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CompletedNCT04879108Updated May 10, 2021

The Effectiveness of Transcutaneous Electrical Nerve Stimulation After Thoracic Surgery

An interventional study of Physiotherapy rehabilitation and Transcutaneous Electrical Nerve Stimulation and Physiotherapy Rehabilitation in Thoracic, Surgery and Pain, sponsored by Marmara University. Completed. Open to participants aged 20 Years to 75 Years. Per ClinicalTrials.gov, last updated 2021-05-10.

Sponsored by Marmara University · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 11 years 9 months after the study started (first participant enrolled Jul 2009, registered May 2021).
Phase
Not applicable
Study type
Interventional
Enrollment
60
Allocation
Randomized
Ages
20 Years to 75 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Thoracic
  • Surgery
  • Pain
  • Pulmonary Function
  • Functional Capacity

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Keywords

  • transcutaneous electrical nerve stimulation
  • physiotherapy and rehabilitation
  • thoracic surgery
  • pain
  • pulmonary function
  • functional capacity
03

In context

Aortic Dissection

386 studies on the registry are indexed under Aortic Dissection; 117 are open to participants now.

This study's enrollment of 60 is below the median of 84 across 198 interventional studies indexed under Aortic Dissection.

Browse Aortic Dissection studies →

Lead sponsor

Marmara University is the lead sponsor of 576 studies on the registry; 136 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
20 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Patients undergoing lobectomy for lung cancer

Exclusion criteria

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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Single (Outcomes assessor)
Enrollment
60 participants (actual)

Study arms

  • 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

  • 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

Interventions

  • OtherPhysiotherapy 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.

  • OtherPhysiotherapy 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.

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: Change from Baseline Functional Exercise Capacity at postoperative 5th days.

  2. 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.

    Time frame: Change from Baseline Functional Exercise Capacity at postoperative 5th days.

  3. 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.

    Time frame: Change from Baseline Functional Exercise Capacity at postoperative 5th days.

  4. 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.

    Time frame: Baseline and postoperative 5th days.

  5. 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.

    Time frame: Change from Baseline Functional Exercise Capacity at postoperative 5th days.

Secondary outcomes

  1. 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.

    Time frame: Baseline and postoperative 5th days.

07

Study locations

No study locations are listed for this record.

08

References and documents

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. PubMed 16331341 ↗
  • 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. PubMed 17442449 ↗
  • 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. PubMed 18066640 ↗
  • 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. PubMed 9066400 ↗
  • 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. PubMed 15277962 ↗
  • 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. PubMed 16281665 ↗
  • 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. PubMed 19910359 ↗

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 10, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04879108
Lead sponsor
Marmara University
Responsible party
Sponsor
First posted
May 10, 2021
Start date
Jul 20, 2009
Primary completion
Apr 30, 2011
Completion
Sep 5, 2011
Last update
May 10, 2021

Study contacts

Aysel Yildiz Ozer, PT, PhD
principal investigator · Marmara University
Nilgun Gurses, Prof
study director · Bezmialem Vakif University
Alper Toker, Prof
study chair · Istanbul University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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