Comparing the effect of two methods of point and switch radial shock wave therapy on pain intensity and electrophysiological parameters of median nerve in patients with carpal tunnel syndrome
1. Comparing the effect of two methods of point and switch radial shock wave therapy on pain intensity, hand function, sensory distal latency and motor distal latency
2. Comparing the effect of two methods of point / switch radial shock wave therapy and routine physiotherapy on pain intensity, hand function, sensory distal latency and motor distal latency
Design
A clinical trial with parallel group trial, double blinded with simple randomization.
Settings and conduct
Patients with mild to moderate carpal tunnel syndrome that referred to neurology clinic of Ayatollah Rouhani Hospital in Babol city.
They are first examined by a neurologist, then we select 60 patients with consideration of inclusion and exclusion criteria of study.
Participants/Inclusion and exclusion criteria
Positive Phalen's test and compression test in physical examination
Paresthesia, numbness or pain for more than 3 months
Visual analogue scale (VAS) ≥ 3 and VAS < 6
Confirmed diagnosis of mild to moderate CTS with electrophysiological study
Intervention groups
Routine physiotherapy protocol: include transcutaneous nerve electrical stimulation, ultrasound therapy and short cock up splint and vitamin B1 300 mg
Point group protocol: patients will receive routine physiotherapy protocol with 4 sessions of shock wave therapy with point application of shock wave.
Switch group protocol: patients will receive routine physiotherapy protocol with 4 sessions of shock wave therapy with switch application of shock wave.
Main outcome variables
Pain intensity
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20200706048028N1
Registration date:2020-08-24, 1399/06/03
Registration timing:registered_while_recruiting
Last update:2020-08-24, 1399/06/03
Update count:0
Registration date
2020-08-24, 1399/06/03
Registrant information
Name
Yahya Javadian
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 11 3223 8307
Email address
javad835@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-07-29, 1399/05/08
Expected recruitment end date
2021-02-18, 1399/11/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparing the effect of two methods of point and switch radial shock wave therapy on pain intensity and electrophysiological parameters of median nerve in patients with carpal tunnel syndrome
Public title
Comparing the effect of two methods of radial shock wave therapy in patients with carpal tunnel syndrome
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients 20-70 years of age with tingling and numbness or hand pain more than 3 month and confirmed mild to moderate carpal tunnel syndrome by electrophysiological study
Exclusion criteria:
Age
From 20 years old to 70 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Outcome assessor
Sample size
Target sample size:
45
Randomization (investigator's opinion)
Randomized
Randomization description
Participants are divided into three groups using simple randomization method
Blinding (investigator's opinion)
Double blinded
Blinding description
The investigators who evaluate the electrodiagnostic and clinical measurements will blind to the allocation and to each other,
The patients are blinding too.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Babol University of Medical Sciences
Street address
Babol university of medical sciences, Ganjafrooz Street , Babol , Mazandaran ,Iran
City
Babol
Province
Mazandaran
Postal code
47176-47745
Approval date
2020-07-05, 1399/04/15
Ethics committee reference number
IR.MUBABOL.HRI.REC.1399.106
Health conditions studied
1
Description of health condition studied
Mild to moderate Carpal Tunnel Syndrome
ICD-10 code
G56.00
ICD-10 code description
Carpal tunnel syndrome, unspecified upper limb
Primary outcomes
1
Description
Pain intensity
Timepoint
Before intervention, after intervention and 1 month after intervention
Method of measurement
The visual analog scale (VAS) was used to evaluate the degree of pain, which was self assessed by the patients, and the scale ranges from 0 to10
Secondary outcomes
1
Description
Evaluating symptoms severity and functional status of hand
Timepoint
Before intervention, after intervention and 1 month after intervention
Method of measurement
The Boston questionnaire consists of a symptoms severity scale (SSS) and a functional status scale (FSS), and it was answered by the patients. SSS is evaluated by 11 questions concerning pain, tingling, night symptoms, numbness, and hand weakness and responses range from no symptoms (1point) to symptoms too severe to perform activity (5 point). The average of these 11 scores was used to quantify the severity of patients’ symptoms. FSS consists of 8 questions concerning functional activities and responses range from functional activities with less deficiency (1 point) to functional activities with high deficiency (5 point). The average of these 8 scores was used to quantify the patients’ functional status.
2
Description
sensory and motor distal latency
Timepoint
Before and after intervention
Method of measurement
EDX evaluating (Nerve Conduction Study)
Intervention groups
1
Description
Routine physiotherapy group: Patients in this group receive routine physiotherapy including patient education, TENS, therapeutic ultrasound 3 days a week for 10 sessions and ask them to use short cock-up splint and vitamin B1 300 mg.TENS administer for 20 min each session, at a frequency of 80 HZ, with a pulse duration of 60 µs and at intensity that produce a comfortable tingling sensation. negative electrode is placed on carpal tunnel, and positive electrode is placed on palmar surface of hand.Therapeutic ultrasound administer to the palmar carpal tunnel area for 5 min per session, at a frequency 1 MHZ with intensity of 1 W/cm2 and duty cycle of 50%. we instruct patients to wear the short cock-up splint at night for two weeks and ask them to consumption of vitamin B1 300 mg each day for 4 weeks.
Category
Rehabilitation
2
Description
Point shock wave therapy group: patients in this group receive routine physiotherapy including patient education, TENS, therapeutic ultrasound 3 days a week for 10 sessions and ask them to use short cock-up splint and vitamin B1 300 mg exactly similar to routine group, in addition to the aforementioned routine physiotherapy, patient in the point shock wave therapy group receive shock wave therapy for 4 sessions as described below.for shock wave therapy, patients sit in a relax position with their forearm and finger resting on the table. with the palm facing up, the shock wave probe places perpendicularly on patients palm over the median nerve on carpal tunnel after application of the coupling gel. the median nerve is localized by anatomic landmarks on the wrist (scaphoid-pisiform level). shock wave administrate without anesthesia using a pneumatic generator (STORZ Medical Masterpuls MP100, Tagerwilen, switzerland) with 1500 shocks, at a pressure of 1/5 Bar and a rate of 6 pulse per second with point application (hold probe of shock wave stationary over the carpal tunnel).
Category
Rehabilitation
3
Description
Switch shock wave therapy group: patients in this group receive routine physiotherapy including patient education, TENS, therapeutic ultrasound 3 days a week for 10 sessions and ask them to use short cock-up splint and vitamin B1 300 mg exactly similar to routine group, in addition to the aforementioned routine physiotherapy, patient in the point shock wave therapy group receive shock wave therapy for 4 sessions as described below.for shock wave therapy, patients sit in a relax position with their forearm and finger resting on the table. with the palm facing up, the shock wave probe places perpendicularly on patients palm over the median nerve on carpal tunnel after application of the coupling gel. the median nerve is localized by anatomic landmarks on the wrist (scaphoid-pisiform level). shock wave administrate without anesthesia using a pneumatic generator (STORZ Medical Masterpuls MP100, Tagerwilen, switzerland) with 1000 shocks, at a pressure of 1/5 Bar and a rate of 6 pulse per second with point application (hold probe of shock wave stationary over the carpal tunnel), and 500 shocks are applied with switch application (switch shock wave’s probe on median nerve pathways on palmar surface of hand).
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
Rouhani hospital in Babol city
Full name of responsible person
Yahya Javadian
Street address
Babol university of medical sciences, Ganjafrooz Street , Babol , Mazandaran ,Iran
City
Babol
Province
Mazandaran
Postal code
47176-47745
Phone
+98 11 3219 9592
Email
javad835@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Babol University of Medical Sciences
Full name of responsible person
Reza Ghadimi
Street address
Babol university of medical sciences, Ganjafrooz Street , Babol , Mazandaran ,Iran
City
Babol
Province
Mazandaran
Postal code
47176-47745
Phone
+98 11 3219 9952
Email
javad835@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?