Comparing the effect of physiotherapy and physiotherapy accompanied by acupuncture on pain, functional ability, grip strength and treatment efficacy in patients with carpal tunnel syndrome
comparing the effect of physiotherapy and physiotherapy accompanied by acupuncture on pain; functional ability; grip strength and treatment efficacy in patients with carpal tunnel syndrome
Design
superiority, parallel group Stratified randomization clinical trial with blinded outcome assessment.
Settings and conduct
The study population included patients with carpal tunnel syndrome whose disease was confirmed by an orthopedic specialist and referred to the clinics of Mashhad University of Medical Sciences. Patients will receive informed consent form approved by the Ethics Committee of Mashhad University of Medical Sciences if they are eligible for inclusion and if they wish to participate in the study.The therapist and assessor are two different individuals and neither intervention group will be aware. Physiotherapy was similar in both groups.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Patients with clinical symptoms of carpal tunnel syndrome for more than one month.
Exclusion criteria: Pregnant women, have history of surgery and fracture, having systemic diseases, having grade 3 carpal tunnel syndrome, having contraindications of acupuncture.
Intervention groups
receive physiotherapy in one group and physiotherapy accompained acupuncture in other group
Comparing the effect of physiotherapy and physiotherapy accompanied by acupuncture on pain, functional ability, grip strength and treatment efficacy in patients with carpal tunnel syndrome
Public title
Comparing the effect of physiotherapy and physiotherapy accompanied by acupuncture in patients with carpal tunnel syndrome
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Having symptoms for more than a month
Having clinical symptoms to diagnose carpal tunnel syndrome
Exclusion criteria:
Being pregnant
History of hand surgery
have carpal tunnel syndrome grade 3
receive treatment or injection in past 6 month
History of systemic disease
Having a wrist fracture
acupuncture Prohibition
Age
From 18 years old to 65 years old
Gender
Both
Phase
2-3
Groups that have been masked
Care provider
Outcome assessor
Sample size
Target sample size:
40
Randomization (investigator's opinion)
Randomized
Randomization description
The envelope method is that the envelopes will be prepared and Random Numbers printed by a member of the Research Team with the help of the Randomaize.com site and placed inside the envelope. sealed envelope content not visible from the outside. We provide 2 envelopes, including physiotherapy and physiotherapy with acupuncture, and place the envelopes in two boxes separated by gender so that we have 20 sealed envelopes in each box containing 10 physiotherapy and 10 Physiotherapy with acupuncture, like the other box , first the purpose of the study is explained to the person who meets the conditions, and will be included in the study if they complete a written informed consent form. they are according to gender take envelope.
Blinding (investigator's opinion)
Single blinded
Blinding description
Outcome assessor will not be aware of the intervention.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Mashhad University of Medical Sciences
Street address
Building Ghoreshi, Central Organization of Mashhad University of Medical Sciences, Daneshgah Avenue, Mashhad, Iran.
City
Mashhad
Province
Razavi Khorasan
Postal code
1394491388
Approval date
2019-03-10, 1397/12/19
Ethics committee reference number
IR.MUMS.REC.1397.311
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
pre test; post test
Method of measurement
visual analog scale
2
Description
fanctional ability
Timepoint
before intervention, after intervention
Method of measurement
BCT Questioner,Quick DASH
3
Description
grip strength
Timepoint
before intervention, after intervention
Method of measurement
dynamometer
Secondary outcomes
empty
Intervention groups
1
Description
control group: individuals will receive 10 sessions of physiotherapy 3 sessions per week and each session will last about 45 to 60 minutes. In addition to routine procedures (electrotherapy including tennis and ultrasound and watt pack), patients were also treated with a program of stretching exercises with hand techniques (nerve and tendon gliding exercises techniques)
Category
Treatment - Other
2
Description
Intervention group: In the physiotherapy group with acupuncture, the physiotherapy program is standard conservative methods, and similar with control group. And also in 3 physiotherapy sessions, patients receive acupuncture for 2 minutes in addition. Acupuncture is performed by the acupuncture specialist in Tai Yin, Hegu, ASHI, Neiguan points after disinfection of the site and using disposable needles of equal depth and angle.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Emam Reza Hospital
Full name of responsible person
Dr Hossein Negahban
Street address
Emam Reza Hospital
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913316
Phone
+98 51 3854 2031
Email
NegahbanH@mums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Dr Mohsen Tafaghodi
Street address
Building Ghoreshi, Central Organization of Mashhad University of Medical Sciences, Daneshgah Avenue, Mashhad, Iran.
City
Mashhad
Province
Razavi Khorasan
Postal code
1394491388
Phone
+98 35 1384 2081
Email
tafaghodim@mums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mashhad 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
Mashhad University of Medical Sciences
Full name of responsible person
Dr Hossein Negahban
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Physiotherapy
Street address
mashhad univesity of medical science, Azadi Square, Vakil Abad Avenue, Mashhad, Iran.
City
Mashhad
Province
Razavi Khorasan
Postal code
9177948964
Phone
+98 51 3884 6713
Email
honegahban@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Dr Hossein Negahban
Position
professor
Latest degree
Ph.D.
Other areas of specialty/work
Physiotherapy
Street address
mashhad univesity of medical science, Azadi Square, Vakil Abad Avenue, Mashhad, Iran.
City
Mashhad
Province
Razavi Khorasan
Postal code
9177948964
Phone
+98 51 3884 6713
Email
honegahban@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Dr Hossein Negahban
Position
professor
Latest degree
Ph.D.
Other areas of specialty/work
Physiotherapy
Street address
mashhad univesity of medical science, Azadi Square, Vakil Abad Avenue, Mashhad, Iran.
City
Mashhad
Province
Razavi Khorasan
Postal code
9177948964
Phone
+98 51 3884 6710
Email
honegahban@yahoo.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