Osteoarthritis, KneeNCT06306079
Using Gait Modification to Treat Knee Osteoarthritis in Saudi Arabia: Possibilities and Acceptability.
A study testing Lateral Wedge insole in people with Osteoarthritis, Knee and Pain, run by King Khalid University at 1 site in Saudi Arabia.
Trial summary
A variety of biomechanical gait modification interventions can elevate knee loading and improve knee symptoms in knee osteoarthritis patients. However, there was a lack of acceptability and adherence regarding modification interventions without any explanation. Read more about this study
- Who is it for?
- Ages 45 years and older
- Conditions the study is for
- Osteoarthritis, Knee, Pain, Biomechanical Lesion
- What is being tested?
- Lateral Wedge insole
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 17 participants
- Where
- 1 siteSaudi Arabia
- Study dates
- 13 Apr 2022to 30 Dec 2022
- 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
- KOA Patient participants:
- Adults aged above 45 years old.
- Both Male \& Female.
- Radiographically or KOA participants meet any diagnostic classification guidelines/criteria (American College of Rheumatology classification criteria) or any eligible diagnostic guidelines.
- Typical knee pain while walking > 3 on an 11-point scale (0-10) in at least one knee pain or tenderness, primarily in the medial knee.
Who cannot join
- Severe KOA subjects (on the waiting list for knee arthroplasty).
- Knee post-operation or corticosteroid intra-articular injection last 6 months.
- Inability to walk for longer than 20 minutes without experiencing severe pain.
- Painful treadmill walking or unable to walk without heavy assistance, such as a lifting belt or walker frame.
- Significant knee effusion, musculoskeletal or neurological diseases that influence gait parameters.
- It is presently undergoing physiotherapy treatment.
- Rheumatoid Arthritis (RA), gout, one or both knees replaced, low back pain, hip OA, any serious knee or lower limb injuries in the past 24 months.
Trial locations and contacts
1 site in 1 country.
Saudi Arabia1 site
King Faisal Specialist Hospital & Research Centre
Jeddah, Western
About this study
Official title: The Possibilities and Acceptability of Applying Gait Modification to the Treatment of Knee Osteoarthritis in Saudi Arabia Based on the Perceptions of Patients and Physiotherapists. A Mixed-methods Feasibility Study.
A variety of biomechanical gait modification interventions can elevate knee loading and improve knee symptoms in knee osteoarthritis patients. However, there was a lack of acceptability and adherence regarding modification interventions without any explanation.
Thus, this study investigates the feasibility and acceptability of foot insoles as a gait modification tool among Saudi Arabian knee osteoarthritis patients and physiotherapists.
Read more
This study aims to answer the following:
- Which gait modification intervention is most likely to be implemented in Saudi Arabia (SA) clinical practice, taking context, patients' clinical and research evidence into consideration?
- In Saudi Arabia, can this proposed foot-insole intervention be implemented? Is there sufficient experience among physiotherapists regarding gait modification to deliver it, and will patients engage with it? How can KOA rehabilitation outcomes be evaluated in the future?
The participants will be conducted over three phases:
- The patients' interview and therapists' focus group discussion will be used to examine KOA patients' and clinicians' perspectives on enabling and accepting gait modifications in phase 1.
- The feasibility study will explore how a small number of KOA patients tolerate gait modifications and consider the most relevant outcome measures, such as pain and function, in phase (2).
- A small group of knee osteoarthritis patients and their physiotherapists who participated in phase (2) will be asked to participate in a descriptive survey in phase (3). To examine the acceptability and feasibility of the study intervention in phase (2).
Read the detailed description
Since several different types of gait modifications have been studied, it has been challenging to determine which are most likely to be used by patients and healthcare professionals.
A notable number of Saudi Arabians suffer from knee osteoarthritis (KOA), which reported a 29.5% prevalence of KOA; another recent study reported a 24.5% prevalence of KOA among the elderly. A 2002 study found that 30.8% of those aged 46-55 and 60.6% aged 66-75 were affected. Thus, KOA is roughly equally distributed between genders and is more prevalent among elderly and overweight individuals, so policymakers should focus on raising awareness to prevent and treat affected individuals. The healthcare system in SA is publicly funded and accessible; 79% of patients use the public system, and the rest obtain private care. In most cases, private patients have insurance coverage. The public healthcare system has three primary, secondary, and tertiary care levels. Rehabilitation and gait modification investigations are not available at the primary level.
This snapshot of the literary review raises questions about the viability of the long-term use of learned/assistive gait modifications. The studies reported dissatisfaction with the gait modification approach but gave no reasons. Since most studies focus on results in a short time or a specific area, pre-training courses measuring acceptability and commitment can fill the gaps in previous studies. After determining the importance of gait modification, the question becomes, should it be integrated into the therapy strategy or other rehabilitative methods to increase the treatment's clinical efficacy? It is essential to understand the practices, views and expectations of KOA patients and health professionals concerning gait modifications.
- Conditions
- Osteoarthritis, Knee, Pain, Biomechanical Lesion
- Being tested
- Lateral Wedge insole
- Keywords
- Knee osteoarthritis, Insole, Biomechanical, Saudi Arabia
- 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.
Lateral Wedge insoleDevice
Also called Footwear insole, Ankle foot orthoses
Insoles with lateral wedges are placed in patients' shoes to control biomechanical knee loading on the medial side of the knee. Insoles with lateral wedges are designed to be thinner on the inside (medially of the foot) and thicker on the outside (laterally of the foot) to relieve knee biomechanical loading parameters.
| Study group | Role | What they receive |
|---|---|---|
| Feasibility intervention | Experimental | The intervention will be foot insole (lateral wedge) insole, which has already been delivered in routine UK NHS and SA environments by at least one physiotherapist. Clinical testing will be done with 15-25 knee osteoarthritis subjects. These individuals will be assigned to a single intervention group for 4-6 weeks of re-gait training intervention. It involves a personalised gait retraining programme (sizable insole) for the KOA subjects to evaluate the impact on knee pain and improve function. It is set within 4-6 weeks of VAS and the WOMAC tools for knee pain \& function outcome. Receives: Device: Lateral Wedge insole |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain level
The change from baseline pain intensity level at 6-weeks, based on the nine points of a visual analogue scale, where 0 represents (no pain) and 9 represents (worst pain).
Measured: 6 weeks post-intervention.
Western Ontario and McMaster Universities Arthritis Index-total
The change from baseline pain, stiffness and physical activity levels at 6-weeks.
Each question is scored from 0 to 4, which are: None (0), Mild (1), Moderate (2), Severe (3), and Extreme (4).
Scores are summed for each subscale, ranging from 0-20 for pain, 0-8 for stiffness, and 0-68 for Physical Function.
A higher WOMAC score indicates worse pain, stiffness, and functional limitations.
Measured: 6 weeks post-intervention.
Likert scale
Measuring knee osteoarthritic subjects' satisfaction based on the 5 point Likert scale survey.
Measured: 6 weeks post-intervention.
Likert scale
Measuring therapists' agreement based on the 5-point Likert scale survey.
Measured: 6 weeks post-intervention supervision.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2024
- Study start13 Apr 2022
- Primary completion15 Oct 2022
- Study completion30 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Osteoarthritis, 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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- A gait modification (Lateral wedge insole) program will be conducted over 4 to 6 weeks in the physiotherapy gym or adjusted treadmill and outside the clinic during the day (at least 8 hours per day). * During the session, the researcher will observe participants inside the clinic and ensure that the modified gait application is applied, and outside the clinic will be followed by telephone. * Participants will walk on the gym floor or an adjusted treadmill for at least 15 to 20 minutes during each session. Participants will be instructed to use the mirror for feedback and achieve the target modified gait procedure. However, it will be emphasised gait modification procedures exhibited at baseline pain and function, and then at the end of the trial, it will focus on subjects' acceptability.
- Masking
- None (open label)
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- King Khalid University
- Sponsor type
- University, hospital or other
- Collaborators
- University of Nottingham
- Responsible party
- Principal investigator, Abdullah Al Assiri, King Khalid University
- Investigators
- Abdullah Al Assiri, PhD student, Principal investigator, University of Nottingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06306079
- Sponsor's protocol ID
- KKUMC
- Other IDs
- Abdullah Al Assiri, Prof Pip Logan, Professor Ana Valdes, Dr. Benjamin Smith
- Status last verified
- Mar 2024
- First submitted
- 31 Dec 2022
- Last updated
- 12 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Al-Arfaj A, Al-Boukai AA. Prevalence of radiographic knee osteoarthritis in Saudi Arabia. Clin Rheumatol. 2002 May;21(2):142-5. doi: 10.1007/s10067-002-8273-8.
PubMed 12086165Al-Modeer MA, Hassanien NS, Jabloun CM. Profile of morbidity among elderly at home health care service in Southern Saudi Arabia. J Family Community Med. 2013 Jan;20(1):53-7. doi: 10.4103/2230-8229.108187.
PubMed 23723732Khalid W. AlKuwaity, Tasneem N. Mohammad, Malik A. Hussain, Annas Alkhanani, A. M. . A. (2018) 'Prevalence and Determinant Factors of Osteoarthritis of the Knee Joint among Elderly in Arar, KSA', The Egyptian Journal of Hospital Medicine, 72(9).
Almalki M, Fitzgerald G, Clark M. Health care system in Saudi Arabia: an overview. East Mediterr Health J. 2011 Oct;17(10):784-93. doi: 10.26719/2011.17.10.784.
PubMed 22256414Pollo FE, Otis JC, Backus SI, Warren RF, Wickiewicz TL. Reduction of medial compartment loads with valgus bracing of the osteoarthritic knee. Am J Sports Med. 2002 May-Jun;30(3):414-21. doi: 10.1177/03635465020300031801.
PubMed 12016084Butler RJ, Marchesi S, Royer T, Davis IS. The effect of a subject-specific amount of lateral wedge on knee mechanics in patients with medial knee osteoarthritis. J Orthop Res. 2007 Sep;25(9):1121-7. doi: 10.1002/jor.20423.
PubMed 17469197Kutzner I, Damm P, Heinlein B, Dymke J, Graichen F, Bergmann G. The effect of laterally wedged shoes on the loading of the medial knee compartment-in vivo measurements with instrumented knee implants. J Orthop Res. 2011 Dec;29(12):1910-5. doi: 10.1002/jor.21477. Epub 2011 Jun 8.
PubMed 21656850Fantini Pagani CH, Hinrichs M, Bruggemann GP. Kinetic and kinematic changes with the use of valgus knee brace and lateral wedge insoles in patients with medial knee osteoarthritis. J Orthop Res. 2012 Jul;30(7):1125-32. doi: 10.1002/jor.22032. Epub 2011 Dec 12.
PubMed 22161816Jones RK, Zhang M, Laxton P, Findlow AH, Liu A. The biomechanical effects of a new design of lateral wedge insole on the knee and ankle during walking. Hum Mov Sci. 2013 Aug;32(4):596-604. doi: 10.1016/j.humov.2012.12.012. Epub 2013 Jul 17.
PubMed 24054897Moyer RF, Birmingham TB, Dombroski CE, Walsh RF, Leitch KM, Jenkyn TR, Giffin JR. Combined effects of a valgus knee brace and lateral wedge foot orthotic on the external knee adduction moment in patients with varus gonarthrosis. Arch Phys Med Rehabil. 2013 Jan;94(1):103-12. doi: 10.1016/j.apmr.2012.09.004. Epub 2012 Sep 17.
PubMed 22995151
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Possibilities and Acceptability of Applying Gait Modification to the Treatment of Knee Osteoarthritis in Saudi Arabia Based on the Perceptions of Patients and Physiotherapists. A Mixed-methods Feasibility Study.
- ClinicalTrials.gov ID
- NCT06306079
- Acronym / sponsor ID
- KKUMC
- Conditions
- Osteoarthritis, Knee, Pain, Biomechanical Lesion
- Keywords
- Knee osteoarthritis, Insole, Biomechanical, Saudi Arabia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 17 participants (actual)
- Lead sponsor
- King Khalid UniversityUniversity, hospital or other
- Collaborators
- University of Nottingham
- Study start
- 13 Apr 2022 (actual)
- Primary completion
- 15 Oct 2022 (actual)
- Study completion
- 30 Dec 2022 (actual)
- First posted
- 12 Mar 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.
A variety of biomechanical gait modification interventions can elevate knee loading and improve knee symptoms in knee osteoarthritis patients. However, there was a lack of acceptability and adherence regarding modification interventions without any explanation.
Thus, this study investigates the feasibility and acceptability of foot insoles as a gait modification tool among Saudi Arabian knee osteoarthritis patients and physiotherapists.
This study aims to answer the following:
- Which gait modification intervention is most likely to be implemented in Saudi Arabia (SA) clinical practice, taking context, patients' clinical and research evidence into consideration?
- In Saudi Arabia, can this proposed foot-insole intervention be implemented? Is there sufficient experience among physiotherapists regarding gait modification to deliver it, and will patients engage with it? How can KOA rehabilitation outcomes be evaluated in the future?
The participants will be conducted over three phases:
- The patients' interview and therapists' focus group discussion will be used to examine KOA patients' and clinicians' perspectives on enabling and accepting gait modifications in phase 1.
- The feasibility study will explore how a small number of KOA patients tolerate gait modifications and consider the most relevant outcome measures, such as pain and function, in phase (2).
- A small group of knee osteoarthritis patients and their physiotherapists who participated in phase (2) will be asked to participate in a descriptive survey in phase (3). To examine the acceptability and feasibility of the study intervention in phase (2).
Detailed description
Since several different types of gait modifications have been studied, it has been challenging to determine which are most likely to be used by patients and healthcare professionals.
A notable number of Saudi Arabians suffer from knee osteoarthritis (KOA), which reported a 29.5% prevalence of KOA; another recent study reported a 24.5% prevalence of KOA among the elderly. A 2002 study found that 30.8% of those aged 46-55 and 60.6% aged 66-75 were affected. Thus, KOA is roughly equally distributed between genders and is more prevalent among elderly and overweight individuals, so policymakers should focus on raising awareness to prevent and treat affected individuals. The healthcare system in SA is publicly funded and accessible; 79% of patients use the public system, and the rest obtain private care. In most cases, private patients have insurance coverage. The public healthcare system has three primary, secondary, and tertiary care levels. Rehabilitation and gait modification investigations are not available at the primary level.
This snapshot of the literary review raises questions about the viability of the long-term use of learned/assistive gait modifications. The studies reported dissatisfaction with the gait modification approach but gave no reasons. Since most studies focus on results in a short time or a specific area, pre-training courses measuring acceptability and commitment can fill the gaps in previous studies. After determining the importance of gait modification, the question becomes, should it be integrated into the therapy strategy or other rehabilitative methods to increase the treatment's clinical efficacy? It is essential to understand the practices, views and expectations of KOA patients and health professionals concerning gait modifications.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- A gait modification (Lateral wedge insole) program will be conducted over 4 to 6 weeks in the physiotherapy gym or adjusted treadmill and outside the clinic during the day (at least 8 hours per day). * During the session, the researcher will observe participants inside the clinic and ensure that the modified gait application is applied, and outside the clinic will be followed by telephone. * Participants will walk on the gym floor or an adjusted treadmill for at least 15 to 20 minutes during each session. Participants will be instructed to use the mirror for feedback and achieve the target modified gait procedure. However, it will be emphasised gait modification procedures exhibited at baseline pain and function, and then at the end of the trial, it will focus on subjects' acceptability.
| Arm | Type | Receives |
|---|---|---|
| Feasibility intervention | Experimental | Device: Lateral Wedge insoleThe intervention will be foot insole (lateral wedge) insole, which has already been delivered in routine UK NHS and SA environments by at least one physiotherapist. Clinical testing will be done with 15-25 knee osteoarthritis subjects. These individuals will be assigned to a single intervention group for 4-6 weeks of re-gait training intervention. It involves a personalised gait retraining programme (sizable insole) for the KOA subjects to evaluate the impact on knee pain and improve function. It is set within 4-6 weeks of VAS and the WOMAC tools for knee pain \& function outcome. |
Who may qualify
- Ages
- 45 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Adults aged above 45 years old.
- Both Male \& Female.
- Radiographically or KOA participants meet any diagnostic classification guidelines/criteria (American College of Rheumatology classification criteria) or any eligible diagnostic guidelines.
- Typical knee pain while walking > 3 on an 11-point scale (0-10) in at least one knee pain or tenderness, primarily in the medial knee.
Key exclusion criteria (7 listed)
- Severe KOA subjects (on the waiting list for knee arthroplasty).
- Knee post-operation or corticosteroid intra-articular injection last 6 months.
- Inability to walk for longer than 20 minutes without experiencing severe pain.
- Painful treadmill walking or unable to walk without heavy assistance, such as a lifting belt or walker frame.
- Significant knee effusion, musculoskeletal or neurological diseases that influence gait parameters.
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 |
|---|---|---|
| Lateral Wedge insoleAlso: Footwear insole, Ankle foot orthosesInsoles with lateral wedges are placed in patients' shoes to control biomechanical knee loading on the medial side of the knee. Insoles with lateral wedges are designed to be thinner on the inside (medially of the foot) and thicker on the outside (laterally of the foot) to relieve knee biomechanical loading parameters. | Device | Feasibility intervention |
Primary outcome
Pain level
Time frame: 6 weeks post-intervention.
The change from baseline pain intensity level at 6-weeks, based on the nine points of a visual analogue scale, where 0 represents (no pain) and 9 represents (worst pain).
Western Ontario and McMaster Universities Arthritis Index-total
Time frame: 6 weeks post-intervention.
The change from baseline pain, stiffness and physical activity levels at 6-weeks. Each question is scored from 0 to 4, which are: None (0), Mild (1), Moderate (2), Severe (3), and Extreme (4). Scores are summed for each subscale, ranging from 0-20 for pain, 0-8 for stiffness, and 0-68 for Physical Function. A higher WOMAC score indicates worse pain, stiffness, and functional limitations.
Likert scale
Time frame: 6 weeks post-intervention.
Measuring knee osteoarthritic subjects' satisfaction based on the 5 point Likert scale survey.
Likert scale
Time frame: 6 weeks post-intervention supervision.
Measuring therapists' agreement based on the 5-point Likert scale survey.
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 12 Mar 2024.
- Results publication: PubMed 12086165Al-Arfaj A, Al-Boukai AA. Prevalence of radiographic knee osteoarthritis in Saudi Arabia. Clin Rheumatol. 2002 May;21(2):142-5. doi: 10.1007/s10067-002-8273-8.
- Results publication: PubMed 23723732Al-Modeer MA, Hassanien NS, Jabloun CM. Profile of morbidity among elderly at home health care service in Southern Saudi Arabia. J Family Community Med. 2013 Jan;20(1):53-7. doi: 10.4103/2230-8229.108187.
- Results publicationKhalid W. AlKuwaity, Tasneem N. Mohammad, Malik A. Hussain, Annas Alkhanani, A. M. . A. (2018) 'Prevalence and Determinant Factors of Osteoarthritis of the Knee Joint among Elderly in Arar, KSA', The Egyptian Journal of Hospital Medicine, 72(9).
- Results publication: PubMed 22256414Almalki M, Fitzgerald G, Clark M. Health care system in Saudi Arabia: an overview. East Mediterr Health J. 2011 Oct;17(10):784-93. doi: 10.26719/2011.17.10.784.
- Results publication: PubMed 12016084Pollo FE, Otis JC, Backus SI, Warren RF, Wickiewicz TL. Reduction of medial compartment loads with valgus bracing of the osteoarthritic knee. Am J Sports Med. 2002 May-Jun;30(3):414-21. doi: 10.1177/03635465020300031801.
- Results publication: PubMed 17469197Butler RJ, Marchesi S, Royer T, Davis IS. The effect of a subject-specific amount of lateral wedge on knee mechanics in patients with medial knee osteoarthritis. J Orthop Res. 2007 Sep;25(9):1121-7. doi: 10.1002/jor.20423.
- Results publication: PubMed 21656850Kutzner I, Damm P, Heinlein B, Dymke J, Graichen F, Bergmann G. The effect of laterally wedged shoes on the loading of the medial knee compartment-in vivo measurements with instrumented knee implants. J Orthop Res. 2011 Dec;29(12):1910-5. doi: 10.1002/jor.21477. Epub 2011 Jun 8.
- Results publication: PubMed 22161816Fantini Pagani CH, Hinrichs M, Bruggemann GP. Kinetic and kinematic changes with the use of valgus knee brace and lateral wedge insoles in patients with medial knee osteoarthritis. J Orthop Res. 2012 Jul;30(7):1125-32. doi: 10.1002/jor.22032. Epub 2011 Dec 12.
- Results publication: PubMed 24054897Jones RK, Zhang M, Laxton P, Findlow AH, Liu A. The biomechanical effects of a new design of lateral wedge insole on the knee and ankle during walking. Hum Mov Sci. 2013 Aug;32(4):596-604. doi: 10.1016/j.humov.2012.12.012. Epub 2013 Jul 17.
- Results publication: PubMed 22995151Moyer RF, Birmingham TB, Dombroski CE, Walsh RF, Leitch KM, Jenkyn TR, Giffin JR. Combined effects of a valgus knee brace and lateral wedge foot orthotic on the external knee adduction moment in patients with varus gonarthrosis. Arch Phys Med Rehabil. 2013 Jan;94(1):103-12. doi: 10.1016/j.apmr.2012.09.004. Epub 2012 Sep 17.
- 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.
Abdullah Al Assiri, PhD student principal investigator
University of Nottingham
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lateral Wedge insole in people with Osteoarthritis, Knee and Pain, run by King Khalid University at 1 site in Saudi Arabia.
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 5 inclusion and 7 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 12 Mar 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 Saudi Arabia. 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 level (time frame: 6 weeks post-intervention.). 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 NCT06306079, which also lists 10 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 12 Mar 2024.