TENS for Relief of Postoperative Pain in Orthopedic Patients

Study Overview
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Brief Summary
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To ensure early mobilization, minimize suffering, and to prevent postoperative complications postoperative pain, should be reduced as soon and as effectively as possible. A non-pharmacological post-operative intervention in terms of the application of transcutaneous electrical nerve stimulation (TENS), could have the potential to accelerate early mobilization and reduce the use of opioids. The overall aim is to demonstrate that the addition of TENS to standard postoperative pain management of orthopedic patients can alleviate pain during mobilization and at rest

Detailed Description
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Annually, more than 200 million people undergo surgery worldwide and the number is increasing.To ensure early mobilization, minimize suffering, and to prevent postoperative complications and subsequent mortality, postoperative pain, should be reduced as soon and as effectively as possible. Acute complications include impaired mobility, respiratory difficulties, pneumonia, protracted healing processes, thromboembolic events like deep vein thrombosis or pulmonary embolism, and prolonged need for care . Acute postoperative pain also has several negative long-term effects gas, risk of residual pain, higher mortality risk and worsened patient outcome at 6 months especially in hip fractures of older individuals. A non-pharmacological post-operative intervention in terms of the application of transcutaneous electrical nerve stimulation (TENS), could have the potential to accelerate early mobilization and reduce the use of opioids .TENS is a non-invasive method that delivers electrical impulses through electrodes placed on the skin and has been shown to be an effective supplement that can decrease postoperative pain after thoracic and abdominal surgery . However, it is yet unclear whether TENS after orthopedic hip prosthesis surgery can reduce post-operative pain to improve early mobilization, decrease opioid consumption and shorten hospitalization time. The overall aim is to demonstrate that the addition of TENS to standard postoperative pain management of orthopedic patients can alleviate pain during mobilization and at rest. The primary aim of this feasibility study using a CE-marked TENS device with applied textile electrodes in a pair of pants is to reduce postoperative pain during mobilization following hip prosthesis surgery.

Official Title
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Transcutaneous Electrical Nerve Stimulation (TENS) Integrated Into Pants for Relief of Postoperative Pain in Orthopedic Patients

Conditions
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Orthopedic Disorder, Post Operative Pain, Hip Fractures, Hip Osteoarthritis

Intervention / Treatment
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* Device: transcutaneous electrical nerve stimulation (TENS)
* Device: Sham transcutaneous electrical nerve stimulation (TENS)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients 18 years and above. Diagnosis of hip prosthesis surgery or hip fracture surgery. Must be cognitively adequate. Must be without terminal illness. Exclusion Criteria: Pregnancy Skin wounds Pacemaker Intracardiac defibrillator Ongoing thrombolysis or thromboprophylaxis treatment Class 3 and 4 heart disease Difficulties to understand the Swedish language Drug and narcotic abuses Postoperative delirium syndrome Epidural catheter.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: This study will be a prospective, randomized, single-blinded, placebo-controlled repeated measures design.
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: TENS<br>The Chattanooga Physio TENS (DJO Global, Vista, CA) will be applied with mixed burst / TENS alternated, which is a 30-minutes programmed. The stimulation frequencies of this alternative vary every 3 seconds, producing a combined stimulation of 80 Hz and 2 Hz. The energy intensity level will firstly be adjusted for 80 Hz (TENS) until a tingling sensation is felt, and then the procedure will be repeat for 2 Hz to produce visible, but not painful, muscle twitches. The patient will use a pair of pants with integrated stimulation electrodes, to which the CE-marked TENS device (Chattanooga Physio, DJO Nordic, Malmö, Sweden) will be connected and used to provide pain relief, in addition to usual postoperative care. The TENS device will be connected to the textile electrodes of the pants, which are located just 5cm in front, respectively behind the hip incision dressing. | Device: transcutaneous electrical nerve stimulation (TENS)<br>* Chattanooga Physio TENS (DJO Global, Vista, CA)<br>* Other names: electrical nerve stimulation;|
| Sham Comparator: Control<br>The control group will also receive the TENS-pants described above with integrated stimulation electrodes, connected to TENS treatment. However, the TENS treatment to the control group will be set so that no electricity will reach the patient. In all other regards, the control group will follow the same protocol as the intervention group. | Device: Sham transcutaneous electrical nerve stimulation (TENS)<br>* Sham treatment with Chattanooga Physio TENS (DJO Global, Vista, CA)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain estimation during rest | A 11-point numeric pain rating scale (Minimum 0, Maximum 10, higher score means worse outcome, i.e more pain) assessment will be performed during inactivity | Immediately after 30-minute TENS application during inactivity | 
| Pain estimation during activity | A 11-point numeric pain rating scale (Minimum 0, Maximum 10, higher score means worse outcome, i.e more pain) assessment will be performed during activity after the Standardized three-meter Walking test (WALK3m) | Immediately after 30-minute TENS application during activity | 
| Patient Global Impression of Change (PGIC) | The patient's belief about the efficacy of treatment, which ranged from 1 (minimum, no change) to 7 (maximum, a great deal better) will be assessed by PGIC. | Immediately after 30-minute TENS application | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mobility testing | The Standardized three-meter Walking test (WALK3m). With a stopwatch, the patient will be instructed to walk a 3 meters distance beginning from a marked position, in comfortable steps, to a stop position, turn around and walk back to the marked position where he or she started. The timing will begin when the patient starts on the word go, and the timing will end when the patient stopped at the marked position where they started. | Immediately after 30-minute TENS application | 
| Analgesic consumption | Extra analgesic consumption during the entire intervention will be documented. Under the intervention period, which is the first two times 30-minute TENS stimulation intervention, a 30-minute inactive interval, and there after another two times 30-minute stimulation intervention, all supplementary analgesics consumed will be documented to assess and evaluate the effect of the intervention. | During intervention | 
| Patients-reported impression of TENS | A short follow-up will be performed before discharge 24 hours after the surgery. The patient in both active and placebo groups will be a asked the following questions: Was TENS therapy comfortable for you? Would you like to use TENS again if you would undergo another surgery in the future? Were the TENS trousers comfortable to wear for you? The NRS will also be used to measure patient's satisfaction of the TENS- treatment (from 0, no satisfaction, to 10, major satisfaction with the treatment) | Within 3 hours after the intervention. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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transcutaneous electrical nerve stimulation, Patient Global Impression of Change, numeric pain rating scale