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

NCT05497869 | Completed DMC

• 1 other identifier: RiphahIU Shafaq
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Postgastrectomy Syndrome

Keywords

Pectoralis minor tightness; post mastectomy women; active release technique; breast cancer

Outcome Measures

Primary Outcomes (4)

• 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

  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

  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

  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

  3rd week

Study Arms (2)

Experimental interventional group

EXPERIMENTAL

Active Release Technique (ART)

Other: active release group

active control group

ACTIVE COMPARATOR

conventional group

Other: active control group

Interventions

active release group 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.

Experimental interventional group

active control group 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

active control group

Eligibility Criteria

• Age: 40 Years - 60 Years
• Gender Eligibility Details: only female mastectomy patient will be included
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Riphah International University: lead

Study Sites (1)

Federal Breast Cancer Screening center (PIMS)

Islamabad, Capital, 46000, Pakistan

Location

MeSH Terms

Conditions

Postgastrectomy Syndromes; Breast Neoplasms

Condition Hierarchy (Ancestors)

Stomach Diseases; Gastrointestinal Diseases; Digestive System Diseases; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Aisha Razzaq, MSPT-OMPT

  Riphah International University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 10, 2022
• First Posted: August 11, 2022
• Study Start: August 10, 2022
• Primary Completion: December 30, 2022
• Study Completion: January 15, 2023
• Last Updated: January 25, 2023

Record last verified: 2023-01

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)