Studying the effectiveness of Frankincense on electrodiagnostic study and clinical symptoms in patients with Carpal Tunnel Syndrome .
Design
A concealed, randomized, blinded, sham controlled clinical trial with a parallel group design of 28 samples, enrolled in 2017
Settings and conduct
In all petients admitted to Emam Khomeini PM&R clinics and have inclusion criteria ,electrodiagnostic parameters,VAS for pain severity ,Grip power,Boston questionnaire parameters are measured in both groups before and after intervention.
Participants/Inclusion and exclusion criteria
Inclusion criteria: patients aged >=18 years with unilateral or bilateral mild or moderate CTS; patients who have at least two signs or one sign and one symptom of CTS such as numbness, paresthesia, positive Tinel or Phalen tests; patients who agree to participate in this study.
Exclusion criteria: patients with severe CTS; Patients with history of previous surgical release of the carpal tunnel; patient who have intra canal corticosteroids injection in last 6 months; patients with cervical radiculopathy.
Intervention groups
Intervention group: they receive topical Frankincense derived product ,twice a day with standard treatment (cockup splint) for six weeks.
Control group: they receive placebo, with the same appearance ,smell and viscosity as the intervention, twice a day with standard treatment (cockup splint) for six weeks.
Main outcome variables
Electrodiagnostic parameters; pain severity based on VAS; Grip power; functional status scale and symptom severity scale.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180731040647N1
Registration date:2019-02-24, 1397/12/05
Registration timing:retrospective
Last update:2019-02-24, 1397/12/05
Update count:0
Registration date
2019-02-24, 1397/12/05
Registrant information
Name
Seyede Zahra Emami Razavi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 6119 2291
Email address
z-emamirazavi@tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-11-06, 1397/08/15
Expected recruitment end date
2019-02-19, 1397/11/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation the effectiveness of Frankincense on symptoms,signs & electrodiagnostic parameters of patients with carpal tunnel syndrome.
Public title
Effect of Frankincense on carpal tunnel syndrome
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients aged >=18 years
Patients with unilateral or bilateral mild or moderate CTS
Patients who heve at least two signs or one sign and one symptom of CTS, such as numbness, paresthesia, positive Tinel or Phalen tests
patients who agreed to participate in this study
Exclusion criteria:
Patients with severe CTS
Patients with history of previous surgical release of the median nerve
Patients with sequelae of fracture of the wrist
Patient who have intra canal corticosteroids injection in the last 6 months
Patients with cervical radiculopathy
Patient who have taken analgesics or cortcosteroid
Patients with any undelying disease such as DM, CRF, neuropathy
Alcoholic patients
Patients who have allergy to drug or placebo
Patients who do not agree to participate or who do not sign the consent form
Age
From 18 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Care provider
Investigator
Outcome assessor
Data analyser
Data and Safety Monitoring Board
Sample size
Target sample size:
36
More than 1 sample in each individual
Number of samples in each individual:
2
hands of the patients with mild or moderate CTS.
Randomization (investigator's opinion)
Randomized
Randomization description
Subject selection will be done by simple randomization among patients
with Carpal Tunnel Syndrome ,coming to physical medicine & rehabilitation clinics affiliated with Tehran University of Medical Sciences in 2018-2019. Treatment allocation was constructed with table of random numbers . In addition, numbered opaque envelopes used to conceal random sequence.
Blinding (investigator's opinion)
Triple blinded
Blinding description
The study is triple blind. The patients ,the clinical teams and the people who analyze the data are kept blind.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Tehran university of Medical Sciences
Mononeuropathies of upper limb,urrent traumatic nerve disorder,Carpal tunnel syndrome
Primary outcomes
1
Description
Pain score based on visual analogue scale
Timepoint
Before intervention and 2,6 weeks after intervention
Method of measurement
Visual Analogue Scale
2
Description
Grip power in affected hand
Timepoint
Before intervention and 2 and 6 weeks after intervention
Method of measurement
hand dynamometry
3
Description
Electrodiagnostic parameters including median sensory and motor nerve conduction studies to determine initial latency and base to peak amplitude are registered.
Timepoint
Before intervention and 2,6 weeks after intervention
Method of measurement
Electrodiagnostic machine.
4
Description
symptom severity scale & functional status scale
Timepoint
Before intervention and 2,6 weeks after intervention
Method of measurement
Boston Questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: they go under treatment of topical product,derived from Frankincense ,every other 12 hours for 6 weeks on their volar surface of wrist.they also wear cock up splints as a standard care for mild or moderate carpal tunnel syndrome.
Category
Treatment - Drugs
2
Description
Control group: they go under treatment of placebo,which is completely similar to drug in appearance,color and viscosity ,every other 12 hours ,for 6 weeks on their volar surface of wrist.they also wear cock up splints as a standard care for mild or moderate carpal tunnel syndrome.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Khomeini Hospital Complex Center
Full name of responsible person
Setareh Rohani Shahraki
Street address
Keshavarz Blvd,Tehran,Iran
City
Tehran
Province
Tehran
Postal code
1419733141
Phone
+98 21 6658 2678
Email
Imamhospital@tums.ac.ir
Web page address
http://ikhc2.tums.ac.ir/
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
ِDr.Shahin Akhoundzadeh
Street address
Ghods st, Keshavarz Blvd
City
Tehran
Province
Tehran
Postal code
1417653761
Phone
+98 21 8163 3698
Email
tums_edu@tums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?