Protocol summary

Summary
The aim of this study was to investigate the effects of dry needle and relative rest in infants with trigger finger. For this purpose, 60 patients with a trigger finger are randomly assigned to two groups of dry needles and rest group. All of these patients have symptoms of pain and tenderness in the A1 locus, and a sense of pain and disability during bending and tilting of the finger as well as a measurable mass. Touch in the tendon. The disease grade is ranked by the Quinnell's grading system. The pulley thickness and tendon diameter are evaluated by an ultrasound machine before and one week after the intervention. Disability and handicap disorder is measured by the DASH questionnaire. The amount of pain is assessed by VAS. Grip and pinch strength are measured by dynamometer . In the intervention group, the location of the tendon prominence through the touch and, according to the country, the surface anatomical markings of the tendon are acupuncture needles of 16 mm diameter, 8 mm in three lateral medial directions, and in parallel with the tendon with a 45 ° angle of inclination and 10 turns in the direction And counterclockwise. In the control group, the patient is advised to reduce his activity and return to assessment for seven days. Changes in measurements before and after treatment are analyzed by spss software.

General information

Acronym
TF
IRCT registration information
IRCT registration number: IRCT2015101024453N1
Registration date: 2017-09-09, 1396/06/18
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2017-09-09, 1396/06/18
Registrant information
Name
Morteza Azizian
Name of organization / entity
Tehran university of medical sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 7753 5132
Email address
m-azizian@razi.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Rehabilitation school
Expected recruitment start date
2017-05-29, 1396/03/08
Expected recruitment end date
2017-08-30, 1396/06/08
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Effects of Dry Needling on, Ultrasonographic features , Pain, Hand functional performance in Patients with Trigger Finger compare to the Control Group
Public title
The Effects of Dry Needling on the Trigger Finger
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: 1-Not having Fear of Needle 2- Getting in one of the three groups of trigger finger disorder (having three symptoms of pain and Tenderness at the position of A1 pulley, feeling pain and discomfort when flexing and extending finger, and nodule palpation 3. At least 4 weeks of history of the disease 4. Disorders of movement during finger movement 5. Did not have previous surgery in the affected area 6. The health of the proximal joints 7- Ability to perform the desired tests 8. No pacemaker 9) Absence of ulcers in the target area 10. Not having coagulation problems 11. Have Satisfaction to participate in the study and willingness to cooperate. 12. Do Not having rheumatoid arthritis. 13. Not taking analgesic and sedative medications after the onset of intervention 14. No drug use 16. The absence of neurological diseases Exclusion Criteria: 1. Any damage to the skin of the infection and trauma during the study 2. Unwillingness to continue cooperation 3. Perform any surgeries during the research 4. Fear of the needle during the intervention stages 5. Any trauma and fracture during the evaluation process 6. Any hematoma and edema
Age
From 30 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 60
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features
In this study, in addition to the examination of ultrasound of the tendon diameter and the thickness of the pulley, the effectiveness of the hand is measured through a questionnaire.

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Tehran University of Medical Scienses
Street address
The Committee on Ethics in the Research of the Faculty of Nursing and Midwifery and the Faculty of Rehabilitation, Ms. Zahra Tavakol
City
Tehran
Postal code
9123643003
Approval date
2017-05-29, 1396/03/08
Ethics committee reference number
IR.TUMS.FNM.REC.1396.2449

Health conditions studied

1

Description of health condition studied
Trigger finger
ICD-10 code
M65.3
ICD-10 code description
Trigger finger, Nodular tendinous disease

Primary outcomes

1

Description
Thickness of pulley
Timepoint
before and seven day after intervention
Method of measurement
Musculoskeletal ultrasonography in millimeters

2

Description
tendon Diameter
Timepoint
before and seven day after intervention
Method of measurement
Musculoskeletal ultrasonography in millimeters

3

Description
power of pinch
Timepoint
before and seven day after intervention
Method of measurement
Kilograms - pinch gauge

4

Description
Disabilities of the Arm, Shoulder and Hand
Timepoint
before and seven day after intervention
Method of measurement
Disabilities of Hand - DASH

5

Description
power of gripe
Timepoint
before and seven day after intervention
Method of measurement
Kilograms - dynamometer

6

Description
pain
Timepoint
before and seven day after intervention
Method of measurement
visual analog scale

7

Description
Quinnell grading
Timepoint
before and seven day after intervention
Method of measurement
Quinnell grading system

Secondary outcomes

1

Description
pain
Timepoint
Immediately after needling
Method of measurement
VAS

Intervention groups

1

Description
In the intervention group,Dry needling is done by the needle making company DongBang of South Korea. the location of the tendon prominence through the touch and, according to, the surface anatomical landmark . the tendon are acupuncture needles of 16 mm diameter, 8 mm in three lateral medial directions, and in parallel with the tendon with a 45 ° angle of inclination and 10 turns in the direction And counterclockwise. In the control group, the patient is advised to reduce his activity and return to assessment for seven days.
Category
Other

2

Description
Control group: Give enough time to the body to take care of the body repair. Provide advice to the patient to reduce the activity of his or her hands and not carry out heavy work for one week after the initial assessment.
Category
Lifestyle

Recruitment centers

1

Recruitment center
Name of recruitment center
Taleghani Educational Hospital,Shahid Beheshti University of Medical Sciences
Full name of responsible person
Mohamad Ali okhovatpour
Street address
Tabnak St. Velenjak Region, Chamran High Way, Tehran, Iran
City
Tehran

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
School of Rehabilitation of Tehran University of Medical Sciences,
Full name of responsible person
Gholamreza Olyaei
Street address
Piche Shemiran, Enghelab Ave
City
Tehran
Grant name
32554
Grant code / Reference number
2232145
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
School of Rehabilitation of Tehran University of Medical Sciences,
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty

Person responsible for general inquiries

Contact
Name of organization / entity
School of Rehabilitation of Tehran University of Medical Sciences
Full name of responsible person
Hosain Bagheri
Position
Professor
Other areas of specialty/work
Street address
Piche Shemiran, Enghelab Ave,
City
Tehran
Postal code
789456123
Phone
+98 21 7753 3393
Fax
+98 21 7752 8468
Email
hbagheri@tums.ac.ir
Web page address
www.rehab.tums.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
School of Rehabilitation of Tehran University of Medical Sciences
Full name of responsible person
Hosain bagheri
Position
Professor
Other areas of specialty/work
Street address
Piche Shemiran, Enghelab Ave,
City
Tehran
Postal code
789456123
Phone
+98 21 7753 3393
Fax
+98 21 7752 8468
Email
hbagheri@tums.ac.ir
Web page address
www.reheb.tums.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
faculty of Rehabilitation, Tehran University of Medical Sciences
Full name of responsible person
Azadh shadmeher
Position
Professor
Other areas of specialty/work
Street address
Enghelab Avenue, phicheshemiran
City
Tehran
Postal code
Phone
+98 21 7753 3393
Fax
+98 21 7752 8468
Email
hbagheri@tums.ac.ir
Web page address
www.reheh.tums.ac.ir

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
Loading...