Effects of Active Release Technique (ART) on Pectoralis Minor Tightness in Post Mastectomy Women.

NCT ID: NCT05497869

Last Updated: 2023-01-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-08-10
• Study Completion Date: 2023-01-15

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.

Conditions

Postgastrectomy Syndrome

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Experimental interventional group

Active Release Technique (ART)

Group Type: EXPERIMENTAL

active release group

Intervention Type: OTHER

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 group

conventional group

Group Type: ACTIVE_COMPARATOR

active control group

Intervention Type: OTHER

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

Interventions

active release group

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.

Intervention Type: OTHER

active control group

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

Intervention Type: OTHER

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).

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Riphah International University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Aisha Razzaq, MSPT-OMPT

Role: PRINCIPAL_INVESTIGATOR

Riphah International University

Locations

Federal Breast Cancer Screening center (PIMS)

Islamabad, Capital, Pakistan

Countries

Pakistan

Other Identifiers

RiphahIU Shafaq

Identifier Type: -

Identifier Source: org_study_id