Postgastrectomy SyndromeNCT05497869
Effects of Active Release Technique (ART) on Pectoralis Minor Tightness in Post Mastectomy Women.
A study testing active release group in people with Postgastrectomy Syndrome, run by Riphah International University at 1 site in Pakistan.
Trial summary
The aim of this research is to determine the Effects of Active Release Technique (ART) on pectoralis minor tightness in post mastectomy women. Randomized controlled trials will be done at Nuclear Medicine, Oncology and Radiotherapy Institute (NORI) Hospital. The sample size will be 60. Read more about this study
- Who is it for?
- Ages 40 to 60 years, women only
- Conditions the study is for
- Postgastrectomy Syndrome
- What is being tested?
- active release group
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 sitePakistan
- Study dates
- 10 Aug 2022to 15 Jan 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 60 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- women complaining chest tightness
- Mastectomy (Unilateral/ Bilateral/ Partial/ Radical)
- Postoperative chemotherapy or radiation therapy
Who cannot join
- Tumor Metastasis with other tissue/ organ.
- Underlying Cardiac issues.
- Shoulder joint pathology before surgery.
- Post mastectomy pain syndrome (Pain beyond 3 months).
Trial locations and contacts
1 site in 1 country.
Pakistan1 site
Federal Breast Cancer Screening center (PIMS)
Islamabad, Capital, 46000
About this study
The aim of this research is to determine the Effects of Active Release Technique (ART) on pectoralis minor tightness in post mastectomy women. Randomized controlled trials will be done at Nuclear Medicine, Oncology and Radiotherapy Institute (NORI) Hospital. The sample size will be 60. The subjects were divided in two groups, with 30 subjects in Group A and 30 in Group B. Study duration was of 6 months. Sampling technique applied was Non probability Convenience Sampling technique. Only women aged 40-60 years with Mastectomy (Unilateral/ Bilateral/ Partial/ Radical) and Postoperative chemotherapy/ radiation therapy were included. Tools used in the study are Numeric Pain Rating Score (NPRS), Shoulder Pain and Disability Index (SPADI), Vernier Caliper and Rigid standard plastic transparent right angle. Data was analyzed through SPSS 21.
Read the detailed description
Breast cancer may be a malignant neoplasm, an abnormal growth (carcinoma) originated in breast tissue that invade the encompassing tissue, grows infiltrative and destructive, and may metastasize.It is outlined pathologically by location of origin within the breast (e.g. ducts, lobes), size of the tumor, standing of the nodes, and also the presence of markers indicating tumor staging. Mostly, early-stage breast cancer diagnosed in women undergo surgical procedures, nearly half withstand breast-conserving surgery and one third experience mastectomy.
It is generally believed that physiotherapy aims to aid recovery and prevent complications following mastectomy however no well-designed, randomized controlled trial has investigated the effect of active release technique (ART) specifically on pectoralis minor in post-operative breast cancer women. Hence, a physiotherapy rehabilitation plan of care consisting of patient education, early mobilization along Active Release Technique (ART) may prevent postoperative complications like chest tightness and reduced shoulder mobility. This will enhance muscular relaxation, improve restricted mobility, and will result in improved quality of life as compared to standard care or conventional treatment alone.
- Conditions
- Postgastrectomy Syndrome
- Being tested
- active release group, active control group
- Keywords
- Pectoralis minor tightness, post mastectomy women, active release technique, breast cancer
- Medical subject headings
- Postgastrectomy Syndromes, Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
active release groupOther
Patient is in supine lying position with 15-20° shoulder abduction. Then place finger tips under Pectoralis minor tendon and position the arm in 90°/90° shoulder abduction and elbow flexion. Apply the pressure while stroking the tender area and ask the patient to adduct the arm then bring shoulder backward while maintain the pressure 3 sets of 10 repetition/ 4 days per week for 3 weeks.
active control groupOther
Conventional treatment- includes gentle shoulder ROMs i.e. flexion, extension, abduction, adduction, internal rotation and external rotation with-in pain free range, 10 repetitions each for 3 times a day
| Study group | Role | What they receive |
|---|---|---|
| Experimental interventional group | Experimental | Active Release Technique (ART) Receives: Other: active release group |
| active control group | Active comparator | conventional group Receives: Other: active control group |
What is being measured
The primary outcome is the main question the study is designed to answer.
NPRS
Shoulder/Arm pain will assessed using a numerical pain rating scale (NPRS), and scoring range 0, no pain, to 10, maximum pain. pain will be measure from baseline to 1st week to 2nd and 3rd week
Measured: 3rd week
Shoulder Pain and Disability Index (SPADI)
The SPADI is a valid and reliable 13-item shoulder specific instrument measuring both shoulder disability and pain which is divided into two subscales: pain (5 items) and disability (8 items). Scores on both subscales are rated from 0 (no pain or disability) to 10 (worst pain imaginable or so difficult to perform tasks that help is required). The SPADI has proven to be a reliable, valid, and sensitive instrument. Total SPADI score, (0-130), in which, (0-29= little or no pain/disability), (30-49= Mild to moderate pain/disability), (50-130= Moderate to severe pain/disability) It will be measure from baseline to 1st week to 2nd and 3rd week
Measured: 3rd week
pectoralis minor length through vernier caliper
it will be measure from baseline to 1st week to 2nd and 3rd week. Vernier® caliper (intraclass correlation coefficient 0.83-0.87) is used to measure pectoralis minor length. The patients were in the supine position with a normal, relaxed posture. The caliper arms were placed between the coracoid processes to the fourth rib 1-finger apart from lateral to the sternum. As 2.6 cm or 1inch distance has been proposed as the normal length of pectoralis minor muscle
Measured: 3rd week
pectoralis minor length through Rigid standard plastic transparent right angle
it will be measure from baseline to 1st week to 2nd and 3rd week. This tool used to measure the linear distance in millimeter from the table to the posterior acromion of the patients in supine position with the arms by the side and elbows in flexed and rested on abdomen. Without adding any pressure on the table, the base of the protractor was placed on the bed and the vertical side was placed posterior to the acromion
Measured: 3rd week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Aug 2022
- Study start10 Aug 2022
- Primary completion30 Dec 2022
- Study completion15 Jan 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postgastrectomy SyndromeStudies of the same condition, open and under way.
- More trials run by Riphah International UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Aisha Razzaq, MSPT-OMPT, Principal investigator, Riphah International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05497869
- Sponsor's protocol ID
- RiphahIU Shafaq
- Status last verified
- Jan 2023
- First submitted
- 10 Aug 2022
- Last updated
- 25 Jan 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Active Release Technique (ART) on Pectoralis Minor Tightness in Post Mastectomy Women.
- ClinicalTrials.gov ID
- NCT05497869
- Acronym / sponsor ID
- RiphahIU Shafaq
- Conditions
- Postgastrectomy Syndrome
- Keywords
- Pectoralis minor tightness, post mastectomy women, active release technique, breast cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 10 Aug 2022 (actual)
- Primary completion
- 30 Dec 2022 (actual)
- Study completion
- 15 Jan 2023 (actual)
- First posted
- 11 Aug 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of this research is to determine the Effects of Active Release Technique (ART) on pectoralis minor tightness in post mastectomy women. Randomized controlled trials will be done at Nuclear Medicine, Oncology and Radiotherapy Institute (NORI) Hospital. The sample size will be 60. The subjects were divided in two groups, with 30 subjects in Group A and 30 in Group B. Study duration was of 6 months. Sampling technique applied was Non probability Convenience Sampling technique. Only women aged 40-60 years with Mastectomy (Unilateral/ Bilateral/ Partial/ Radical) and Postoperative chemotherapy/ radiation therapy were included. Tools used in the study are Numeric Pain Rating Score (NPRS), Shoulder Pain and Disability Index (SPADI), Vernier Caliper and Rigid standard plastic transparent right angle. Data was analyzed through SPSS 21.
Detailed description
Breast cancer may be a malignant neoplasm, an abnormal growth (carcinoma) originated in breast tissue that invade the encompassing tissue, grows infiltrative and destructive, and may metastasize.It is outlined pathologically by location of origin within the breast (e.g. ducts, lobes), size of the tumor, standing of the nodes, and also the presence of markers indicating tumor staging. Mostly, early-stage breast cancer diagnosed in women undergo surgical procedures, nearly half withstand breast-conserving surgery and one third experience mastectomy.
It is generally believed that physiotherapy aims to aid recovery and prevent complications following mastectomy however no well-designed, randomized controlled trial has investigated the effect of active release technique (ART) specifically on pectoralis minor in post-operative breast cancer women. Hence, a physiotherapy rehabilitation plan of care consisting of patient education, early mobilization along Active Release Technique (ART) may prevent postoperative complications like chest tightness and reduced shoulder mobility. This will enhance muscular relaxation, improve restricted mobility, and will result in improved quality of life as compared to standard care or conventional treatment alone.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental interventional group | Experimental | Other: active release groupActive Release Technique (ART) |
| active control group | Active comparator | Other: active control groupconventional group |
Who may qualify
- Ages
- 40 to 60 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- women complaining chest tightness
- Mastectomy (Unilateral/ Bilateral/ Partial/ Radical)
- Postoperative chemotherapy or radiation therapy
Key exclusion criteria (4 listed)
- Tumor Metastasis with other tissue/ organ.
- Underlying Cardiac issues.
- Shoulder joint pathology before surgery.
- Post mastectomy pain syndrome (Pain beyond 3 months).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| active release groupPatient is in supine lying position with 15-20° shoulder abduction. Then place finger tips under Pectoralis minor tendon and position the arm in 90°/90° shoulder abduction and elbow flexion. Apply the pressure while stroking the tender area and ask the patient to adduct the arm then bring shoulder backward while maintain the pressure 3 sets of 10 repetition/ 4 days per week for 3 weeks. | Other | Experimental interventional group |
| active control groupConventional treatment- includes gentle shoulder ROMs i.e. flexion, extension, abduction, adduction, internal rotation and external rotation with-in pain free range, 10 repetitions each for 3 times a day | Other | active control group |
Primary outcome
NPRS
Time frame: 3rd week
Shoulder/Arm pain will assessed using a numerical pain rating scale (NPRS), and scoring range 0, no pain, to 10, maximum pain. pain will be measure from baseline to 1st week to 2nd and 3rd week
Shoulder Pain and Disability Index (SPADI)
Time frame: 3rd week
The SPADI is a valid and reliable 13-item shoulder specific instrument measuring both shoulder disability and pain which is divided into two subscales: pain (5 items) and disability (8 items). Scores on both subscales are rated from 0 (no pain or disability) to 10 (worst pain imaginable or so difficult to perform tasks that help is required). The SPADI has proven to be a reliable, valid, and sensitive instrument. Total SPADI score, (0-130), in which, (0-29= little or no pain/disability), (30-49= Mild to moderate pain/disability), (50-130= Moderate to severe pain/disability) It will be measure from baseline to 1st week to 2nd and 3rd week
pectoralis minor length through vernier caliper
Time frame: 3rd week
it will be measure from baseline to 1st week to 2nd and 3rd week. Vernier® caliper (intraclass correlation coefficient 0.83-0.87) is used to measure pectoralis minor length. The patients were in the supine position with a normal, relaxed posture. The caliper arms were placed between the coracoid processes to the fourth rib 1-finger apart from lateral to the sternum. As 2.6 cm or 1inch distance has been proposed as the normal length of pectoralis minor muscle
pectoralis minor length through Rigid standard plastic transparent right angle
Time frame: 3rd week
it will be measure from baseline to 1st week to 2nd and 3rd week. This tool used to measure the linear distance in millimeter from the table to the posterior acromion of the patients in supine position with the arms by the side and elbows in flexed and rested on abdomen. Without adding any pressure on the table, the base of the protractor was placed on the bed and the vertical side was placed posterior to the acromion
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jan 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Aisha Razzaq, MSPT-OMPT principal investigator
Riphah International University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing active release group in people with Postgastrectomy Syndrome, run by Riphah International University at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
NPRS (time frame: 3rd week). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jan 2023.