Total Knee ArthroplastyNCT03542981
Interferential Current Therapy After Total Knee Arthroplasty
A study testing Interferential Current in people with Total Knee Arthroplasty, run by Ege University at 1 site in Turkey (Türkiye).
Trial summary
Interferential current is widely used as a popular treatment in painful musculoskeletal disorders. And total knee arthroplasty patients present with extreme pain immediately after surgery. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Total Knee Arthroplasty
- What is being tested?
- Interferential Current
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 113 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 9 Sep 2014to 1 Sep 2015
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- •Patients who underwent total knee arthroplasty surgery
Who cannot join
- Patients who had experienced of any electrotherapy prior to the TKA to be sure blinding of therapy
- Patients who had history of any contraindication for electrotherapy
- Patients who had chronic pain rather than knee OA
- Patients who had experienced a known or suspected joint infection or a specific condition (ie, peripheral or central nervous system lesions, neoplasm, diabetes mellitus, osteonecrosis, recent trauma and pacemaker)
- Patients who had history of stroke, central nervous disease, mental impairment or poor general health status that would interfere with functional assessments during the study
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Ege University School of Medicine Hospital
Izmir, Bornova, 35030
About this study
Official title: Is Interferential Current Effective in the Management of Pain, Range of Motion, Edema Following Total Knee Arthroplasty Surgery?: Randomized Double-blind Controlled Trial
Interferential current is widely used as a popular treatment in painful musculoskeletal disorders. And total knee arthroplasty patients present with extreme pain immediately after surgery. So this study is aimed to investigate the effectiveness of interferential current implementation following total knee arthroplasty surgery. In this study interferential current compared with sham interferential current . Patients were assessed with pain, range of motion , edema and the amount of used paracetamol.
Read the detailed description
A total of 132 patients ranging in 60-85 years who were undergoing their first total knee arthroplasty due to knee OA were recruited into a randomized, double-blind, prospective and controlled study. Participants were recruited at the Orthopedics and Traumatology inpatient clinic. The patients were seen postoperative first day and were assigned to receive either interferential current or sham interferential current by block randomization. After the procedure was explained to each subject, interferential current treatment was applied 2 times for 5 days, each treatment was continued approximately 30 minutes. Four electrodes were used to deliver quadripolar interferential current Subjects were told that in order to produce an effect, the intensity of the stimulator must be maintained at a "strong but comfortable level" at all times. The sham interferential current treatment consisted of the placement of the same pads for the same time but no electrical stimulation was applied to the probes. At the same time, all patients received standard postoperatively rehabilitation program. Patients were assessed with pain, range of motion , edema and the amount of used paracetamol.
- Conditions
- Total Knee Arthroplasty
- Being tested
- Interferential Current, Sham Interferential Current
- Keywords
- pain, surgery, interferential current, total knee arthroplasty
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Interferential CurrentDevice
Sham Interferential CurrentDevice
| Study group | Role | What they receive |
|---|---|---|
| Interferential Current Treatment | Active comparator | Interferential Current group received interferential current treatment 30 minutes, 2 times a day for 5 days after the surgery. Receives: Device: Interferential Current |
| Sham Interferential Current Treatment | Sham comparator | In the sham interferential Current treatment, no electrical stimulation was applied to the probes with the same pads for the same time. Receives: Device: Sham Interferential Current |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Pain from baseline measured by visual analog scale
Pain intensity that was measured by visual analog scale (minimum score:0; maximum score:100)(higher values represent worse outcome)
Measured: Change in pain measured 5th and 30th days after surgery
Secondary outcomes (3)
Change of Range of Motion from baseline
The measurement of the range of the motion was performed by a goniometer of active extension and flexion (higher values represent better outcome)
Measured: Change of Range of Motion measured 5th and 30th days after surgery
Change of Edema from baseline
Edema as a change in circumference from the preoperative value was measured by a meter (higher values represent worse outcome)
Measured: Change of Edema measured 5th and 30th days after surgery
Amount of used paracetamol
the paracetamol intake was recorded as gr. (higher values represent worse outcome)
Measured: 5th and 30th days after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jun 2018
- Study start9 Sep 2014
- Primary completion1 Sep 2015
- Study completion1 Sep 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Total Knee ArthroplastyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 113 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ege University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mehmet Resul KADI, Ege University
- Investigators
- mehmet r kadı, MD, Principal investigator, Ege University School of MedicineSimin Hepguler, prof, Study director, Ege University School of MedicineFunda C Atamaz, prof, Study chair, Ege University School of MedicineEmine Dede, md, Study chair, Ege University School of MedicineSemih Aydogu, prof, Study chair, Ege University School of MedicineKemal Aktuğlu, prof, Study chair, Ege University School of MedicineNadir Ozkayın, prof, Study chair, Ege University School of MedicineCihat Ozturk, prof, Study chair, Ege University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03542981
- Sponsor's protocol ID
- TKP35IF
- Status last verified
- May 2018
- First submitted
- 7 May 2018
- Last updated
- 1 Jun 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Is Interferential Current Effective in the Management of Pain, Range of Motion, Edema Following Total Knee Arthroplasty Surgery?: Randomized Double-blind Controlled Trial
- ClinicalTrials.gov ID
- NCT03542981
- Acronym / sponsor ID
- TKP35IF
- Conditions
- Total Knee Arthroplasty
- Keywords
- pain, surgery, interferential current, total knee arthroplasty
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 113 participants (actual)
- Lead sponsor
- Ege UniversityUniversity, hospital or other
- Study start
- 9 Sep 2014 (actual)
- Primary completion
- 1 Sep 2015 (actual)
- Study completion
- 1 Sep 2015 (actual)
- First posted
- 1 Jun 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Interferential current is widely used as a popular treatment in painful musculoskeletal disorders. And total knee arthroplasty patients present with extreme pain immediately after surgery. So this study is aimed to investigate the effectiveness of interferential current implementation following total knee arthroplasty surgery. In this study interferential current compared with sham interferential current . Patients were assessed with pain, range of motion , edema and the amount of used paracetamol.
Detailed description
A total of 132 patients ranging in 60-85 years who were undergoing their first total knee arthroplasty due to knee OA were recruited into a randomized, double-blind, prospective and controlled study. Participants were recruited at the Orthopedics and Traumatology inpatient clinic. The patients were seen postoperative first day and were assigned to receive either interferential current or sham interferential current by block randomization. After the procedure was explained to each subject, interferential current treatment was applied 2 times for 5 days, each treatment was continued approximately 30 minutes. Four electrodes were used to deliver quadripolar interferential current Subjects were told that in order to produce an effect, the intensity of the stimulator must be maintained at a "strong but comfortable level" at all times. The sham interferential current treatment consisted of the placement of the same pads for the same time but no electrical stimulation was applied to the probes. At the same time, all patients received standard postoperatively rehabilitation program. Patients were assessed with pain, range of motion , edema and the amount of used paracetamol.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Interferential Current Treatment | Active comparator | Device: Interferential CurrentInterferential Current group received interferential current treatment 30 minutes, 2 times a day for 5 days after the surgery. |
| Sham Interferential Current Treatment | Sham comparator | Device: Sham Interferential CurrentIn the sham interferential Current treatment, no electrical stimulation was applied to the probes with the same pads for the same time. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- •Patients who underwent total knee arthroplasty surgery
Key exclusion criteria (5 listed)
- Patients who had experienced of any electrotherapy prior to the TKA to be sure blinding of therapy
- Patients who had history of any contraindication for electrotherapy
- Patients who had chronic pain rather than knee OA
- Patients who had experienced a known or suspected joint infection or a specific condition (ie, peripheral or central nervous system lesions, neoplasm, diabetes mellitus, osteonecrosis, recent trauma and pacemaker)
- Patients who had history of stroke, central nervous disease, mental impairment or poor general health status that would interfere with functional assessments during the study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Interferential Current | Device | Interferential Current Treatment |
| Sham Interferential Current | Device | Sham Interferential Current Treatment |
Primary outcome
Change in Pain from baseline measured by visual analog scale
Time frame: Change in pain measured 5th and 30th days after surgery
Pain intensity that was measured by visual analog scale (minimum score:0; maximum score:100)(higher values represent worse outcome)
3 secondary outcomes
Change of Range of Motion from baseline
Time frame: Change of Range of Motion measured 5th and 30th days after surgery
Change of Edema from baseline
Time frame: Change of Edema measured 5th and 30th days after surgery
Amount of used paracetamol
Time frame: 5th and 30th days after surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jun 2018.
- Individual participant dataSharing planned: No
Related trials for Total Knee Arthroplasty
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Opioid Reduction and Enhanced Recovery in Orthopaedic Surgery (OREOS)-Knee
Knee Arthroplasty, Total, Partial Knee Arthroplasty
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Total Hip Replacement: an Investigation of Robotic-assisted Versus conVentional Surgery and Patient-centred outcomEs
Osteo Arthritis Knee and Hip
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Radiofrequency Ablation for the Treatment of Post-knee Arthroplasty Chronic Pain.
Chronic Post-surgical Pain, Chronic Post Operative Pain
Not yet recruiting
Effects of Different Bispectral Index Target Depths on Early Postoperative Recovery Quality in Elderly Patients Undergoing Total Knee Arthroplasty
Total Knee Arthroplasty, Postoperative Recovery
Enrolling by invitation
Early Outcome of Simultaneous Bilateral Total Knee Replacement With and Without Tourniquet
Arthroplasty, Replacement, Knee, Blood Loss, Surgical
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
mehmet r kadı, MD principal investigator
Ege University School of Medicine
Simin Hepguler, prof study director
Ege University School of Medicine
Funda C Atamaz, prof study chair
Ege University School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Interferential Current in people with Total Knee Arthroplasty, run by Ege University at 1 site in Turkey (Türkiye).
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 1 inclusion and 5 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: finished, as of the sponsor's last update on 1 Jun 2018. 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 Turkey (Türkiye). 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Change in Pain from baseline measured by visual analog scale (time frame: Change in pain measured 5th and 30th days after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 1 Jun 2018.