Knee OsteoarthritisCILM-KOANCT07423182
Effects of Carbon Dioxide Infrared Laser Moxibustion on Pain and Function in Knee Osteoarthritis
A study testing Exercise Program for Knee Osteoarthritis and CO2 Infrared Laser Moxibustion (CILM) in people with Knee Osteoarthritis, run by University of Lahore at 1 site in Pakistan.
Trial summary
Knee osteoarthritis is a prevalent degenerative joint disorder characterized by chronic knee pain, stiffness, reduced range of motion, and limitations in daily functional activities. Read more about this study
- Who is it for?
- Ages 55 to 65 years
- Conditions the study is for
- Knee Osteoarthritis
- What is being tested?
- Exercise Program for Knee Osteoarthritis and CO2 Infrared Laser Moxibustion (CILM)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 68 participants
- Where
- 1 sitePakistan
- Study dates
- 26 Oct 2025to 30 Jul 2026
- 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 55 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults aged 55 to 65 years, male or female. Diagnosis of knee osteoarthritis with radiographic evidence (Kellgren-Lawrence grade 2 or higher).
- Knee osteoarthritis grade II or III according to the American Rheumatism Association (ARA) classification criteria.
- History of moderate to severe knee pain on most days during the past month. Able and willing to provide written informed consent and comply with study procedures.
Who cannot join
- Other diseases affecting the knee, such as rheumatoid arthritis, ankylosing spondylitis, fibromyalgia syndrome, or chronic fatigue syndrome.
- Use of steroid medication or acupuncture or moxibustion treatment within the previous 3 months.
- Intra-articular hyaluronate injection within the previous 6 months. Arthrocentesis or arthroscopy within the previous 1 year. Knee or hip replacement surgery, or planned joint replacement surgery during the trial period.
- Use of other external treatments during the trial (e.g., topical medication for knee pain).
- Body mass index (BMI) greater than 30 kg/m². Lower-limb fracture or injury affecting function. Neurological disorders or nerve root compression affecting the lower limb.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Carbon Dioxide Infrared Laser Moxibustion in Patients With Knee Osteoarthritis: A Double-Blind Randomized Controlled Trial
Knee osteoarthritis is a prevalent degenerative joint disorder characterized by chronic knee pain, stiffness, reduced range of motion, and limitations in daily functional activities. Exercise therapy is widely recommended as a first-line conservative approach to reduce symptoms and improve physical performance; however, a substantial proportion of patients continue to experience persistent pain and functional impairment despite adherence to exercise-based rehabilitation.
Carbon dioxide (CO2) infrared laser moxibustion is a non-invasive far-infrared thermal stimulation modality intended to reproduce the localized heating effects of traditional moxibustion without smoke or odor. It is hypothesized to enhance local microcirculation, support tissue oxygenation, and modulate inflammatory activity, thereby contributing to symptom relief and improved joint function. This double-blind, parallel-group randomized controlled trial will evaluate whether adding carbon dioxide (CO2) infrared laser moxibustion to a standardized knee osteoarthritis exercise program provides greater improvement than exercise alone. Eligible participants with radiographic knee osteoarthritis will be randomly allocated to either (1) an exercise-only program or (2) the same exercise program plus carbon dioxide (CO2) infrared laser moxibustion delivered over an 8-week treatment phase (24 sessions). Outcomes will be measured at baseline and at follow-up visits at Month 3 and Month 6 to determine changes in pain intensity measured by the Numerical Pain Rating Scale (NPRS), knee range of motion measured by goniometry, articular cartilage thickness measured by magnetic resonance imaging (MRI), and biochemical markers including bone alkaline phosphatase (BAP) and serum calcium.
Read the detailed description
This study is a double-blind, parallel-group randomized controlled trial examining the effectiveness of carbon dioxide (CO2) infrared laser moxibustion as an adjunct to exercise therapy in individuals with knee osteoarthritis. Knee osteoarthritis is a multifactorial degenerative condition involving mechanical stress, low-grade inflammation, and progressive joint tissue changes that contribute to pain, restricted movement, and functional limitations. Exercise therapy represents a core component of conservative management; however, residual symptoms are frequently reported, supporting the evaluation of additional non-pharmacological approaches.
Carbon dioxide (CO2) infrared laser moxibustion is a non-invasive modality that delivers far-infrared thermal stimulation to predefined knee-related treatment points, intended to reproduce the therapeutic effects of traditional moxibustion without smoke exposure. Proposed mechanisms include enhancement of local microcirculation, modulation of inflammatory activity, neuromodulatory analgesic effects, and potential support of local tissue metabolism. Participants with radiographic knee osteoarthritis will be allocated to either a standardized exercise program alone or the same exercise program combined with carbon dioxide (CO2) infrared laser moxibustion delivered during an 8-week treatment period.
Participants will be assessed at baseline, at the end of the 8-week intervention period, and during follow-up visits at Month 3 and Month 6 to evaluate short-term and medium-term changes in pain and knee-related outcomes. The findings of this study will contribute to the evidence base for rehabilitation strategies in knee osteoarthritis and inform the potential role of carbon dioxide (CO2) infrared laser moxibustion as an adjunct conservative intervention.
- Conditions
- Knee Osteoarthritis
- Being tested
- Exercise Program for Knee Osteoarthritis, CO2 Infrared Laser Moxibustion (CILM)
- Keywords
- Carbon dioxide infrared laser moxibustion, Laser moxibustion, Exercise therapy, Physical therapy, Knee rehabilitation, Pain intensity, Numerical Pain Rating Scale, Western Ontario and McMaster Universities Osteoarthritis Index, Range of motion, Cartilage thickness, Randomized controlled trial
- 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.
Exercise Program for Knee OsteoarthritisOther
Participants receive a standardized knee osteoarthritis exercise program delivered over an 8-week intervention period, with three supervised sessions per week (24 sessions total), with each session lasting approximately 40 minutes. The program includes warm-up activities followed by progressive strengthening and mobility exercises targeting the knee and surrounding musculature, including step-ups, chair sit-to-stand exercises, quadriceps strengthening, isometric thigh activation, and balance or coordination exercises.
CO2 Infrared Laser Moxibustion (CILM)Device
Also called 10.6 μm Infrared Laser Moxibustion, 10.6 μm CO₂ Laser Moxibustion
CO₂ infrared laser moxibustion is administered using a 10.6 μm CO₂ infrared laser device with an output power range of 160-180 mW. The defocused probe is positioned approximately 2 cm from the skin, producing a light spot with a diameter of approximately 2 cm. Irradiation is applied to predefined knee-related points (ST35, Ex-LE4, and Ashi points) bilaterally, with each point treated for approximately 5 minutes per knee. The total irradiation time per session is approximately 30 minutes, including bilateral point application, with additional time allocated for positioning and safety checks, resulting in a total session duration of approximately 40 minutes. Treatment is delivered three sessions per week for eight weeks (24 sessions total) according to a standardized protocol.
| Study group | Role | What they receive |
|---|---|---|
| Exercise Program Only (Control) | Active comparator | Participants receive a standardized knee osteoarthritis exercise program delivered over an 8-week intervention period, with three supervised sessions per week (24 sessions total). Each session lasts approximately 40 minutes and includes warm-up activities followed by progressive strengthening and mobility exercises targeting the knee and surrounding musculature, including step-ups, chair sit-to-stand exercises, quadriceps strengthening, isometric thigh activation, and balance or coordination exercises. Clinical outcomes are measured at baseline, at the end of the 8-week intervention period, and at follow-up visits at Month 3 and Month 6 according to the study protocol. Receives: Other: Exercise Program for Knee Osteoarthritis; Device: CO2 Infrared Laser Moxibustion (CILM) |
| Exercise Program Plus Carbon Dioxide (CO2) Infrared Laser Moxibustion (CILM) | Experimental | Participants receive the same standardized knee osteoarthritis exercise program delivered over an 8-week intervention period, with three supervised sessions per week (24 sessions total; approximately 40 minutes per session), in combination with carbon dioxide (CO2) infrared laser moxibustion. Carbon dioxide (CO2) infrared laser moxibustion is administered using a 10.6 micrometer CO2 infrared laser device with an output power range of 160 to 180 mW. The defocused probe is positioned approximately 2 cm from the skin, producing a light spot with a diameter of approximately 2 cm. Irradiation is applied to predefined knee-related treatment points including ST35 (Dubi), Ex-LE4 (Neixiyan), and Ashi (tender points), applied bilaterally, with each point treated for approximately 5 minutes per knee. The total irradiation time per session is approximately 30 minutes, with additional time allocated for positioning and safety checks, resulting in a total session duration of approximately 40 minute Receives: Other: Exercise Program for Knee Osteoarthritis; Device: CO2 Infrared Laser Moxibustion (CILM) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain intensity measured by the Numerical Pain Rating Scale (0 to 10)
Change in knee pain intensity measured using the 0 to 10 Numerical Pain Rating Scale (0 = no pain, 10 = worst possible pain).
Measured: Baseline and Week 8
Secondary outcomes (4)
Knee range of motion in flexion and extension
Change in knee joint range of motion in degrees measured using a goniometer.
Measured: Baseline, Week 8, Month 3, and Month 6
Articular cartilage thickness measured by magnetic resonance imaging (MRI)
Change in knee articular cartilage thickness measured using magnetic resonance imaging.
Measured: Baseline and Month 6
Serum bone alkaline phosphatase (BAP)
Change in serum bone alkaline phosphatase concentration measured from venous blood samples.
Measured: Baseline, Month 3, and Month 6
Serum calcium concentration
Change in serum calcium concentration measured from venous blood samples.
Measured: Baseline, Month 3, and Month 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2026
- Study start26 Oct 2025
- Primary completion30 Mar 2026
- Study completion30 Jul 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)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 University of LahoreThe 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
- Two-arm, parallel-group randomized controlled trial comparing a standardized exercise-only program versus the same exercise program combined with carbon dioxide (CO2) infrared laser moxibustion administered over an 8-week treatment period, with follow-up assessments conducted at Month 3 and Month 6.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 68 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Lahore
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rehana Yasmeen Niazi, University of Lahore
- Investigators
- Ashfaq Ahmed, Study director, University Institute of Physical Therapy Univesity of Lahore Pakistan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07423182
- Sponsor's protocol ID
- UOL-IREB-25-12-0037-70137698
- Acronym
- CILM-KOA
- Status last verified
- Sep 2026
- First submitted
- 10 Feb 2026
- Last updated
- 22 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: IPD will not be shared because the study involves identifiable clinical and imaging data collected at local hospital sites, and there is currently no institutional infrastructure or approved data-sharing agreement for external distribution. De-identified data may be made available upon reasonable request to the corresponding investigator, subject to ethics approval and institutional policies.
Publications
Zhao L, Cheng K, Wu F, Du J, Chen Y, Tan MT, Lao L, Shen X. Effect of Laser Moxibustion for Knee Osteoarthritis: A Multisite, Double-blind Randomized Controlled Trial. J Rheumatol. 2021 Jun;48(6):924-932. doi: 10.3899/jrheum.200217. Epub 2020 Jul 1.
PubMed 32611673
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Carbon Dioxide Infrared Laser Moxibustion in Patients With Knee Osteoarthritis: A Double-Blind Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07423182
- Acronym / sponsor ID
- CILM-KOA / UOL-IREB-25-12-0037-70137698
- Conditions
- Knee Osteoarthritis
- Keywords
- Carbon dioxide infrared laser moxibustion, Laser moxibustion, Exercise therapy, Physical therapy, Knee rehabilitation, Pain intensity, Numerical Pain Rating Scale, Western Ontario and McMaster Universities Osteoarthritis Index
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 68 participants (actual)
- Lead sponsor
- University of LahoreUniversity, hospital or other
- Study start
- 26 Oct 2025 (actual)
- Primary completion
- 30 Mar 2026 (actual)
- Study completion
- 30 Jul 2026 (actual)
- First posted
- 20 Feb 2026 (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.
Knee osteoarthritis is a prevalent degenerative joint disorder characterized by chronic knee pain, stiffness, reduced range of motion, and limitations in daily functional activities. Exercise therapy is widely recommended as a first-line conservative approach to reduce symptoms and improve physical performance; however, a substantial proportion of patients continue to experience persistent pain and functional impairment despite adherence to exercise-based rehabilitation.
Carbon dioxide (CO2) infrared laser moxibustion is a non-invasive far-infrared thermal stimulation modality intended to reproduce the localized heating effects of traditional moxibustion without smoke or odor. It is hypothesized to enhance local microcirculation, support tissue oxygenation, and modulate inflammatory activity, thereby contributing to symptom relief and improved joint function. This double-blind, parallel-group randomized controlled trial will evaluate whether adding carbon dioxide (CO2) infrared laser moxibustion to a standardized knee osteoarthritis exercise program provides greater improvement than exercise alone. Eligible participants with radiographic knee osteoarthritis will be randomly allocated to either (1) an exercise-only program or (2) the same exercise program plus carbon dioxide (CO2) infrared laser moxibustion delivered over an 8-week treatment phase (24 sessions). Outcomes will be measured at baseline and at follow-up visits at Month 3 and Month 6 to determine changes in pain intensity measured by the Numerical Pain Rating Scale (NPRS), knee range of motion measured by goniometry, articular cartilage thickness measured by magnetic resonance imaging (MRI), and biochemical markers including bone alkaline phosphatase (BAP) and serum calcium.
Detailed description
This study is a double-blind, parallel-group randomized controlled trial examining the effectiveness of carbon dioxide (CO2) infrared laser moxibustion as an adjunct to exercise therapy in individuals with knee osteoarthritis. Knee osteoarthritis is a multifactorial degenerative condition involving mechanical stress, low-grade inflammation, and progressive joint tissue changes that contribute to pain, restricted movement, and functional limitations. Exercise therapy represents a core component of conservative management; however, residual symptoms are frequently reported, supporting the evaluation of additional non-pharmacological approaches.
Carbon dioxide (CO2) infrared laser moxibustion is a non-invasive modality that delivers far-infrared thermal stimulation to predefined knee-related treatment points, intended to reproduce the therapeutic effects of traditional moxibustion without smoke exposure. Proposed mechanisms include enhancement of local microcirculation, modulation of inflammatory activity, neuromodulatory analgesic effects, and potential support of local tissue metabolism. Participants with radiographic knee osteoarthritis will be allocated to either a standardized exercise program alone or the same exercise program combined with carbon dioxide (CO2) infrared laser moxibustion delivered during an 8-week treatment period.
Participants will be assessed at baseline, at the end of the 8-week intervention period, and during follow-up visits at Month 3 and Month 6 to evaluate short-term and medium-term changes in pain and knee-related outcomes. The findings of this study will contribute to the evidence base for rehabilitation strategies in knee osteoarthritis and inform the potential role of carbon dioxide (CO2) infrared laser moxibustion as an adjunct conservative intervention.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- Two-arm, parallel-group randomized controlled trial comparing a standardized exercise-only program versus the same exercise program combined with carbon dioxide (CO2) infrared laser moxibustion administered over an 8-week treatment period, with follow-up assessments conducted at Month 3 and Month 6.
| Arm | Type | Receives |
|---|---|---|
| Exercise Program Only (Control) | Active comparator | Other: Exercise Program for Knee Osteoarthritis, Device: CO2 Infrared Laser Moxibustion (CILM)Participants receive a standardized knee osteoarthritis exercise program delivered over an 8-week intervention period, with three supervised sessions per week (24 sessions total). Each session lasts approximately 40 minutes and includes warm-up activities followed by progressive strengthening and mobility exercises targeting the knee and surrounding musculature, including step-ups, chair sit-to-stand exercises, quadriceps strengthening, isometric thigh activation, and balance or coordination exercises. Clinical outcomes are measured at baseline, at the end of the 8-week intervention period, and at follow-up visits at Month 3 and Month 6 according to the study protocol. |
| Exercise Program Plus Carbon Dioxide (CO2) Infrared Laser Moxibustion (CILM) | Experimental | Other: Exercise Program for Knee Osteoarthritis, Device: CO2 Infrared Laser Moxibustion (CILM)Participants receive the same standardized knee osteoarthritis exercise program delivered over an 8-week intervention period, with three supervised sessions per week (24 sessions total; approximately 40 minutes per session), in combination with carbon dioxide (CO2) infrared laser moxibustion. Carbon dioxide (CO2) infrared laser moxibustion is administered using a 10.6 micrometer CO2 infrared laser device with an output power range of 160 to 180 mW. The defocused probe is positioned approximately 2 cm from the skin, producing a light spot with a diameter of approximately 2 cm. Irradiation is applied to predefined knee-related treatment points including ST35 (Dubi), Ex-LE4 (Neixiyan), and Ashi (tender points), applied bilaterally, with each point treated for approximately 5 minutes per knee. The total irradiation time per session is approximately 30 minutes, with additional time allocated for positioning and safety checks, resulting in a total session duration of approximately 40 minute |
Who may qualify
- Ages
- 55 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Adults aged 55 to 65 years, male or female. Diagnosis of knee osteoarthritis with radiographic evidence (Kellgren-Lawrence grade 2 or higher).
- Knee osteoarthritis grade II or III according to the American Rheumatism Association (ARA) classification criteria.
- History of moderate to severe knee pain on most days during the past month. Able and willing to provide written informed consent and comply with study procedures.
Key exclusion criteria (5 listed)
- Other diseases affecting the knee, such as rheumatoid arthritis, ankylosing spondylitis, fibromyalgia syndrome, or chronic fatigue syndrome.
- Use of steroid medication or acupuncture or moxibustion treatment within the previous 3 months.
- Intra-articular hyaluronate injection within the previous 6 months. Arthrocentesis or arthroscopy within the previous 1 year. Knee or hip replacement surgery, or planned joint replacement surgery during the trial period.
- Use of other external treatments during the trial (e.g., topical medication for knee pain).
- Body mass index (BMI) greater than 30 kg/m². Lower-limb fracture or injury affecting function. Neurological disorders or nerve root compression affecting the lower limb.
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 |
|---|---|---|
| Exercise Program for Knee OsteoarthritisParticipants receive a standardized knee osteoarthritis exercise program delivered over an 8-week intervention period, with three supervised sessions per week (24 sessions total), with each session lasting approximately 40 minutes. The program includes warm-up activities followed by progressive strengthening and mobility exercises targeting the knee and surrounding musculature, including step-ups, chair sit-to-stand exercises, quadriceps strengthening, isometric thigh activation, and balance or coordination exercises. | Other | Exercise Program Only (Control), Exercise Program Plus Carbon Dioxide (CO2) Infrared Laser Moxibustion (CILM) |
| CO2 Infrared Laser Moxibustion (CILM)Also: 10.6 μm Infrared Laser Moxibustion, 10.6 μm CO₂ Laser MoxibustionCO₂ infrared laser moxibustion is administered using a 10.6 μm CO₂ infrared laser device with an output power range of 160-180 mW. The defocused probe is positioned approximately 2 cm from the skin, producing a light spot with a diameter of approximately 2 cm. Irradiation is applied to predefined knee-related points (ST35, Ex-LE4, and Ashi points) bilaterally, with each point treated for approximately 5 minutes per knee. The total irradiation time per session is approximately 30 minutes, including bilateral point application, with additional time allocated for positioning and safety checks, resulting in a total session duration of approximately 40 minutes. Treatment is delivered three sessions per week for eight weeks (24 sessions total) according to a standardized protocol. | Device | Exercise Program Only (Control), Exercise Program Plus Carbon Dioxide (CO2) Infrared Laser Moxibustion (CILM) |
Primary outcome
Pain intensity measured by the Numerical Pain Rating Scale (0 to 10)
Time frame: Baseline and Week 8
Change in knee pain intensity measured using the 0 to 10 Numerical Pain Rating Scale (0 = no pain, 10 = worst possible pain).
4 secondary outcomes
Knee range of motion in flexion and extension
Time frame: Baseline, Week 8, Month 3, and Month 6
Articular cartilage thickness measured by magnetic resonance imaging (MRI)
Time frame: Baseline and Month 6
Serum bone alkaline phosphatase (BAP)
Time frame: Baseline, Month 3, and Month 6
Serum calcium concentration
Time frame: Baseline, Month 3, and Month 6
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 2026.
- Results publication: PubMed 32611673Zhao L, Cheng K, Wu F, Du J, Chen Y, Tan MT, Lao L, Shen X. Effect of Laser Moxibustion for Knee Osteoarthritis: A Multisite, Double-blind Randomized Controlled Trial. J Rheumatol. 2021 Jun;48(6):924-932. doi: 10.3899/jrheum.200217. Epub 2020 Jul 1.
- Individual participant dataSharing planned: No. IPD will not be shared because the study involves identifiable clinical and imaging data collected at local hospital sites, and there is currently no institutional infrastructure or approved data-sharing agreement for external distribution. De-identified data may be made available upon reasonable request to the corresponding investigator, subject to ethics approval and institutional policies.
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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.
Ashfaq Ahmed study director
University Institute of Physical Therapy Univesity of Lahore Pakistan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise Program for Knee Osteoarthritis and CO2 Infrared Laser Moxibustion (CILM) in people with Knee Osteoarthritis, run by University of Lahore 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 3 inclusion and 5 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 2026. 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?
Pain intensity measured by the Numerical Pain Rating Scale (0 to 10) (time frame: Baseline and Week 8). 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 NCT07423182, which also lists 1 linked publication.
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 2026.