Intermittent low/high-oxygen sessions combined with physical therapy for knee osteoarthritis
Effectiveness of Combining Intermittent Hypoxia-Hyperoxia and Conventional Physical Therapy for Patients With Knee Osteoarthritis: A Randomized Controlled Trial
This study will test whether adding intermittent hypoxia-hyperoxia (alternating low and high oxygen) sessions to regular physical therapy helps people 45 and older with knee osteoarthritis reduce pain and improve walking, balance, and function.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 45 Years and up |
| Sex | All |
| Sponsor | Khyber Medical University Peshawar Academic / other |
| Locations | 1 site (Peshawar, Khyber Pakhtunkhwa) |
| Trial ID | NCT06965946 on ClinicalTrials.gov |
What this trial studies
This is a randomized, assessor- and participant-blinded controlled trial comparing intermittent hypoxia-hyperoxia therapy (IHHT) plus conventional physical therapy versus conventional physical therapy with a normoxic air placebo. Participants will receive 12 treatment sessions over 4 weeks at Rehman Medical Institute in Peshawar, Pakistan. IHHT uses short alternating periods of low (13–15%) and high (40%) oxygen combined with standard rehabilitation exercises. Primary outcomes include pain (NPRS), function (KOOS), balance (Timed Up and Go), gait (Functional Gait Assessment), and inflammatory marker CRP, with pre- and post-intervention assessments and statistical analysis using SPSS.
Who should consider this trial
Good fit: Ideal candidates are adults aged 45 or older with knee pain for at least 3 months, a pain score of 4 or higher, intact cognition (MMSE ≥24), the ability to walk at least 45 meters, and a recent knee X-ray.
Not a fit: People with knee or hip arthroplasty, recent above- or below-knee surgery, radiating lower-limb pain, epilepsy, pregnancy, or neurological conditions affecting walking are excluded and may not receive benefit.
Why it matters
Potential benefit: If successful, this combined approach could offer a low-cost, non-drug way to reduce pain and improve mobility and balance in people with knee osteoarthritis.
How similar studies have performed: IHHT has shown promise in improving physical and psychological outcomes in some musculoskeletal conditions, but rigorous evidence specifically for knee osteoarthritis is scarce.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Participants aged 45 and above. * Participants (both male and female) with knee pain for 3 months or more with any three of the following six items: age of 50 years or more, crepitations, enlarged bone, no palpable warmth, morning stiffness for less than 30 minutes, and bony tenderness. * Patients who can walk and have a minimum score of 4 on the Numeric Pain Rating Scale. * Participants who have intact cognition with a score of 24 and above on Mini Mini- Mental State examination. * Participants able to walk independently for at least 45 meters in the 6-minute walk test. * Participants having a recent X-ray (done within the past 3 months). Exclusion Criteria: * Patients with hip or knee arthroplasty. * Participants with above or below knee surgery or radiating pain to the lower limb. * Patients with history of epilepsy, pregnancy * Diagnosed neurological condition that affects lower-limb strength or walk (e.g., stroke/ basal ganglia dysfunction/ trauma) * Patients who refused to participate in the study or to be randomly allocated. * Patients receiving steroids or any medicine other than that prescribed by the screening orthopaedic surgeon.
Where this trial is running
Peshawar, Khyber Pakhtunkhwa
- Rehman Medical Institute — Peshawar, Khyber Pakhtunkhwa, Pakistan (Recruiting)
Study contacts
- Principal investigator: Dr Rida Shabbir, PhD — Institute of Physical Medicine and Rehabilitation, Khyber Medical University Peshawar
- Study coordinator: Dr Rida Shabbir, PhD*
- Email: ridashabbir@kmu.edu.pk
- Phone: +923460113227
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.