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Orthopedic DisorderNCT05678101

TENS for Relief of Postoperative Pain in Orthopedic Patients

A study testing transcutaneous electrical nerve stimulation (TENS) in people with Orthopedic Disorder and Post Operative Pain, run by Karolinska University Hospital at 1 site in Sweden.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

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… Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
transcutaneous electrical nerve stimulation (TENS)
Type of treatment
Medical device
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
30 participants
Where
1 siteSweden
Study dates
1 Nov 2022to 30 Dec 2025
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patients 18 years and above.
  • Patient has undergone hip fracture surgery.
  • Must be cognitively adequate.
  • Must be without terminal illness.

Who cannot join

  • Pregnancy
  • Skin wounds
  • Pacemaker
  • Intracardiac defibrillator
  • Ongoing thrombolysis or thromboprophylaxis.
  • Class 3 and 4 heart disease
Show all 10Show fewer
  • Difficulties to understand the Swedish language
  • Drug and narcotic abuses
  • Postoperative delirium syndrome
  • Epidural catheter.

Trial locations and contacts

1 site in 1 country.

Sweden1 site
  • Karolinska university Hospital

    Stockholm, 17176

Other trials in Sweden

About this study

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

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 as well as reduce opioid consumption.

Read the detailed description

Hip fracture is most often addressed surgically (Allahabadi et al., 2022; RikshÖFt, 2020), and is commonly associated with a short-term increase in mortality, and long-term reduction in health-related quality of life (Alexiou et al., 2018; Dyer et al., 2016; Gjertsen et al., 2016; Griffin et al., 2015). A large part of this reduction in quality of life can be related to pain and mobility. According to the Swedish National Hip Fracture Registry (RikshÖFt, 2020), 5.8% of the patients registered in 2019 were experiencing severe pain either constantly or during activity at the 4-month follow-up; 42% were experiencing tolerable pain during activity, and 35% were pain-free.

In the larger context of Chronic PostOperative Pain (CPOP), severe pain on postoperative day 1 constitutes an important risk factor (Fletcher et al., 2015). A 10% increase in the amount of time spent in severe pain on postoperative day 1 has been associated with a 30% increase in the incidence of CPOP at a 12-month follow-up. Yet, a 2021 review on the prevention of CPOP (Carley et al., 2021) reported that there were no pharmaceutical pain treatments that could be universally or specifically recommended to reduce the incidence of CPOP.

To effectively manage acute and chronic pain disorders, Transcutaneous Electrical Nerve Stimulation (TENS) has been viewed a safe nonpharmacological addition to standard care (Jafra et al., 2022; Johnson et al., 2022; Vance et al., 2022). Conventional TENS with high frequency (50-100Hz) activates non-noxious afferents considered to inhibit nociceptive transmission at the spinal cord level, i.e., peripheral gate-control. Mixed-frequency TENS adds a low-frequency (mostly 2-10Hz) stimulation that activates small-diameter, high-threshold peripheral afferents considered to trigger brainstem opioid descending pain inhibitory pathways, i.e., central gate-control. Studies have indicated mixed-frequency TENS may be effective to mitigate post-operative pain (Bjordal, Johnson, \& Ljunggreen, 2003; Hamza et al., 1999).

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.

A 2019 study (Elboim-Gabyzon, Najjar, \& Shtarker, 2019) demonstrated pain reduction during activity - but not at rest - following hip fracture with a 30-minute TENS intervention daily on the first 5 postoperative days. A more recent (and currently unpublished) study using TENS integrated in TENS-pants (Opolka et al., 2024) demonstrated pain reduction at rest and during activity with a single 2.5-hour intervention carried out around postoperative day 1 (POD1). However, there is there is still a lack of knowledge regarding the possible effect of a longer TENS intervention repeated over several days. Moreover, there is still a lack of statistical evidence for the opioid sparing effect of TENS following hip fracture surgery.

The primary aim of this study is to assess pain reduction and patient global impression of change following mixed-frequency TENS treatment (or placebo TENS) at rest and during activity on postoperative days 1 to 3, following hip fracture surgery. A secondary aim is to assess improvement in mobility and to test the opioid-sparing effect associated with TENS treatment. Moreover, to simplify TENS application, empower the elderly patients and improve compliance during mobilization, the authors chose to administer TENS using wearable TENS-pants with modular textile electrodes. We hypothesize that a mixed-frequency TENS intervention, carried out on POD1 to POD3, with a daily treatment duration of 3 hours, can lead to a significant opioid sparing effect, more durable pain reduction, and improve the patients' overall perception and recovery.

Being tested
transcutaneous electrical nerve stimulation (TENS), Sham transcutaneous electrical nerve stimulation (TENS)
Keywords
transcutaneous electrical nerve stimulation, Patient Global Impression of Change, numeric pain rating scale, TENS, PGIC, NRS, Post Operative Pain, Hip Fractures
Medical subject headings
Musculoskeletal Diseases, Pain, Postoperative, Hip Fractures

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • transcutaneous electrical nerve stimulation (TENS)Device

    Also called electrical nerve stimulation

    Chattanooga Physio TENS (DJO Global, Vista, CA)

  • Sham transcutaneous electrical nerve stimulation (TENS)Device

    Sham treatment with Chattanooga Physio TENS (DJO Global, Vista, CA)

Study groups in NCT05678101
Study groupRoleWhat they receive
TENSActive comparatorThe Chattanooga Physio TENS (DJO Global, Vista, CA) will be applied with mixed burst / TENS alternated, which is a 30-minute long program where the stimulation frequencies of alternate in 3 second intervals, producing a combined stimulation of 80 Hz and 2 Hz. Two programs/sessions ('a' and 'b') will be applied in succession for a total of 60-minutes (one round). In total, each day will have 3 rounds. The energy intensity level will firstly be adjusted for 80 Hz (TENS) until a tingling sensation is felt but no discomfort, and then the procedure will be repeat for 2 Hz. 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 5cm in front and behind the hip incision dressing respectively.
Receives: Device: transcutaneous electrical nerve stimulation (TENS)
ControlSham comparatorThe 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 such that no electricity will be applied to the patient. In all other regards, the control group will follow the same protocol as the intervention group.
Receives: Device: Sham transcutaneous electrical nerve stimulation (TENS)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

    Measured: During intervention. Mesaured twice per round: First before mobility testing and TENS-session 'a' and a second time during the last 5 minutes of the TENS-session 'a' during inactivity.

  2. 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.

    Measured: During intervention. Measured twice per round after both TENS-session 'a' and 'b' respectively.

  3. 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)

    Measured: During intervention. Measured twice per round: First after mobility testing and before TENS-session 'a' and a second time in the last 5 minutes of TENS-session 'b'.

Secondary outcomes (4)
  1. Mobility testing (Walking test)

    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. Patients will be asked whether or not they were mobilized prior to the intervention.

    Measured: During intervention. Performed and measured twice per round: once before TENS-session 'a' and a second time during the last 5 minutes of TENS-session 'b'.

  2. Analgesic consumption

    Extra analgesic consumption will be documented to assess and evaluate the effect of the intervention during the following: (1) Only intervention (POD 1,2, and 3). In each day there will be three 30x2-minute long rounds of TENS-application with two interposed 30-minute breaks equalling 4 hours x 3 = 12 hours. (2) Totally during post-operative days 1, 2, and 3 equalling 24 x 3 = 72 hours.

    Measured: During intervention. The information will be logged at the end of each day of intervention.

  3. Mobility testing (Put on pants time)

    At the start of each day, before the first intervention round the duration of putting on the TENS-pants will be logged. The timer will start once the first NRS at rest has been taken and the TENS-pants are ready to be applied to the patient and it will stop once the pants are worn and ready for TENS-application.

    Measured: During intervention. Measured once per day: Before the first pain assessment during rest and before TENS-session 'a' of the first round.

  4. Patients-reported impression of TENS (Qualitative assessment)

    A short follow-up will be performed after the intervention.

    The patients in both active and placebo groups will be asked to answer a questionnaire on their attitude toward TENS and the intervention. Answers will be provided on a five-level Likert-type scale on the following statements:

    1. I think TENS therapy is comfortable for me.
    2. I would like to use TENS again if I were to undergo another surgery in the future.
    3. I think the TENS-pants were comfortable to wear.
    4. I would feel confident to put on and take off the TENS-pants by myself.
    5. I would feel confident to put on and take off the TENS-pants with the help of a family member or care assistant.
    6. If you ever need to use TENS-PANTS at home, would you prefer to use "diaper-like" pants or "normal" pants?

    In addition, patients will be asked to provide free-form general comments on the product and study.

    Measured: Immediately after intervention

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Jan 2023
  2. Study start1 Nov 2022
  3. Primary completion1 Dec 2024 (estimated)
  4. Study completion30 Dec 2025 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
This study will be a prospective, randomized, single-blinded, placebo-controlled repeated measures design.
Masking
Single blind
Who is masked
Participant
Enrolment
30 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05678101
Sponsor's protocol ID
2023-ORTHTENS
Status last verified
Oct 2024
First submitted
3 Jan 2023
Last updated
22 Oct 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
Individual data sharing
Yes: IPD will be shared on personal application with good reasoning.

Publications

  • Opolka Y, Sundberg C, Juthberg R, Olesen A, Guo L, Persson NK, Ackermann PW. Transcutaneous Electrical Nerve Stimulation Integrated into Pants for the Relief of Postoperative Pain in Hip Surgery Patients: A Randomized Trial. Pain Res Manag. 2024 Jun 27;2024:6866549. doi: 10.1155/2024/6866549. eCollection 2024.

    PubMed 39145150

Questions about this trial

What is this clinical trial studying?

A study testing transcutaneous electrical nerve stimulation (TENS) in people with Orthopedic Disorder and Post Operative Pain, run by Karolinska University Hospital at 1 site in Sweden.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 22 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Pain estimation during rest (time frame: During intervention. Mesaured twice per round: First before mobility testing and TENS-session 'a' and a second time during the last 5 minutes of the TENS-session 'a' during inactivity.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05678101, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Oct 2024.

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