Clinical trial NCT04879108: The Effectiveness of Transcutaneous Electrical Nerve Stimulation After Thoracic Surgery
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Thoracic
Surgery
Pain
Pulmonary Function
Functional Capacity
Keywords: transcutaneous electrical nerve stimulation
physiotherapy and rehabilitation
thoracic surgery
pain
pulmonary function
functional capacity
Lead sponsor: Marmara University
Sponsor class: OTHER
First posted: 2021-05-10
Enrollment: 60
Sex: ALL
Minimum age (years): 20
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Crossover Assignment Randomized controlled
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Functional Exercise Capacity
timeFrame: Change from Baseline Functional Exercise Capacity at postoperative 5th days.
measure: Forced expiratory volume in one second Spirometric measurement
timeFrame: Change from Baseline Functional Exercise Capacity at postoperative 5th days.
measure: Forced Vital Capacity Spirometric measurement
timeFrame: Change from Baseline Functional Exercise Capacity at postoperative 5th days.
measure: Pain severity
timeFrame: Baseline and postoperative 5th days.
measure: Peak cough flow
timeFrame: Change from Baseline Functional Exercise Capacity at postoperative 5th days.
Secondary outcomes:
measure: Evaluation of dyspnea
timeFrame: Baseline and postoperative 5th days.
Other outcomes:
Locations:
Study officials:
affiliation: Marmara University
name: Aysel Yildiz Ozer, PT, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Bezmialem Vakif University
name: Nilgun Gurses, Prof
role: STUDY_DIRECTOR
affiliation: Istanbul University
name: Alper Toker, Prof
role: STUDY_CHAIR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.