the aim of this study is to investigate the effect of dry needling on the trigger points of the subscapularis muscle and to improve the clinical symptoms of people with frozen shoulder.
Design
Randomized clinical trial with the control group, with parallel groups, single-blinded, on 40 patients, randomization allocation software will be used for randomization.
Settings and conduct
Patients randomly will be divided into two groups. The first group (intervention group) will receive dry needling of the subscapularis muscle during 3 sessions. At the same time, They also benefit from conventional physiotherapy treatment, but the control group will only use conventional physiotherapy treatment.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
subjects were diagnosed with frozen shoulder .
the presence of active trigger points in the subscapularis muscle
Exclusion criteria:
needle phobia
Intervention groups
The intervention group consists of patients with frozen shoulder.
Routine physiotherapy includes Continuous ultrasound with a frequency of 3 MHz for 6 minutes, high-intensity electric current with a frequency of 100 Hz and diversion of 20 minutes, hot pack simultaneously with the application of the current. Postero-anterior, Antero-posterior and caudal glides. The shoulder muscles stretching and active-assistive exercises using a towel as well. They also will receive 3 sessions of dry needling.
The control group consists of patients with frozen shoulder who will only receive routine physiotherapy.
Main outcome variables
Shoulder range of motion; intensity of pain in trigger points of the subscapularis muscles and shoulder joint; Pain pressure threshold of trigger points; Upper limb functional disability
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20200215046499N3
Registration date:2023-04-25, 1402/02/05
Registration timing:prospective
Last update:2023-04-25, 1402/02/05
Update count:0
Registration date
2023-04-25, 1402/02/05
Registrant information
Name
Hakimeh Adigozali
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 41 3337 5359
Email address
adigozalih@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-06-20, 1402/03/30
Expected recruitment end date
2024-03-10, 1402/12/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effects of dry needling on subscapularis and conventional physiotherapy on clinical symptom improvement in people with frozen shoulder
Public title
Effects of dry needling and physiotherapy in patients with frozen shoulder
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Those who have been diagnosed with frozen shoulder by a doctor and have symptoms such as pain and reduced range of motion in the capsular pattern in the shoulder joint for 3 months or more
age between 35 and 65 years old
the presence of active trigger points in the subscapularis muscle on the involved side
Pain intensity of at least 3 out of 10 in the VAS
Exclusion criteria:
skin problems in the neck and shoulder area
Antiplatelet therapy has been used in the three days before the start of the study
In the six months before starting the study, they had a history of cancer and related pain in the shoulder and pectoral region
In the three months before the start of the study, they used corticosteroid injections in the shoulder area
needle fobia
Non-cooperation during treatment
Shoulder arthroscopy surgery
cervical radiculopathy or any neurological injury in upper limb
Patients with rheumatoid or neurological diseases
Patients who use pace makers
Patients with positive subacromial entrapment tests
Age
From 35 years old to 65 years old
Gender
Both
Phase
N/A
Groups that have been masked
Outcome assessor
Sample size
Target sample size:
40
Randomization (investigator's opinion)
Randomized
Randomization description
Simple randomization with a sealed envelope: Two envelopes are prepared with the first and second group titles. Each participant randomly selects one envelope and the envelope number is recorded for the participant. The envelopes are then merged and the next participant selects another envelope from the two envelopes as the previous procedure to complete the randomization process in both groups.
Blinding (investigator's opinion)
Single blinded
Blinding description
evaluator is blind to the type of intervention in each group
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Tabriz University of medical sciences
Street address
Faculty of Rehabilitation Sciences, Tabriz University of medical sciences, 29 Bahman Blvd, Tabriz, Iran
City
Tabriz
Province
East Azarbaijan
Postal code
5166414766
Approval date
2023-03-06, 1401/12/15
Ethics committee reference number
IR.TBZMED.REC.1402.013
Health conditions studied
1
Description of health condition studied
frozen shoulder
ICD-10 code
M75.00
ICD-10 code description
Adhesive capsulitis of unspecified shoulder
Primary outcomes
1
Description
Range of motion of shoulder joint
Timepoint
before and after intervention
Method of measurement
goniometer
Secondary outcomes
1
Description
pain intensity of trigger point
Timepoint
before and after intervention
Method of measurement
Visual analog scale
2
Description
pain intensity of shoulder joint
Timepoint
before and after intervention
Method of measurement
visual analog scale (VAS)
3
Description
Pain pressure threshold of trigger points
Timepoint
before and after intervention
Method of measurement
algometer
4
Description
Upper limb functional disability
Timepoint
at first, fifth and tenth of treatment sessions
Method of measurement
disability of arm, shoulder and hand (DASH)
Intervention groups
1
Description
Intervention group: In addition to receiving the subscapularis dry needling during 3 sessions (in the 3rd, 6th, and 9th sessions of treatment) with a sterile dong bang needle with a size of 30*50 mm, the patient receives conventional physiotherapy treatment provided by the physiotherapist. Conventional treatment includes the use of continuous ultrasound with a frequency of 3 MHz for 6 minutes around the joint capsule, the use of high intensity electric current with a frequency of 80 Hz and diversion for 20 minutes, and the use of a hot pack simultaneously with the application of the current. For the involved shoulder, postero-anterior, antero-posterior and caudal glides can be used with a speed of 2 to 3 glides per second and for a total of 30 seconds for each set. The number of sets for each movement is 5 and the rest time between sets is 30 seconds. We ask the patient to stretch the shoulder muscles as well. The duration of each stretch is 30 seconds and the interval between them is 15 seconds and it is done during 3 sets. We ask the patient to do active-assistive exercises using a towel for 5 minutes a day. The number of conventional treatment sessions is 10 sessions, every other day.
Category
Rehabilitation
2
Description
Control group: People in this group only will receive conventional physiotherapy treatment provided by a physiotherapist. Conventional treatment includes the use of continuous ultrasound with a frequency of 3 MHz for 6 minutes around the joint capsule, the use of high intensity electric current with a frequency of 80 Hz and diversion for 20 minutes, and the use of a hot pack simultaneously with the application of the current. For the involved shoulder, postero-anterior, antero-posterior and caudal glides can be used with speed of 2 to 3 glides per second and for a total of 30 seconds for each set. The number of sets for each movement is 5 and the rest time between sets is 30 seconds. We ask the patient to stretch the shoulder muscles as well. The duration of each stretch is 30 seconds and the interval between them is 15 seconds and it is done during 3 sets. We ask the patient to do active-assistive exercises using a towel for 5 minutes a day. The number of conventional treatment sessions is 10 sessions, every other day.
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
physiotherapy clinic of Asadabadi hospital
Full name of responsible person
Hakimeh adigozalih
Street address
Asad-ََAbadi hospital, Bahar avenue, Tabriz
City
Tabriz
Province
East Azarbaijan
Postal code
5166414766
Phone
+98 41 3280 4293
Email
adigozalih@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
parviz shahabi
Street address
central building, tabriz university of medical sciences, university street, tabriz
City
tabriz
Province
East Azarbaijan
Postal code
5166614766
Phone
+98 41 3337 6923
Email
parvizshahabi@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Tabriz 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
Tabriz University of Medical Sciences
Full name of responsible person
Hakimeh adigozali
Position
assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Physiotherapy
Street address
Faculty of rehabilitation sciences, Tabriz university of medical sciences,29 Bahman Blvd
City
tabriz
Province
East Azarbaijan
Postal code
5166616471
Phone
+98 41 3337 5359
Email
Adigozalih@tbzmed.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Hakimeh adigozali
Position
assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Physiotherapy
Street address
Faculty of rehabilitation sciences, Tabriz university of medical sciences,29 Bahman Blvd
City
tabriz
Province
East Azarbaijan
Postal code
5166616471
Phone
+98 41 3337 5359
Email
Adigozalih@tbzmed.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Hakimeh adigozali
Position
assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Physiotherapy
Street address
Faculty of rehabilitation sciences, Tabriz university of medical sciences,29 Bahman Blvd
City
Tabriz
Province
East Azarbaijan
Postal code
5166616471
Phone
+98 41 3337 5359
Email
Adigozalih@tbzmed.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