Comparing the Clinical and Functinal Outcomes of Treating the Elbow Lateral Epicondylitis (Tennis Elbow) with Dry Needling and Corticosteroid Injection
The aim of this study: Comparing the Clinical and Functinal Outcomes of Dry Needling and Corticosteroid Injection in patients with Elbow Lateral Epicondylitis (Tennis Elbow).
Design study: non-randomized, Not blinded, single-center, trial phase 3.
Population of intervention: Patients with lateral epicondylitis (Tennis Elbow)
Inclusion criteria: pressure pain in humeral epicondyle; Increased pain during extension of wrist And positive mid-finger test
Exclusion criteria: NSAID, Physiotherapy and Sedation therapy in the last two weeks; steroid injection in the last 3 months; Acupuncture or surgery in the last 6 months; Central and peripheral nervous system diseases; Radial nerve entrapment; Inflammatory rheumatic diseases; Gout; radioulnar or radiohumeral osteoarthritis; History of allergic reaction to corticosteroids
Sample size: 100 patients
Intervention: dry needling
Intervention time: When the diagnosis Elbow Lateral Epicondylitis (Tennis Elbow) is definitive
The study outcomes: pain intensity, functional status
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2015082523750N1
Registration date:2016-06-08, 1395/03/19
Registration timing:retrospective
Last update:
Update count:0
Registration date
2016-06-08, 1395/03/19
Registrant information
Name
Mahmoud Abdullahi
Name of organization / entity
Islamic Azad University of Shahroud
Country
Iran (Islamic Republic of)
Phone
+98 27 3339 0360
Email address
m.abdollahi@iau-shahrood.ac.ir
Recruitment status
Recruitment complete
Funding source
personally: by Mahmoud Abdollahi and Frivar Bagheri
Expected recruitment start date
2014-03-20, 1392/12/29
Expected recruitment end date
2016-03-19, 1394/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparing the Clinical and Functinal Outcomes of Treating the Elbow Lateral Epicondylitis (Tennis Elbow) with Dry Needling and Corticosteroid Injection
Public title
Comparing the Clinical and Functinal Outcomes of Treating the Elbow Lateral Epicondylitis (Tennis Elbow) with Dry Needling and Corticosteroid Injection
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Report of pressure pain in humeral epicondyle; Increased pain during extension of wrist In the face of resistance And mid-finger test positive
Exclusion criteria: Treatment of pain in the past two weeks with sedation, NSAID or Physiotherapy; Treatment of pain In the last 3 months with steroid injections; Treatment with acupuncture or surgery in the last 6 months; Central and peripheral nervous system diseases; Radial nerve entrapment; Inflammatory rheumatic diseases; Gout; radioulnar or radiohumeral osteoarthritis; A history of allergic reaction to corticosteroids
Age
No age limit
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
100
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Shahroud University of Medical Sciences
Street address
Central Building of Shahroud University of Medical Sciences, Hafte-Tir Square, Shahroud
City
Shahroud
Postal code
Approval date
2015-01-21, 1393/11/01
Ethics committee reference number
930/35
Health conditions studied
1
Description of health condition studied
Elbow Lateral Epicondylitis (Tennis Elbow)
ICD-10 code
M77.1
ICD-10 code description
Lateral epicondylitis
Primary outcomes
1
Description
pain intensity
Timepoint
Two weeks after the intervention, eight weeks after intervention, 6 months after the intervention.
Method of measurement
Using the VAS and the use of questionnaires quick-DASH score and PRTEE
2
Description
functional status
Timepoint
Two weeks after the intervention, eight weeks after intervention, 6 months after the intervention.
Method of measurement
the use of questionnaires quick-DASH score and PRTEE
Secondary outcomes
empty
Intervention groups
1
Description
Intervention: dry needling
Intervention methods: 1- initially determine the exact location of tenderness in Arjun extensor tendon by examination 2- Local anesthesia by lidocaine 3- Piercing the Damaged tendon by the needle (18) 4- prednisolone 40mg injected with 1ml of lidocaine 2%
Category
Treatment - Surgery
2
Description
control: Corticosteroid
Intervention methods: 1- initially determine the exact location of tenderness in Arjun extensor tendon by examination 2- Local anesthesia by lidocaine 3- prednisolone 40mg injected with 1ml of lidocaine 2%
Category
Treatment - Surgery
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Hussein Hospital
Full name of responsible person
Mahmoud Abdollahi
Street address
Imam Hussein Hospital, Ayatollah tohidi end of the street, Shahroud
City
Shahroud
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Islamic Azad University of Shahroud
Full name of responsible person
Mahmoud Abdullah
Street address
Islamic Azad University of Shahroud, University Blvd., Shahroud
City
Shahroud
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Islamic Azad University of Shahroud
Proportion provided by this source
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
2
Sponsor
Name of organization / entity
Medical School of Islamic Azad University of Shahroud
Full name of responsible person
Frivar Bagheri
Street address
Imam Ali (AS) Doctors Building
City
Shahroud
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Medical School of Islamic Azad University of Shahroud
Proportion provided by this source
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
Medical School of Islamic Azad University of Shahroud
Full name of responsible person
Mahmoud Abdullah
Position
Medical Student
Other areas of specialty/work
Street address
Islamic Azad University of Shahroud, University Blvd., Shahroud
City
Shahroud
Postal code
Phone
+98 23 3239 4532
Fax
Email
M.abdollahi@iau-shahrood.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Islamic Azad University of Shahroud
Full name of responsible person
Frivar Bagheri
Position
Orthopedic specialist and faculty member
Other areas of specialty/work
Street address
Imam Ali (AS) Doctors Building
City
Shahroud
Postal code
Phone
+98 23 3239 4532
Fax
Email
M.abdollahi@iau-shahrood.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Medical School of Islamic Azad University of Shahroud
Full name of responsible person
Mahmoud Abdullahi
Position
Medical Student
Other areas of specialty/work
Street address
Islamic Azad University of Shahroud, University Blvd., Shahroud
City
Shahroud
Postal code
Phone
00
Fax
Email
M.abdollahi@iau-shahrood.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)