The aim of this research is comparing the effect of electroacupuncture and low-level laser on the treatment of frozen shoulder. This study is a double-blind clinical trial because both of patient and assessor are not aware of the kind of treatment methods but the therapist is aware of the treatment methods. Seventy-five patients will refer to the Fattemieh physiotherapy clinic in Rafsanjan. Assessor evaluates the patients based on inclusion criteria, then he divides them to random permuted blocks methods in 3 equal groups and refers to the therapist. Three interventions of this study are electroacupuncture (acupuncture with electricity), low-level laser (Gallium, Aluminum-Arsenide, 810nm, 100mv) and conventional therapy (Ultrasound, Infrared, Transcutaneous Electrical Nerve Stimulation (TENS)). The intensity of pain and movements will be assessed during 1st, 5th, 10th sessions and one month later. Inclusion criteria are having 45-65 years; having limitation of flexing, abduction, lateral and medial rotation of the shoulder movements; pain in active and resistive movements; time of affected to shoulder pain has been previous 3 months; frozen shoulder should be primary kind. Exclusion criteria are having previous surgery and fracture; corticosteroid injection and physiotherapy during 6 months ago; rupture of the rotator cuff; pregnancy and secondary frozen shoulder.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201706163220N8
Registration date:2017-07-24, 1396/05/02
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2017-07-24, 1396/05/02
Registrant information
Name
Dadollah Shahimoridi
Name of organization / entity
Rafsanjan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 39 1822 0040
Email address
d_shahimoridi@rums.ac.ir
Recruitment status
Recruitment complete
Funding source
Rafsanjan University of Medical Sciences
Expected recruitment start date
2017-06-06, 1396/03/16
Expected recruitment end date
2018-04-05, 1397/01/16
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of electroacupuncture and low level laser on treatment of frozen shoulder
Public title
The Effect of electroacupuncture and laser on frozen shoulder
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: aged 45 to 65 years; having limitation of flexion, abduction, lateral and medial rotation of the shoulder movements; pain at active and resistive movements; duration of disease at least 3 months; frozen shoulder of primary type; Exclusion criteria: having previous surgery and fracture of the shoulder; corticosteroid injection and physiotherapy during past 6 months; rupture of the rotator cuff; pregnancy; secondary frozen shoulder due to other diseases
Age
From 45 years old to 65 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
75
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
The ettics committe of Rafsanjan University of Medical Sciences
Street address
Central Organization of Rafsanjan University of medical Sciences, Emam Ali Blvd.
City
Rafsanjan
Postal code
7717893591
Approval date
2017-06-18, 1396/03/28
Ethics committee reference number
IR.RUMS.REC.1396.65
Health conditions studied
1
Description of health condition studied
Frozen shoulder
ICD-10 code
M75.0
ICD-10 code description
Adhesive capsulitis of shoulder
Primary outcomes
1
Description
Pain intensity
Timepoint
1st, 5th, 10th sessions and one month later
Method of measurement
By Visual Analogue Scale (VAS)
2
Description
Shoulder movements
Timepoint
1st, 5th, 10th sessions and one month later
Method of measurement
By goniameter
Secondary outcomes
empty
Intervention groups
1
Description
First group will receive electroacupuncture. Needle is inserted to acupuncture points of shoulder, then electrical stimulation through simulator set connect to patients body, Ying Di, KWD 808 model, made in china, 3HZ and 20 minutes.
Category
Rehabilitation
2
Description
Second group will receive low level laser (Ga Al AS, 810 nm, 100 mv) 6J intensity and 10 minutes per session during 10 session on 9 acupuncture points of the frozen shoulder.
Category
Rehabilitation
3
Description
Third group (conventional physiotherapy) are include Ultrasound, Infrared and TENS sets.
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
Fattemieh Physiotherapy Clinic
Full name of responsible person
Dadollah Shahimoridi
Street address
Alley 17, Moalem St.
City
Rafsanjan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Rafsanjan University of Medical Sciences
Full name of responsible person
Hamid Hakimi
Street address
Educational assistantCentral Organization of Rafsanjan University of Medical Sciences, Emam Ali Blvd.
City
Rafsanjan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Rafsanjan 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
Rafsanjan University of Medical Sciences
Full name of responsible person
Dadollah Shahimoridi
Position
Instructor (Academic member)
Other areas of specialty/work
Street address
Educational Assistant, Central Organization of Rafsanjan University of Medical Sciences, Emam Ali Blvd.
City
Rafsanjan
Postal code
7717893591
Phone
+98 34 3426 2926
Fax
Email
d_shahimoridi@rums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Rafsanjan University of Medical Sciences
Full name of responsible person
Dadollah Shahimoridi
Position
Instructor (Academic member)
Other areas of specialty/work
Street address
Educational Assistant, Central Organization of Rafsanjan University of Medical Sciences, Emam Ali Blvd.
City
Rafsanjan
Postal code
7717893591
Phone
+98 34 3435 5286
Fax
Email
d_shahimoridi@rums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Rafsanjan University of Medical Sciences
Full name of responsible person
Dadollah Shahimoridi
Position
Instector (Academic member)
Other areas of specialty/work
Street address
Educational Assistant, Central Organization of Rafsanjan University of Medical Sciences, Emam Ali Blvd.
City
Rafsanjan
Postal code
7717893591
Phone
+98 34 3426 2926
Fax
+98 34 3428 0097
Email
d_shahimoridi@rums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)