Effects of Transcutaneous Electrical Nerve Stimulation for the Treatment of Pain and Respiratory Function Following Mastopexy With Augmentation: Study Protocol for a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 84
- 试验地点
- 2
- 主要终点
- Pain intensity at rest
研究概览
简要总结
Background: Pain after breast plastic surgery affects quality of life. Physical therapy offers effective interventions for this condition, such as transcutaneous electrical nerve stimulation (TENS). Although this resource has been used for more than 20 years, no studies have been published that support its use following this type of surgery. Therefore, the aim of the proposed study is to evaluate the effect of TENS on pain intensity in patients undergoing mastopexy with implants, given the existing evidence on the success of TENS for other conditions.
Methods: A two-arm, randomized, sham-controlled trial will be conducted with blinded assessors. The study will be carried out at the Exercise Physiology and Metabolism Lab of Finis Terrae University. Eligible participants will be women undergoing mastopexy with implants invited by a board-certified plastic surgeon. The participants will be randomly assigned to one of two study groups: Group 1 (surgery + TENS) and Group 2 (surgery + sham TENS). TENS will be administered only one hour after surgery and will remain for one hour. Four assessments will be performed: before treatment (T0), immediately after treatment (T1), one hour (T2) and four hours after TENS (T3). The primary outcome will be pain intensity at rest, pain intensity during movement (standardized movements of both arms: anterior flexion, abduction, and external rotation), and during respiratory function tests. Secondary outcome measures will be maximum inspiratory pressure (MIP), maximum expiratory pressure (MEP), and vital capacity (VC).
Discussion In this study, the effects of TENS on patients with pain following mastopexy with implants will be compared to the effects of a sham TENS intervention. This RCT will offer novel evidence on the potential benefits of TENS in terms of pain intensity at rest as well as during movements and respiratory function tests.
Keywords TENS, Mastopexy, Plastic Surgery, Physical therapy modalities, Clinical trial protocol
详细描述
OBJECTIVES The aim of the study is to evaluate the effectiveness of transcutaneous stimulation therapy (TENS) on acute pain and respiratory function in patients undergoing mastopexy with implants.
THE PRIMARY OBJECTIVE The primary objective is to assess pain intensity at rest during active arm movements (flexion, rotation, and abduction), and during respiratory muscle strength tests using the numeric pain scale (NRS) after surgery, immediately after the application of the therapy, as well as one and four hours after the intervention.
THE SECONDARY OBJETIVE The secondary objective is to evaluate changes in measures of respiratory muscle function, such as maximum inspiratory pressure (MIP), maximum expiratory pressure (MEP), and vital capacity (VC) as well as the consumption of analgesics for pain after surgery, immediately after the application of the therapy, and one and four hours after the intervention.
TRIAL DESIGN A two-arm, randomized, sham-controlled trial (RCT) will be conducted. The participants and assessor will be blinded to the allocation of the patients to the different groups. This study is reported in accordance with the Consolidated Standards of Trial Reporting (CONSORT). The protocol was developed following the recommendations of Standard Protocol Elements: Recommendations for Interventional Trials (SPIRIT).
The study has received approval from the Human Research Ethics Committee of the Eastern Metropolitan Health Service in Santiago, Chile (approval date: July 31, 2023; process N° 20230731) and will be conducted in accordance with the ethical precepts stipulated in the Declaration of Helsinki.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
盲法说明
After the website (https://www.randomizer.org) generates a number sequence, blind allocation will be performed using consecutively numbered opaque envelopes. The envelopes will be sealed and stored in a secure cabinet. The main investigator will perform sample randomization and blind assignment. The researcher in charge of administering the treatments will open the envelopes immediately prior to the intervention. The patient, researcher and assessor will have no knowledge about the treatment applied (blinding of assessor and subjects). Only the researcher who administers the intervention (active or sham TENS) will have knowledge of the treatment and will instruct the participant not to provide information on the sensation of electrical stimulus to the assessor measuring pain levels.
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •female sex, age between 18 to 55 years in the immediate postoperative period of mastopexy with implants;
- •score > 3 for pain intensity on the numeric pain scale (NRS) reported during post-surgery screening;
- •no previous experience with the use of TENS or electrical currents for analgesia;
- •not having undergone any other type of surgery in the chest region, taking medications to control pain or anxiety, or having a history of pain in the breast region.
- •None of the individuals should use bronchodilator therapy or medications that directly act on the respiratory system.
排除标准
- •frequent use of bronchodilators, analgesics, muscle relaxants, or psychotropics or allergy to any medication that interferes with surgery (morphine, dipyrone, propofol, lidocaine);
- •pregnancy, previous abdominal surgeries, or pre-surgical breast pain;
- •any type of inflammatory disease, systemic lupus erythematosus, dermatomyositis or dermatitis in the treatment area, cancer, tumors of any type diagnosed in the previous five years;
- •history of epilepsy, metal devices implanted in the body;
- •any musculoskeletal injury in the cervical spine, neck or shoulder in the previous three months (fractures, sprains, tendinopathies, dislocations or muscle ruptures) or having a cardiac device, such as an internal automatic defibrillator or pacemaker.
- •All patients undergoing combined surgeries or who undergo another surgical procedure in addition to mastopexy with implants or who have knowledge or previous use of TENS or electrical currents for the treatment of pain will be excluded.
结局指标
主要结局
Pain intensity at rest
时间窗: This will be performed at rest immediately after the intervention (T1), 1 hour after treatment (T2) and 4 hour after treatment (T3)
The primary outcome will be pain intensity, which will be measured using the numeric rating scale (NRS). The NRS is a simple, easy-to-use scale on which the respondent is asked to rate the intensity of current pain using a scale ranging from 0 ("no pain") to 10 ("worst pain imaginable"). This tool has established validity and reliability for measuring acute and postoperative pain intensity. It also has similar sensitivity and correlates to the visual analogue scale.
Pain intensity during movement
时间窗: This will be performed during movement of arms immediately after the intervention (T1), 1 hour after treatment (T2) and 4 hour after treatment (T3)
The primary outcome will be pain intensity, which will be measured using the numeric rating scale (NRS). The NRS is a simple, easy-to-use scale on which the respondent is asked to rate the intensity of current pain using a scale ranging from 0 ("no pain") to 10 ("worst pain imaginable"). This tool has established validity and reliability for measuring acute and postoperative pain intensity. It also has similar sensitivity and correlates to the visual analogue scale.
次要结局
- Maximum Expiratory Pressure (MEP)(Immediately after treatment (T1), 1 h after treatment (T2) and 4 h after treatment (T3))
- Vital Capacity (VC)(Immediately after treatment (T1), 1 h after treatment (T2) and 4 h after treatment (T3))
- Maximum Inspiratory Pressure (MIP)(Immediately after treatment (T1), 1 h after treatment (T2) and 4 h after treatment (T3))
研究者
Esteban Fortuny
Physical Therapy
Finis Terrae University