Knee OsteoarthritisNCT06227078
Effects of Kinesiotaping and Physiotherapy in Grade 2 Osteoarthritis Following Degenerative Meniscal Tears
A study testing Kinesiotaping in people with Knee Osteoarthritis and Meniscus Tear, run by Gopal Nambi at 1 site in Saudi Arabia.
Trial summary
Degenerative meniscal tears are a common cause of osteoarthritis commonly diagnosed in football players and are considered a major risk factor for the development of knee osteoarthritis. Read more about this study
- Who is it for?
- Ages 18 to 35 years
- Conditions the study is for
- Knee Osteoarthritis, Meniscus Tear
- What is being tested?
- Kinesiotaping
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 56 participants
- Where
- 1 siteSaudi Arabia
- Study dates
- 1 Sep 2021to 30 Aug 2023
- 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 18 to 35 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Diagnosis of Knee Osteoarthritis:
- Individuals with a confirmed diagnosis of knee osteoarthritis based on clinical and/or radiological assessments.
- Mild to Moderate Knee OA:
- Kinesiotaping may be more appropriate for individuals with mild to moderate knee OA rather than severe cases.
- Presence of Pain and Discomfort:
- Individuals experiencing pain, discomfort, or limitations in function related to knee osteoarthritis.
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- Functional Limitations:
- Those with functional limitations in activities of daily living or reduced mobility due to knee OA.
- No Contraindications:
- Individuals without contraindications to kinesiotaping, such as skin allergies, infections, or open wounds in the application area.
- Willingness to Participate:
- Individuals who are willing to participate in and adhere to the kinesiotaping intervention.
- Not Responsive to Other Conservative Treatments:
- Those who have tried and not responded adequately to other conservative treatments for knee OA, such as exercise, physical therapy, or oral medications.
- Absence of Serious Comorbidities:
- Individuals without serious comorbidities or medical conditions that may contraindicate the use of kinesiotaping.
- Individual Preferences:
- Consideration of individual preferences and acceptance of kinesiotaping as part of the treatment plan.
Who cannot join
- 1. Skin Conditions:
- Active skin infections, allergies, or open wounds in the area where kinesiotape is to be applied.
- Skin conditions that may be aggravated or worsened by the adhesive in the tape. 2. Vascular Disorders:
- Conditions that affect blood circulation, such as peripheral vascular disease, deep vein thrombosis, or other vascular disorders, which may be worsened by the application of kinesiotape.
- 3. Peripheral Neuropathy:
- Individuals with peripheral neuropathy or other nerve disorders, as kinesiotaping may affect sensation, and there is a risk of injury or discomfort.
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- 4. Cancer or Tumors:
- Active cancer or tumors in the region where kinesiotape is to be applied, as kinesiotaping could interfere with cancer treatment or exacerbate symptoms.
- 5. Joint Instability:
- Individuals with severe joint instability, as kinesiotape may not provide sufficient support for highly unstable joints.
- 6. Allergies to Tape Components:
- Known allergies to the materials or adhesive used in kinesiotape. 7. Circulatory Disorders:
- Severe circulatory disorders, which may be exacerbated by the pressure or tension applied by kinesiotape.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Clinical and Functional Effects of Kinesiotaping and Physiotherapy in Grade 2 Osteoarthritis Following Degenerative Meniscal Tears in Football Players - A Randomized Control Trial
Degenerative meniscal tears are a common cause of osteoarthritis commonly diagnosed in football players and are considered a major risk factor for the development of knee osteoarthritis. This study aimed to investigate the Clinical and functional effects of kinesiotaping and physiotherapy in grade 2 osteoarthritis following degenerative meniscal tears in football players.
Read the detailed description
Degenerative meniscal tears represent a prevalent issue among football players and are frequently associated with an increased risk of developing knee osteoarthritis. This study seeks to explore the clinical and functional impacts of employing kinesiotaping and physiotherapy as interventions in grade 2 osteoarthritis resulting from degenerative meniscal tears in football players.
Kinesiotaping is a therapeutic technique involving the application of specialized elastic tapes to targeted areas, aiming to support injured muscles and joints, enhance circulation, and alleviate pain. Physiotherapy, on the other hand, employs a range of exercises and modalities to promote healing and improve joint function. Both modalities are commonly used in sports medicine to manage musculoskeletal injuries.
The investigation focuses on football players diagnosed with grade 2 osteoarthritis secondary to degenerative meniscal tears. Grade 2 osteoarthritis signifies moderate cartilage loss and potential joint instability. The participants will be divided into two groups: one receiving kinesiotaping in combination with physiotherapy and the other undergoing conventional physiotherapy alone.
Clinical assessments will include pain levels, joint swelling, and range of motion. Functional outcomes such as strength, agility, and proprioception will be measured through standardized tests. The study's duration and follow-up periods will allow for a comprehensive evaluation of both short-term and long-term effects.
The hypothesis underlying this research posits that the combined approach of kinesiotaping and physiotherapy will yield superior outcomes compared to traditional physiotherapy alone. Potential benefits may include reduced pain, improved joint stability, enhanced functional capacity, and a decreased risk of further degeneration.
By shedding light on the efficacy of these interventions, this study aspires to contribute valuable insights to the field of sports medicine, aiding in the development of evidence-based strategies for managing degenerative meniscal tears and mitigating the risk of osteoarthritis in football players. The findings could inform clinical practice and potentially influence rehabilitation protocols for athletes facing similar challenges.
- Conditions
- Knee Osteoarthritis, Meniscus Tear
- Being tested
- Kinesiotaping
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
KinesiotapingDevice
Kinesiotaping is commonly used in sports medicine and rehabilitation settings. It is applied by trained professionals, such as physiotherapists or athletic trainers, who are skilled in assessing individual needs and determining the appropriate taping technique for specific conditions. The tape is typically worn for several days, allowing for continuous therapeutic effects.
It's important to note that while kinesiotaping has gained popularity, its effectiveness is still a subject of ongoing research, and its application should be part of a comprehensive treatment plan. Individual responses to kinesiotape may vary, and its use is often combined with other therapeutic interventions for optimal results.
| Study group | Role | What they receive |
|---|---|---|
| Active Kinesiotaping + Physiotherapy | Active comparator | The application of kinesiotaping for grade 2 osteoarthritis involves the application of an anchor strip at one end of the affected joint, typically with no stretch. Apply the kinesiotape with the desired amount of stretch, usually around 50-80% of its maximum stretch capacity. Direct the tape along the muscle or joint in a specific pattern, such as "I," "Y," or "X" depending on the therapeutic goal. Finish with an anchor strip at the opposite end, with no stretch to secure the tape in place.
Physiotherapy:
Apply TENS: Low-frequency TENS (2-10 Hz) that produces a tingling or buzzing sensation without causing discomfort or pain. TENS sessions may last between 20 to 30 minutes per session.
Strengthening exercises:
1. Quadriceps Sets:
2. Straight Leg Raises:
3. Seated Leg Press:
4. Hamstring Curls:
5. Calf Raises:
* Repeat the exercises for 10 times, 3 sets in a session for 8 weeks. Receives: Device: Kinesiotaping |
| Placebo Kinesiotaping + Physiotherapy | Placebo comparator | The application of kinesiotaping for grade 2 osteoarthritis involves the application of an anchor strip at one end of the affected joint, typically with no stretch. Apply the kinesiotape without stretch, Direct the tape along the muscle or joint in a specific pattern, such as "I," "Y," or "X" depending on the therapeutic goal. Finish with an anchor strip at the opposite end, with no stretch to secure the tape in place.
Physiotherapy:
Apply TENS: Low-frequency TENS (2-10 Hz) that produces a tingling or buzzing sensation without causing discomfort or pain. TENS sessions may last between 20 to 30 minutes per session.
Strengthening exercises:
1. Quadriceps Sets:
2. Straight Leg Raises:
3. Seated Leg Press:
4. Hamstring Curls:
5. Calf Raises:
* Repeat the exercises for 10 times, 3 sets in a session for 8 weeks. Receives: Device: Kinesiotaping |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain intensity - Visual analog scale
The VAS is usually presented as a straight line, often 10 centimeters (or another standard length), with two endpoints representing extreme points on a continuum. For example, one end may be labeled "No Pain" or "No Symptoms," and the other end labeled "Worst Pain Imaginable" or "Maximum Symptoms."
Measured: Baseline
Pain intensity - Visual analog scale
The VAS is usually presented as a straight line, often 10 centimeters (or another standard length), with two endpoints representing extreme points on a continuum. For example, one end may be labeled "No Pain" or "No Symptoms," and the other end labeled "Worst Pain Imaginable" or "Maximum Symptoms."
Measured: 8 weeks
Pain intensity - Visual analog scale
The VAS is usually presented as a straight line, often 10 centimeters (or another standard length), with two endpoints representing extreme points on a continuum. For example, one end may be labeled "No Pain" or "No Symptoms," and the other end labeled "Worst Pain Imaginable" or "Maximum Symptoms."
Measured: 6 months
Secondary outcomes (12)
Functional disability - WOMAC
The WOMAC scale consists of three subscales, each assessing a different dimension of health related to osteoarthritis.
Measured: Baseline
Functional disability - WOMAC
The WOMAC scale consists of three subscales, each assessing a different dimension of health related to osteoarthritis.
Measured: 8 weeks
Functional disability - WOMAC
The WOMAC scale consists of three subscales, each assessing a different dimension of health related to osteoarthritis.
Measured: 6 months
Sports performance - Timed up and go test
Ask the individual to sit in the chair with their back against the backrest and their arms on the chair arms (if available). On the "go" signal, instruct them to stand up, walk around the first cone, return to the chair, and sit back down. Use a stopwatch to measure the time it takes for the individual to complete the task. Faster times generally indicate better agility and functional mobility.
Measured: Baseline
Sports performance - Timed up and go test
Ask the individual to sit in the chair with their back against the backrest and their arms on the chair arms (if available). On the "go" signal, instruct them to stand up, walk around the first cone, return to the chair, and sit back down. Use a stopwatch to measure the time it takes for the individual to complete the task. Faster times generally indicate better agility and functional mobility.
Measured: 8 weeks
Sports performance - Timed up and go test
Ask the individual to sit in the chair with their back against the backrest and their arms on the chair arms (if available). On the "go" signal, instruct them to stand up, walk around the first cone, return to the chair, and sit back down. Use a stopwatch to measure the time it takes for the individual to complete the task. Faster times generally indicate better agility and functional mobility.
Measured: 6 months
Sports performance - 40 Metre zig zag test
Set up a zigzagging path using cones or markers. The path should be 40 meters in total length. The zigzag pattern should include sharp turns, requiring participants to change direction quickly. Explain the test to the participant, emphasizing the need to navigate through the zigzag path as quickly as possible.
Emphasize the importance of agility, speed, and quick changes in direction. Use a stopwatch or timer to measure the time it takes for the participant to complete the 40-meter zigzag course. On the "go" signal, the participant should start from the beginning and navigate through the zigzag path as quickly as possible.
Time should be recorded when the participant crosses the finishing line.
Measured: Baseline
Sports performance - 40 Metre zig zag test
Set up a zigzagging path using cones or markers. The path should be 40 meters in total length. The zigzag pattern should include sharp turns, requiring participants to change direction quickly. Explain the test to the participant, emphasizing the need to navigate through the zigzag path as quickly as possible.
Emphasize the importance of agility, speed, and quick changes in direction. Use a stopwatch or timer to measure the time it takes for the participant to complete the 40-meter zigzag course. On the "go" signal, the participant should start from the beginning and navigate through the zigzag path as quickly as possible.
Time should be recorded when the participant crosses the finishing line.
Measured: 8 weeks
Sports performance - 40 Metre zig zag test
Set up a zigzagging path using cones or markers. The path should be 40 meters in total length. The zigzag pattern should include sharp turns, requiring participants to change direction quickly. Explain the test to the participant, emphasizing the need to navigate through the zigzag path as quickly as possible.
Emphasize the importance of agility, speed, and quick changes in direction. Use a stopwatch or timer to measure the time it takes for the participant to complete the 40-meter zigzag course. On the "go" signal, the participant should start from the beginning and navigate through the zigzag path as quickly as possible.
Time should be recorded when the participant crosses the finishing line.
Measured: 6 months
Quality of life - SF-12
The Short Form Health Survey (SF-12) is a widely used and validated questionnaire designed to assess health-related quality of life (HRQoL) across various populations. It is a shorter version of the SF-36 and provides a quick and reliable measure of general health status. The SF-12 includes 12 questions covering eight health domains and yields two summary measures: the Physical Component Summary (PCS) and the Mental Component Summary (MCS).
Measured: Baseline
Quality of life - SF-12
The Short Form Health Survey (SF-12) is a widely used and validated questionnaire designed to assess health-related quality of life (HRQoL) across various populations. It is a shorter version of the SF-36 and provides a quick and reliable measure of general health status. The SF-12 includes 12 questions covering eight health domains and yields two summary measures: the Physical Component Summary (PCS) and the Mental Component Summary (MCS).
Measured: 8 weeks
Quality of life - SF-12
The Short Form Health Survey (SF-12) is a widely used and validated questionnaire designed to assess health-related quality of life (HRQoL) across various populations. It is a shorter version of the SF-36 and provides a quick and reliable measure of general health status. The SF-12 includes 12 questions covering eight health domains and yields two summary measures: the Physical Component Summary (PCS) and the Mental Component Summary (MCS).
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2024
- Study start1 Sep 2021
- Primary completion30 Aug 2023
- Study completion30 Aug 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Knee OsteoarthritisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 56 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gopal Nambi
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Gopal Nambi, Prince Sattam Bin Abdulaziz University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06227078
- Sponsor's protocol ID
- RHPT/021/093
- Status last verified
- Jan 2024
- First submitted
- 17 Jan 2024
- Last updated
- 26 Jan 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 26 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical and Functional Effects of Kinesiotaping and Physiotherapy in Grade 2 Osteoarthritis Following Degenerative Meniscal Tears in Football Players - A Randomized Control Trial
- ClinicalTrials.gov ID
- NCT06227078
- Acronym / sponsor ID
- RHPT/021/093
- Conditions
- Knee Osteoarthritis, Meniscus Tear
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 56 participants (actual)
- Lead sponsor
- Gopal NambiUniversity, hospital or other
- Study start
- 1 Sep 2021 (actual)
- Primary completion
- 30 Aug 2023 (actual)
- Study completion
- 30 Aug 2023 (actual)
- First posted
- 26 Jan 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.
Degenerative meniscal tears are a common cause of osteoarthritis commonly diagnosed in football players and are considered a major risk factor for the development of knee osteoarthritis. This study aimed to investigate the Clinical and functional effects of kinesiotaping and physiotherapy in grade 2 osteoarthritis following degenerative meniscal tears in football players.
Detailed description
Degenerative meniscal tears represent a prevalent issue among football players and are frequently associated with an increased risk of developing knee osteoarthritis. This study seeks to explore the clinical and functional impacts of employing kinesiotaping and physiotherapy as interventions in grade 2 osteoarthritis resulting from degenerative meniscal tears in football players.
Kinesiotaping is a therapeutic technique involving the application of specialized elastic tapes to targeted areas, aiming to support injured muscles and joints, enhance circulation, and alleviate pain. Physiotherapy, on the other hand, employs a range of exercises and modalities to promote healing and improve joint function. Both modalities are commonly used in sports medicine to manage musculoskeletal injuries.
The investigation focuses on football players diagnosed with grade 2 osteoarthritis secondary to degenerative meniscal tears. Grade 2 osteoarthritis signifies moderate cartilage loss and potential joint instability. The participants will be divided into two groups: one receiving kinesiotaping in combination with physiotherapy and the other undergoing conventional physiotherapy alone.
Clinical assessments will include pain levels, joint swelling, and range of motion. Functional outcomes such as strength, agility, and proprioception will be measured through standardized tests. The study's duration and follow-up periods will allow for a comprehensive evaluation of both short-term and long-term effects.
The hypothesis underlying this research posits that the combined approach of kinesiotaping and physiotherapy will yield superior outcomes compared to traditional physiotherapy alone. Potential benefits may include reduced pain, improved joint stability, enhanced functional capacity, and a decreased risk of further degeneration.
By shedding light on the efficacy of these interventions, this study aspires to contribute valuable insights to the field of sports medicine, aiding in the development of evidence-based strategies for managing degenerative meniscal tears and mitigating the risk of osteoarthritis in football players. The findings could inform clinical practice and potentially influence rehabilitation protocols for athletes facing similar challenges.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active Kinesiotaping + Physiotherapy | Active comparator | Device: KinesiotapingThe application of kinesiotaping for grade 2 osteoarthritis involves the application of an anchor strip at one end of the affected joint, typically with no stretch. Apply the kinesiotape with the desired amount of stretch, usually around 50-80% of its maximum stretch capacity. Direct the tape along the muscle or joint in a specific pattern, such as "I," "Y," or "X" depending on the therapeutic goal. Finish with an anchor strip at the opposite end, with no stretch to secure the tape in place. Physiotherapy: Apply TENS: Low-frequency TENS (2-10 Hz) that produces a tingling or buzzing sensation without causing discomfort or pain. TENS sessions may last between 20 to 30 minutes per session. Strengthening exercises: 1. Quadriceps Sets: 2. Straight Leg Raises: 3. Seated Leg Press: 4. Hamstring Curls: 5. Calf Raises: * Repeat the exercises for 10 times, 3 sets in a session for 8 weeks. |
| Placebo Kinesiotaping + Physiotherapy | Placebo comparator | Device: KinesiotapingThe application of kinesiotaping for grade 2 osteoarthritis involves the application of an anchor strip at one end of the affected joint, typically with no stretch. Apply the kinesiotape without stretch, Direct the tape along the muscle or joint in a specific pattern, such as "I," "Y," or "X" depending on the therapeutic goal. Finish with an anchor strip at the opposite end, with no stretch to secure the tape in place. Physiotherapy: Apply TENS: Low-frequency TENS (2-10 Hz) that produces a tingling or buzzing sensation without causing discomfort or pain. TENS sessions may last between 20 to 30 minutes per session. Strengthening exercises: 1. Quadriceps Sets: 2. Straight Leg Raises: 3. Seated Leg Press: 4. Hamstring Curls: 5. Calf Raises: * Repeat the exercises for 10 times, 3 sets in a session for 8 weeks. |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (18 listed)
- Individuals with a confirmed diagnosis of knee osteoarthritis based on clinical and/or radiological assessments.
- Kinesiotaping may be more appropriate for individuals with mild to moderate knee OA rather than severe cases.
- Individuals experiencing pain, discomfort, or limitations in function related to knee osteoarthritis.
- Those with functional limitations in activities of daily living or reduced mobility due to knee OA.
- Individuals without contraindications to kinesiotaping, such as skin allergies, infections, or open wounds in the application area.
Key exclusion criteria (13 listed)
- 1. Skin Conditions:
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 |
|---|---|---|
| KinesiotapingKinesiotaping is commonly used in sports medicine and rehabilitation settings. It is applied by trained professionals, such as physiotherapists or athletic trainers, who are skilled in assessing individual needs and determining the appropriate taping technique for specific conditions. The tape is typically worn for several days, allowing for continuous therapeutic effects. It's important to note that while kinesiotaping has gained popularity, its effectiveness is still a subject of ongoing research, and its application should be part of a comprehensive treatment plan. Individual responses to kinesiotape may vary, and its use is often combined with other therapeutic interventions for optimal results. | Device | Active Kinesiotaping + Physiotherapy, Placebo Kinesiotaping + Physiotherapy |
Primary outcome
Pain intensity - Visual analog scale
Time frame: Baseline
The VAS is usually presented as a straight line, often 10 centimeters (or another standard length), with two endpoints representing extreme points on a continuum. For example, one end may be labeled "No Pain" or "No Symptoms," and the other end labeled "Worst Pain Imaginable" or "Maximum Symptoms."
Pain intensity - Visual analog scale
Time frame: 8 weeks
The VAS is usually presented as a straight line, often 10 centimeters (or another standard length), with two endpoints representing extreme points on a continuum. For example, one end may be labeled "No Pain" or "No Symptoms," and the other end labeled "Worst Pain Imaginable" or "Maximum Symptoms."
Pain intensity - Visual analog scale
Time frame: 6 months
The VAS is usually presented as a straight line, often 10 centimeters (or another standard length), with two endpoints representing extreme points on a continuum. For example, one end may be labeled "No Pain" or "No Symptoms," and the other end labeled "Worst Pain Imaginable" or "Maximum Symptoms."
12 secondary outcomes
Functional disability - WOMAC
Time frame: Baseline
Functional disability - WOMAC
Time frame: 8 weeks
Functional disability - WOMAC
Time frame: 6 months
Sports performance - Timed up and go test
Time frame: Baseline
Sports performance - Timed up and go test
Time frame: 8 weeks
Sports performance - Timed up and go test
Time frame: 6 months
Sports performance - 40 Metre zig zag test
Time frame: Baseline
Sports performance - 40 Metre zig zag test
Time frame: 8 weeks
Sports performance - 40 Metre zig zag test
Time frame: 6 months
Quality of life - SF-12
Time frame: Baseline
Quality of life - SF-12
Time frame: 8 weeks
Quality of life - SF-12
Time frame: 6 months
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 26 Jan 2024.
- Individual participant dataSharing planned: Yes
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Kinesiotaping in people with Knee Osteoarthritis and Meniscus Tear, run by Gopal Nambi 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 18 inclusion and 13 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 26 Jan 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. Some participants in this study may receive a placebo. 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 intensity - Visual analog scale (time frame: Baseline). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 26 Jan 2024.