The Effectiveness of Transcutaneous Electrical Nerve Stimulation After Thoracic Surgery

The Role of Transcutaneous Electrical Nerve Stimulation Combined With Physiotherapy and Rehabilitation Program on Pulmonary Function and Functional Exercise Capacity in Patients Undergoing Thoracic Surgery? A Randomized Controlled Trial

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.

Study Overview

• Status: Completed
• Conditions: Pain; Surgery; Pulmonary Function; Functional Capacity; Thoracic
• Intervention / Treatment: Other: Physiotherapy rehabilitation and Transcutaneous Electrical Nerve Stimulation; Other: Physiotherapy Rehabilitation

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 Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Physiotherapy rehabilitation and Transcutaneous Electrical Nerve Stimulation (TENS) group; 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.	Other: Physiotherapy rehabilitation and Transcutaneous Electrical Nerve Stimulation; Physiotherapy rehabilitation and Transcutaneous Electrical Nerve Stimulation (TENS) group received TENS therapy in addition to physiotherapy rehabilitation 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. Transcutaneous Electrical Nerve Stimulation 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 and Rehabilitation for 30 min, twice a day, 5 day a week. Patients were evaluated before the surgery and the end of postoperative 5th day.
Active Comparator: Physiotherapy rehabilitation Group; 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.	Other: Physiotherapy Rehabilitation; Physiotherapy and Rehabilitation was performed for 5 days after surgery, twice a day, for 30 min, 5 day a week after thoracic surgery. The program was included respiratory and posture exercises, coughing, enhancing mobility. Patients were evaluated before the surgery and the end of postoperative 5th day.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Functional Exercise Capacity	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.	Change from Baseline Functional Exercise Capacity at postoperative 5th days.
Forced expiratory volume in one second Spirometric measurement	Forced expiratory volume in one second spirometric measurement was measured. Test was carried out according to American Thoracic Society / European Respiratory Society criteria.	Change from Baseline Functional Exercise Capacity at postoperative 5th days.
Forced Vital Capacity Spirometric measurement	Forced Vital Capacity spirometric measurement was measured. Test was carried out according to American Thoracic Society / European Respiratory Society criteria.	Change from Baseline Functional Exercise Capacity at postoperative 5th days.
Pain severity	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.	Baseline and postoperative 5th days.
Peak cough flow	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.	Change from Baseline Functional Exercise Capacity at postoperative 5th days.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Evaluation of dyspnea	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.	Baseline and postoperative 5th days.

Collaborators and Investigators

• Sponsor: Marmara University
• Investigators: Principal Investigator: Aysel Yildiz Ozer, PT, PhD, Marmara University; Study Director: Nilgun Gurses, Prof, Bezmialem Vakif University; Study Chair: Alper Toker, Prof, Istanbul University

Publications and helpful links

General Publications

• Erdogan M, Erdogan A, Erbil N, Karakaya HK, Demircan A. Prospective, Randomized, Placebo-controlled Study of the Effect of TENS on postthoracotomy pain and pulmonary function. World J Surg. 2005 Dec;29(12):1563-70. doi: 10.1007/s00268-005-7934-6.
• Cesario A, Ferri L, Galetta D, Pasqua F, Bonassi S, Clini E, Biscione G, Cardaci V, di Toro S, Zarzana A, Margaritora S, Piraino A, Russo P, Sterzi S, Granone P. Post-operative respiratory rehabilitation after lung resection for non-small cell lung cancer. Lung Cancer. 2007 Aug;57(2):175-80. doi: 10.1016/j.lungcan.2007.02.017. Epub 2007 Apr 17.
• Kaneda H, Saito Y, Okamoto M, Maniwa T, Minami K, Imamura H. Early postoperative mobilization with walking at 4 hours after lobectomy in lung cancer patients. Gen Thorac Cardiovasc Surg. 2007 Dec;55(12):493-8. doi: 10.1007/s11748-007-0169-8. Epub 2007 Dec 11.
• Benedetti F, Amanzio M, Casadio C, Cavallo A, Cianci R, Giobbe R, Mancuso M, Ruffini E, Maggi G. Control of postoperative pain by transcutaneous electrical nerve stimulation after thoracic operations. Ann Thorac Surg. 1997 Mar;63(3):773-6. doi: 10.1016/s0003-4975(96)01249-0.
• Sancho J, Servera E, Diaz J, Marin J. Comparison of peak cough flows measured by pneumotachograph and a portable peak flow meter. Am J Phys Med Rehabil. 2004 Aug;83(8):608-12. doi: 10.1097/01.phm.0000133431.70907.a2.
• Meek PM. Measurement of dyspnea in chronic obstructive pulmonary disease: what is the tool telling you? Chron Respir Dis. 2004;1(1):29-37. doi: 10.1191/1479972304cd008ra.
• Freynet A, Falcoz PE. Is transcutaneous electrical nerve stimulation effective in relieving postoperative pain after thoracotomy? Interact Cardiovasc Thorac Surg. 2010 Feb;10(2):283-8. doi: 10.1510/icvts.2009.219576. Epub 2009 Nov 12.

Study record dates

Study Major Dates

• Study Start (Actual): July 20, 2009
• Primary Completion (Actual): April 30, 2011
• Study Completion (Actual): September 5, 2011

Study Registration Dates

• First Submitted: May 2, 2021
• First Submitted That Met QC Criteria: May 4, 2021
• First Posted (Actual): May 10, 2021

Study Record Updates

• Last Update Posted (Actual): May 10, 2021
• Last Update Submitted That Met QC Criteria: May 4, 2021
• Last Verified: May 1, 2021

More Information

Terms related to this study

• Keywords: pain; thoracic surgery; pulmonary function; functional capacity; transcutaneous electrical nerve stimulation; physiotherapy and rehabilitation
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Aneurysm; Aneurysm, Dissecting
• Other Study ID Numbers: 5563

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No