by VAS, Monofilament test, Boston Questionnaire and Vigorimeter by the researcher in three periods :preoperative period, 6 and 8 weeks after surgery to therefore this study was not blind.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2017041233390N1
Registration date: 2017-07-07, 1396/04/16
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2017-07-07, 1396/04/16
Registrant information
Name
Roya Mahmoodi
Name of organization / entity
University of Social Welfare and Rehabilitation Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 2218 0037
Email address
ma.farzad@uswr.ac.ir
Recruitment status
Recruitment complete
Funding source
Investigator
Expected recruitment start date
2016-01-19, 1394/10/29
Expected recruitment end date
2017-01-19, 1395/10/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of rehabilitation interventions based on the patient's condition, on the sensation, function and pain of patients with carpal tunnel syndrome after surgery
Public title
The effect of rehabilitation on patients with carpal tunnel syndrome after surgery
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Patients with carpal tunnel syndrome is diagnosed by a specialist and NCV test and Phalen tests and tinnel sign be positive; patients with idiopathic CTS; people who do not experience trauma and ankle injuries or have not had previous surgery. Exclusion criteria: Injury or trauma during intervention; double Crush Syndrome; certain diseases such as rheumatoid arthritis, autoimmune and metabolic disorders
Age
No age limit
Gender
Female
Phase
2
Groups that have been masked
No information
Sample size
Target sample size: 30
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
In this study randomization has done with random cards.

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of The University of Social Welfare and Rehabilitation Sciences
Street address
The University of Social Welfare and Rehabilitation Sciences, Kodakyar St, Daneshjo Blvd, Evin, Tehran, Iran
City
Tehran
Postal code
Approval date
2017-04-29, 1396/02/09
Ethics committee reference number
IR.USWR.REC.1396.1

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
Befor surgery and intervention, 6 weeks after intervention and surgery and 8 weeks after intervention and surgery
Method of measurement
Visual Analogue Scale

2

Description
Sensation
Timepoint
Befor surgery and intervention, 6 weeks after intervention and surgery and 8 weeks after intervention and surgery
Method of measurement
Semmes Weinstein Test of Monofilaments

3

Description
Function
Timepoint
Befor surgery and intervention, 6 weeks after intervention and surgery and 8 weeks after intervention and surgery
Method of measurement
Boston Questionnaire(function section)

4

Description
Hand power(tip pinch, key pinch, grip)
Timepoint
Befor surgery and intervention, 6 weeks after intervention and surgery and 8 weeks after intervention and surgery
Method of measurement
Vigorimeter

Secondary outcomes

1

Description
Symptoms
Timepoint
Befor surgery and intervention, 6 weeks after intervention and surgery and 8 weeks after intervention and surgery
Method of measurement
Boston Questionnaire(symptoms section)

Intervention groups

1

Description
Intervention group receives rehabilitation treatment (the early motion), depending on the patient condition, this rehabilitation, depending on the patient include scar reduction techniques, standard techniques to control edema, stretching exercises,range of motion exercises for involved and uninvolved joints, nerve and tendon gliding exercises, light and tolerable activities of daily living and tolerable tasks and activities related to the job.
Category
Rehabilitation

2

Description
The control group (dressing) do not receives any intervention. Actually this group recieves routine post-operative care such as dressing and recommendations for action, according to the doctor.
Category
Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Iran Hand Rehabilitation Center
Full name of responsible person
Roya Mahmoodi
Street address
Iran Hand Rehabilitation Center, third floor, Corner of the Twelve Street, Yousef Abad, Tehran
City
Tehran

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
-----------------
Full name of responsible person
Roya Mahmoodi
Street address
Department of Occupational Therapy, The University of Social Welfare and Rehabilitation Sciences, Kodakyar St, Daneshjo Blvd, Evin, Tehran, Iran
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
-----------------
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
The University of Social Welfare and Rehabilitation Sciences
Full name of responsible person
Roya Mahmoodi
Position
Master student of occupational therapy
Other areas of specialty/work
Street address
Department of Occupational Therapy, The University of Social Welfare and Rehabilitation Sciences, Kodakyar St, Daneshjo Blvd, Evin, Tehran, Iran
City
Tehran
Postal code
Phone
+98 21 2218 0037
Fax
Email
royamahmoodi95@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
The University of Social Welfare and Rehabilitation Sciences
Full name of responsible person
Maryam Farzad
Position
PhD candidate of occupational therapy, associated professor
Other areas of specialty/work
Street address
Department of Occupational Therapy, The University of Social Welfare and Rehabilitation Sciences, Kodakyar St, Daneshjo Blvd, Evin, Tehran, Iran
City
Tehran
Postal code
Phone
+98 21 2218 0037
Fax
Email
ma.farzad@uswr.ac.ir; maryam_frzd@yahoo.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
The University of Social Welfare and Rehabilitation Sciences
Full name of responsible person
Roya Mahmoodi
Position
Master student occupational therapy
Other areas of specialty/work
Street address
Department of Occupational Therapy, The University of Social Welfare and Rehabilitation Sciences, Kodakyar St, Daneshjo Blvd, Evin, Tehran, Iran
City
Teharn
Postal code
Phone
00
Fax
Email
royamahmoodi95@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
Loading...