Protocol summary
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Study aim
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Evaluation the effect of TECAR and exercise therapy protocol on pain reduction and functional improvement of in patients with frozen shoulder
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Design
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Randomised control trial with two group, intervention and control, single blinded, pre and post operative care
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Settings and conduct
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Tarbiat Modares University Motion analysis laboratory
Prossessor blinded
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Participants/Inclusion and exclusion criteria
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inclusion criteria:
patients in age 40-65 years.
3-6 months have passed since the onset of symptoms (Frozen phase).
The onset of pain is not traumatic or secondary and the disease is primary.
Pain during flexion or abduction is in the range of 3-5 VAS.
At least 30% limitation of motion compared to the healthy side in flexion, abduction, and rotation (internal and external) movements, both active and passive (neither the patient nor the examiner is able to complete the range of motion).MRI should be negative and without associated pathology.
Hawkins and Jobs clinical tests should be negative
Exclusion criteria:
Physiotherapy treatment in the past three months
Change in medication regimen in the past three months
History of pathologies such as cervical and thoracic involvement, rotator cuff injury, arthritis, history of trauma, fracture and surgery in the shoulder of the healthy and affected side.Local steroid injection or any intra-articular injection of the shoulder within the past six months
Shoulder muscle strength less than 3 on MMT
Exclusion criteria:
Unwillingness to continue cooperation
Emergence of any unforeseen problem
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Intervention groups
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TECAR and exercise therapy group
Sham and exercise group
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Main outcome variables
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pain
function
tissue elasticity characteristic changes
General information
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Reason for update
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changing the supervisor and one of the assessment methods
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT20220305054195N1
Registration date:
2022-11-21, 1401/08/30
Registration timing:
prospective
Last update:
2025-11-06, 1404/08/15
Update count:
1
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Registration date
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2022-11-21, 1401/08/30
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Registrant information
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Recruitment status
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Recruitment complete
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Funding source
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Expected recruitment start date
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2025-11-21, 1404/08/30
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Expected recruitment end date
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2026-04-20, 1405/01/31
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Actual recruitment start date
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empty
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Actual recruitment end date
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empty
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Trial completion date
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empty
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Scientific title
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Evaluation the effect of TECAR and exercise therapy protocol on pain reduction and functional improvement of in patients with frozen shoulder
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Public title
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Investigation of the effect of tecar and exercise therapy on pain and function of frozen shoulder
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Purpose
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Treatment
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Inclusion/Exclusion criteria
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Inclusion criteria:
People between the ages of 40 and 65
3-6 months have passed since the onset of symptoms (Frozen phase)
The onset of the pain is not traumatic or secondary and the disease is primary.
Pain during flexion or abduction should be in the range of 3-5 VAS.
There should be a limitation of movement of at least 30% compared to the healthy side in flexion, abduction, and rotation (internal and external) movements, both active and passive (neither the patient nor the examiner is able to complete the range of motion).
MRI should be negative and without associated pathology.
Hawkins and Jobs' clinical tests are negative.
Exclusion criteria:
Physiotherapy treatment in the past 3 months
Changes in medication regimen in the past three months
History of pathologies such as cervical and thoracic involvement, rotator cuff injury, arthritis, history of trauma, fracture, and surgery in the shoulder of the healthy and affected side
Local steroid injection or any injection into the shoulder joint within the past six months
قدرت عضلات شانه کمتر از 3 در MMT
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Age
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From 45 years old to 75 years old
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Gender
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Both
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Phase
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N/A
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Groups that have been masked
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- Data and Safety Monitoring Board
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Sample size
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Target sample size:
12
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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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.
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Blinding (investigator's opinion)
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Single blinded
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Blinding description
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the data proccessor doesnt know about every person belong to which group therefore she would compare and judge the datas whithout bias.
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Placebo
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Used
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Assignment
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Parallel
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Other design features
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Ethics committees
1
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Ethics committee
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Approval date
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2022-10-31, 1401/08/09
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Ethics committee reference number
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IR.MODARES.REC.1401.157
Health conditions studied
1
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Description of health condition studied
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frozen shoulder
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ICD-10 code
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M75.0
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ICD-10 code description
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Adhesive capsulitis of shoulder
Primary outcomes
1
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Description
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pain score
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Timepoint
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Before and 48 hours after the intervention
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Method of measurement
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shoulder pain and disability scale (SPADI) Questionnaire
2
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Description
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tendon elasticity
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Timepoint
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Before and 48 hours after the intervention
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Method of measurement
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sonography
3
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Description
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Shoulder joint kinetics
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Timepoint
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Before and 48 hours after the intervention
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Method of measurement
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vicon system motion analysis
4
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Description
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Disability score
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Timepoint
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Before and 48 hours after the intervention
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Method of measurement
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shoulder pain and disability scale (SPADI) Questionnaire
Intervention groups
1
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Description
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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.
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Category
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Treatment - Devices
2
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Description
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Control group: sham group and intensity is zero
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Category
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Placebo
1
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Sponsor
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Grant name
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Grant code / Reference number
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Is the source of funding the same sponsor organization/entity?
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Yes
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Title of funding source
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Tarbiat Modares Univercity
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Proportion provided by this source
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80
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Public or private sector
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Public
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Academic
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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Undecided - It is not yet known if there will be a plan to make this available
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Study Protocol
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Undecided - It is not yet known if there will be a plan to make this available
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Statistical Analysis Plan
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Undecided - It is not yet known if there will be a plan to make this available
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Informed Consent Form
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Undecided - It is not yet known if there will be a plan to make this available
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Clinical Study Report
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Yes - There is a plan to make this available
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Analytic Code
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Undecided - It is not yet known if there will be a plan to make this available
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Data Dictionary
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Undecided - It is not yet known if there will be a plan to make this available
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Title and more details about the data/document
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Providing data after analysis and conclusions
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When the data will become available and for how long
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Providing data after analysis and conclusions
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To whom data/document is available
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supervisor
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Under which criteria data/document could be used
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to using other researchers
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From where data/document is obtainable
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researcher
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What processes are involved for a request to access data/document
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email
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Comments
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