Osteo Arthritis KneeNCT06965946
Intermittent Hypoxia-Hyperoxia Combined With Physical Therapy for Knee Osteoarthritis
A study testing Intermittent Hypoxia-Hyperoxia Therapy (IHHT) and Conventional Physical Therapy in people with Osteo Arthritis Knee, run by Khyber Medical University Peshawar at 1 site in Pakistan.
Trial summary
This randomized controlled trial aims to evaluate the effectiveness of combining intermittent hypoxia-hyperoxia therapy (IHHT) with conventional physical therapy in improving pain, function, gait, balance, and general health among patients with knee osteoarthritis. Read more about this study
- Who is it for?
- Ages 45 years and older
- Conditions the study is for
- Osteo Arthritis Knee
- What is being tested?
- Intermittent Hypoxia-Hyperoxia Therapy (IHHT) and Conventional Physical Therapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 sitePakistan
- Study dates
- 15 May 2025to 22 Jun 2026
- 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 45 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effectiveness of Combining Intermittent Hypoxia-Hyperoxia and Conventional Physical Therapy for Patients With Knee Osteoarthritis: A Randomized Controlled Trial
This randomized controlled trial aims to evaluate the effectiveness of combining intermittent hypoxia-hyperoxia therapy (IHHT) with conventional physical therapy in improving pain, function, gait, balance, and general health among patients with knee osteoarthritis. The study will be conducted at the Physical Therapy Department of Rehman Medical Institute, Peshawar, Pakistan, over a period of one year.
Read the detailed description
Osteoarthritis (OA) is a prevalent chronic condition that leads to joint pain, stiffness, and impaired mobility, particularly among middle-aged and elderly populations. In Pakistan, knee OA is common and significantly impacts quality of life. Existing treatments are largely symptomatic and often insufficient, especially in resource-constrained settings.
Intermittent hypoxia-hyperoxia training (IHHT), involving alternating periods of low (13-15%) and high (40%) oxygen concentrations, has shown promise in improving physical and psychological outcomes in musculoskeletal disorders. However, evidence regarding its efficacy in knee OA is scarce, especially in low- and middle-income countries.
This trial seeks to explore whether the combination of IHHT and conventional physical therapy leads to superior improvements in clinical outcomes compared to conventional therapy alone. Participants will undergo 12 treatment sessions over 4 weeks. The primary outcome measures include pain (NPRS), function (KOOS), balance (Timed Up and Go Test), gait (Functional Gait Assessment), and inflammatory markers (CRP). The feasibility, safety, and effectiveness of this novel intervention will also be evaluated.
The study design includes assessor and participant blinding and uses rigorous methods including pre- and post-intervention assessments and statistical analysis with SPSS. Findings from this study may inform future guidelines for non-pharmacological, low-cost interventions for knee OA rehabilitation in similar contexts.
- Conditions
- Osteo Arthritis Knee
- Being tested
- Intermittent Hypoxia-Hyperoxia Therapy (IHHT), Conventional Physical Therapy, Normoxic Air Placebo
- Keywords
- Knee Osteoarthritis, Intermittent Hypoxia, Hypoxic-Hyperoxic Therapy, Rehabilitation, Functional Mobility
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intermittent Hypoxia-Hyperoxia Therapy (IHHT)Procedure or surgery
Also called Olive OLV 10H Hypoxia Generator
Participants receive 4 cycles per session of 5 minutes of hypoxia (13-15% O₂) followed by 2 minutes of hyperoxia (40% O₂) using a hypoxia generator (Olive OLV 10H). Sessions are delivered before each conventional physical therapy session, 3 times per week for 4 weeks (total 12 sessions). Participants are monitored for heart rate, blood pressure, and oxygen saturation throughout the intervention.
Conventional Physical TherapyProcedure or surgery
Participants receive individualized conventional physical therapy for knee osteoarthritis based on current clinical practices in tertiary hospitals of Peshawar. Therapy is delivered 3 times per week for 4 weeks (total 12 sessions) and includes strength training, mobility exercises, and patient education.
Normoxic Air PlaceboProcedure or surgery
Participants in the control group inhale normoxic air (19.8% O₂) using the same Olive OLV 10H hypoxia generator to maintain blinding. Each session consists of 4 cycles of 5 minutes of normoxia followed by 2 minutes of normoxia, simulating the timing of hypoxia-hyperoxia therapy. Sessions are administered prior to conventional physical therapy, 3 times per week for 4 weeks (total 12 sessions). Patients are monitored for vital signs throughout.
| Study group | Role | What they receive |
|---|---|---|
| Intermittent Hypoxia-Hyperoxia + Conventional Therapy | Experimental | Participants in this group will receive Intermittent Hypoxia-Hyperoxia Therapy (IHHT) administered using a hypoxia generator. Each session will include 4 cycles of 5 minutes of hypoxia (13-15% O₂) followed by 2 minutes of hyperoxia (40% O₂). This therapy will be provided before each conventional physical therapy session. A total of 12 sessions (3 per week for 4 weeks) will be administered. Conventional therapy will follow the current best practices used by physical therapists in tertiary care hospitals in Peshawar. Receives: Procedure: Intermittent Hypoxia-Hyperoxia Therapy (IHHT); Procedure: Conventional Physical Therapy |
| Conventional Therapy with Normoxic Air | Active comparator | Participants in this group will receive only conventional physical therapy along with normoxic air (19.8% O₂) exposure using the same device setup to maintain blinding. They will receive 4 sessions of normoxia (5 minutes) followed by 2 minutes of normoxia as a placebo for IHHT. This will also be done prior to each of the 12 physical therapy sessions (3 per week for 4 weeks). Receives: Procedure: Conventional Physical Therapy; Procedure: Normoxic Air Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain Reduction
Measured on the Numeric Pain Rating Scale (NPRS), which has levels ranging from 0 to 10 in severity. 0 indicates no pain, and 10 indicates severe pain. The scale is divided into 3 categories. 1-3 indicates mild pain, 4-6 indicates moderate pain, and 7-10 indicates severe pain.
Measured: Baseline and 4 weeks (12 sessions of therapy)
Functional Status - KOOS Activities of Daily Living Subscale
The Knee Injury and Osteoarthritis Outcome Score (KOOS) will be used to assess pain, recreation and quality of life, symptoms and stiffness, ADL and functional sports. The scores of each category will be calculated and converted to percentages (100%). 0-39% will indicate severe condition, 40- 59% will indicate moderate condition, 60-79% will indicate mild condition, and 80-100% will indicate no dysfunction.
Measured: Baseline and 4 weeks
Inflammatory Marker - C-Reactive Protein (CRP)
Change in serum CRP levels measured through a blood sample as a biomarker of osteoarthritis-related inflammation. CRP levels will be taken on a continuous scale.
Measured: Baseline and 4 weeks
Balance - Timed Up and Go Test (TUG)
Time taken (in seconds) to rise from a chair, walk 3 meters, turn, walk back, and sit down using a stop watch. A time of < or equal to 10 seconds will be considered normal, 11-20 seconds indicates good mobility with functional indipendence. > or equal to 20 seconds indicates that person needs assistance outside, 30 seconds or more indicates that person is prone to fall. MCID for time up and Go test is 2.1 seconds.
Measured: Baseline and 4 weeks
Secondary outcomes (2)
Gait Performance - Functional Gait Assessment (FGA) Score
Evaluation of gait performance and stability using the FGA scale. Normal (score of 3) performances will be walking a distance of 6 meters in less than 5.5 seconds with no assistive device and no evidence of imbalance, a normal gait pattern, and not deviating more than 6 inches out of 12 12-inch walkway width. Mild impairment (score of 2) will be recorded when a person walks 6 meters with the use of an assistive device at a slower speed and mild gait deviation (15.24-25.4 cm) outside 12 12-inch walkway. Participants will be scored 1, moderate impairment, if they walk with a slower speed, abnormal gait pattern, evidence of imbalance, deviates 10-15 inches outside 12 12-inch walkway width. Participants will be said to have severe impairment, score of 0, if they can not walk 6 meters (20 feet) without assistance, severe gait deviations or imbalance, deviates greater than 15 inches outside 12 12-inch walkway width or will not attempt the task.
Measured: Baseline and 4 weeks
Functional mobility - 6-Minute Walk Test (6MWT)
Distance (in meters) covered during a 6-minute walk test to assess aerobic capacity and endurance. Normal score ranges from 400-700 meters. The participants will be asked to walk for 6 minutes, and the distance covered will be noted. The MCID for the 6-minute walk test is 45 meters.
Measured: Baseline and 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 May 2025
- Study start15 May 2025
- Primary completion18 Jun 2026
- Study completion22 Jun 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Osteo Arthritis KneeStudies 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
- Model description
- This is a two-arm parallel-group randomized controlled trial. Participants will be randomly assigned to either the experimental group receiving intermittent hypoxia-hyperoxia therapy along with conventional physical therapy or to the control group receiving conventional physical therapy with normoxic air. Both groups will receive 12 treatment sessions over four weeks.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Khyber Medical University Peshawar
- Sponsor type
- University, hospital or other
- Collaborators
- Rehman Medical Institute - RMI
- Responsible party
- Sponsor
- Investigators
- Dr Rida Shabbir, PhD, Principal investigator, Institute of Physical Medicine and Rehabilitation, Khyber Medical University PeshawarDr Haider Darain, PhD, Principal investigator, Institute of Physical Medicine and Rehabilitation, Khyber Medical University PeshawarDr Aatik Arsh, PhD, Principal investigator, Institute of Physical Medicine and Rehabilitation, Khyber Medical University Peshawar
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06965946
- Sponsor's protocol ID
- KMU/DIR/CTU/2025/002
- Status last verified
- Jun 2026
- First submitted
- 2 May 2025
- Last updated
- 25 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual participant data (IPD) underlying the results reported in this trial will be made available to researchers upon reasonable request. This includes outcome measures such as pain scores, gait and balance assessments, CRP levels, and KOOS subscale results.
Publications
Mohd Yunus MH, Lee Y, Nordin A, Chua KH, Bt Hj Idrus R. Remodeling Osteoarthritic Articular Cartilage under Hypoxic Conditions. Int J Mol Sci. 2022 May 11;23(10):5356. doi: 10.3390/ijms23105356.
PubMed 35628163Cui A, Li H, Wang D, Zhong J, Chen Y, Lu H. Global, regional prevalence, incidence and risk factors of knee osteoarthritis in population-based studies. EClinicalMedicine. 2020 Nov 26;29-30:100587. doi: 10.1016/j.eclinm.2020.100587. eCollection 2020 Dec.
PubMed 34505846Katz JN, Arant KR, Loeser RF. Diagnosis and Treatment of Hip and Knee Osteoarthritis: A Review. JAMA. 2021 Feb 9;325(6):568-578. doi: 10.1001/jama.2020.22171.
PubMed 33560326Rahimi F, Sadeghisani M, Karimzadeh A. Efficacy of transcranial direct current stimulation in patients with knee osteoarthritis: A systematic review. Neurophysiol Clin. 2023 Dec;53(6):102918. doi: 10.1016/j.neucli.2023.102918. Epub 2023 Nov 8.
PubMed 37944293Benderdour M, Martel-Pelletier J, Pelletier JP, Kapoor M, Zunzunegui MV, Fahmi H. Cellular Aging, Senescence and Autophagy Processes in Osteoarthritis. Curr Aging Sci. 2015;8(2):147-57. doi: 10.2174/1874609808666150727111530.
PubMed 26212056Chang WJ, Bennell KL, Hodges PW, Hinman RS, Young CL, Buscemi V, Liston MB, Schabrun SM. Addition of transcranial direct current stimulation to quadriceps strengthening exercise in knee osteoarthritis: A pilot randomised controlled trial. PLoS One. 2017 Jun 30;12(6):e0180328. doi: 10.1371/journal.pone.0180328. eCollection 2017.
PubMed 28665989Azizi S, Rezasoltani Z, Najafi S, Mohebi B, Tabatabaee SM, Dadarkhah A. Transcranial direct current stimulation for knee osteoarthritis: a single-blind randomized sham-controlled trial. Neurophysiol Clin. 2021 Aug;51(4):329-338. doi: 10.1016/j.neucli.2020.12.002. Epub 2020 Dec 13.
PubMed 33323306
Study at a glance
From the registry record, last updated by the sponsor on 25 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Combining Intermittent Hypoxia-Hyperoxia and Conventional Physical Therapy for Patients With Knee Osteoarthritis: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06965946
- Acronym / sponsor ID
- KMU/DIR/CTU/2025/002
- Conditions
- Osteo Arthritis Knee
- Keywords
- Knee Osteoarthritis, Intermittent Hypoxia, Hypoxic-Hyperoxic Therapy, Rehabilitation, Functional Mobility
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Khyber Medical University PeshawarUniversity, hospital or other
- Collaborators
- Rehman Medical Institute - RMI
- Study start
- 15 May 2025 (actual)
- Primary completion
- 18 Jun 2026 (actual)
- Study completion
- 22 Jun 2026 (actual)
- First posted
- 11 May 2025 (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.
This randomized controlled trial aims to evaluate the effectiveness of combining intermittent hypoxia-hyperoxia therapy (IHHT) with conventional physical therapy in improving pain, function, gait, balance, and general health among patients with knee osteoarthritis. The study will be conducted at the Physical Therapy Department of Rehman Medical Institute, Peshawar, Pakistan, over a period of one year.
Detailed description
Osteoarthritis (OA) is a prevalent chronic condition that leads to joint pain, stiffness, and impaired mobility, particularly among middle-aged and elderly populations. In Pakistan, knee OA is common and significantly impacts quality of life. Existing treatments are largely symptomatic and often insufficient, especially in resource-constrained settings.
Intermittent hypoxia-hyperoxia training (IHHT), involving alternating periods of low (13-15%) and high (40%) oxygen concentrations, has shown promise in improving physical and psychological outcomes in musculoskeletal disorders. However, evidence regarding its efficacy in knee OA is scarce, especially in low- and middle-income countries.
This trial seeks to explore whether the combination of IHHT and conventional physical therapy leads to superior improvements in clinical outcomes compared to conventional therapy alone. Participants will undergo 12 treatment sessions over 4 weeks. The primary outcome measures include pain (NPRS), function (KOOS), balance (Timed Up and Go Test), gait (Functional Gait Assessment), and inflammatory markers (CRP). The feasibility, safety, and effectiveness of this novel intervention will also be evaluated.
The study design includes assessor and participant blinding and uses rigorous methods including pre- and post-intervention assessments and statistical analysis with SPSS. Findings from this study may inform future guidelines for non-pharmacological, low-cost interventions for knee OA rehabilitation in similar contexts.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- This is a two-arm parallel-group randomized controlled trial. Participants will be randomly assigned to either the experimental group receiving intermittent hypoxia-hyperoxia therapy along with conventional physical therapy or to the control group receiving conventional physical therapy with normoxic air. Both groups will receive 12 treatment sessions over four weeks.
| Arm | Type | Receives |
|---|---|---|
| Intermittent Hypoxia-Hyperoxia + Conventional Therapy | Experimental | Procedure: Intermittent Hypoxia-Hyperoxia Therapy (IHHT), Procedure: Conventional Physical TherapyParticipants in this group will receive Intermittent Hypoxia-Hyperoxia Therapy (IHHT) administered using a hypoxia generator. Each session will include 4 cycles of 5 minutes of hypoxia (13-15% O₂) followed by 2 minutes of hyperoxia (40% O₂). This therapy will be provided before each conventional physical therapy session. A total of 12 sessions (3 per week for 4 weeks) will be administered. Conventional therapy will follow the current best practices used by physical therapists in tertiary care hospitals in Peshawar. |
| Conventional Therapy with Normoxic Air | Active comparator | Procedure: Conventional Physical Therapy, Procedure: Normoxic Air PlaceboParticipants in this group will receive only conventional physical therapy along with normoxic air (19.8% O₂) exposure using the same device setup to maintain blinding. They will receive 4 sessions of normoxia (5 minutes) followed by 2 minutes of normoxia as a placebo for IHHT. This will also be done prior to each of the 12 physical therapy sessions (3 per week for 4 weeks). |
Who may qualify
- Ages
- 45 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
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 |
|---|---|---|
| Intermittent Hypoxia-Hyperoxia Therapy (IHHT)Also: Olive OLV 10H Hypoxia GeneratorParticipants receive 4 cycles per session of 5 minutes of hypoxia (13-15% O₂) followed by 2 minutes of hyperoxia (40% O₂) using a hypoxia generator (Olive OLV 10H). Sessions are delivered before each conventional physical therapy session, 3 times per week for 4 weeks (total 12 sessions). Participants are monitored for heart rate, blood pressure, and oxygen saturation throughout the intervention. | Procedure or surgery | Intermittent Hypoxia-Hyperoxia + Conventional Therapy |
| Conventional Physical TherapyParticipants receive individualized conventional physical therapy for knee osteoarthritis based on current clinical practices in tertiary hospitals of Peshawar. Therapy is delivered 3 times per week for 4 weeks (total 12 sessions) and includes strength training, mobility exercises, and patient education. | Procedure or surgery | Conventional Therapy with Normoxic Air, Intermittent Hypoxia-Hyperoxia + Conventional Therapy |
| Normoxic Air PlaceboParticipants in the control group inhale normoxic air (19.8% O₂) using the same Olive OLV 10H hypoxia generator to maintain blinding. Each session consists of 4 cycles of 5 minutes of normoxia followed by 2 minutes of normoxia, simulating the timing of hypoxia-hyperoxia therapy. Sessions are administered prior to conventional physical therapy, 3 times per week for 4 weeks (total 12 sessions). Patients are monitored for vital signs throughout. | Procedure or surgery | Conventional Therapy with Normoxic Air |
Primary outcome
Pain Reduction
Time frame: Baseline and 4 weeks (12 sessions of therapy)
Measured on the Numeric Pain Rating Scale (NPRS), which has levels ranging from 0 to 10 in severity. 0 indicates no pain, and 10 indicates severe pain. The scale is divided into 3 categories. 1-3 indicates mild pain, 4-6 indicates moderate pain, and 7-10 indicates severe pain.
Functional Status - KOOS Activities of Daily Living Subscale
Time frame: Baseline and 4 weeks
The Knee Injury and Osteoarthritis Outcome Score (KOOS) will be used to assess pain, recreation and quality of life, symptoms and stiffness, ADL and functional sports. The scores of each category will be calculated and converted to percentages (100%). 0-39% will indicate severe condition, 40- 59% will indicate moderate condition, 60-79% will indicate mild condition, and 80-100% will indicate no dysfunction.
Inflammatory Marker - C-Reactive Protein (CRP)
Time frame: Baseline and 4 weeks
Change in serum CRP levels measured through a blood sample as a biomarker of osteoarthritis-related inflammation. CRP levels will be taken on a continuous scale.
Balance - Timed Up and Go Test (TUG)
Time frame: Baseline and 4 weeks
Time taken (in seconds) to rise from a chair, walk 3 meters, turn, walk back, and sit down using a stop watch. A time of < or equal to 10 seconds will be considered normal, 11-20 seconds indicates good mobility with functional indipendence. > or equal to 20 seconds indicates that person needs assistance outside, 30 seconds or more indicates that person is prone to fall. MCID for time up and Go test is 2.1 seconds.
2 secondary outcomes
Gait Performance - Functional Gait Assessment (FGA) Score
Time frame: Baseline and 4 weeks
Functional mobility - 6-Minute Walk Test (6MWT)
Time frame: Baseline and 4 weeks
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 25 Jun 2026.
- Background: PubMed 35628163Mohd Yunus MH, Lee Y, Nordin A, Chua KH, Bt Hj Idrus R. Remodeling Osteoarthritic Articular Cartilage under Hypoxic Conditions. Int J Mol Sci. 2022 May 11;23(10):5356. doi: 10.3390/ijms23105356.
- Background: PubMed 34505846Cui A, Li H, Wang D, Zhong J, Chen Y, Lu H. Global, regional prevalence, incidence and risk factors of knee osteoarthritis in population-based studies. EClinicalMedicine. 2020 Nov 26;29-30:100587. doi: 10.1016/j.eclinm.2020.100587. eCollection 2020 Dec.
- Background: PubMed 33560326Katz JN, Arant KR, Loeser RF. Diagnosis and Treatment of Hip and Knee Osteoarthritis: A Review. JAMA. 2021 Feb 9;325(6):568-578. doi: 10.1001/jama.2020.22171.
- Background: PubMed 37944293Rahimi F, Sadeghisani M, Karimzadeh A. Efficacy of transcranial direct current stimulation in patients with knee osteoarthritis: A systematic review. Neurophysiol Clin. 2023 Dec;53(6):102918. doi: 10.1016/j.neucli.2023.102918. Epub 2023 Nov 8.
- Background: PubMed 26212056Benderdour M, Martel-Pelletier J, Pelletier JP, Kapoor M, Zunzunegui MV, Fahmi H. Cellular Aging, Senescence and Autophagy Processes in Osteoarthritis. Curr Aging Sci. 2015;8(2):147-57. doi: 10.2174/1874609808666150727111530.
- Background: PubMed 28665989Chang WJ, Bennell KL, Hodges PW, Hinman RS, Young CL, Buscemi V, Liston MB, Schabrun SM. Addition of transcranial direct current stimulation to quadriceps strengthening exercise in knee osteoarthritis: A pilot randomised controlled trial. PLoS One. 2017 Jun 30;12(6):e0180328. doi: 10.1371/journal.pone.0180328. eCollection 2017.
- Background: PubMed 33323306Azizi S, Rezasoltani Z, Najafi S, Mohebi B, Tabatabaee SM, Dadarkhah A. Transcranial direct current stimulation for knee osteoarthritis: a single-blind randomized sham-controlled trial. Neurophysiol Clin. 2021 Aug;51(4):329-338. doi: 10.1016/j.neucli.2020.12.002. Epub 2020 Dec 13.
- Individual participant dataSharing planned: Yes. De-identified individual participant data (IPD) underlying the results reported in this trial will be made available to researchers upon reasonable request. This includes outcome measures such as pain scores, gait and balance assessments, CRP levels, and KOOS subscale results.
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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.
Dr Rida Shabbir, PhD principal investigator
Institute of Physical Medicine and Rehabilitation, Khyber Medical University Peshawar
Dr Haider Darain, PhD principal investigator
Institute of Physical Medicine and Rehabilitation, Khyber Medical University Peshawar
Dr Aatik Arsh, PhD principal investigator
Institute of Physical Medicine and Rehabilitation, Khyber Medical University Peshawar
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intermittent Hypoxia-Hyperoxia Therapy (IHHT) and Conventional Physical Therapy in people with Osteo Arthritis Knee, run by Khyber Medical University Peshawar 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 6 inclusion and 6 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 25 Jun 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 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 Reduction (time frame: Baseline and 4 weeks (12 sessions of therapy)). The study lists 4 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 NCT06965946, which also lists 7 linked publications.
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 25 Jun 2026.