Comparison of neurodynamic technique and the air compression massage therapy on sensory and motor parameters of median nerve in patients with mild to moderate carpal tunnel syndrome
Determination of effect of neurodynamic technique and the air compression massage therapy on sensory and motor parameters of median nerve in patients with mild to moderate carpal tunnel syndrome
Design
A randomized not blinded clinical trial with a parallel groups, on 30 patients
Settings and conduct
Patients who will be referred to rehabilitation unit of Razi Hospital in Birjand by inclusion criteria.First, Boston questionnaire will be completed by patients to evaluate subjective symptoms. Then, the initial evaluation of sensory and motor parameters of the Median nerve will be performed by a skilled neurologist by NEMUS 2EBM.Then, patients will be randomly divided into two groups of routine therapy group (tens, ultrasound, neurodyminamic techniques) and air pressure massage therapy group (tens, ultrasound, pressure device model WIC2008). At the end of the treatment, the evaluation will be performed again by NEMUS 2EBM and the Boston questionnaire will be completed again by the patient.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
Years: Range:18-60, males and females
Sensory peak latency more than 3.5 msec
Persons with parasthesia ,pain in distribution of median nerve
People with a desire to enter the study
Exclusion criteria:
Thenar atrophy
Systemic peripheral neuropathy
History of carpal tunnel release
Metabolic and vascular disorders
Pregnancy
Previous history of injection steroid carpal tunnel
Previous history of truma in carpal tunnel region
Intervention groups
group A: Neurodynamic teqnicue
group B : Air compression massage
Main outcome variables
Motor latency, Sensory peak latency, Sensory velocity, subjective symptoms(pain and function)
General information
Reason for update
Acronym
سندروم تونل کارپال cts
IRCT registration information
IRCT registration number:IRCT20180714040466N4
Registration date:2021-10-23, 1400/08/01
Registration timing:retrospective
Last update:2021-10-23, 1400/08/01
Update count:0
Registration date
2021-10-23, 1400/08/01
Registrant information
Name
Fateme Ghiasi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 54 3341 6708
Email address
f_ghiasi_p@zaums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-06-22, 1400/04/01
Expected recruitment end date
2021-09-11, 1400/06/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of neurodynamic technique and the air compression massage therapy on sensory and motor parameters of median nerve in patients with mild to moderate carpal tunnel syndrome
Public title
Comparison of neurodynamic technique and the air compression massage therapy on parameters of median nerve in patients with carpal tunnel syndrome
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Years: Range:18-60, males and females
Sensory peak latency more than 3.5 msec
Persons with parasthesia in distribution of median nerve
Persons with pain in distribution of median nerve
People with a desire to enter the study
Exclusion criteria:
Thenar atrophy
Systemic peripheral neuropathy
History of carpal tunnel release
Metabolic disorders
Vascular disorders
Previous history of trauma in carpal tunnel region
Previous history of injection steroid in carpal tunnel
Pregnancy
Age
From 18 years old to 60 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
30
Randomization (investigator's opinion)
Randomized
Randomization description
Based on the number of patients in each group,the particular sort of treatment( Neurodynamic Techniques group or Air compression massage group) is written on a piece of paper.Each paper is placed in a sealed envelope.One envelope will be chosen randomly by the therapist at the first session of the patient treatment and the patient's treatment technique is selected based on that.If any of the patients is omitted from the study, one envelope related to the excluded patient treatment group will be replaced and they will mixed again.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Zahedan University of Medical Sciences
Street address
Dr. Hesabi Blvd
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9816743463
Approval date
2021-07-17, 1400/04/26
Ethics committee reference number
IR.ZAUMS.REC.1400.123
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
Symptom of carpal tunnel syndrome
Timepoint
Before and after treatment
Method of measurement
Bostone examiner
2
Description
Sensory and motor parameters of median nerve
Timepoint
Before and after of treatment
Method of measurement
Electrodyagnostic
Secondary outcomes
empty
Intervention groups
1
Description
Control group: Neurodynamic technique.ULTT2a neurodynamic technique will be performed for 3 weeks. ULTT2a steps include: (1) shoulder girdle depression (2) shoulder abduction (3) external shoulder rotation and forearm supination (4) finger and wrist extension (5) elbow extension . The technique is in 5 separate sets and each set contains 10 repetitions that will be done every other day.
Category
Rehabilitation
2
Description
Intervention group: Air compression massage. In this group, the WIC2008 compression device will be used for treatment. While the person is sitting, the person's arm will be fully supported on the armrest in a completely relaxed position, the affected limb will be completely inside the device pad, adjusted alternately with a maximum pressure of 120 mm Hg and a minimum pressure of 0 mm Hg. The filling time of the device is 3 seconds and its discharge time is 12 seconds and the treatment lasts for ten minutes. The treatment will be done for three weeks and one day in between.
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
Razi hospital
Full name of responsible person
Samane Khorashadizade
Street address
Razi Hosp, Ghafari Blvd
City
Birjand
Province
South Khorasan
Postal code
97185555558
Phone
+98 56 3162 6098
Email
samane.khorashadizade@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Zahedan University of Medical Sciences
Full name of responsible person
Dr.Noormohammad Bakhshani
Street address
Dr.Hessabi Blvd
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9817643463
Phone
+98 54 3329 5796
Email
public @zamus.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Zahedan 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
Zahedan University of Medical Sciences
Full name of responsible person
Dr.Fateme Ghiasi
Position
Asistance professor
Latest degree
Ph.D.
Other areas of specialty/work
Physiotherapy
Street address
Khatam al anbia Hosp, Jame jam Blvd
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9815733169
Phone
+98 54 3322 0501
Email
f_ghiasi_p@zamus.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Zahedan University of Medical Sciences
Full name of responsible person
Dr.Fateme Ghiasi
Position
Asistance professor
Latest degree
Ph.D.
Other areas of specialty/work
Physiotherapy
Street address
Khatam al anbia Hosp, Jame jam Blvd
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9815733169
Phone
+98 54 3322 0501
Email
f_ghiasi_p@zamus.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Zahedan University of Medical Sciences
Full name of responsible person
Dr.Fateme Ghiasi
Position
Asistance professor
Latest degree
Ph.D.
Other areas of specialty/work
Physiotherapy
Street address
Khatam al anbia Hosp, Jame jam Blvd Zahedan
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9815733169
Phone
+98 54 3322 0501
Email
f_ghiasi_p@zamus.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available