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Studying the effect of strain counterstrain therapy on shoulder pain and range of motion in People with breast cancer after mastectomy surgery with chronic active trigger point pain

Protocol summary

Study aim
The purpose is to investigate the effect of strain counterstrain treatment on pain, pressure pain threshold, shoulder range of motion, shoulder pain and disability index, and quality of life questionnaire in people with cancer after mastectomy with chronic active trigger point pain. If the hypotheses are confirmed, this method can be used as one of the effective treatment methods available in the treatment of this group of patients.
Design
Clinical trial with control group, parallel groups, randomized, on 38 patients, coins were used for randomization .
Settings and conduct
38 patients are entered in accordance with the study conditions, they are initially evaluated in patient centers, and after receiving 12 intervention sessions, the final evaluation is done at the end of the 12th session.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Age 35-65 years At least 6 months have passed since adjuvant treatment Having an active trigger point in at least two of the studied muscles The presence of pain in the upper limb Having pain 7-3 Exclusion criteria: Patients or return of breast cancer Bilateral mastectomy People with fibromyalgia Degenerative diseases of spine Taking anti-inflammatory medication in the last week Symptoms of upper extremity neuropathy People with depression People with lymphedema grade two and above Not wanting to participate in study
Intervention groups
Intervention group: in this group, in addition to the methods in the control group, since first session the strain counterstrain method will be used for the number of 5 more active trigger points in people. Control group: In the control group of subjects, after entering the study, people will be taught exercises and people will do the exercises.
Main outcome variables
pain intensity Pressure pain threshold range of motion Shoulder Pain and Disability Index Cancer Quality of Life Questionnaire

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20231107059979N1
Registration date: 2023-12-09, 1402/09/18
Registration timing: registered_while_recruiting

Last update: 2023-12-09, 1402/09/18
Update count: 0
Registration date
2023-12-09, 1402/09/18
Registrant information
Name
Fatemeh Dehghan sanij
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 4438 5491
Email address
f-dehghans@razi.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-12-08, 1402/09/17
Expected recruitment end date
2024-05-27, 1403/03/07
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Studying the effect of strain counterstrain therapy on shoulder pain and range of motion in People with breast cancer after mastectomy surgery with chronic active trigger point pain
Public title
Effect of strain counterstrain treatment on shoulder pain and range of motion
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Age range 35-65 years At least 6 months have passed from adjuvant treatment (chemotherapy and radiation therapy) after mastectomy Having an active trigger point in at least two muscles from the subscapularis, pectoralis major, infraspinatus and upper trapezius muscles The presence of pain in the upper limb region according to the diffusion pattern of muscle trigger point pain Pain score 7-3
Exclusion criteria:
Patients or return of breast cancer Bilateral mastectomy People with fibromyalgia Degenerative diseases of the spine Taking pain reliever, anti-inflammatory, muscle relaxant medicine in the last week Signs and symptoms of upper extremity neuropathy People with depression who receive medication and treatment for this issue People with lymphedema grade two and above Not willing to participate in the study or wanting to leave the study
Age
From 35 years old to 65 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 38
Randomization (investigator's opinion)
Randomized
Randomization description
Simple randomization (two patients who are very similar in terms of age, scar area, pain intensity, and body mass index are assigned to one of the control and test groups by tossing a coin.)
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Factorial
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Research Ethics Committees of School of Nursing and Midwifery & Rehabilitation - Tehran University o
Street address
Unit 6 , No 7 ,khojaste pour St , Ashrafi Esfahani Blv
City
Tehran
Province
Tehran
Postal code
1473144113
Approval date
2023-11-05, 1402/08/14
Ethics committee reference number
IR.TUMS.FNM.REC.1402.155

Health conditions studied

1

Description of health condition studied
unilateral mastectomy
ICD-10 code
Z90.1
ICD-10 code description
Acquired absence of breast and nipple

Primary outcomes

1

Description
Pain intensity: It is a tool that determines the intensity of pain.
Timepoint
The beginning of the study (before the start of the intervention) - the last session (the twelfth session after the intervention)
Method of measurement
Visual analog scale: the person places a vertical mark on a continuous 100 mm line segment to indicate the intensity of pain, this line starts with the number 0, which indicates the absence of pain and discomfort, and the number 10, which indicates the worst pain that the person Ever experienced ends. In this study, the person reports the intensity of spontaneous pain, pain during active movement and pain with constant pressure applied by a pressure algometer in the upper limb area.

2

Description
Pressure Pain Threshold: The amount of direct pressure required to elicit a pain response in the target area.
Timepoint
The beginning of the study (before the start of the intervention) - the last session (the twelfth session after the intervention)
Method of measurement
Pressure pain threshold: after determining the active trigger point in the studied muscles (subscapularis, pectoralis major, infraspinatus and upper trapezius), the pressure algometer device is used to measure the pressure pain threshold of the active trigger point. The study subjects are asked to inform the pain threshold, after measuring 3 times, the average value is recorded as the pressure pain threshold.

Secondary outcomes

1

Description
Range of motion (ROM): The range of motion that occurs at a joint or set of joints.
Timepoint
The beginning of the study (before the start of the intervention) - the last session (the twelfth session after the intervention)
Method of measurement
In this study, passive range of motion of the shoulder is measured by a goniometer (standard, Saehan brand, large size).

2

Description
Shoulder Pain and Disability Index (SPDI): shoulder pain and disability index questionnaire, which aims to assess shoulder pain and disability and is filled by the individual.
Timepoint
The beginning of the study (before the start of the intervention) - the last session (the twelfth session after the intervention)
Method of measurement
This questionnaire has two dimensions, one is pain (5 questions) and the other is functional activities (8 questions) and the scoring of this questionnaire is based on a spectrum of 10 options, the score of each option is the same as the selected number, and finally the individual score is a number between zero and 130 and a larger number indicates greater disability.

3

Description
European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30): This questionnaire is used to measure the quality of life in cancer patients.
Timepoint
The beginning of the study (before the start of the intervention) - the last session (the twelfth session after the intervention)
Method of measurement
This questionnaire has 30 questions in 5 functional scales including: physical (5 questions), role playing (2 questions), emotional (2 questions), cognitive (4 questions), social (2 questions) and 9 symptom domains (fatigue, nausea and vomiting, pain, shortness of breath, sleep disorder, loss of appetite, constipation, diarrhea and financial problems) and evaluates the overall quality of life.

Intervention groups

1

Description
Intervention group: In this group, in addition to the methods in the control group from the first session the strain counterstrain method will be used for the 5 more active trigger points in people. Strain counterstrain method: In this method, the trigger point is identified by touch, and the therapist increases the pressure while still touching it so that the patient reports the onset of pain. Then passively put the muscle in a comfortable (shortened) position to reduce 70% of the pain and maintain a gentle touch on the trigger point, after 90 seconds the release is done and the therapist opens the patient to the resting position. This intervention will be repeated twice for each trigger point.
Category
Rehabilitation

2

Description
Control group: In the control group of subjects, after entering the study, people will be taught exercises and people will do the exercises. Start the exercises with 5 minutes of walking, then perform active stretching of the neck and upper trunk, flexion and extension (two repetitions of 20 seconds), perform active movement of the cervical spine for flexion, extension, and rotation (one set and ten repetitions). Performing active movement of the upper limbs for flexion, extension, abduction and adduction of the shoulder (two sets and ten repetitions) and finally performing relaxation exercises with deep breathing for 5 minutes (total duration of the exercises is 25 minutes).
Category
Rehabilitation

Recruitment centers

1

Recruitment center
Name of recruitment center
Dr. Azimi Nejadan's office
Full name of responsible person
Fatemeh Dehghan Sanij
Street address
No. 11, 4th floor, 14th Gandhi St., Vali Asr St
City
Tehran
Province
Tehran
Postal code
0000000000
Phone
+98 21 8887 3915
Email
f-dehghans@razi.tums.ac.ir

2

Recruitment center
Name of recruitment center
کلینیک آل احمد
Full name of responsible person
Fatemeh Dehghan Sanij
Street address
Unit 7 , No 14/2 ,Mohammadi St , Ashrafi Esfahani Blv
City
Tehran
Province
Tehran
Postal code
1461655391
Phone
+98 21 4438 5491
Email
f-dehghans@razi.tums.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Zeinab Shiravi
Street address
Enghelab St, corner of Safi Alisha St., Faculty of Rehabilitation
City
Tehran
Province
Tehran
Postal code
0000000000
Phone
+98 21 7753 3939
Email
Zshiravi@sina.tums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran 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
Tehran University of Medical Sciences
Full name of responsible person
Fatemeh Dehghan Sanij
Position
Physiotherapist
Latest degree
Bachelor
Other areas of specialty/work
Physiotherapy
Street address
Unit 7 , No 14/2 ,Mohammadi St , Ashrafi Esfahani Blv
City
Tehran
Province
Tehran
Postal code
1461655391
Phone
+98 21 4438 5491
Email
f-dehghans@razi.tums.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
زینب شیروی
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Physiotherapy
Street address
Enghelab St, corner of Safi Alisha St., Faculty of Rehabilitation
City
Tehran
Province
Tehran
Postal code
0000000000
Phone
+98 21 7753 3939
Email
Zshiravi@sina.tums.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Fatemeh Dehghan Sanij
Position
Physiotherapist
Latest degree
Bachelor
Other areas of specialty/work
Physiotherapy
Street address
Unit 7 , No 14/2 ,Mohammadi St , Ashrafi Esfahani Blv
City
Tehran
Province
Tehran
Postal code
1461655391
Phone
+98 21 4438 5491
Email
f-dehghans@razi.tums.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
Yes - There is 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
Title and more details about the data/document
هنوز تصمیم نگرفته‌ام - برنامه انتشار آن هنوز مشخص نیست
When the data will become available and for how long
هنوز تصمیم نگرفته‌ام - برنامه انتشار آن هنوز مشخص نیست
To whom data/document is available
هنوز تصمیم نگرفته‌ام - برنامه انتشار آن هنوز مشخص نیست
Under which criteria data/document could be used
هنوز تصمیم نگرفته‌ام - برنامه انتشار آن هنوز مشخص نیست
From where data/document is obtainable
هنوز تصمیم نگرفته‌ام - برنامه انتشار آن هنوز مشخص نیست
What processes are involved for a request to access data/document
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