Evaluation of the effect of interventions near and far to the carpal tunnel site using dry needle method and routine physiotherapy on clinical and paraclinical indicators of patients with carpal tunnel syndrome (CTS)
Comparison of the effect of interventions near and far to the carpal tunnel site using dry needle method and routine physiotherapy on clinical and paraclinical indicators of patients with carpal tunnel syndrome (CTS)
Design
Single-blind randomized clinical trial
Settings and conduct
The study population is patients with carpal tunnel syndrome whose disease is confirmed by an orthopedic physician and referred to the clinics of Yazd University of Medical Sciences for treatment. After the evaluation, if the patients are eligible to enter the study and if they wish to participate in the study, they will receive the informed consent form approved by the ethics committee of Yazd University of Medical Sciences and fully explain the implementation method to them. Be. The therapist and evaluator are two different people and neither group will be aware of the intervention. Physiotherapy and dry needle treatment and control are similar in all three groups. The intervention in the dry needle group is in the form of dry needle insertion along the upper limb chain and in the routine physiotherapy group is in the form of mobility of the flexor tendons. All three groups will receive guideline treatment, including the use of wrist brace. Patients will be followed up before the intervention and one month after the intervention.
Participants/Inclusion and exclusion criteria
Having clinical signs to diagnose carpal tunnel syndrome. At least 6 months (in cases of early diagnosis of mild to moderate carpal tunnel syndrome)
Intervention groups
Intervention group one: The group receiving dry needling.
Intervention group two: The group receiving routine physiotherapy.
Main outcome variables
muscle and fascia thickness; carpal tunnel space; nerve conduction; score of Boston Carpal Tunnel Questionnaire, visual pain scale.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20130612013651N4
Registration date:2020-07-23, 1399/05/02
Registration timing:prospective
Last update:2020-07-23, 1399/05/02
Update count:0
Registration date
2020-07-23, 1399/05/02
Registrant information
Name
Ali Barzegar
Name of organization / entity
Yazd University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 35 3233 2091
Email address
bafronei@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-08-04, 1399/05/14
Expected recruitment end date
2020-10-05, 1399/07/14
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the effect of interventions near and far to the carpal tunnel site using dry needle method and routine physiotherapy on clinical and paraclinical indicators of patients with carpal tunnel syndrome (CTS)
Public title
Evaluation of the effect of interventions near and far to the carpal tunnel using dry needle method and routine physiotherapy
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Having clinical signs to diagnose carpal tunnel syndrome.
Have symptoms of the disease in the last 6 months.
Age range 20 to 65 years.
Exclusion criteria:
Pregnancy.
Having a history of carpal tunnel syndrome hand surgery.
systemic diseases.
Therapeutic intervention has been performed in the last 6 months.
Age
From 20 years old to 65 years old
Gender
Both
Phase
2-3
Groups that have been masked
Outcome assessor
Data analyser
Sample size
Target sample size:
45
Randomization (investigator's opinion)
Randomized
Randomization description
A simple individual randomization method will be used which is only equal in terms of the number of people in each group and the envelope randomization tool is sealed. The groupings are hidden in the envelope in the package, which the intruder accidentally opens by removing the envelope and specifies the grouping. 45 bags including 15 packages of routine physiotherapy, 15 packages of dry acupuncture and 15 packages of control are classified into three groups. The type of intervention in this study is explained to the person who observes the conditions, and if the form of informed informed consent is completed, it will be included in the study.
Blinding (investigator's opinion)
Single blinded
Blinding description
The evaluator is the person who collects the data obtained from the intervention or control. The evaluator will not be aware of the random assignment of the groups. Will collect and record the answers based on the defined codes.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Yazd University of Medical Sciences
Before and after the intervention and one month follow-up interval
Method of measurement
electromyography device
2
Description
Muscle and fascia thickness
Timepoint
Before and after the intervention and follow-up interval
Method of measurement
sonography
Secondary outcomes
1
Description
pain intensity
Timepoint
Before and after the intervention and follow-up interval
Method of measurement
Visual analoug scale
2
Description
Functional ability
Timepoint
Before and after the intervention and follow-up interval
Method of measurement
Boston Questionnaire
Intervention groups
1
Description
Dry needle intervention group: In this group, patient receives dryneedle for 20 minutes. Dry needling is performed on the muscles of Palmaris longus, pronator of fear, flexor digitrom, biceps brachii and pectoralis major after disinfection of the site and using a disposable needle with the same depth and angle by an acupuncturist. During the intervention, the patient uses a wrist brace simultaneously throughout the night and as much as possible daily.
Category
Treatment - Other
2
Description
Routine physiotherapy intervention group: Flexor tendon gliding exercises of the fingers and median nerve gliding are repeated 10 times, held for 5 seconds, and 3 sessions per week for 2 weeks. During the intervention, the patient uses a wrist brace simultaneously throughout the night and as much as possible daily.
Category
Treatment - Other
3
Description
Control group: The patient uses the wrist brace all night and as much as possible daily.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid sadughi hospital
Full name of responsible person
Ali Barzegar
Street address
Shahid sadughi hospital, Shahid ghandi avenue
City
Yazd
Province
Yazd
Postal code
8916815235
Phone
+98 35 3827 6825
Email
barzegarali66@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor for Research, Yazd University of Medical Sciences
Full name of responsible person
Dr. Masoud Mirzaei
Street address
Yazd University of Medical Sciences, Yazd, Iran
City
Yazd
Province
Yazd
Postal code
8916189165
Phone
+98 35 3724 0171
Email
info@ssu.ac.ir
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, Yazd University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Ali Barzegar
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Physiotherapy
Street address
Shahid sadughi hospital, Shahid ghandi avenue
City
Yazd
Province
Yazd
Postal code
8916815235
Phone
+98 35 3827 6825
Email
barzegarali66@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Ali Barzegar
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Physiotherapy
Street address
Shahid sadughi hospital, Shahid ghandi avenue
City
Yazd
Province
Yazd
Postal code
8916815235
Phone
+98 35 3827 6825
Email
barzegarali66@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Ali Barzegar
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Physiotherapy
Street address
Shahid sadughi hospital, Shahid ghandi avenue
City
Yazd
Province
Yazd
Postal code
8916815235
Phone
+98 35 3827 6825
Email
barzegarali66@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available