Knee OsteoarthritisNCT06511557
Comparison of Effect of Virtual Reality and Kinetic Chain Exercises in Knee Osteoarthritis
A study testing Non immersive virtual reality ( xbox kinetic) and Kinetic chain exercises in people with Knee Osteoarthritis, run by Riphah International University at 1 site in Pakistan.
Trial summary
It is necessary to explore the novel rehabilitation strategies to treat knee osteoarthritis. Although kinetic chain exercises have shown efficacy but there is growing interest in Virtual Reality training using Xbox Kinect because it has the potential to enhance motivation and patient's adherence to Rehabilitation. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Knee Osteoarthritis
- What is being tested?
- Non immersive virtual reality ( xbox kinetic) and Kinetic chain exercises
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 46 participants
- Where
- 1 sitePakistan
- Study dates
- 16 Nov 2023to 30 Sep 2024
- 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 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Both male \& female
- Age 50 or older.
- Body mass index (BMI) between 18.9kg/m2 and 29.9 kg/m2.
- Diagnosed with Grade II knee OA
- Have knee pain > 4 on NPRS
- Ability to engage in moderate physical activity.
Who cannot join
- Severe comorbidities limiting physical activity.
- History of Hip and Knee arthroplasty.
- Cognitive impairments affecting comprehension
Trial locations and contacts
1 site in 1 country.
Pakistan1 site, 1 recruiting
- Recruiting
IIMCT Railway General Hospital
Rawalpindi, Punjab Province, 46000
Iqra Khan, Mphil, 03354671744, iqrakhan485@gmail.com
Tahira Nazeer, MS-OMPT
About this study
Official title: Comparative Effect of Non Immersive Virtual Reality Based Training (Xbox Kinect) and Kinetic Chain Exercises in Patient With Knee Osteoarthritis.
It is necessary to explore the novel rehabilitation strategies to treat knee osteoarthritis. Although kinetic chain exercises have shown efficacy but there is growing interest in Virtual Reality training using Xbox Kinect because it has the potential to enhance motivation and patient's adherence to Rehabilitation. The aim of this study is to compare the effectiveness of both interventions and provide a valuable insight to optimize the therapeutic strategies for treating knee osteoarthritis.
Read the detailed description
Knee osteoarthritis (OA) is a prevalent musculoskeletal condition that impacts the quality of life. Despite various treatment options, managing knee OA is still a challenge for healthcare professionals. However, there is growing interest in exploring the innovative interventions to decrease symptoms and improve functional outcome in patients with knee OA.The project will be a Randomized control trial conducted to check the effect of Virtual Reality and Kinetic chain exercises in patients with knee osteoarthritis.so that we can have best treatment option. Duration of this study will be of 8 weeks , convenient sampling will be done, subjects following eligibility criteria from IIMCT Pakistan Railway general Hospital will be randomly allocated in two groups, baseline assessment will be done, Group A will be given Xbox kinetic training and Group B will be given Kinetic chain exercises . Outcome measures if this research will be pain , Range if Motion , function and disability. Post intervention assessment will be done via NPRS , WOMAC , KOOS_PS and goniometric measurements of Knee ranges .Data was analyzed by using SPSS software. There is lack of research comparing the effectiveness of Virtual Reality Xbox Kinect and kinetic chain exercises in patients with knee osteoarthritis. There are studies that have explored the effectiveness of these interventions separately. In past, few researches support the fact that virtual reality rehabilitation is more effective than conventional physical therapy and few researches are in support of kinetic chain exercises being more effective for knee osteoarthritis. However there is no study that has compared these both interventions. Therefore there is a need for further research to compare both of these interventions which in future will provide optimal, more personalized and effective rehabilitation strategy for individuals with knee osteoarthritis
- Conditions
- Knee Osteoarthritis
- Being tested
- Non immersive virtual reality ( xbox kinetic), Kinetic chain exercises
- Keywords
- Knee Osteoarthritis, Xbox kinetic, Virtual Reality Rehabilitation, Kinetic chain exercises
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Non immersive virtual reality ( xbox kinetic)Device
Treatment starts with a gentle warm-up i.e. hot pack for 10 minutes and gentle stretching of Quadriceps, hamstrings and calves. Each game was performed for 10 minutes with 1 minute rest between games. 3 sessions Per Weeks for 8 weeks (45 Min per Session) were given. All the exergames target muscles like Hamstring, Quadriceps and calves to improve function of knee joint and reduce pain.
Baseline assessment was done at the start of the session and proper cool down and stretching will be performed at the end of each session to promote flexibility and reduce muscle soreness
Kinetic chain exercisesOther
Session starts with a gentle warm-up i.e. Hot pack for 10 minutes and gentle stretching. Each exercise is performed in 2 sets, each set of 10 repetitions with 1min rest between sets. 3 sessions Per Weeks for 8 weeks (45 Min Per Session) were given .Kinetic chain exercises involve integrated movements that engage multiple joints and muscle groups \& focus on strengthening muscles like quadriceps, hamstrings, glutes, and calf muscles, improving joint stability, function, and reducing pain. Baseline assessment was done at the start of the session and proper cool down and stretching was performed at the end of each session to promote flexibility and reduce muscle soreness
| Study group | Role | What they receive |
|---|---|---|
| Non immersive virtual reality (Xbox kinetic) | Experimental | * Track and field.
* Skiing.
* Dance Central.
* Kinect sports. Receives: Device: Non immersive virtual reality ( xbox kinetic) |
| Kinetic Chain Exercises | Active comparator | Closed chain:
Terminal Knee Extension.
* Semi squat.
* Forward step up and down.
Open chain:
* SLR in lying.
* Knee extension in sitting. Receives: Other: Kinetic chain exercises |
What is being measured
The primary outcome is the main question the study is designed to answer.
Numeric Pain Rating Scale:
The Numeric Pain Rating Scale (NPRS) is used to assess pain. On an 11-point Numeric scale, 0 represents no pain and 10 Represents the worst imaginable pain.
Measured: [Time Frame: 8 weeks]
Knee injury and Osteoarthritis Outcome score (KOOS PS):
It is a self- administered questionnaire, designed for the assessment of individuals with knee osteoarthritis and injury. It consists of five subscales such as Pain, Activities of daily living , Symptoms, Sport and recreational activities and Quality of life related to knee. The KOOS short form typically consists of 7 questions covering five domains:
Pain: 1 question Other Symptoms: 1 question Function in Daily Living (ADL): 1 question Function in Sport and Recreation (Sport/Rec): 2 questions Knee-related Quality of Life (QOL): 2 questions Each question is scored on a Likert scale ranging from 0 to 4, with 0 indicating no symptoms and 4 indicating extreme symptoms. The total score for the KOOS short form can range from 0 to 28 but we use reverse percentage for scoring which is from 0 to 100 precent with higher scores indicating greater severity in knee function.
Measured: [Time Frame: 8 weeks]
Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC):
It is a self-administered questionnaire widely used for the assessment of Health status of individuals With Osteoarthritis of Hip or Knee. It has three subscales such as Pain, Stiffness and Physical Function.
The WOMAC questionnaire consists of 24 questions divided into three subscales:
Pain (5 questions) Stiffness (2 questions) Physical Function (17 questions) Each question is answered on a Likert scale ranging from 0 to 4, with 0 indicating no symptoms and 4 indicating extreme symptoms. Therefore, the total score for the WOMAC index can range from 0 to 96, with higher scores indicating greater severity of osteoarthritis symptoms.
Measured: [Time Frame: 8 weeks]
Range of Motion (Goniometer):
It is employed as a benchmark technique for the assessment of Range of motion of a joint, measured using a goniometer. Goniometer measures the joint ranges in every plane of the joint , it's measurements are highly reliable.
Measured: [Time Frame: 8 weeks]
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2024
- Study start16 Nov 2023
- Primary completion1 Aug 2024 (estimated)
- Study completion30 Sep 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Knee OsteoarthritisStudies of the same condition, open and under way.
- More trials run by Riphah International UniversityThe 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
- Model description
- Clinical study in which two or more groups of participants receive different interventions. Participants are assigned to one of the treatment arms at the beginning of the trial and continue in that arm throughout the length of the trial. Assignment to a group usually is randomized
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 46 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- syed shakil urrehman, PhD, Principal investigator, Riphah International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06511557
- Sponsor's protocol ID
- REC/RCR & AHS /23/01115
- Status last verified
- Jul 2024
- First submitted
- 15 Jul 2024
- Last updated
- 22 Jul 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Lim WB, Al-Dadah O. Conservative treatment of knee osteoarthritis: A review of the literature. World J Orthop. 2022 Mar 18;13(3):212-229. doi: 10.5312/wjo.v13.i3.212. eCollection 2022 Mar 18.
PubMed 35317254Hall M, van der Esch M, Hinman RS, Peat G, de Zwart A, Quicke JG, Runhaar J, Knoop J, van der Leeden M, de Rooij M, Meulenbelt I, Vliet Vlieland T, Lems WF, Holden MA, Foster NE, Bennell KL. How does hip osteoarthritis differ from knee osteoarthritis? Osteoarthritis Cartilage. 2022 Jan;30(1):32-41. doi: 10.1016/j.joca.2021.09.010. Epub 2021 Sep 29.
PubMed 34600121Ozudogru A, Gelecek N. Effects of closed and open kinetic chain exercises on pain, muscle strength, function, and quality of life in patients with knee osteoarthritis. Rev Assoc Med Bras (1992). 2023 Jul 17;69(7):e20230164. doi: 10.1590/1806-9282.20230164. eCollection 2023.
PubMed 37466598Ng WH, Jamaludin NI, Sahabuddin FNA, Ab Rahman S, Ahmed Shokri A, Shaharudin S. Comparison of the open kinetic chain and closed kinetic chain strengthening exercises on pain perception and lower limb biomechanics of patients with mild knee osteoarthritis: a randomized controlled trial protocol. Trials. 2022 Apr 15;23(1):315. doi: 10.1186/s13063-022-06153-8.
PubMed 35428274Byra J, Czernicki K. The Effectiveness of Virtual Reality Rehabilitation in Patients with Knee and Hip Osteoarthritis. J Clin Med. 2020 Aug 14;9(8):2639. doi: 10.3390/jcm9082639.
PubMed 32823832Raposo F, Ramos M, Lucia Cruz A. Effects of exercise on knee osteoarthritis: A systematic review. Musculoskeletal Care. 2021 Dec;19(4):399-435. doi: 10.1002/msc.1538. Epub 2021 Mar 5.
PubMed 33666347van den Bosch MHJ. Osteoarthritis year in review 2020: biology. Osteoarthritis Cartilage. 2021 Feb;29(2):143-150. doi: 10.1016/j.joca.2020.10.006. Epub 2020 Nov 24.
PubMed 33242602Dantas LO, Salvini TF, McAlindon TE. Knee osteoarthritis: key treatments and implications for physical therapy. Braz J Phys Ther. 2021 Mar-Apr;25(2):135-146. doi: 10.1016/j.bjpt.2020.08.004. Epub 2020 Sep 8.
PubMed 33262080Nambi G, Abdelbasset WK, Elsayed SH, Khalil MA, Alrawaili SM, Alsubaie SF. Comparative effects of virtual reality training and sensory motor training on bone morphogenic proteins and inflammatory biomarkers in post-traumatic osteoarthritis. Sci Rep. 2020 Sep 28;10(1):15864. doi: 10.1038/s41598-020-72587-2.
PubMed 32985509
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Effect of Non Immersive Virtual Reality Based Training (Xbox Kinect) and Kinetic Chain Exercises in Patient With Knee Osteoarthritis.
- ClinicalTrials.gov ID
- NCT06511557
- Acronym / sponsor ID
- REC/RCR & AHS /23/01115
- Conditions
- Knee Osteoarthritis
- Keywords
- Knee Osteoarthritis, Xbox kinetic, Virtual Reality Rehabilitation, Kinetic chain exercises
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 46 participants (estimated)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 16 Nov 2023 (actual)
- Primary completion
- 1 Aug 2024 (estimated)
- Study completion
- 30 Sep 2024 (estimated)
- First posted
- 22 Jul 2024 (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.
It is necessary to explore the novel rehabilitation strategies to treat knee osteoarthritis. Although kinetic chain exercises have shown efficacy but there is growing interest in Virtual Reality training using Xbox Kinect because it has the potential to enhance motivation and patient's adherence to Rehabilitation. The aim of this study is to compare the effectiveness of both interventions and provide a valuable insight to optimize the therapeutic strategies for treating knee osteoarthritis.
Detailed description
Knee osteoarthritis (OA) is a prevalent musculoskeletal condition that impacts the quality of life. Despite various treatment options, managing knee OA is still a challenge for healthcare professionals. However, there is growing interest in exploring the innovative interventions to decrease symptoms and improve functional outcome in patients with knee OA.The project will be a Randomized control trial conducted to check the effect of Virtual Reality and Kinetic chain exercises in patients with knee osteoarthritis.so that we can have best treatment option. Duration of this study will be of 8 weeks , convenient sampling will be done, subjects following eligibility criteria from IIMCT Pakistan Railway general Hospital will be randomly allocated in two groups, baseline assessment will be done, Group A will be given Xbox kinetic training and Group B will be given Kinetic chain exercises . Outcome measures if this research will be pain , Range if Motion , function and disability. Post intervention assessment will be done via NPRS , WOMAC , KOOS_PS and goniometric measurements of Knee ranges .Data was analyzed by using SPSS software. There is lack of research comparing the effectiveness of Virtual Reality Xbox Kinect and kinetic chain exercises in patients with knee osteoarthritis. There are studies that have explored the effectiveness of these interventions separately. In past, few researches support the fact that virtual reality rehabilitation is more effective than conventional physical therapy and few researches are in support of kinetic chain exercises being more effective for knee osteoarthritis. However there is no study that has compared these both interventions. Therefore there is a need for further research to compare both of these interventions which in future will provide optimal, more personalized and effective rehabilitation strategy for individuals with knee osteoarthritis
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Clinical study in which two or more groups of participants receive different interventions. Participants are assigned to one of the treatment arms at the beginning of the trial and continue in that arm throughout the length of the trial. Assignment to a group usually is randomized
| Arm | Type | Receives |
|---|---|---|
| Non immersive virtual reality (Xbox kinetic) | Experimental | Device: Non immersive virtual reality ( xbox kinetic)* Track and field. * Skiing. * Dance Central. * Kinect sports. |
| Kinetic Chain Exercises | Active comparator | Other: Kinetic chain exercisesClosed chain: Terminal Knee Extension. * Semi squat. * Forward step up and down. Open chain: * SLR in lying. * Knee extension in sitting. |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Both male \& female
Key exclusion criteria (3 listed)
- Severe comorbidities limiting physical activity.
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 |
|---|---|---|
| Non immersive virtual reality ( xbox kinetic)Treatment starts with a gentle warm-up i.e. hot pack for 10 minutes and gentle stretching of Quadriceps, hamstrings and calves. Each game was performed for 10 minutes with 1 minute rest between games. 3 sessions Per Weeks for 8 weeks (45 Min per Session) were given. All the exergames target muscles like Hamstring, Quadriceps and calves to improve function of knee joint and reduce pain. Baseline assessment was done at the start of the session and proper cool down and stretching will be performed at the end of each session to promote flexibility and reduce muscle soreness | Device | Non immersive virtual reality (Xbox kinetic) |
| Kinetic chain exercisesSession starts with a gentle warm-up i.e. Hot pack for 10 minutes and gentle stretching. Each exercise is performed in 2 sets, each set of 10 repetitions with 1min rest between sets. 3 sessions Per Weeks for 8 weeks (45 Min Per Session) were given .Kinetic chain exercises involve integrated movements that engage multiple joints and muscle groups \& focus on strengthening muscles like quadriceps, hamstrings, glutes, and calf muscles, improving joint stability, function, and reducing pain. Baseline assessment was done at the start of the session and proper cool down and stretching was performed at the end of each session to promote flexibility and reduce muscle soreness | Other | Kinetic Chain Exercises |
Primary outcome
Numeric Pain Rating Scale:
Time frame: [Time Frame: 8 weeks]
The Numeric Pain Rating Scale (NPRS) is used to assess pain. On an 11-point Numeric scale, 0 represents no pain and 10 Represents the worst imaginable pain.
Knee injury and Osteoarthritis Outcome score (KOOS PS):
Time frame: [Time Frame: 8 weeks]
It is a self- administered questionnaire, designed for the assessment of individuals with knee osteoarthritis and injury. It consists of five subscales such as Pain, Activities of daily living , Symptoms, Sport and recreational activities and Quality of life related to knee. The KOOS short form typically consists of 7 questions covering five domains: Pain: 1 question Other Symptoms: 1 question Function in Daily Living (ADL): 1 question Function in Sport and Recreation (Sport/Rec): 2 questions Knee-related Quality of Life (QOL): 2 questions Each question is scored on a Likert scale ranging from 0 to 4, with 0 indicating no symptoms and 4 indicating extreme symptoms. The total score for the KOOS short form can range from 0 to 28 but we use reverse percentage for scoring which is from 0 to 100 precent with higher scores indicating greater severity in knee function.
Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC):
Time frame: [Time Frame: 8 weeks]
It is a self-administered questionnaire widely used for the assessment of Health status of individuals With Osteoarthritis of Hip or Knee. It has three subscales such as Pain, Stiffness and Physical Function. The WOMAC questionnaire consists of 24 questions divided into three subscales: Pain (5 questions) Stiffness (2 questions) Physical Function (17 questions) Each question is answered on a Likert scale ranging from 0 to 4, with 0 indicating no symptoms and 4 indicating extreme symptoms. Therefore, the total score for the WOMAC index can range from 0 to 96, with higher scores indicating greater severity of osteoarthritis symptoms.
Range of Motion (Goniometer):
Time frame: [Time Frame: 8 weeks]
It is employed as a benchmark technique for the assessment of Range of motion of a joint, measured using a goniometer. Goniometer measures the joint ranges in every plane of the joint , it's measurements are highly reliable.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jul 2024.
- Background: PubMed 35317254Lim WB, Al-Dadah O. Conservative treatment of knee osteoarthritis: A review of the literature. World J Orthop. 2022 Mar 18;13(3):212-229. doi: 10.5312/wjo.v13.i3.212. eCollection 2022 Mar 18.
- Background: PubMed 34600121Hall M, van der Esch M, Hinman RS, Peat G, de Zwart A, Quicke JG, Runhaar J, Knoop J, van der Leeden M, de Rooij M, Meulenbelt I, Vliet Vlieland T, Lems WF, Holden MA, Foster NE, Bennell KL. How does hip osteoarthritis differ from knee osteoarthritis? Osteoarthritis Cartilage. 2022 Jan;30(1):32-41. doi: 10.1016/j.joca.2021.09.010. Epub 2021 Sep 29.
- Background: PubMed 37466598Ozudogru A, Gelecek N. Effects of closed and open kinetic chain exercises on pain, muscle strength, function, and quality of life in patients with knee osteoarthritis. Rev Assoc Med Bras (1992). 2023 Jul 17;69(7):e20230164. doi: 10.1590/1806-9282.20230164. eCollection 2023.
- Background: PubMed 35428274Ng WH, Jamaludin NI, Sahabuddin FNA, Ab Rahman S, Ahmed Shokri A, Shaharudin S. Comparison of the open kinetic chain and closed kinetic chain strengthening exercises on pain perception and lower limb biomechanics of patients with mild knee osteoarthritis: a randomized controlled trial protocol. Trials. 2022 Apr 15;23(1):315. doi: 10.1186/s13063-022-06153-8.
- Background: PubMed 32823832Byra J, Czernicki K. The Effectiveness of Virtual Reality Rehabilitation in Patients with Knee and Hip Osteoarthritis. J Clin Med. 2020 Aug 14;9(8):2639. doi: 10.3390/jcm9082639.
- Background: PubMed 33666347Raposo F, Ramos M, Lucia Cruz A. Effects of exercise on knee osteoarthritis: A systematic review. Musculoskeletal Care. 2021 Dec;19(4):399-435. doi: 10.1002/msc.1538. Epub 2021 Mar 5.
- Background: PubMed 33242602van den Bosch MHJ. Osteoarthritis year in review 2020: biology. Osteoarthritis Cartilage. 2021 Feb;29(2):143-150. doi: 10.1016/j.joca.2020.10.006. Epub 2020 Nov 24.
- Background: PubMed 33262080Dantas LO, Salvini TF, McAlindon TE. Knee osteoarthritis: key treatments and implications for physical therapy. Braz J Phys Ther. 2021 Mar-Apr;25(2):135-146. doi: 10.1016/j.bjpt.2020.08.004. Epub 2020 Sep 8.
- Background: PubMed 32985509Nambi G, Abdelbasset WK, Elsayed SH, Khalil MA, Alrawaili SM, Alsubaie SF. Comparative effects of virtual reality training and sensory motor training on bone morphogenic proteins and inflammatory biomarkers in post-traumatic osteoarthritis. Sci Rep. 2020 Sep 28;10(1):15864. doi: 10.1038/s41598-020-72587-2.
- 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. This study is not recruiting at the moment.
syed shakil urrehman, PhD principal investigator
Riphah International University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Non immersive virtual reality ( xbox kinetic) and Kinetic chain exercises in people with Knee Osteoarthritis, run by Riphah International University 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 3 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: status not confirmed, as of the sponsor's last update on 22 Jul 2024. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Imran Amjad, PhD (033324390125, imran.amjad@riphah.edu.pk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Numeric Pain Rating Scale: (time frame: [Time Frame: 8 weeks]). 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 NCT06511557, which also lists 9 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 22 Jul 2024.