Knee OsteoarthritisNCT04546659
Retro-walking in Knee Osteoarthritis
A study testing Retrowalking and Conventional Therapy in people with Knee Osteoarthritis, run by Riphah International University at 1 site in Pakistan.
Trial summary
In osteoarthritis the most affected joint is knee due to degenerative changes. Degenerative changes cause age-related wear-and-tear and may be accelerated by injury, health and lifestyle factors, and possibly by genetic predisposition to joint pain or musculoskeletal disorders. Read more about this study
- Who is it for?
- Ages 40 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Knee Osteoarthritis
- What is being tested?
- Retrowalking and Conventional Therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 1 sitePakistan
- Study dates
- 1 May 2020to 1 Feb 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 40 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patient suffering with Osteoarthritis knee for three months at least
- Age ranges from 40-70
- knee OA as per the American College of Rheumatology clinical and radiographic diagnostic criteria will participate
- 1-3 radiographic grades on the Kellgren-Lawrence scale
- Both genders will be included
- being able to cooperate
- Bilateral knee osteoarthritis
Who cannot join
- Traumatic knee pain, fractures or ruptured ligaments, meniscopathy of knee joint
- Inflammatory and Infectious knee conditions (RA, gout, psoriatic arthritis)
- Balance problem
- Any recent surgical intervention of knee joint or those who had undergone arthroplasty
- Surgeries in hip or knee
- Tumors/malignancy of bone
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Retro-walking on Pain, Functional Disability and Performance in Knee Osteoarthritis
In osteoarthritis the most affected joint is knee due to degenerative changes. Degenerative changes cause age-related wear-and-tear and may be accelerated by injury, health and lifestyle factors, and possibly by genetic predisposition to joint pain or musculoskeletal disorders. Knee osteoarthritis causes pain, swelling \& stiffness in joint. Patients unable to perform ADL's and IADL's due to pain.
Various treatment methods are used for management of knee osteoarthritis. But physiotherapy approach is best option for making patients independent after medical management. This study will be a randomized control trial, used to compare the effectiveness of retro-walking and conventional therapy to improve pain, functional disability and performance in knee osteoarthritic patient. Subjects with knee osteoarthritis meeting the predetermined inclusion \& exclusion criteria will divide into two groups using lottery method. Time up \& Go (TUG), Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) \& Numeric Pain Rating Scale (NPRS) tools for screening will be used for data collection. Subjects in one group will be treated with retro-walking \& conventional therapy and other will be treated with conventional therapy. Each subject will receive a total 6 weeks treatment session, with 3 treatment sessions per week. Recorded values will be analyzed for any change using SPSS 21 version.
Read the detailed description
Knee osteoarthritis causes chronic disability in the older population worldwide. Its prevalence increases dramatically with age. Prevalence of radiographic osteoarthritis is estimated at 80 % of all adults at or over the age of 65 years. The common impairments such as knee pain, decreased functional mobility, quadriceps strength, and stiffness leading to physical disability have been associated with knee osteoarthritis .
The prevalence of osteoarthritis is gradually in- creasing in both low- and high-income countries.The Global Burden of Disease studies recently indicated that knee osteoarthritis is the fastest increasing major health dis- order and the second global cause of disability. In the lower extremity, the knee is often affected, and knee osteoarthritis results in significant mobility restrictions and a substantial financial burden. The risk of osteoarthritis associated disability is equal to that of cardiac disorders and more common than any other medical problem in older populations. The common clinical manifestations of knee osteoarthritis include pain, stiffness, joint enlargement, crepitus, muscle weakness, deformity, impaired proprioception, reduced joint motion, and disability. Therapeutic exercises are often used to improve physiological impairments such as reduced joint motion, muscle weakness, impaired balance, disability, and proprioception.
Forward walking provides an increased opportunity to train the entire gait cycle, facilitating an enhanced gait pattern in children with cerebral palsy. Backward walking is recommended to improve the components of forward walking in those children. Hoog kamer et al. reported that backward walking uses the same rhythm circuitry of forward walking, but additionally requires specialized control circuits. Gait rehabilitation with backward walking puts emphasis on positioning the foot behind the body and, thus, facilitates hip extension while performing a knee flexion that can be useful for patients who have synergistic influences in the lower extremity. A longer period of muscles activity of the legs during backward walking training can result in greater muscle strength gain as compared with for- ward walking training. Furthermore, training in backward walking could require higher physiological and perceptual responses than forward walking at matched speed, as backward walking is the performance of a novel task for most children with cerebral palsy.
Among the current possible gait training methods, backward walking has emerged as an important therapy. Backward walking is regulated by the same central pattern generator as forward walking. Unlike forward walking, backward walking has no heel contact in the early stance phase and thus leads to lower compression force at the patella femoral joint and decreased force absorption at the knee joint. In addition, lower limb muscle activity during backward walking is intensified on account of the higher recruitment of motor units. During the loading response phase of backward walking, the ground reaction force rapidly increases to support the weight of the entire body. The absence of visual cues during backward walking results in increased spatial and smaller temporal gait parameters. Therefore, backward walking can be considered as a treatment strategy to improve gait.
Many pharmacological treatment strategies may improve disease-related impairments; however, have limited impact on gait. In recent years, backward walking has become an attractive alternative for training and rehabilitation purposes to improve mobility. For individuals with stroke, both over ground and treadmill backward walking training has been affective to improve walking speed, stride length , gait asymmetry, gait cycle phases, functional capacity and balance. Similarly, in children with cerebral palsy, Backward Walking treadmill training improved gait speed, step length, Stride Length and functional capacity and the addition of over ground Backward Walking to a traditional physical therapy program improved overall postural instability.
To our knowledge, there is a lack of studies has evaluated the Effects of Retro-walking on pain, functional disability and performance in knee osteoarthritis. Investigator developed a program to apply retro-walking to Osteoarthritic patients. Repetition of movements will be added to program. This program is design to improve knee performance, functional ability \& reduce pain. The purpose of the present study is to examine the efficiency of retro-walking to improve functional disability and performance and reduce pain in patients with osteoarthritis.
Investigator predict that retro-walking will improve performance, functional disability \& pain in patients with knee osteoarthritis; they will enhance their performance, movement as well as functional abilities. Also so there is awareness in community for the efficacy of neurodevelopmental therapy for the management in Down syndrome infants.
- Conditions
- Knee Osteoarthritis
- Being tested
- Retrowalking, Conventional Therapy
- Keywords
- Knee osteoarthritis, knee joint, pain
- Medical subject headings
- Osteoarthritis, Knee, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RetrowalkingOther
Treatment of retro-walking including supervised 10 min retro-walking training with 5 min of warm-up and cool down on a flat surface at their comfortable speed
Conventional TherapyOther
Treatment of conventional therapy involve Isometric Quadriceps exercise, SLR, Isometric hip adduction exercises, Terminal knee extension exercise 1 set of 10 Reps twice a day.
| Study group | Role | What they receive |
|---|---|---|
| Group A | Experimental | Osteoarthritic patient receiving Conventional therapy and Retrowalking Receives: Other: Retrowalking; Other: Conventional Therapy |
| Group B | Active comparator | Osteoarthritic patient receiving Conventional therapy Receives: Other: Conventional Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Western Ontario & Mc-master Osteoarthritis Index
The WOMAC takes approximately 12 minutes to complete, and can be taken on paper, over the telephone or computer. Both the computerized and the mobile versions of the test have been found to be comparable to the paper form, with no significant difference.
The test questions are scored on a scale of 0-4, which correspond to: None (0), Mild (1), Moderate (2), Severe (3), and Extreme (4).
The scores for each subscale are summed up, with a possible score range of 0-20 for Pain, 0-8 for Stiffness, and 0-68 for Physical Function. Usually a sum of the scores for all three subscales gives a total WOMAC score, however there are other methods that have been used to combine scores.
Higher scores on the WOMAC indicate worse pain, stiffness, and functional limitations.
Measured: 12 weeks
Secondary outcomes (2)
Time Up & Go Test
An older adult who takes ≥12 seconds to complete the TUG is at risk for falling.
Cut of scores indicating risk of falls by Population (in seconds) Community dwelling adults - 13.5 Older stroke patients - 14 Frail elderly - 32.6 LE amputees - 19 PD - 11.5 Hip OA - 10 - Vestibular disorders - 11.1 Cut-off times to classify subjects as high risk for falling vary based on the study and participants.
Measured: 12 weeks
Numeric Pain Rating Scale
The Numeric Pain Rating Scale (NPRS) (an outcome measure) that is a unidimensional measure of pain intensity in adults,including those with chronic pain due to rheumatic diseases.
0 means no pain and 10 means the worst possible pain
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2020
- Study start1 May 2020
- Primary completion1 Jan 2021
- Study completion1 Feb 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)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
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Muhammad Hashim, PPDPT, Principal investigator, Riphah International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04546659
- Sponsor's protocol ID
- REC/Lhr/20/1055 Saira Shabbir
- Status last verified
- Mar 2021
- First submitted
- 4 Sep 2020
- Last updated
- 1 Apr 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Goh SL, Persson MSM, Stocks J, Hou Y, Welton NJ, Lin J, Hall MC, Doherty M, Zhang W. Relative Efficacy of Different Exercises for Pain, Function, Performance and Quality of Life in Knee and Hip Osteoarthritis: Systematic Review and Network Meta-Analysis. Sports Med. 2019 May;49(5):743-761. doi: 10.1007/s40279-019-01082-0.
PubMed 30830561Gondhalekar GA, Deo MV. Retrowalking as an adjunct to conventional treatment versus conventional treatment alone on pain and disability in patients with acute exacerbation of chronic knee osteoarthritis: a randomized clinical trial. N Am J Med Sci. 2013 Feb;5(2):108-12. doi: 10.4103/1947-2714.107527.
PubMed 23641371Jeong HS, Lee SC, Jee H, Song JB, Chang HS, Lee SY. Proprioceptive Training and Outcomes of Patients With Knee Osteoarthritis: A Meta-Analysis of Randomized Controlled Trials. J Athl Train. 2019 Apr;54(4):418-428. doi: 10.4085/1062-6050-329-17. Epub 2019 Apr 17.
PubMed 30995119Black DW. Treatment of knee arthrofibrosis and quadriceps insufficiency after patellar tendon repair: a case report including use of the graston technique. Int J Ther Massage Bodywork. 2010 Jun 23;3(2):14-21.
PubMed 21589706Chen ZH, Ye XL, Chen WJ, Chen GQ, Wu JT, Wu H, Xu XM. Effectiveness of backward walking for people affected by stroke: A systematic review and meta-analysis of randomized controlled trials. Medicine (Baltimore). 2020 Jul 2;99(27):e20731. doi: 10.1097/MD.0000000000020731.
PubMed 32629648
Study at a glance
From the registry record, last updated by the sponsor on 1 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Retro-walking on Pain, Functional Disability and Performance in Knee Osteoarthritis
- ClinicalTrials.gov ID
- NCT04546659
- Acronym / sponsor ID
- REC/Lhr/20/1055 Saira Shabbir
- Conditions
- Knee Osteoarthritis
- Keywords
- Knee osteoarthritis, knee joint, pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 1 May 2020 (actual)
- Primary completion
- 1 Jan 2021 (actual)
- Study completion
- 1 Feb 2021 (actual)
- First posted
- 14 Sep 2020 (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.
In osteoarthritis the most affected joint is knee due to degenerative changes. Degenerative changes cause age-related wear-and-tear and may be accelerated by injury, health and lifestyle factors, and possibly by genetic predisposition to joint pain or musculoskeletal disorders. Knee osteoarthritis causes pain, swelling \& stiffness in joint. Patients unable to perform ADL's and IADL's due to pain.
Various treatment methods are used for management of knee osteoarthritis. But physiotherapy approach is best option for making patients independent after medical management. This study will be a randomized control trial, used to compare the effectiveness of retro-walking and conventional therapy to improve pain, functional disability and performance in knee osteoarthritic patient. Subjects with knee osteoarthritis meeting the predetermined inclusion \& exclusion criteria will divide into two groups using lottery method. Time up \& Go (TUG), Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) \& Numeric Pain Rating Scale (NPRS) tools for screening will be used for data collection. Subjects in one group will be treated with retro-walking \& conventional therapy and other will be treated with conventional therapy. Each subject will receive a total 6 weeks treatment session, with 3 treatment sessions per week. Recorded values will be analyzed for any change using SPSS 21 version.
Detailed description
Knee osteoarthritis causes chronic disability in the older population worldwide. Its prevalence increases dramatically with age. Prevalence of radiographic osteoarthritis is estimated at 80 % of all adults at or over the age of 65 years. The common impairments such as knee pain, decreased functional mobility, quadriceps strength, and stiffness leading to physical disability have been associated with knee osteoarthritis .
The prevalence of osteoarthritis is gradually in- creasing in both low- and high-income countries.The Global Burden of Disease studies recently indicated that knee osteoarthritis is the fastest increasing major health dis- order and the second global cause of disability. In the lower extremity, the knee is often affected, and knee osteoarthritis results in significant mobility restrictions and a substantial financial burden. The risk of osteoarthritis associated disability is equal to that of cardiac disorders and more common than any other medical problem in older populations. The common clinical manifestations of knee osteoarthritis include pain, stiffness, joint enlargement, crepitus, muscle weakness, deformity, impaired proprioception, reduced joint motion, and disability. Therapeutic exercises are often used to improve physiological impairments such as reduced joint motion, muscle weakness, impaired balance, disability, and proprioception.
Forward walking provides an increased opportunity to train the entire gait cycle, facilitating an enhanced gait pattern in children with cerebral palsy. Backward walking is recommended to improve the components of forward walking in those children. Hoog kamer et al. reported that backward walking uses the same rhythm circuitry of forward walking, but additionally requires specialized control circuits. Gait rehabilitation with backward walking puts emphasis on positioning the foot behind the body and, thus, facilitates hip extension while performing a knee flexion that can be useful for patients who have synergistic influences in the lower extremity. A longer period of muscles activity of the legs during backward walking training can result in greater muscle strength gain as compared with for- ward walking training. Furthermore, training in backward walking could require higher physiological and perceptual responses than forward walking at matched speed, as backward walking is the performance of a novel task for most children with cerebral palsy.
Among the current possible gait training methods, backward walking has emerged as an important therapy. Backward walking is regulated by the same central pattern generator as forward walking. Unlike forward walking, backward walking has no heel contact in the early stance phase and thus leads to lower compression force at the patella femoral joint and decreased force absorption at the knee joint. In addition, lower limb muscle activity during backward walking is intensified on account of the higher recruitment of motor units. During the loading response phase of backward walking, the ground reaction force rapidly increases to support the weight of the entire body. The absence of visual cues during backward walking results in increased spatial and smaller temporal gait parameters. Therefore, backward walking can be considered as a treatment strategy to improve gait.
Many pharmacological treatment strategies may improve disease-related impairments; however, have limited impact on gait. In recent years, backward walking has become an attractive alternative for training and rehabilitation purposes to improve mobility. For individuals with stroke, both over ground and treadmill backward walking training has been affective to improve walking speed, stride length , gait asymmetry, gait cycle phases, functional capacity and balance. Similarly, in children with cerebral palsy, Backward Walking treadmill training improved gait speed, step length, Stride Length and functional capacity and the addition of over ground Backward Walking to a traditional physical therapy program improved overall postural instability.
To our knowledge, there is a lack of studies has evaluated the Effects of Retro-walking on pain, functional disability and performance in knee osteoarthritis. Investigator developed a program to apply retro-walking to Osteoarthritic patients. Repetition of movements will be added to program. This program is design to improve knee performance, functional ability \& reduce pain. The purpose of the present study is to examine the efficiency of retro-walking to improve functional disability and performance and reduce pain in patients with osteoarthritis.
Investigator predict that retro-walking will improve performance, functional disability \& pain in patients with knee osteoarthritis; they will enhance their performance, movement as well as functional abilities. Also so there is awareness in community for the efficacy of neurodevelopmental therapy for the management in Down syndrome infants.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A | Experimental | Other: Retrowalking, Other: Conventional TherapyOsteoarthritic patient receiving Conventional therapy and Retrowalking |
| Group B | Active comparator | Other: Conventional TherapyOsteoarthritic patient receiving Conventional therapy |
Who may qualify
- Ages
- 40 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Patient suffering with Osteoarthritis knee for three months at least
- Age ranges from 40-70
- knee OA as per the American College of Rheumatology clinical and radiographic diagnostic criteria will participate
- 1-3 radiographic grades on the Kellgren-Lawrence scale
- Both genders will be included
Key exclusion criteria (6 listed)
- Traumatic knee pain, fractures or ruptured ligaments, meniscopathy of knee joint
- Inflammatory and Infectious knee conditions (RA, gout, psoriatic arthritis)
- Balance problem
- Any recent surgical intervention of knee joint or those who had undergone arthroplasty
- Surgeries in hip or knee
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 |
|---|---|---|
| RetrowalkingTreatment of retro-walking including supervised 10 min retro-walking training with 5 min of warm-up and cool down on a flat surface at their comfortable speed | Other | Group A |
| Conventional TherapyTreatment of conventional therapy involve Isometric Quadriceps exercise, SLR, Isometric hip adduction exercises, Terminal knee extension exercise 1 set of 10 Reps twice a day. | Other | Group A, Group B |
Primary outcome
Western Ontario & Mc-master Osteoarthritis Index
Time frame: 12 weeks
The WOMAC takes approximately 12 minutes to complete, and can be taken on paper, over the telephone or computer. Both the computerized and the mobile versions of the test have been found to be comparable to the paper form, with no significant difference. The test questions are scored on a scale of 0-4, which correspond to: None (0), Mild (1), Moderate (2), Severe (3), and Extreme (4). The scores for each subscale are summed up, with a possible score range of 0-20 for Pain, 0-8 for Stiffness, and 0-68 for Physical Function. Usually a sum of the scores for all three subscales gives a total WOMAC score, however there are other methods that have been used to combine scores. Higher scores on the WOMAC indicate worse pain, stiffness, and functional limitations.
2 secondary outcomes
Time Up & Go Test
Time frame: 12 weeks
Numeric Pain Rating Scale
Time frame: 12 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 1 Apr 2021.
- Background: PubMed 30830561Goh SL, Persson MSM, Stocks J, Hou Y, Welton NJ, Lin J, Hall MC, Doherty M, Zhang W. Relative Efficacy of Different Exercises for Pain, Function, Performance and Quality of Life in Knee and Hip Osteoarthritis: Systematic Review and Network Meta-Analysis. Sports Med. 2019 May;49(5):743-761. doi: 10.1007/s40279-019-01082-0.
- Background: PubMed 23641371Gondhalekar GA, Deo MV. Retrowalking as an adjunct to conventional treatment versus conventional treatment alone on pain and disability in patients with acute exacerbation of chronic knee osteoarthritis: a randomized clinical trial. N Am J Med Sci. 2013 Feb;5(2):108-12. doi: 10.4103/1947-2714.107527.
- Background: PubMed 30995119Jeong HS, Lee SC, Jee H, Song JB, Chang HS, Lee SY. Proprioceptive Training and Outcomes of Patients With Knee Osteoarthritis: A Meta-Analysis of Randomized Controlled Trials. J Athl Train. 2019 Apr;54(4):418-428. doi: 10.4085/1062-6050-329-17. Epub 2019 Apr 17.
- Background: PubMed 21589706Black DW. Treatment of knee arthrofibrosis and quadriceps insufficiency after patellar tendon repair: a case report including use of the graston technique. Int J Ther Massage Bodywork. 2010 Jun 23;3(2):14-21.
- Background: PubMed 32629648Chen ZH, Ye XL, Chen WJ, Chen GQ, Wu JT, Wu H, Xu XM. Effectiveness of backward walking for people affected by stroke: A systematic review and meta-analysis of randomized controlled trials. Medicine (Baltimore). 2020 Jul 2;99(27):e20731. doi: 10.1097/MD.0000000000020731.
- Individual participant dataSharing planned: No
Related trials for Knee Osteoarthritis
Recruiting
Aquatic Exercise in Patients With Knee Osteoarthritis
Central Sensitization, Knee Osteoarthristis
Active, not recruiting
14022 ATTUNE Cementless RP Clinical Performance Evaluation
Osteoarthritis
Not yet recruiting
Patient Satisfaction After Robotic-Assisted Versus Conventional Total Knee Arthroplasty
Osteoarthritis (Knee), Robotic Assisted Arthroplasty
Active, not recruiting
Study to Evaluate the Safety and Effectiveness of the REAL INTELLIGENCE™ CORI™ in Total Knee Arthroplasty (TKA) Procedure
Arthroplasty, Replacement
Active, not recruiting
Comparative Effect of Dual Task Training and Rhythmic Stabilization in Knee Osteoarthritis Patients
Knee Osteoarthritis
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.
Muhammad Hashim, PPDPT 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 Retrowalking and Conventional Therapy 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 7 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 1 Apr 2021. 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?
Western Ontario & Mc-master Osteoarthritis Index (time frame: 12 weeks). 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 NCT04546659, which also lists 5 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 1 Apr 2021.