Osteoarthritis, KneeNCT05052593
Compressive Myofascial Release in Knee Osteoarthritis
A study testing compressive myofascial release and conventional treatment group in people with Osteoarthritis, Knee, run by Riphah International University at 2 sites in Pakistan.
Trial summary
The purpose of the study is to compare the effects of compressive myofascial release and conventional knee osteoarthritis treatment to correct lateral patellar tracking. A randomized control trial was conducted at Railway General Hospital, Ahad Medicare clinics and physiotherapy Centre and The Health Professional… Read more about this study
- Who is it for?
- Ages 50 years and olderHealthy volunteers can take part
- Conditions the study is for
- Osteoarthritis, Knee
- What is being tested?
- compressive myofascial release and conventional treatment group
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- 2 sitesPakistan
- Study dates
- 14 Aug 2020to 31 Jul 2021
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Includes diagnosed cases of knee osteoarthritis
- Grades 2-3 according to the Kellgren and Lawrence method of grading(1)
- Includes patients from the age group of 50 years and above(3)
- Includes knee osteoarthritis patients with lateral tracking of patella which will assessed through Q angle test(4)
Who cannot join
- history of recent trauma to knee
- History of hip disease
- Past history of knee surgery/arthroplasty
- Intraarticular corticosteroid injection
Trial locations and contacts
2 sites in 1 country.
Pakistan2 sites
Bone and joints centre
Rawalpindi, Punjab Province, 46000
Railway General Hospital
Rawalpindi, Punjab Province
About this study
Official title: Effects of Compressive Myofascial Release of Vastus Lateralis on Lateral Patellar Tracking in Patients With Knee Osteoarthritis.
The purpose of the study is to compare the effects of compressive myofascial release and conventional knee osteoarthritis treatment to correct lateral patellar tracking. A randomized control trial was conducted at Railway General Hospital, Ahad Medicare clinics and physiotherapy Centre and The Health Professional physiotherapy clinic Bahria town phase 6. The sample size was 52 calculated through open-epi tool. The participants were divided into two interventional groups each having 26 participants. The study duration was six months. Sampling technique applied was non probability convenient sampling for recruitment and group randomization using sealed enveloped method. Only participants who were 50 years above with grade 2 and 3 knee osteoarthritis were included in the study. Tools used in this study are Q angle, numeric pain rating scale, goniometry and WOMAC questionnaire, Self structured Questionnaire. Data was collected at baseline, at the end of 3rd session and 6th session. Data analyzed through SPSS version 23.
Read the detailed description
knee osteoarthritis is commonly manifested as decreased joint space, sub chondral bone sclerosis, bony spur formation, cartilage loss and mainly lateral patellar tracking(2).Lateral patellar tracking is a condition in which patellar move laterally in relation to femoral groove on flexion and extension(4). Patellofemoral disorders are very common in patients of knee OA. One of the very common manifestation of which is lateral patellar tracking(5). Patella move laterally due to certain disorders of knee that include patellofemoral pain syndrome and anterior knee pain. Q-angle is used as an indicator of patellofemoral pain syndrome. When Q angle exceeds its normal limit i.e. 15-20 degrees it leads to lateral mal positioning of patella(6). Rozenfeld, E et al. in 2019 conducted a cross sectional study with a diagnosis of anterior knee pain that suggests highest prevalence of myofascial trigger points in distal vastus lateralis and mid and distal vastus lateralis. It also reported that presence of trigger points in anterior knee pain(7). There are several techniques that are used to release trigger points.
- Conditions
- Osteoarthritis, Knee
- Being tested
- compressive myofascial release, conventional treatment group
- Keywords
- knee osteoarthritis, compressive myofascial release, lateral patellar tracking
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
compressive myofascial releaseOther
Patients in this group will receive treatment through CMR that includes shaking the muscle belly of vastus lateralis for 30 seconds. Then the hip is fully extended on treatment table and CMR is applied on Vastus lateralis muscle for 1 minute. Treatment consists of broad strokes applied with clinicians knuckles to release superficial restrictions, followed by more specific strokes applied with clinicians' thumb on tight muscle. Strokes are applied at a contact point of 45 degree. With pressure directed from distal to proximal.
conventional treatment groupOther
Patients in this group will receive treatment of Hot pack and Tens for 20 minutes, Range of motion exercises (knee flexion and extension ROM's), Stretching exercises (3sets, 10 reps for 5 second hold)
| Study group | Role | What they receive |
|---|---|---|
| Compressive myofascial release | Experimental | . patients in this group will receive treatment through CMR that includes shaking the muscle belly of vastus lateralis for 30 seconds. Then the hip is fully extended on treatment table and CMR is applied on Vastus lateralis muscle for 1 minute. Treatment consists of broad strokes applied with clinicians knuckles to release superficial restrictions, followed by more specific strokes applied with clinicians' thumb on tight muscle. Strokes are applied at a contact point of 45 degree. with pressure directed from distal to proximal.
Conventional treatment of Hot pack and Tens for 20 minutes, Range of motion exercises (knee flexion and extension ROM's), Stretching exercises (3sets, 10 reps for 5 second hold) Receives: Other: compressive myofascial release |
| Conventional treatment | Active comparator | Patients in this group will receive treatment of Hot pack and Tens for 20 minutes, Range of motion exercises (knee flexion and extension ROM's), Stretching exercises (3sets, 10 reps for 5 second hold) Receives: Other: conventional treatment group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Western Ontario and McMaster Universities Arthrosis Index (WOMAC) scale:
Western Ontario and McMaster Universities Arthrosis Index WOMAC was first developed in 1988 by Bellamy for use in patients with hip and knee osteoarthritis is a self-administered tool comprising of 24 items divided into 3 sub scales. It was used to assess pain, stiffness and physical function in knee osteoarthritis patients which were allocated in the study. Patient's pain is assessed by asking about intensity of pain in different positions including pain intensity at rest through 5 questions. Patient is asked about stiffness level in the morning and evening (2 questions). Patients is also assessed for difficulty doing several daily and self-care activities in 17 different questions. Each item in sub scale carries maximum score of 4 and minimum score of 0. Overall score of WOMAC scale is 100 with a cutoff value of 39. In first session, 2 and 4 weeks after treatment sessions.
Measured: 4th Week
Secondary outcomes (1)
Numeric Pain Rating Scale:
Numeric pain rating scale is a type of scale which is used to measure pain intensity. It is easy to use as the patient can report the intensity of his/her pain by simply looking at the scale. The scale has ratings from 0 to 10, where the point 0 means no pain, the points 1, 2 and 3 measure pain of mild intensity, the points 4,5 and 6 measure pain of moderate intensity and the demarcations 7,8,9 and 10 measures severe intensity of pain. It was used in this study to measure the intensity of knee joint pain reported by each patient. Numeric pain rating scale is preferred over visual analog scale for use in elderly individuals. The patients are asked about the subjective examination of intensity of pain after describing the demarcations present on the scale to the patient about the maximum and minimum values. In first session, 2 and 4 weeks after treatment sessions.
Measured: 4th Week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2021
- Study start14 Aug 2020
- Primary completion30 Jul 2021
- Study completion31 Jul 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (24)Papers the sponsor has linked to this study.
- Other trials for Osteoarthritis, KneeStudies 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
- the purpose of this study is to compare the effects of compressive myofascial release on lateral patellar tracking inpatients with knee osteoarthritis. an RCT trial was conducted at Railway general hospital, Ahad medi care clinics and physiotherapy centre rawat and THP Bahria town phase 6.sample size was 52 calculated through open-epi tool. participants divided into control and experimental group.participants diagnosed with grade 2and 3 K\&L classification of knee OA included.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Lal Gul Khan, MScPT, Principal investigator, Riphah International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05052593
- Sponsor's protocol ID
- REC/00870 Rubia Batool
- Status last verified
- Sep 2021
- First submitted
- 11 Jun 2021
- Last updated
- 22 Sep 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Brandt KD, Fife RS, Braunstein EM, Katz B. Radiographic grading of the severity of knee osteoarthritis: relation of the Kellgren and Lawrence grade to a grade based on joint space narrowing, and correlation with arthroscopic evidence of articular cartilage degeneration. Arthritis Rheum. 1991 Nov;34(11):1381-6. doi: 10.1002/art.1780341106.
PubMed 1953815Zhang Y, Jordan JM. Epidemiology of osteoarthritis. Clin Geriatr Med. 2010 Aug;26(3):355-69. doi: 10.1016/j.cger.2010.03.001.
PubMed 20699159Hunter DJ, Felson DT. Clinical review: osteoarthritis. British Medical Journal [periódico online]. 2006:639-42.
Doucette SA, Goble EM. The effect of exercise on patellar tracking in lateral patellar compression syndrome. Am J Sports Med. 1992 Jul-Aug;20(4):434-40. doi: 10.1177/036354659202000412.
PubMed 1415887Ntagiopoulos PG, Dejour D. Patellofemoral Pain, Instability, and Arthritis. Patellofemoral Pain, Instability, and Arthritis: Clinical Presentation, Imaging, and Treatment. 2020:1.
Turkmen F, Acar MA, Kacira BK, Korucu IH, Erkocak OF, Yolcu B, Toker S. A new diagnostic parameter for patellofemoral pain. Int J Clin Exp Med. 2015 Jul 15;8(7):11563-6. eCollection 2015.
PubMed 26379982Rozenfeld E, Finestone AS, Moran U, Damri E, Kalichman L. The prevalence of myofascial trigger points in hip and thigh areas in anterior knee pain patients. J Bodyw Mov Ther. 2020 Jan;24(1):31-38. doi: 10.1016/j.jbmt.2019.05.010. Epub 2019 May 14.
PubMed 31987560Stanek J, Sullivan T, Davis S. Comparison of Compressive Myofascial Release and the Graston Technique for Improving Ankle-Dorsiflexion Range of Motion. J Athl Train. 2018 Feb;53(2):160-167. doi: 10.4085/1062-6050-386-16. Epub 2018 Jan 26.
PubMed 29373060Vijayakumar M, Jaideep A, Khankal R. Effectiveness of Compressive Myofascial Release Vs Instrument Assisted Soft Tissue Mobilization in Subjects with Active Trigger Points of the Calf Muscle Limiting Ankle Dorsiflexion. International Journal of Health Sciences and Research. 2019;9(4):98-106
De Souza IG, Pavan Kumar G. Effect of Releasing Myofascial Chain in Patients with Patellofemoral Pain Syndrome-A Randomized Clinical Trial. Int J Cur Res Rev| Vol. 2020;12(08):5.
Kohn MD, Sassoon AA, Fernando ND. Classifications in Brief: Kellgren-Lawrence Classification of Osteoarthritis. Clin Orthop Relat Res. 2016 Aug;474(8):1886-93. doi: 10.1007/s11999-016-4732-4. Epub 2016 Feb 12. No abstract available.
PubMed 26872913Ferre IM, Roof MA, Anoushiravani AA, Wasterlain AS, Lajam CM. Understanding the Observed Sex Discrepancy in the Prevalence of Osteoarthritis. JBJS Rev. 2019 Sep;7(9):e8. doi: 10.2106/JBJS.RVW.18.00182. No abstract available.
PubMed 31567717Nguyen TV. Osteoarthritis in southeast Asia. International Journal of Clinical Rheumatology. 2014.
Jordan JM, Helmick CG, Renner JB, Luta G, Dragomir AD, Woodard J, Fang F, Schwartz TA, Abbate LM, Callahan LF, Kalsbeek WD, Hochberg MC. Prevalence of knee symptoms and radiographic and symptomatic knee osteoarthritis in African Americans and Caucasians: the Johnston County Osteoarthritis Project. J Rheumatol. 2007 Jan;34(1):172-80.
PubMed 17216685Dor A, Kalichman L. A myofascial component of pain in knee osteoarthritis. J Bodyw Mov Ther. 2017 Jul;21(3):642-647. doi: 10.1016/j.jbmt.2017.03.025. Epub 2017 Apr 6.
PubMed 28750978
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Compressive Myofascial Release of Vastus Lateralis on Lateral Patellar Tracking in Patients With Knee Osteoarthritis.
- ClinicalTrials.gov ID
- NCT05052593
- Acronym / sponsor ID
- REC/00870 Rubia Batool
- Conditions
- Osteoarthritis, Knee
- Keywords
- knee osteoarthritis, compressive myofascial release, lateral patellar tracking
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 14 Aug 2020 (actual)
- Primary completion
- 30 Jul 2021 (actual)
- Study completion
- 31 Jul 2021 (actual)
- First posted
- 22 Sep 2021 (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.
The purpose of the study is to compare the effects of compressive myofascial release and conventional knee osteoarthritis treatment to correct lateral patellar tracking. A randomized control trial was conducted at Railway General Hospital, Ahad Medicare clinics and physiotherapy Centre and The Health Professional physiotherapy clinic Bahria town phase 6. The sample size was 52 calculated through open-epi tool. The participants were divided into two interventional groups each having 26 participants. The study duration was six months. Sampling technique applied was non probability convenient sampling for recruitment and group randomization using sealed enveloped method. Only participants who were 50 years above with grade 2 and 3 knee osteoarthritis were included in the study. Tools used in this study are Q angle, numeric pain rating scale, goniometry and WOMAC questionnaire, Self structured Questionnaire. Data was collected at baseline, at the end of 3rd session and 6th session. Data analyzed through SPSS version 23.
Detailed description
knee osteoarthritis is commonly manifested as decreased joint space, sub chondral bone sclerosis, bony spur formation, cartilage loss and mainly lateral patellar tracking(2).Lateral patellar tracking is a condition in which patellar move laterally in relation to femoral groove on flexion and extension(4). Patellofemoral disorders are very common in patients of knee OA. One of the very common manifestation of which is lateral patellar tracking(5). Patella move laterally due to certain disorders of knee that include patellofemoral pain syndrome and anterior knee pain. Q-angle is used as an indicator of patellofemoral pain syndrome. When Q angle exceeds its normal limit i.e. 15-20 degrees it leads to lateral mal positioning of patella(6). Rozenfeld, E et al. in 2019 conducted a cross sectional study with a diagnosis of anterior knee pain that suggests highest prevalence of myofascial trigger points in distal vastus lateralis and mid and distal vastus lateralis. It also reported that presence of trigger points in anterior knee pain(7). There are several techniques that are used to release trigger points.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- the purpose of this study is to compare the effects of compressive myofascial release on lateral patellar tracking inpatients with knee osteoarthritis. an RCT trial was conducted at Railway general hospital, Ahad medi care clinics and physiotherapy centre rawat and THP Bahria town phase 6.sample size was 52 calculated through open-epi tool. participants divided into control and experimental group.participants diagnosed with grade 2and 3 K\&L classification of knee OA included.
| Arm | Type | Receives |
|---|---|---|
| Compressive myofascial release | Experimental | Other: compressive myofascial release. patients in this group will receive treatment through CMR that includes shaking the muscle belly of vastus lateralis for 30 seconds. Then the hip is fully extended on treatment table and CMR is applied on Vastus lateralis muscle for 1 minute. Treatment consists of broad strokes applied with clinicians knuckles to release superficial restrictions, followed by more specific strokes applied with clinicians' thumb on tight muscle. Strokes are applied at a contact point of 45 degree. with pressure directed from distal to proximal. Conventional treatment of Hot pack and Tens for 20 minutes, Range of motion exercises (knee flexion and extension ROM's), Stretching exercises (3sets, 10 reps for 5 second hold) |
| Conventional treatment | Active comparator | Other: conventional treatment groupPatients in this group will receive treatment of Hot pack and Tens for 20 minutes, Range of motion exercises (knee flexion and extension ROM's), Stretching exercises (3sets, 10 reps for 5 second hold) |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Includes diagnosed cases of knee osteoarthritis
- Grades 2-3 according to the Kellgren and Lawrence method of grading(1)
- Includes patients from the age group of 50 years and above(3)
- Includes knee osteoarthritis patients with lateral tracking of patella which will assessed through Q angle test(4)
Key exclusion criteria (4 listed)
- history of recent trauma to knee
- History of hip disease
- Past history of knee surgery/arthroplasty
- Intraarticular corticosteroid injection
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 |
|---|---|---|
| compressive myofascial releasePatients in this group will receive treatment through CMR that includes shaking the muscle belly of vastus lateralis for 30 seconds. Then the hip is fully extended on treatment table and CMR is applied on Vastus lateralis muscle for 1 minute. Treatment consists of broad strokes applied with clinicians knuckles to release superficial restrictions, followed by more specific strokes applied with clinicians' thumb on tight muscle. Strokes are applied at a contact point of 45 degree. With pressure directed from distal to proximal. | Other | Compressive myofascial release |
| conventional treatment groupPatients in this group will receive treatment of Hot pack and Tens for 20 minutes, Range of motion exercises (knee flexion and extension ROM's), Stretching exercises (3sets, 10 reps for 5 second hold) | Other | Conventional treatment |
Primary outcome
Western Ontario and McMaster Universities Arthrosis Index (WOMAC) scale:
Time frame: 4th Week
Western Ontario and McMaster Universities Arthrosis Index WOMAC was first developed in 1988 by Bellamy for use in patients with hip and knee osteoarthritis is a self-administered tool comprising of 24 items divided into 3 sub scales. It was used to assess pain, stiffness and physical function in knee osteoarthritis patients which were allocated in the study. Patient's pain is assessed by asking about intensity of pain in different positions including pain intensity at rest through 5 questions. Patient is asked about stiffness level in the morning and evening (2 questions). Patients is also assessed for difficulty doing several daily and self-care activities in 17 different questions. Each item in sub scale carries maximum score of 4 and minimum score of 0. Overall score of WOMAC scale is 100 with a cutoff value of 39. In first session, 2 and 4 weeks after treatment sessions.
1 secondary outcome
Numeric Pain Rating Scale:
Time frame: 4th Week
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 22 Sep 2021.
- Background: PubMed 1953815Brandt KD, Fife RS, Braunstein EM, Katz B. Radiographic grading of the severity of knee osteoarthritis: relation of the Kellgren and Lawrence grade to a grade based on joint space narrowing, and correlation with arthroscopic evidence of articular cartilage degeneration. Arthritis Rheum. 1991 Nov;34(11):1381-6. doi: 10.1002/art.1780341106.
- Background: PubMed 20699159Zhang Y, Jordan JM. Epidemiology of osteoarthritis. Clin Geriatr Med. 2010 Aug;26(3):355-69. doi: 10.1016/j.cger.2010.03.001.
- BackgroundHunter DJ, Felson DT. Clinical review: osteoarthritis. British Medical Journal [periódico online]. 2006:639-42.
- Background: PubMed 1415887Doucette SA, Goble EM. The effect of exercise on patellar tracking in lateral patellar compression syndrome. Am J Sports Med. 1992 Jul-Aug;20(4):434-40. doi: 10.1177/036354659202000412.
- BackgroundNtagiopoulos PG, Dejour D. Patellofemoral Pain, Instability, and Arthritis. Patellofemoral Pain, Instability, and Arthritis: Clinical Presentation, Imaging, and Treatment. 2020:1.
- Background: PubMed 26379982Turkmen F, Acar MA, Kacira BK, Korucu IH, Erkocak OF, Yolcu B, Toker S. A new diagnostic parameter for patellofemoral pain. Int J Clin Exp Med. 2015 Jul 15;8(7):11563-6. eCollection 2015.
- Background: PubMed 31987560Rozenfeld E, Finestone AS, Moran U, Damri E, Kalichman L. The prevalence of myofascial trigger points in hip and thigh areas in anterior knee pain patients. J Bodyw Mov Ther. 2020 Jan;24(1):31-38. doi: 10.1016/j.jbmt.2019.05.010. Epub 2019 May 14.
- Background: PubMed 29373060Stanek J, Sullivan T, Davis S. Comparison of Compressive Myofascial Release and the Graston Technique for Improving Ankle-Dorsiflexion Range of Motion. J Athl Train. 2018 Feb;53(2):160-167. doi: 10.4085/1062-6050-386-16. Epub 2018 Jan 26.
- BackgroundVijayakumar M, Jaideep A, Khankal R. Effectiveness of Compressive Myofascial Release Vs Instrument Assisted Soft Tissue Mobilization in Subjects with Active Trigger Points of the Calf Muscle Limiting Ankle Dorsiflexion. International Journal of Health Sciences and Research. 2019;9(4):98-106
- BackgroundDe Souza IG, Pavan Kumar G. Effect of Releasing Myofascial Chain in Patients with Patellofemoral Pain Syndrome-A Randomized Clinical Trial. Int J Cur Res Rev| Vol. 2020;12(08):5.
- Background: PubMed 26872913Kohn MD, Sassoon AA, Fernando ND. Classifications in Brief: Kellgren-Lawrence Classification of Osteoarthritis. Clin Orthop Relat Res. 2016 Aug;474(8):1886-93. doi: 10.1007/s11999-016-4732-4. Epub 2016 Feb 12. No abstract available.
- Background: PubMed 31567717Ferre IM, Roof MA, Anoushiravani AA, Wasterlain AS, Lajam CM. Understanding the Observed Sex Discrepancy in the Prevalence of Osteoarthritis. JBJS Rev. 2019 Sep;7(9):e8. doi: 10.2106/JBJS.RVW.18.00182. No abstract available.
- 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.
Lal Gul Khan, MScPT principal investigator
Riphah International University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing compressive myofascial release and conventional treatment group in people with Osteoarthritis, Knee, run by Riphah International University at 2 sites 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 4 inclusion and 4 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 22 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Western Ontario and McMaster Universities Arthrosis Index (WOMAC) scale: (time frame: 4th Week). 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 NCT05052593, which also lists 24 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 Sep 2021.