Knee OsteoarthritisNCT07741162
Paraspinal NMES and Spinopelvic Alignment After Knee Arthroplasty
A study testing Standard Postoperative Rehabilitation Program, Quadriceps Neuromuscular Electrical Stimulation and Paraspinal Neuromuscular Electrical Stimulation in people with Knee Osteoarthritis and Postoperative Rehabilitation, run by Bursa Yuksek Ihtisas Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
Total knee arthroplasty (TKA) is a widely performed surgical procedure for patients with severe knee osteoarthritis. Following TKA, changes in lower extremity alignment and gait mechanics may influence the spinopelvic sagittal alignment, and postoperative rehabilitation programs traditionally focus on the knee joint… Read more about this study
- Who is it for?
- Ages 40 to 80 years
- Conditions the study is for
- Knee Osteoarthritis, Postoperative Rehabilitation
- What is being tested?
- Standard Postoperative Rehabilitation Program, Quadriceps Neuromuscular Electrical Stimulation and Paraspinal Neuromuscular Electrical Stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 30 Sep 2026to 30 Jul 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 40 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age between 40 and 80 years
- Diagnosis of primary knee osteoarthritis scheduled for total knee arthroplasty
- Radiographic evidence of Kellgren-Lawrence grade 3-4 knee osteoarthritis
- Preoperative knee flexion contracture ≥ 5°
- Measurable spinopelvic malalignment, defined as meeting at least one of the following criteria: pelvic tilt (PT) > 20°, sagittal vertical axis (SVA) > 50 mm, or lumbar lordosis (LL) < 40°
- IIntact cognitive function based on clinical judgment, sufficient to understand and follow verbal commands, cooperate with the rehabilitation program, and reliably comply with functional assessment procedures
- Provision of written informed consent
- Able to stand independently and undergo standing lateral radiography
Who cannot join
- Prior lumbar or thoracic spinal surgery
- History of hip arthroplasty
- Prior knee arthroplasty (revision arthroplasty patients)
- Active inflammatory arthritis (e.g., rheumatoid arthritis, psoriatic arthritis)
- Neurological disease, including stroke, Parkinson's disease, peripheral neuropathy, or spinal cord pathology
- Contraindications to NMES, including active cardiac pacemaker, implanted defibrillator, deep vein thrombosis, skin integrity impairment, malignancy, or epilepsy
Show all 12Show fewer
- Severe hip osteoarthritis or other lower extremity pathology significantly affecting spinopelvic alignment (e.g., leg length discrepancy, developmental hip dysplasia, contracture)
- Inability to complete the standard rehabilitation protocol due to postoperative complications
- Osteoporotic vertebral fracture or significant osteoporosis (T-score < -2.5 at L1-L4)
- Active treatment for malignancy
- Psychiatric or medical condition that would prevent completion of the follow-up period
- General contraindications to exercise
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site
University of Health Sciences, Bursa Yuksek Ihtisas Training and Research Hospital
Bursa
Sinem Akselim, +905336391332, sinemakselim@gmail.com
About this study
Official title: Effect of Paraspinal Neuromuscular Electrical Stimulation Added to Rehabilitation Program on Spinopelvic Alignment Parameters After Total Knee Arthroplasty: A Prospective Randomized Controlled Trial
Total knee arthroplasty (TKA) is a widely performed surgical procedure for patients with severe knee osteoarthritis. Following TKA, changes in lower extremity alignment and gait mechanics may influence the spinopelvic sagittal alignment, and postoperative rehabilitation programs traditionally focus on the knee joint without addressing the lumbopelvic chain.
This study aims to investigate whether adding paraspinal neuromuscular electrical stimulation (NMES) to a standard postoperative rehabilitation program (which includes quadriceps NMES) affects spinopelvic sagittal alignment parameters in patients undergoing TKA for primary knee osteoarthritis, compared with standard rehabilitation and quadriceps NMES alone.
Read more
In this single-center, prospective, randomized, single-blind (outcome assessor-blinded) controlled trial, eligible participants aged 40-80 years with primary knee osteoarthritis scheduled for TKA and with measurable spinopelvic malalignment will be randomly assigned in a 1:1 ratio to receive either standard rehabilitation with quadriceps NMES plus paraspinal NMES (intervention group) or standard rehabilitation with quadriceps NMES alone (control group) for 4 weeks (20 sessions).
The primary outcome is the change in radiographic spinopelvic parameters - including pelvic tilt, sacral slope, pelvic incidence, lumbar lordosis, sagittal vertical axis, and spinosacral angle - measured on standing lateral whole-spine radiographs at baseline (preoperative), before rehabilitation, after the 4-week intervention, and at 6-month follow-up. Secondary outcomes include knee and back pain (VAS), functional and quality-of-life measures (WOMAC, Knee Society Score, Forgotten Joint Score, Oswestry Disability Index, Nottingham Health Profile), performance-based tests (Timed Up and Go, 6-Minute Walk Test), and knee range of motion.
The investigators hypothesize that adding paraspinal NMES to standard rehabilitation will result in greater improvement in spinopelvic alignment parameters, and potentially in clinical/functional outcomes, compared with standard rehabilitation alone.
- Conditions
- Knee Osteoarthritis, Postoperative Rehabilitation
- Being tested
- Standard Postoperative Rehabilitation Program, Quadriceps Neuromuscular Electrical Stimulation, Paraspinal Neuromuscular Electrical Stimulation
- Keywords
- Total knee arthroplasty, Spinopelvic alignment, Neuromuscular electrical stimulation, Postoperative rehabilitation, Paraspinal muscles
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard Postoperative Rehabilitation ProgramOther
A structured rehabilitation program including early postoperative mobilization (days 1-3: standing, short-distance ambulation, quadriceps isometric exercises, ankle pumping, breathing exercises, cold application), pre-rehabilitation phase (days 4-15: assisted ambulation, straight leg raise, passive range-of-motion exercises), and active rehabilitation phase (weeks 2-3: active-assisted knee ROM exercises, closed kinetic chain exercises, balance training, stair and gait training), along with pain and edema control throughout.
Quadriceps Neuromuscular Electrical StimulationDevice
Also called Chattanooga Physio NMES device
Surface NMES applied bilaterally over the vastus medialis obliquus and rectus femoris muscles (long-sitting position, knee at 30° flexion). Parameters: 50 Hz frequency, 300-400 µs pulse width, duty cycle 1:3 (10 sec on-30 sec off), intensity titrated to patient tolerance to produce visible muscle contraction, 20 minutes/session, once daily, 5 days/week, for 4 weeks.
Paraspinal Neuromuscular Electrical StimulationDevice
Also called Chattanooga Physio NMES device
Surface NMES applied bilaterally to the lumbar paraspinal muscles (erector spinae and multifidus) via 4 hydrogel electrodes placed bilaterally around the L4-L5 spinous processes, in prone position. Parameters: 50 Hz frequency, 250-350 µs pulse width, duty cycle 1:3 (10 sec on-30 sec off), intensity titrated to patient tolerance to produce visible muscle contraction, 20 minutes/session, once daily, 5 days/week, for 4 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Experimental: Intervention Group | Experimental | Standard Rehabilitasyon + Quadriceps NMES + Paraspinal NMES Description: Participants in this arm will receive the standard postoperative rehabilitation program combined with quadriceps NMES, plus additional paraspinal (erector spinae and multifidus) NMES applied bilaterally over the L4-L5 region for 20 minutes/day, 5 days/week, for 4 weeks. Receives: Other: Standard Postoperative Rehabilitation Program; Device: Quadriceps Neuromuscular Electrical Stimulation; Device: Paraspinal Neuromuscular Electrical Stimulation |
| Active Comparator: Control Group | Active comparator | Standard Rehabilitasyon + Quadriceps NMES Description: Participants in this arm will receive the same standard postoperative rehabilitation program combined with quadriceps NMES (bilateral VMO and rectus femoris electrode placement) for 20 minutes/day, 5 days/week, for 4 weeks, without paraspinal NMES. Receives: Other: Standard Postoperative Rehabilitation Program; Device: Quadriceps Neuromuscular Electrical Stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline in Pelvic Tilt (PT)
Pelvic tilt will be measured as the angle between the line connecting the midpoint of the sacral plate to the center of the femoral head axis and the vertical line, assessed on standing lateral whole-spine radiographs (36-inch cassette) by two independent physicians blinded to group allocation. Measurements will be performed using PACS-integrated measurement software. Interobserver reliability (ICC ≥ 0.85) and intraobserver reliability (repeat measurement at 2-week interval) will be assessed.
Unit of Measure: degrees
Measured: Baseline (preoperative, T0), before rehabilitation (postoperative, T1), end of 4-week intervention (postoperative week 6, T2), and 6-month follow-up (T4)
Change from Baseline in Sagittal Vertical Axis (SVA)
The horizontal distance between the C7 plumb line and the posterosuperior corner of S1 will be measured on standing lateral whole-spine radiographs.
Unit of Measure: millimeters
Measured: Baseline (T0), before rehabilitation (T1), end of 4-week intervention (T2), and 6-month follow-up (T4)
Change from Baseline in Radiographic Spinopelvic Angular Parameters (Sacral Slope, Lumbar Lordosis, Spinosacral Angle)
Sacral slope (angle between the S1 superior endplate and horizontal), lumbar lordosis (Cobb angle between L1 and S1), and spinosacral angle (angle between the line connecting the C7 center to the sacral plate midpoint and the sacral plate) will be measured on the same standing lateral whole-spine radiographs described above.
Unit of Measure: degrees
Measured: Baseline (T0), before rehabilitation (T1), end of 4-week intervention (T2), and 6-month follow-up (T4)
Secondary outcomes (9)
Change from Baseline in Knee Pain (Visual Analog Scale)
Knee pain will be assessed using a 0-10 cm Visual Analog Scale, with scores ranging from 0 (no pain) to 10 (worst imaginable pain); higher scores indicate greater pain intensity.
Unit of Measure: score on a scale (0-10)
Measured: Baseline (preoperative, T0), before rehabilitation (postoperative, T1), end of 4-week intervention (postoperative week 6, T2), postoperative month 3 (T3), and 6-month follow-up (T4)
Change from Baseline in Low Back Pain (Visual Analog Scale)
Low back pain will be assessed using a 0-10 cm Visual Analog Scale, with scores ranging from 0 (no pain) to 10 (worst imaginable pain); higher scores indicate greater pain intensity.
Unit of Measure: score on a scale (0-10)
Measured: Baseline (preoperative, T0), before rehabilitation (postoperative, T1), end of 4-week intervention (postoperative week 6, T2), postoperative month 3 (T3), and 6-month follow-up (T4)
Change from Baseline in WOMAC Osteoarthritis Index Score
Knee-related pain, stiffness, and physical function will be assessed using the Turkish-validated WOMAC index, with a total score ranging from 0 to 96; higher scores indicate greater symptom severity and worse function.
Unit of Measure: score on a scale
Measured: Baseline (preoperative, T0), end of 4-week intervention (postoperative week 6, T2), postoperative month 3 (T3), and 6-month follow-up (T4)
Change from Baseline in Knee Society Score (KSS)
Knee pain, range of motion, and functional status will be assessed using the Knee Society Score, comprising a knee score and a function score, each ranging from 0 to 100; higher scores indicate better knee status and function.
Unit of Measure: score on a scale
Measured: Baseline (preoperative, T0), before rehabilitation (postoperative, T1), end of 4-week intervention (postoperative week 6, T2), postoperative month 3 (T3), and 6-month follow-up (T4)
Change from Baseline in Forgotten Joint Score (FJS)
Awareness of the artificial joint during daily activities will be assessed using the FJS, with scores ranging from 0 to 100; higher scores indicate lower joint awareness, reflecting a better outcome.
Unit of Measure: score on a scale (0-100)
Measured: Baseline (preoperative, T0), before rehabilitation (postoperative, T1), end of 4-week intervention (postoperative week 6, T2), postoperative month 3 (T3), and 6-month follow-up (T4)
Change from Baseline in Timed Up and Go (TUG) Test
Functional mobility will be assessed using the TUG test, measuring the time required to stand up from a chair, walk 3 meters, turn, return, and sit down. Higher times indicate poorer mobility.
Unit of Measure: seconds
Measured: Baseline (preoperative, T0), end of 4-week intervention (postoperative week 6, T2), postoperative month 3 (T3), and 6-month follow-up (T4)
Change from Baseline in 6-Minute Walk Test Distance
Aerobic capacity and functional endurance will be assessed using the distance walked in 6 minutes. Greater distance indicates better functional capacity.
Unit of Measure: meters
Measured: Baseline (preoperative, T0), end of 4-week intervention (postoperative week 6, T2), postoperative month 3 (T3), and 6-month follow-up (T4)
Change from Baseline in Oswestry Disability Index
Low back function-related disability will be assessed using the Turkish-validated Oswestry Disability Index, with scores ranging from 0% to 100%; higher scores indicate greater disability.
Unit of Measure: percentage
Measured: Baseline (preoperative, T0), end of 4-week intervention (postoperative week 6, T2), postoperative month 3 (T3), and 6-month follow-up (T4)
Change from Baseline in Nottingham Health Profile
General health-related quality of life will be assessed using the Turkish-validated Nottingham Health Profile.
Unit of Measure: score on a scale
Measured: Baseline (preoperative, T0), end of 4-week intervention (postoperative week 6, T2), and 6-month follow-up (T4)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2026
- Study start30 Sep 2026 (estimated)
- Primary completion30 Jul 2027 (estimated)
- Study completion30 Jul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Knee OsteoarthritisStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Bursa Yuksek Ihtisas Training and Research Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Sinem Akselim, Bursa Yuksek Ihtisas Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07741162
- Sponsor's protocol ID
- 2026-9/11
- Status last verified
- Jul 2026
- First submitted
- 23 Jul 2026
- Last updated
- 29 Sep 2026
- Results posted
- No
- Data monitoring committee
- 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 29 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Paraspinal Neuromuscular Electrical Stimulation Added to Rehabilitation Program on Spinopelvic Alignment Parameters After Total Knee Arthroplasty: A Prospective Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07741162
- Acronym / sponsor ID
- 2026-9/11
- Conditions
- Knee Osteoarthritis, Postoperative Rehabilitation
- Keywords
- Total knee arthroplasty, Spinopelvic alignment, Neuromuscular electrical stimulation, Postoperative rehabilitation, Paraspinal muscles
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Bursa Yuksek Ihtisas Training and Research HospitalOther government
- Study start
- 30 Sep 2026 (estimated)
- Primary completion
- 30 Jul 2027 (estimated)
- Study completion
- 30 Jul 2027 (estimated)
- First posted
- 3 Aug 2026 (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 a widely performed surgical procedure for patients with severe knee osteoarthritis. Following TKA, changes in lower extremity alignment and gait mechanics may influence the spinopelvic sagittal alignment, and postoperative rehabilitation programs traditionally focus on the knee joint without addressing the lumbopelvic chain.
This study aims to investigate whether adding paraspinal neuromuscular electrical stimulation (NMES) to a standard postoperative rehabilitation program (which includes quadriceps NMES) affects spinopelvic sagittal alignment parameters in patients undergoing TKA for primary knee osteoarthritis, compared with standard rehabilitation and quadriceps NMES alone.
In this single-center, prospective, randomized, single-blind (outcome assessor-blinded) controlled trial, eligible participants aged 40-80 years with primary knee osteoarthritis scheduled for TKA and with measurable spinopelvic malalignment will be randomly assigned in a 1:1 ratio to receive either standard rehabilitation with quadriceps NMES plus paraspinal NMES (intervention group) or standard rehabilitation with quadriceps NMES alone (control group) for 4 weeks (20 sessions).
The primary outcome is the change in radiographic spinopelvic parameters - including pelvic tilt, sacral slope, pelvic incidence, lumbar lordosis, sagittal vertical axis, and spinosacral angle - measured on standing lateral whole-spine radiographs at baseline (preoperative), before rehabilitation, after the 4-week intervention, and at 6-month follow-up. Secondary outcomes include knee and back pain (VAS), functional and quality-of-life measures (WOMAC, Knee Society Score, Forgotten Joint Score, Oswestry Disability Index, Nottingham Health Profile), performance-based tests (Timed Up and Go, 6-Minute Walk Test), and knee range of motion.
The investigators hypothesize that adding paraspinal NMES to standard rehabilitation will result in greater improvement in spinopelvic alignment parameters, and potentially in clinical/functional outcomes, compared with standard rehabilitation alone.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental: Intervention Group | Experimental | Other: Standard Postoperative Rehabilitation Program, Device: Quadriceps Neuromuscular Electrical Stimulation, Device: Paraspinal Neuromuscular Electrical StimulationStandard Rehabilitasyon + Quadriceps NMES + Paraspinal NMES Description: Participants in this arm will receive the standard postoperative rehabilitation program combined with quadriceps NMES, plus additional paraspinal (erector spinae and multifidus) NMES applied bilaterally over the L4-L5 region for 20 minutes/day, 5 days/week, for 4 weeks. |
| Active Comparator: Control Group | Active comparator | Other: Standard Postoperative Rehabilitation Program, Device: Quadriceps Neuromuscular Electrical StimulationStandard Rehabilitasyon + Quadriceps NMES Description: Participants in this arm will receive the same standard postoperative rehabilitation program combined with quadriceps NMES (bilateral VMO and rectus femoris electrode placement) for 20 minutes/day, 5 days/week, for 4 weeks, without paraspinal NMES. |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Age between 40 and 80 years
- Diagnosis of primary knee osteoarthritis scheduled for total knee arthroplasty
- Radiographic evidence of Kellgren-Lawrence grade 3-4 knee osteoarthritis
- Preoperative knee flexion contracture ≥ 5°
- Measurable spinopelvic malalignment, defined as meeting at least one of the following criteria: pelvic tilt (PT) > 20°, sagittal vertical axis (SVA) > 50 mm, or lumbar lordosis (LL) < 40°
Key exclusion criteria (12 listed)
- Prior lumbar or thoracic spinal surgery
- History of hip arthroplasty
- Prior knee arthroplasty (revision arthroplasty patients)
- Active inflammatory arthritis (e.g., rheumatoid arthritis, psoriatic arthritis)
- Neurological disease, including stroke, Parkinson's disease, peripheral neuropathy, or spinal cord pathology
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 |
|---|---|---|
| Standard Postoperative Rehabilitation ProgramA structured rehabilitation program including early postoperative mobilization (days 1-3: standing, short-distance ambulation, quadriceps isometric exercises, ankle pumping, breathing exercises, cold application), pre-rehabilitation phase (days 4-15: assisted ambulation, straight leg raise, passive range-of-motion exercises), and active rehabilitation phase (weeks 2-3: active-assisted knee ROM exercises, closed kinetic chain exercises, balance training, stair and gait training), along with pain and edema control throughout. | Other | Active Comparator: Control Group, Experimental: Intervention Group |
| Quadriceps Neuromuscular Electrical StimulationAlso: Chattanooga Physio NMES deviceSurface NMES applied bilaterally over the vastus medialis obliquus and rectus femoris muscles (long-sitting position, knee at 30° flexion). Parameters: 50 Hz frequency, 300-400 µs pulse width, duty cycle 1:3 (10 sec on-30 sec off), intensity titrated to patient tolerance to produce visible muscle contraction, 20 minutes/session, once daily, 5 days/week, for 4 weeks. | Device | Active Comparator: Control Group, Experimental: Intervention Group |
| Paraspinal Neuromuscular Electrical StimulationAlso: Chattanooga Physio NMES deviceSurface NMES applied bilaterally to the lumbar paraspinal muscles (erector spinae and multifidus) via 4 hydrogel electrodes placed bilaterally around the L4-L5 spinous processes, in prone position. Parameters: 50 Hz frequency, 250-350 µs pulse width, duty cycle 1:3 (10 sec on-30 sec off), intensity titrated to patient tolerance to produce visible muscle contraction, 20 minutes/session, once daily, 5 days/week, for 4 weeks. | Device | Experimental: Intervention Group |
Primary outcome
Change from Baseline in Pelvic Tilt (PT)
Time frame: Baseline (preoperative, T0), before rehabilitation (postoperative, T1), end of 4-week intervention (postoperative week 6, T2), and 6-month follow-up (T4)
Pelvic tilt will be measured as the angle between the line connecting the midpoint of the sacral plate to the center of the femoral head axis and the vertical line, assessed on standing lateral whole-spine radiographs (36-inch cassette) by two independent physicians blinded to group allocation. Measurements will be performed using PACS-integrated measurement software. Interobserver reliability (ICC ≥ 0.85) and intraobserver reliability (repeat measurement at 2-week interval) will be assessed. Unit of Measure: degrees
Change from Baseline in Sagittal Vertical Axis (SVA)
Time frame: Baseline (T0), before rehabilitation (T1), end of 4-week intervention (T2), and 6-month follow-up (T4)
The horizontal distance between the C7 plumb line and the posterosuperior corner of S1 will be measured on standing lateral whole-spine radiographs. Unit of Measure: millimeters
Change from Baseline in Radiographic Spinopelvic Angular Parameters (Sacral Slope, Lumbar Lordosis, Spinosacral Angle)
Time frame: Baseline (T0), before rehabilitation (T1), end of 4-week intervention (T2), and 6-month follow-up (T4)
Sacral slope (angle between the S1 superior endplate and horizontal), lumbar lordosis (Cobb angle between L1 and S1), and spinosacral angle (angle between the line connecting the C7 center to the sacral plate midpoint and the sacral plate) will be measured on the same standing lateral whole-spine radiographs described above. Unit of Measure: degrees
9 secondary outcomes
Change from Baseline in Knee Pain (Visual Analog Scale)
Time frame: Baseline (preoperative, T0), before rehabilitation (postoperative, T1), end of 4-week intervention (postoperative week 6, T2), postoperative month 3 (T3), and 6-month follow-up (T4)
Change from Baseline in Low Back Pain (Visual Analog Scale)
Time frame: Baseline (preoperative, T0), before rehabilitation (postoperative, T1), end of 4-week intervention (postoperative week 6, T2), postoperative month 3 (T3), and 6-month follow-up (T4)
Change from Baseline in WOMAC Osteoarthritis Index Score
Time frame: Baseline (preoperative, T0), end of 4-week intervention (postoperative week 6, T2), postoperative month 3 (T3), and 6-month follow-up (T4)
Change from Baseline in Knee Society Score (KSS)
Time frame: Baseline (preoperative, T0), before rehabilitation (postoperative, T1), end of 4-week intervention (postoperative week 6, T2), postoperative month 3 (T3), and 6-month follow-up (T4)
Change from Baseline in Forgotten Joint Score (FJS)
Time frame: Baseline (preoperative, T0), before rehabilitation (postoperative, T1), end of 4-week intervention (postoperative week 6, T2), postoperative month 3 (T3), and 6-month follow-up (T4)
Change from Baseline in Timed Up and Go (TUG) Test
Time frame: Baseline (preoperative, T0), end of 4-week intervention (postoperative week 6, T2), postoperative month 3 (T3), and 6-month follow-up (T4)
Change from Baseline in 6-Minute Walk Test Distance
Time frame: Baseline (preoperative, T0), end of 4-week intervention (postoperative week 6, T2), postoperative month 3 (T3), and 6-month follow-up (T4)
Change from Baseline in Oswestry Disability Index
Time frame: Baseline (preoperative, T0), end of 4-week intervention (postoperative week 6, T2), postoperative month 3 (T3), and 6-month follow-up (T4)
Change from Baseline in Nottingham Health Profile
Time frame: Baseline (preoperative, T0), end of 4-week intervention (postoperative week 6, T2), and 6-month follow-up (T4)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Sep 2026.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Standard Postoperative Rehabilitation Program, Quadriceps Neuromuscular Electrical Stimulation and Paraspinal Neuromuscular Electrical Stimulation in people with Knee Osteoarthritis and Postoperative Rehabilitation, run by Bursa Yuksek Ihtisas Training and Research Hospital 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 8 inclusion and 12 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: opening soon, as of the sponsor's last update on 29 Sep 2026. 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. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sinem Akselim (+905336391332, sinemakselim@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from Baseline in Pelvic Tilt (PT) (time frame: Baseline (preoperative, T0), before rehabilitation (postoperative, T1), end of 4-week intervention (postoperative week 6, T2), and 6-month follow-up (T4)). 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?
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 29 Sep 2026.