Clinical trial NCT05497869: Effects of Active Release Technique (ART) on Pectoralis Minor Tightness in Post Mastectomy Women.
Official title: Effects of Active Release Technique (ART) on Pectoralis Minor Tightness in Post Mastectomy Women.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Postgastrectomy Syndrome
Keywords: Pectoralis minor tightness
post mastectomy women
active release technique
breast cancer
Lead sponsor: Riphah International University
Sponsor class: OTHER
First posted: 2022-08-11
Enrollment: 60
Sex: FEMALE
Minimum age (years): 40
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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. 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.

Eligibility criteria: Inclusion Criteria:

* women complaining chest tightness
* Mastectomy (Unilateral/ Bilateral/ Partial/ Radical)
* Postoperative chemotherapy or radiation therapy

Exclusion Criteria:

* Tumor Metastasis with other tissue/ organ.
* Underlying Cardiac issues.
* Shoulder joint pathology before surgery.
* Post mastectomy pain syndrome (Pain beyond 3 months).

Primary outcomes:
measure: NPRS
timeFrame: 3rd week
measure: Shoulder Pain and Disability Index (SPADI)
timeFrame: 3rd week
measure: pectoralis minor length through vernier caliper
timeFrame: 3rd week
measure: pectoralis minor length through Rigid standard plastic transparent right angle
timeFrame: 3rd week
Secondary outcomes:
Other outcomes:
Locations:
city: Islamabad
country: Pakistan
facility: Federal Breast Cancer Screening center (PIMS)
state: Capital
Study officials:
affiliation: Riphah International University
name: Aisha Razzaq, MSPT-OMPT
role: PRINCIPAL_INVESTIGATOR
References: