Total Knee ArthoplastyNCT05470244
TENS in Post-operative Total Knee Arthroplasty Recovery and Intra-venous Analgesics Requirement
A study testing Routine Physical Therapy and Intra-venous analgesic regimen and Transcutaneous Electrical Nerve Stimulation along with Routine Physical Therapy and Intra-venous analgesic regimen in people with Total Knee Arthoplasty and Knee Pain, run by University of Lahore at 1 site in Pakistan.
Trial summary
Total knee arthroplasty (TKA) is among the major advancements for the treatment of knee pain and improvement of physical function when conservative management fails to comply with. The success of this arthoplasty results in more functional mobility and better quality of life. Read more about this study
- Who is it for?
- Ages 31 to 70 years
- Conditions the study is for
- Total Knee Arthoplasty, Knee Pain
- What is being tested?
- Routine Physical Therapy and Intra-venous analgesic regimen and Transcutaneous Electrical Nerve Stimulation along with Routine Physical Therapy and Intra-venous analgesic regimen
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 sitePakistan
- Study dates
- 13 Jul 2022to 15 Dec 2022
- 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 31 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Both male and female
- Aged between 31-70 years
- Total Knee Arthoplasty, who had been diagnosed with knee osteoarthritis, inflammatory arthritis, trauma, fracture result in total knee arthoplasty.
Who cannot join
- Any allergic condition of skin
- Chronic consumption of opioids
- History of dysplasia or malignancy to knee joint
- Any major bone operation of lower limb
- BMI higher than 35 kg m-2
- History of mental disorder
- Neurological illness e.g. Alzheimer which might interfere with assessment process.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Transcutaneous Electrical Nerve Stimulation in Post-operative Total Knee Arthroplasty Recovery and Intra-venous Analgesics Requirement
Total knee arthroplasty (TKA) is among the major advancements for the treatment of knee pain and improvement of physical function when conservative management fails to comply with. The success of this arthoplasty results in more functional mobility and better quality of life. However, management of pain after TKA in post-operative period is a big challenge to deal.
Read the detailed description
Transcutaneous electrical nerve stimulation is a cost effective, non-invasive electrotherapeutic modality used in alleviating pain in both acute and chronic conditions affecting neuromusculoskeletal system of the body.
- Conditions
- Total Knee Arthoplasty, Knee Pain
- Being tested
- Routine Physical Therapy and Intra-venous analgesic regimen, Transcutaneous Electrical Nerve Stimulation along with Routine Physical Therapy and Intra-venous analgesic regimen
- Keywords
- Total Knee Arthoplasty, Knee Pain, Post-operative, Transcutaneous electrical nerve stimulation, Intra-venous, Analgesics requirement, Recovery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Routine Physical Therapy and Intra-venous analgesic regimenOther
ROM Exercises will be performed and analgesics including the NSAIDs and narcotics as per prescription of surgeon/physician will be given to all subjects
Transcutaneous Electrical Nerve Stimulation along with Routine Physical Therapy and Intra-venous analgesic regimenOther
High frequency stimulations via Transcutaneous Electrical Nerve Simulator will be applied. ROM Exercises will be performed and analgesics including the NSAIDs and narcotics as per prescription of surgeon/physician will be given to all subjects
| Study group | Role | What they receive |
|---|---|---|
| Therapeutic Exercise Group | Active comparator | This group will receive Routine Physical therapy protocol along with prescribed intra-venous regimen. Receives: Other: Routine Physical Therapy and Intra-venous analgesic regimen |
| TENS Plus Therapeutic Exercise Group | Experimental | This group will receive high frequency Transcutaneous Electrical Nerve Stimulation with routine physical therapy and prescribed intra-venous regimen. Receives: Other: Transcutaneous Electrical Nerve Stimulation along with Routine Physical Therapy and Intra-venous analgesic regimen |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain Intensity
Pain intensity will be measured using Visual Analogue Scale
Measured: Pain intensity will be measured at baseline,and change in pain intensity will be measured from baseline to 24 hour, 48 hour and 72 hours.
Rang of Motion
Knee Rang of Motion will be measured using Universal Goniometer
Measured: Knee Range of Motion will be measured at baseline, and Change in Knee Range of Motion will be measured from baseline to 24 hour, 48 hour and 72 hours
Intra-venous analgesic requirement
Dose and frequency of intravenous analgesic requirement will be observed through Patient's file
Measured: Analgesics requirement will be observed at first post-operative day, at second post-operative day, at third post-operative day
Secondary outcomes (1)
Length of Hospital Stay
Length of Hospital Stay of patient
Measured: It will be measured from the time of randomization till the time of discharge from hospital upto ten days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2022
- Study start13 Jul 2022
- Primary completion15 Dec 2022
- Study completion15 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Total Knee ArthoplastyStudies of the same condition, open and under way.
- More trials run by University of LahoreThe sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Lahore
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ayesha Jamil, University of Lahore
- Investigators
- Prof. Dr. Ashfaq Ahmed, PhD, Study director, University of Lahore
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05470244
- Sponsor's protocol ID
- TKR
- Status last verified
- Apr 2023
- First submitted
- 12 Jul 2022
- Last updated
- 7 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: it will be shared immediately after publication
Publications
Jamil A, Javed A, Adeel M, Naseem MA. Effects of transcutaneous electrical nerve stimulation in postoperative total knee arthroplasty pain and intravenous analgesic requirement. Sci Rep. 2026 May 23;16(1):23573. doi: 10.1038/s41598-026-54205-9.
PubMed 42177223
Study at a glance
From the registry record, last updated by the sponsor on 7 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Transcutaneous Electrical Nerve Stimulation in Post-operative Total Knee Arthroplasty Recovery and Intra-venous Analgesics Requirement
- ClinicalTrials.gov ID
- NCT05470244
- Acronym / sponsor ID
- TKR
- Conditions
- Total Knee Arthoplasty, Knee Pain
- Keywords
- Total Knee Arthoplasty, Knee Pain, Post-operative, Transcutaneous electrical nerve stimulation, Intra-venous, Analgesics requirement, Recovery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- University of LahoreUniversity, hospital or other
- Study start
- 13 Jul 2022 (actual)
- Primary completion
- 15 Dec 2022 (actual)
- Study completion
- 15 Dec 2022 (actual)
- First posted
- 22 Jul 2022 (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.
Total knee arthroplasty (TKA) is among the major advancements for the treatment of knee pain and improvement of physical function when conservative management fails to comply with. The success of this arthoplasty results in more functional mobility and better quality of life. However, management of pain after TKA in post-operative period is a big challenge to deal.
Detailed description
Transcutaneous electrical nerve stimulation is a cost effective, non-invasive electrotherapeutic modality used in alleviating pain in both acute and chronic conditions affecting neuromusculoskeletal system of the body.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Therapeutic Exercise Group | Active comparator | Other: Routine Physical Therapy and Intra-venous analgesic regimenThis group will receive Routine Physical therapy protocol along with prescribed intra-venous regimen. |
| TENS Plus Therapeutic Exercise Group | Experimental | Other: Transcutaneous Electrical Nerve Stimulation along with Routine Physical Therapy and Intra-venous analgesic regimenThis group will receive high frequency Transcutaneous Electrical Nerve Stimulation with routine physical therapy and prescribed intra-venous regimen. |
Who may qualify
- Ages
- 31 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Both male and female
- Aged between 31-70 years
- Total Knee Arthoplasty, who had been diagnosed with knee osteoarthritis, inflammatory arthritis, trauma, fracture result in total knee arthoplasty.
Key exclusion criteria (7 listed)
- Any allergic condition of skin
- Chronic consumption of opioids
- History of dysplasia or malignancy to knee joint
- Any major bone operation of lower limb
- BMI higher than 35 kg m-2
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 |
|---|---|---|
| Routine Physical Therapy and Intra-venous analgesic regimenROM Exercises will be performed and analgesics including the NSAIDs and narcotics as per prescription of surgeon/physician will be given to all subjects | Other | Therapeutic Exercise Group |
| Transcutaneous Electrical Nerve Stimulation along with Routine Physical Therapy and Intra-venous analgesic regimenHigh frequency stimulations via Transcutaneous Electrical Nerve Simulator will be applied. ROM Exercises will be performed and analgesics including the NSAIDs and narcotics as per prescription of surgeon/physician will be given to all subjects | Other | TENS Plus Therapeutic Exercise Group |
Primary outcome
Pain Intensity
Time frame: Pain intensity will be measured at baseline,and change in pain intensity will be measured from baseline to 24 hour, 48 hour and 72 hours.
Pain intensity will be measured using Visual Analogue Scale
Rang of Motion
Time frame: Knee Range of Motion will be measured at baseline, and Change in Knee Range of Motion will be measured from baseline to 24 hour, 48 hour and 72 hours
Knee Rang of Motion will be measured using Universal Goniometer
Intra-venous analgesic requirement
Time frame: Analgesics requirement will be observed at first post-operative day, at second post-operative day, at third post-operative day
Dose and frequency of intravenous analgesic requirement will be observed through Patient's file
1 secondary outcome
Length of Hospital Stay
Time frame: It will be measured from the time of randomization till the time of discharge from hospital upto ten days
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 7 Apr 2023.
- Derived from this study: PubMed 42177223Jamil A, Javed A, Adeel M, Naseem MA. Effects of transcutaneous electrical nerve stimulation in postoperative total knee arthroplasty pain and intravenous analgesic requirement. Sci Rep. 2026 May 23;16(1):23573. doi: 10.1038/s41598-026-54205-9.
- Individual participant dataSharing planned: Yes. it will be shared immediately after publication
Related trials for Total Knee Arthoplasty
Not yet recruitingObservational study
Postsurgical Pain and Opioid Use in Older Adults: Effects of Mild Cognitive Impairment
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Effects of Progressive Restricted Blood Flow Exercises in Post Total Knee Arthroplasty
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Active, not recruiting
Patient Utilization of Opioid Destruction Bags in the Post-op Period
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Recruiting
Effect of Progressive Muscle Relaxation on Fear of Falling, Pain, and Anxiety in Arthroplasty Patients
Arthoplasty, Pain, Anxiety
Recruiting
BLOCK-study: Better Local Orthopedic Pain Control After Knee Arthroplasty
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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.
Prof. Dr. Ashfaq Ahmed, PhD study director
University of Lahore
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Routine Physical Therapy and Intra-venous analgesic regimen and Transcutaneous Electrical Nerve Stimulation along with Routine Physical Therapy and Intra-venous analgesic regimen in people with Total Knee Arthoplasty and Knee Pain, run by University of Lahore at 1 site in Pakistan.
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 3 inclusion and 7 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 7 Apr 2023. 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 Pakistan. 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. 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?
Pain Intensity (time frame: Pain intensity will be measured at baseline,and change in pain intensity will be measured from baseline to 24 hour, 48 hour and 72 hours.). 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 NCT05470244, 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 7 Apr 2023.