Knee OsteoarthritisPhase 3NCT07399743
Effects of Lower Body Positive Pressure Therapy Versus Alpha Lipoic Acid and Omega-3 Fatty Acids on Knee Osteoarthritis
A Phase 3 study testing Alpha-Lipoic Acid (ALA)+PT, Omega-3 cap+ PT and Lower body positive pressure therapy (LBPP)+PT in people with Knee Osteoarthritis, run by Badr University.
Trial summary
Here is a concise, clear summary (~250 words / well under 5000 characters) while preserving the key scientific points: --- Knee osteoarthritis (KOA) is highly prevalent among overweight women, affecting more than 30% of those with BMI ≥25 kg/m². Read more about this study
- Who is it for?
- Ages 20 to 45 years, women only
- Conditions the study is for
- Knee Osteoarthritis
- What is being tested?
- Alpha-Lipoic Acid (ALA)+PT, Omega-3 cap+ PT and Lower body positive pressure therapy (LBPP)+PT
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 160 participants
- Where
- No sites listed yet
- Study dates
- 15 Feb 2026to 1 Jul 2026
- Phase
- Phase 3
- 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 20 to 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Female participants aged between 20-45 years.
- Their BMI ranged between 20-25 kg/m².
- All had radiographic confirmation of mild to moderate knee osteoarthritis.
- Medical history recorded with no major prior injuries or surgeries affecting outcomes.
- Participants reported knee pain, functional limitation, and activity-related symptoms.
- Radiographic grading confirmed as Kellgren-Lawrence grade II or III.
Who cannot join
- No recent traumatic hip, knee, or ankle surgery within the past 6 months.
- No severe knee OA (Kellgren-Lawrence grade 0 or 4).
- No history of rheumatoid arthritis, chronic reactive arthritis, or psoriatic arthritis.
- Free from conditions that limit safe study participation or adherence to protocol.
- No neurological impairments affecting lower limb function.
- No contraindications to exercise or physiotherapy (e.g., severe cardiovascular, respiratory, or metabolic conditions).
- Not pregnant or planning pregnancy during the study.
- Not involved in other clinical trials or conflicting interventions (e.g., intra-articular injections, surgery, or rehab programs).
About this study
Official title: Effects of Lower Body Positive Pressure Therapy Versus Alpha Lipoic Acid and Omega-3 Fatty Acids on Pain, Function, and Inflammation in Overweight Women With Knee Osteoarthritis: A Randomized Controlled Clinical Trial
Here is a concise, clear summary (~250 words / well under 5000 characters) while preserving the key scientific points:
---
Read more
Knee osteoarthritis (KOA) is highly prevalent among overweight women, affecting more than 30% of those with BMI ≥25 kg/m². Excess body weight increases knee joint loading by 4-6 times per additional kilogram, accelerating cartilage degeneration, subchondral bone changes, and synovial inflammation. These alterations result in chronic pain, stiffness, functional limitation, and reduced quality of life, with obesity-related metabolic inflammation further worsening disease progression.
Standard physical therapy (PT) remains first-line treatment, yet provides only modest benefits, achieving approximately 15-20% WOMAC improvement at 12 weeks, while up to half of overweight patients continue to experience significant symptoms. Lower body positive pressure therapy (LBPP) via antigravity treadmill offers a biomechanical enhancement by unloading 40-80% of body weight, enabling pain-free gait training and reducing joint impact forces by up to 80%. Studies report 30-40% WOMAC improvement and better walking capacity compared with conventional PT.
Nevertheless, mechanical interventions alone do not address the inflammatory and oxidative mechanisms driving KOA. Alpha-lipoic acid (600 mg/day) and omega-3 fatty acids (1.5-2 g/day) provide targeted biochemical modulation, reducing pro-inflammatory cytokines, oxidative stress, and cartilage-degrading enzymes, with reported 25-35% functional improvement in clinical trials.
Despite the promise of both approaches, no randomized trial has directly compared adding LBPP versus combined ALA and omega-3 supplementation to standard PT in overweight women with KOA. This study aims to fill this gap by evaluating the relative effectiveness of biomechanical versus biochemical adjuncts to optimize management of KOA in this high-risk population.
- Conditions
- Knee Osteoarthritis
- Being tested
- Alpha-Lipoic Acid (ALA)+PT, Omega-3 cap+ PT, Lower body positive pressure therapy (LBPP)+PT, Standard physical therapy (PT)
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Alpha-Lipoic Acid (ALA)+PTDrug
Thioctacid 600+PT
Omega-3 cap+ PTDrug
Omega-3 cap 2000 mg BID (Limitless Omega) + PT
Lower body positive pressure therapy (LBPP)+PTDevice
LBPP: AlterG 40-60% unload, 30 min (3×/week) + PT
Standard physical therapy (PT)Device
PT typically includes quadriceps strengthening, flexibility exercises, proprioceptive training, stationary cycling, and aquatic therapy
| Study group | Role | What they receive |
|---|---|---|
| ALA tab 300 mg BID (Thioctacid) + PT | Active comparator | Not described Receives: Drug: Alpha-Lipoic Acid (ALA)+PT |
| Omega-3 cap 2000 mg BID (Limitless Omega) + PT | Active comparator | Not described Receives: Drug: Omega-3 cap+ PT |
| LBPP (AlterG 40-60% unload, 30 min 3×/week) + PT | Active comparator | Not described Receives: Device: Lower body positive pressure therapy (LBPP)+PT |
| PT | Active comparator | Not described Receives: Device: Standard physical therapy (PT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in VAS pain score (0-10 cm)
Measured: from baseline to 12 weeks
Change in WOMAC total score (0-96)
Measured: from baseline to 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2026
- Study start15 Feb 2026 (estimated)
- Primary completion1 Jun 2026 (estimated)
- Study completion1 Jul 2026 (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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 160 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Badr University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Eman Said Sawan, Badr University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07399743
- Sponsor's protocol ID
- IRB00014233-49
- Status last verified
- Feb 2026
- First submitted
- 3 Feb 2026
- Last updated
- 10 Feb 2026
- 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 10 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Lower Body Positive Pressure Therapy Versus Alpha Lipoic Acid and Omega-3 Fatty Acids on Pain, Function, and Inflammation in Overweight Women With Knee Osteoarthritis: A Randomized Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT07399743
- Acronym / sponsor ID
- IRB00014233-49
- Conditions
- Knee Osteoarthritis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 160 participants (estimated)
- Lead sponsor
- Badr UniversityUniversity, hospital or other
- Study start
- 15 Feb 2026 (estimated)
- Primary completion
- 1 Jun 2026 (estimated)
- Study completion
- 1 Jul 2026 (estimated)
- First posted
- 10 Feb 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.
Here is a concise, clear summary (~250 words / well under 5000 characters) while preserving the key scientific points:
---
Knee osteoarthritis (KOA) is highly prevalent among overweight women, affecting more than 30% of those with BMI ≥25 kg/m². Excess body weight increases knee joint loading by 4-6 times per additional kilogram, accelerating cartilage degeneration, subchondral bone changes, and synovial inflammation. These alterations result in chronic pain, stiffness, functional limitation, and reduced quality of life, with obesity-related metabolic inflammation further worsening disease progression.
Standard physical therapy (PT) remains first-line treatment, yet provides only modest benefits, achieving approximately 15-20% WOMAC improvement at 12 weeks, while up to half of overweight patients continue to experience significant symptoms. Lower body positive pressure therapy (LBPP) via antigravity treadmill offers a biomechanical enhancement by unloading 40-80% of body weight, enabling pain-free gait training and reducing joint impact forces by up to 80%. Studies report 30-40% WOMAC improvement and better walking capacity compared with conventional PT.
Nevertheless, mechanical interventions alone do not address the inflammatory and oxidative mechanisms driving KOA. Alpha-lipoic acid (600 mg/day) and omega-3 fatty acids (1.5-2 g/day) provide targeted biochemical modulation, reducing pro-inflammatory cytokines, oxidative stress, and cartilage-degrading enzymes, with reported 25-35% functional improvement in clinical trials.
Despite the promise of both approaches, no randomized trial has directly compared adding LBPP versus combined ALA and omega-3 supplementation to standard PT in overweight women with KOA. This study aims to fill this gap by evaluating the relative effectiveness of biomechanical versus biochemical adjuncts to optimize management of KOA in this high-risk population.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| ALA tab 300 mg BID (Thioctacid) + PT | Active comparator | Drug: Alpha-Lipoic Acid (ALA)+PT |
| Omega-3 cap 2000 mg BID (Limitless Omega) + PT | Active comparator | Drug: Omega-3 cap+ PT |
| LBPP (AlterG 40-60% unload, 30 min 3×/week) + PT | Active comparator | Device: Lower body positive pressure therapy (LBPP)+PT |
| PT | Active comparator | Device: Standard physical therapy (PT) |
Who may qualify
- Ages
- 20 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
Key exclusion criteria (8 listed)
- No recent traumatic hip, knee, or ankle surgery within the past 6 months.
- No severe knee OA (Kellgren-Lawrence grade 0 or 4).
- No history of rheumatoid arthritis, chronic reactive arthritis, or psoriatic arthritis.
- Free from conditions that limit safe study participation or adherence to protocol.
- No neurological impairments affecting lower limb function.
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 |
|---|---|---|
| Alpha-Lipoic Acid (ALA)+PTThioctacid 600+PT | Drug | ALA tab 300 mg BID (Thioctacid) + PT |
| Omega-3 cap+ PTOmega-3 cap 2000 mg BID (Limitless Omega) + PT | Drug | Omega-3 cap 2000 mg BID (Limitless Omega) + PT |
| Lower body positive pressure therapy (LBPP)+PTLBPP: AlterG 40-60% unload, 30 min (3×/week) + PT | Device | LBPP (AlterG 40-60% unload, 30 min 3×/week) + PT |
| Standard physical therapy (PT)PT typically includes quadriceps strengthening, flexibility exercises, proprioceptive training, stationary cycling, and aquatic therapy | Device | PT |
Primary outcome
Change in VAS pain score (0-10 cm)
Time frame: from baseline to 12 weeks
Change in WOMAC total score (0-96)
Time frame: from baseline to 12 weeks
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 10 Feb 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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Alpha-Lipoic Acid (ALA)+PT, Omega-3 cap+ PT and Lower body positive pressure therapy (LBPP)+PT in people with Knee Osteoarthritis, run by Badr University.
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 6 inclusion and 8 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 10 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
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 VAS pain score (0-10 cm) (time frame: from baseline to 12 weeks). The study lists 2 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 10 Feb 2026.