Clinical trial NCT05288036: Effectiveness of PNF Training for Improving for Muscle Strength, Function, and Pain After Axillary Lymph Node Dissection
Official title: Effectiveness of Proprioceptive Neuromuscular Facilitation for Improving for Shoulder Biomechanical Parameters, Function, and Pain After Axillary Lymph Node Dissection: a Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breast Cancer
Muscle Strength
Keywords: Proprioceptive Neuromuscular Facilitation
Pain
Axillary Disease
Lead sponsor: Istanbul Medipol University Hospital
Sponsor class: OTHER
First posted: 2022-03-18
Enrollment: 66
Sex: FEMALE
Minimum age (years): 30
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Breast cancer is the most common type of cancer affecting women of all ages worldwide. Advanced and comprehensive treatment options have increased survival rate and life expectancy, necessitating a focus on the complications of breast cancer treatment. Although axillary lymph node dissection (ALND) causes high morbidity, it is an integral part of surgical treatment in patients with invasive breast cancer and axillary lymph node metastasis. Axillary lymph node dissection and radiotherapy are associated with pain, physical symptoms, and decreased functional abilities in the upper extremity. This study aimed to compare the potential effects of proprioceptive neuromuscular facilitation (PNF) technique on muscle strength, pain and functionality in this patient group with progressive resistance exercise (PRT).

Detailed description: Breast cancer is the most common type of cancer affecting women of all ages worldwide. An increase in the incidence of breast cancer is observed with the effect of widespread screening programs today. Improved and comprehensive treatment options (surgery, radiotherapy, systemic adjuvant and neoadjuvant therapy, hormonal therapy) have increased the survival rate and life expectancy. This has necessitated a focus on the short, medium and long term complications of breast cancer treatment and their management.

Although axillary lymph node dissection (ALND) causes high morbidity, it is an integral part of surgical treatment in patients with invasive breast cancer and axillary lymph node metastasis (2). Radiotherapy is routinely used to reduce the local recurrence rate after ALND. 73% of the patients who received these treatments reported that they had at least 1 complaint of limitation of shoulder joint range of motion, loss of strength in the operated arm, pain, lymphedema numbness, fibrosis, fatigue, and inability in activities of daily living in the postoperative period.

It is known that the muscle strength of the operated side arm is less than the strength of the contralateral extremity and the strength of healthy women due to many reasons such as deterioration of the soft tissue integrity of the chest wall with surgery, inactivity tendencies of the patients due to protecting the operated arm, adhesions that may occur with radiotherapy, and fibrosis formations making movement difficult. In addition, one-third of women with breast cancer treated with surgery experience permanent loss of strength in their upper extremity muscles for more than 1 year after treatment. According to the results of a study investigating the causes of persistent pain after breast cancer treatment, ALND and radiotherapy administration are the two main risk factors for persistent pain, and 21% of women who have ALND experience persistent shoulder/arm pain throughout their lives. Adequate muscle strength and no pain during movement are of great importance for the quality of movement and for the smooth performance of daily life activities. In a study on patients' evaluation of their own upper extremity functionality, women receiving breast cancer treatment stated that they were more functionally limited than their healthy peers and had difficulties in activities of daily living. In a study of large populations, it was reported that the prevalence of functional limitations in women receiving breast cancer treatment ranged from 18% to 54%. Functional limitations complicate the situation and bring the need for additional treatments to improve daily living activities, as well as the application of treatments related to the current disease to the patient.

Exercise is one of the most commonly used modalities in the rehabilitation of patients receiving breast cancer treatment. The main goals of exercise in these patients are to increase muscle strength, reduce pain, increase limited range of motion and contribute to the ability to continue activities of daily living. Resistance exercises are the most commonly used method to provide strength gain and restoration, and there are many studies in the literature on their positive effects on strength enhancement in the affected extremity.

The proprioceptive neuromuscular facilitation (PNF) technique applied for the treatment of the operated shoulder/arm may play a role in regaining strength, power and endurance by increasing the response of neuromuscular mechanisms by stimulating the proprioceptors. At the same time, there are studies showing that this treatment modality provides a significant reduction in shoulder-arm pain and provides painless quality movement. With this technique, functional restoration is provided thanks to the movement patterns applied in the diagonal direction. These gains reveal the importance of using the PNF technique more frequently in breast cancer patient groups where it is applicable.

The PNF technique is emerging as a therapeutic option to increase muscle strength, reduce pain, and improve functionality in patients treated for breast cancer with ALND. The aim of this study is to compare the efficacy of resistance exercise and PNF technique, the effectiveness of which was defined on the patient, on the aforementioned subjects.Patients who applied to Istanbul Medipol University General Surgery Department for routine control after breast cancer treatment were determined. Individuals who were willing to participate and met the inclusion criteria were divided into 3 groups (PNF, progressive resistant ex., control) using the website www.randomizer.org.

Exercise was applied to both Proprioceptive Neuromuscular Facilitation (PNF) and Progressive Resistance Exercise (PRE) groups, 2 days a week for 8 weeks. Each session lasted an average of 1 hour. Exercise sessions; It was carried out under the supervision of the same physiotherapist with experience in the field and individually with each patient. At the beginning and at the end of the treatment, warm-up-cooling exercises including mild stretching exercises to increase the range of motion were performed for 5-10 minutes. In both groups, exercises were performed only for the affected extremity.

Eligibility criteria: Inclusion Criteria:

* Individuals diagnosed with stage II-III breast cancer
* 30-65 years old
* ALND was performed by the same surgeon regardless of breast resection level.
* Receiving radiotherapy
* Individuals who spent the first six months after surgery were included in the study.

Exclusion Criteria:

* Diagnosed with stage IV or metastatic breast cancer
* Developing bilateral breast cancer
* Developing lymphedema in the postoperative period
* Any contraindication to exercise
* Participating in any physiotherapy program for the upper extremity in the last 6 months
* Have significant cardiac, pulmonary or metabolic comorbid disease
* Individuals with communication problems were excluded from the study.

Primary outcomes:
measure: Isokinetic dynamometer
timeFrame: "8 weeks"."Two measurements were made to evaluate the change before treatment (baseline) and at the end of treatment (8 weeks later).".
measure: Disabilities of the Arm, Shoulder, and Hand (DASH)
timeFrame: "8 weeks"."Two measurements were made to evaluate the change before treatment (baseline) and at the end of treatment (8 weeks later).".
measure: Visual Analogue Scale (VAS)
timeFrame: "8 weeks". "Two measurements were made to evaluate the change before treatment (baseline) and at the end of treatment (8 weeks later).".
measure: Global Rating Of Change Scale (GRC)
timeFrame: "8 weeks". "Baseline and 8th week".
Secondary outcomes:
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Medipol Mega University Hospital
Study officials:
affiliation: Medipol University
name: Pelin Basim, Assoc. prof.
role: STUDY_DIRECTOR
References:
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citation: da Silveira DSP, Dos Santos MJ, da Silva ET, Sarri AJ, das Neves LMS, Guirro ECO. Proprioceptive neuromuscular facilitation in the functionality and lymphatic circulation of the upper limb of women undergoing breast cancer treatment. Clin Biomech (Bristol). 2020 Dec;80:105158. doi: 10.1016/j.clinbiomech.2020.105158. Epub 2020 Aug 31.
citation: Kraemer WJ, Ratamess NA. Fundamentals of resistance training: progression and exercise prescription. Med Sci Sports Exerc. 2004 Apr;36(4):674-88. doi: 10.1249/01.mss.0000121945.36635.61.
citation: Cormie P, Singh B, Hayes S, Peake JM, Galvao DA, Taaffe DR, Spry N, Nosaka K, Cornish B, Schmitz KH, Newton RU. Acute Inflammatory Response to Low-, Moderate-, and High-Load Resistance Exercise in Women With Breast Cancer-Related Lymphedema. Integr Cancer Ther. 2016 Sep;15(3):308-17. doi: 10.1177/1534735415617283. Epub 2015 Nov 17.