The Effectiveness of Transcutaneous Electrical Nerve Stimulation After Thoracic Surgery

Not Applicable

Completed

• Conditions: Thoracic; Pain; Functional Capacity; Surgery; Pulmonary Function
• Interventions: Other: Physiotherapy rehabilitation and Transcutaneous Electrical Nerve Stimulation; Other: Physiotherapy Rehabilitation

• Registration Number: NCT04879108
• Lead Sponsor: Marmara University

Brief Summary

The purpose of this randomised and controlled study is to investigate the effects of transcutaneous electrical nerve stimulation combined with physiotherapy and rehabilitation program on pulmonary function and functional exercise capacity.

Detailed Description

Post-thoracotomy pain is one of the most severe types of post-surgical pain. When pain after thoracotomy is not treated effectively, it causes decrease in pulmonary compliance, inability to cough and deep breathing. Increased secretion leads to atelectasis and pneumonia. After surgery, early mobilization, providing airway cleaning (humidification, aspiration, forced expiration, assisted coughing), oxygen therapy, controlled breathing exercises, the use of incentive spirometry and such selected exercises, including posture and general exercises physiotherapy and rehabilitation approaches can prevent complications. A carefully planned pre and postoperative chest physiotherapy and rehabilitation program minimizes postoperative complications; it will restore normal function in these patients. Post-surgical physiotherapy applications should be combined with pain therapy for effective participation of the patient.

Local anesthetics, opioids and different special analgesia techniques including intercostal, paravertebral, interpleural and epidural blocks are used to relieve pain after thoracotomy. However, these techniques have serious side effects such as nausea, vomiting, respiratory depression, and sleepiness. It has been reported that the use of Transcutaneous Electrical Nerve Stimulation (TENS), in addition to traditional analgesia methods, may reduce the use of analgesics, side effects, and postoperative recovery period, and is useful for pain control. After cardiac surgery, TENS has been found useful in the treatment of postoperative incision pain. It has been reported that TENS therapy after thoracotomy as effective as patient-controlled analgesia.

Therefore, this study planned to investigate the effects of transcutaneous electrical nerve stimulation combined with physiotherapy and rehabilitation program on pulmonary function and functional exercise capacity in patients undergoing thoracic surgery.

Study Timeline

• Study Start: 2009-07-20
• Primary Completion: 2011-04-30
• Study Completion: 2011-09-05
• Status Verified: 2021-05
• Study First Submitted: 2021-05-02
• Study First Submitted QC: 2021-05-04
• Last Update Submitted: 2021-05-04
• Study First Posted: 2021-05-10
• Last Update Posted: 2021-05-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

• Patients undergoing lobectomy for lung cancer

Exclusion Criteria

• Patients undergoing pneumonectomy.
• Patients undergoing smaller resection than lobectomy.
• Presence of serious arrhythmia, pacemaker, severe cardiac failure,
• Patients with cooperation disorder
• Presence of neurological or orthopedic problems affecting the extremities.
• Patients with severe psychiatric disorders

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Physiotherapy rehabilitation and Transcutaneous Electrical Nerve Stimulation (TENS) group	Physiotherapy rehabilitation and Transcutaneous Electrical Nerve Stimulation	Physiotherapy rehabilitation and Transcutaneous Electrical Nerve Stimulation (TENS) group received TENS therapy in addition to physiotherapy rehabilitation approaches after thoracic surgery. Physiotherapy and rehabilitation program was started after surgery and it was performed for 30 min, twice a day, 5 day a week. The program was included respiratory and posture exercises, coughing, enhancing mobility. TENS therapy was performed with the a 2-channel portable TENS device and using disposable electrodes. TENS applied on both sides of the incision line. After surgery, TENS was performed before the Physiotherapy rehabilitation for 30 min, twice a day, 5 day a week. Patients were evaluated before the surgery and the end of postoperative 5th day.
Physiotherapy rehabilitation Group	Physiotherapy Rehabilitation	This group was enrolled only physiotherapy and rehabilitation program after thoracic surgery. Physiotherapy and rehabilitation program was started after surgery and it was performed for 30 min, twice a day, 5 day a week. The program was included respiratory and posture exercises, coughing, enhancing mobility. Patients were evaluated before the surgery and the end of postoperative 5th day.

Primary Outcome Measures

Name	Time	Method
Functional Exercise Capacity	Change from Baseline Functional Exercise Capacity at postoperative 5th days.	Functional exercise capacity was measured with the 6 Minute Walk Test according to the American Thoracic Society guidelines. The 6 minutes walking distance was recorded in meters.
Forced expiratory volume in one second Spirometric measurement	Change from Baseline Functional Exercise Capacity at postoperative 5th days.	Forced expiratory volume in one second spirometric measurement was measured. Test was carried out according to American Thoracic Society / European Respiratory Society criteria.
Forced Vital Capacity Spirometric measurement	Change from Baseline Functional Exercise Capacity at postoperative 5th days.	Forced Vital Capacity spirometric measurement was measured. Test was carried out according to American Thoracic Society / European Respiratory Society criteria.
Pain severity	Baseline and postoperative 5th days.	Visual Analogue Scale that is an easy, reproducible, minimal tool-requiring, and understandable measurement tool for the assessment of pain intensity was used. This scale consists of a horizontal, straight line. There is a value of 0 at the beginning of the line and 10 at the end.
Peak cough flow	Change from Baseline Functional Exercise Capacity at postoperative 5th days.	It was evaluated with the peak flow meter device while the patient was sitting upright in a chair with a back. The test method is explained and a trial test is carried out. The nosepiece was attached to the nose and the mouthpiece of the device was wrapped tightly with the lips.; It was asked to take a deep breath and suddenly and quickly blow into the device fron the patient. The best out of three acceptable tests was recorded.

Secondary Outcome Measures

Name	Time	Method
Evaluation of dyspnea	Baseline and postoperative 5th days.	It was evaluated with a 0-10 point borg scale. Dyspnea was measured at rest and after exertion. An increase in score is interpreted as an increase in dyspnea.