The effectiveness of extracorporeal shock wave therapy and wrist splint versus wrist splint for management of carpal tunnel syndrome .A single blind randomized controlled trial. subjects:Patients 18-70 years of age; tingling and numbness or hand pain more than 1 month; mild to moderate carpal tunnel syndrome by electrophysiological study. Exclusion criteria:severe carpal tunnel syndrome; pregnancy; previous carpal tunnel decompression surgery in affected hand; corticosteroid injection to the carpal tunnel within last 3 months; history of wrist fracture in affected hand.Sample size:40.Intervention: Extracorporeal shock wave therapy and wrist splint versus wrist splint for management of carpal tunnel syndrome.patients of both groups receive wrist splint and ergonomic training for 12 weeks. patients of intervention group also receive 3 sessions of ESWT once a week.Outcome:change in tingling and pain and EDX parameters assessed with visual analog scale, persian version quick DASH questionnaire and nerve Conduction Study.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2014083118991N1
Registration date:2014-10-16, 1393/07/24
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2014-10-16, 1393/07/24
Registrant information
Name
Fatemeh Ghazaei
Name of organization / entity
Iran University of Medical Science
Country
Iran (Islamic Republic of)
Phone
+98 21 8214 1229
Email address
fateme_ghazaei@yahoo.com
Recruitment status
Recruitment complete
Funding source
Iran University of Medical Science
Expected recruitment start date
2014-10-08, 1393/07/16
Expected recruitment end date
2014-12-07, 1393/09/16
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effectiveness of extracorporeal shock wave therapy and wrist splint versus wrist splint for management of carpal tunnel syndrome
Public title
The effectiveness of extracorporeal shock wave therapy and wrist splint for management of carpal tunnel syndrome
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Patients 18-70 years of age; tingling and numbness or hand pain more than 1 month; vas equal or more than 4; positive tinel's sign or phalen's test; confirmed mild to moderate carpal tunnel syndrome by electrophysiological study.
Exclusion criteria: severe carpal tunnel syndrome; pregnancy; previous carpal tunnel decompression surgery in affected hand; corticosteroid injection to the carpal tunnel within last 3 months; history of wrist fracture in affected hand; abnormal EDX findings except carpal tunnel syndrome such as radiculopathy or polyneuropathy.
Age
From 18 years old to 70 years old
Gender
Both
Phase
3
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
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Iran University of Medical Science
Street address
Tehran, Shahid Hemat Highway, Iran University of Medical Science
City
Tehran
Postal code
Approval date
2014-10-01, 1393/07/09
Ethics committee reference number
93د 3170/105
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
tingling and pain intensity
Timepoint
before beginning treatment, 3, 8 and 12 weeks after treatment
Method of measurement
visual analog scale
2
Description
severity of symptoms and functional status
Timepoint
before beginning treatment, 3, 8 and 12 weeks after treatment
Method of measurement
persian quick DASH questionnaire
3
Description
sensory and motor distal latency and amplitude of median nerve
Timepoint
Before beginning treatment, 3, 8 and 12 weeks after treatment
Method of measurement
EDX evaluating (nerve Conduction Study)
Secondary outcomes
1
Description
Any side effect after intervention
Timepoint
during ESWT therapy, 3, 8 and 12 weeks after therapy
Method of measurement
Ask from patient
Intervention groups
1
Description
intervention : ESWT receive in 3 sessions once a week. each patient receive ESWT over median nerve at carpal tunnel while the patient's forearm is placed on the table with the palm facing up with this protocol: 1000 shocks at a frequency of 6 Hz and energy level of 1.5 bar while probe is oriented perpendicular to patient's palm and ultrasound gel is used as a coupling agent.All patients receive wrist night splint in a neutral position with ergonomic training including avoidance of repeated and extreme wrist movements for 12 weeks.
Category
Treatment - Devices
2
Description
control:patients of control group receive wrist night splint in a neutral position with ergonomic training including avoidance of repeated and extreme wrist movements for 12 weeks.