Evaluation the effect of TECAR and exercise therapy protocol on pain reduction and functional improvement of the kinetic and kinematic of the glenohumeral and scapulothorasic joints in patients with frozen shoulder
Evaluation the effect of TECAR and exercise on pain and function of the kinetic and kinematic in frozen shoulder
Design
Randomised control trial with two group, intervention and control, single blinded, pre and post operative care
Settings and conduct
Tarbiat Modares University Motion analysis laboratory
Prossessor blinded
Participants/Inclusion and exclusion criteria
idiopathic (primary) frozen shoulder patients that their disease lasting at least 3 months and maximum 4 months.
inclusion criteria:
patients in age 45-70 years.
in both gender
Right shoulder involvement (dominant hand)
In the range of BMI 25-29.9 (Overweight people) whose arm circumference is not greater than 27.9 cm.
Local pain in the entero-medial part of the shoulder that radiate distally (biceps muscle area) as well as laterally (deltoid area).
At least three months and at most four months have passed since the onset of symptoms (Frozen phase)
The onset of pain is spontaneous and gradual
Pain during daily activities in the range of 3 to 5,in VAS scale.
restrictions on active and passive movements (neither the patient nor the examiner is able to complete the range of motion).
Radiographs of AP and axillary views are normal.
Neir, Hawkin and Jobs clinical tests are negative
Exclusion criteria:
Receive physiotherapy and medication for the past three months.
History of degenerative pathologies such as cervical involvement, rotator cuff injury, arthritis, trauma, fracture and shoulder surgery
Local steroid injections or any injections into the shoulder joint over the past six months
Shoulder muscle strength less than 3 in MMT
Reluctance to continue cooperation
Intervention groups
TECAR and exercise therapy group
Sham and exercise group
Main outcome variables
pain
function
kinematic and kinetics
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20220305054195N1
Registration date:2022-11-21, 1401/08/30
Registration timing:prospective
Last update:2022-11-21, 1401/08/30
Update count:1
Registration date
2022-11-21, 1401/08/30
Registrant information
Name
Fateme Babaei Heris
Name of organization / entity
Tarbiat Modares University
Country
Iran (Islamic Republic of)
Phone
+98 21 6556 8896
Email address
fatemebabaei@modares.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-11-22, 1401/09/01
Expected recruitment end date
2024-11-21, 1403/09/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation the effect of TECAR and exercise therapy protocol on pain reduction and functional improvement of the kinetic and kinematic of the glenohumeral and scapulothorasic joints in patients with frozen shoulder
Public title
Investigation of the effect of repetition on kinematics and kinetics and pain and function of frozen shoulder
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
idiopathic (primary) frozen shoulder patients. Disease lasting at least 3 months and maximum 4 months.
Exclusion criteria:
Patients in age 45-70 years.
ln both gender (male and female).
Right shoulder involvement (dominant hand).
In the range of BMI 25-29.9 (overweight poeple) and Arm circumference is not greater than 27.9 cm.
Local pain in the entero-medial part of the shoulder that radiate distally (biceps muscle area) as well as laterally (deltoid area).
At least three months and at most four months have passed since the onset of symptoms (Frozen phase).
The onset of pain is spontaneous.
Pain during daily activities in the range of 3 to 5, in VAS scale.
Restrictions on active and passive movements (neither the patient nor the examiner is able to complete the range of motion).
Radiographs of AP and axillary views are normal.
Neir, Hawkin and Jobs clinical tests are negative.
Age
From 45 years old to 75 years old
Gender
Both
Phase
N/A
Groups that have been masked
Data and Safety Monitoring Board
Sample size
Target sample size:
12
Randomization (investigator's opinion)
Randomized
Randomization description
In order to implement a random sequence on participants, in a way that is not specified before the individual assignment, the assigned group is used to Sequentially numbered, sealed, opaque envelopes (SNOSE) .At the start of the enterance of participants, based on the arrangement of eligible participants to study, one of the letter envelopes is opened. Based on sample size, a number of papers are prepared and each random sequence created on a record card inside the envelopes. In order to maintain a random sequence, the number of papers is made in the same order and placed inside the box. At the time of the start of the participants' registration, based on the arrival of the study, one of the envelopes is opened and the allocated group of this participant is revealed.
Blinding (investigator's opinion)
Single blinded
Blinding description
the data proccessor doesnt know about every person belong to which group therefore she would compare and judge the datas whithout bias.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of tarbiat modares university
Street address
Jalal_e_ale_ahmad
City
Tehran
Province
Tehran
Postal code
1411713116
Approval date
2022-10-31, 1401/08/09
Ethics committee reference number
IR.MODARES.REC.1401.157
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 score
Timepoint
Before and 48 hours after the intervention
Method of measurement
shoulder pain and disability scale (SPADI) Questionnaire
2
Description
shoulder joint kinematics
Timepoint
Before and 48 hours after the intervention
Method of measurement
vicon system motion analysis
3
Description
shoulder muscles electromyography
Timepoint
Before and 48 hours after the intervention
Method of measurement
surface electromyograph electodes
4
Description
Shoulder joint kinetics
Timepoint
Before and 48 hours after the intervention
Method of measurement
vicon system motion analysis
5
Description
Disability score
Timepoint
Before and 48 hours after the intervention
Method of measurement
shoulder pain and disability scale (SPADI) Questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: TECAR therapy, 7 sessions for every patient, 3 days per week, every session 20 minuts duration, with coupling medium cream as intermediator 20 milimeter for every one.
Category
Treatment - Devices
2
Description
Control group: sham group and intensity is zero
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Motion analysis laboratory of Tarbiat modares univercity
Full name of responsible person
Fateme babaei
Street address
jalal-e ale ahmad
City
Tehran
Province
Tehran
Postal code
1411713116
Phone
+98 922 912 8575
Email
spt.fbabayi@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
tarbiat modares univercity
Full name of responsible person
dr ravanbod
Street address
jalal-e-ale ahmad
City
tehran
Province
Tehran
Postal code
1411713116
Phone
+98 21 8288 2014
Email
med@modares.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?