Knee OsteoarthritisNCT06460662
Effects of Agility and Perturbation Based Training in Addition to Routine Physical Therapy
A study testing Routine Physical Therapy in people with Knee Osteoarthritis, run by Riphah International University at 1 site in Pakistan.
Trial summary
Osteoarthritis is a degenerative joint disease. Knee OA patients sometimes report episodes of knee instability that limit their ADLs. The episodes of instability are similar to those reported in knee ligament injuries. Read more about this study
- Who is it for?
- Ages 50 to 60 years
- Conditions the study is for
- Knee Osteoarthritis
- What is being tested?
- Routine Physical Therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 1 sitePakistan
- Study dates
- 30 Jun 2024to 10 Oct 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Both male and female.
- Subjects with Kellgren and Lawrence grade II and III osteoarthritis.
- OA diagnosed subjects according to American College of Rheumatology ACR criteria;
- Morning stiffness ≤ 30 minutes.
- Crepitus with active motion of the knee (while weight bearing).
- Tenderness to palpation of the bony margins of the joint, bony enlargement, and no palpable warmth.
Who cannot join
- Ligament or meniscal injury around the knee.
- Suffering from acute synovitis
- Neuromuscular disorders.
- Cognitive impairments.
- Required use of an assistive device for ambulation.
- Reported a history of 2 or more falls within the previous year.
Show all 9Show fewer
- Undergone total knee arthroplasty.
- Uncontrolled hypertension, history of cardiovascular disease, neurological disorders that affected lower extremity function.
- Severe visual problems.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Agility and Perturbation Based Training in Addition to Routine Physical Therapy on Pain, Function and Quality of Life in Patients With Knee Osteoarthritis
Osteoarthritis is a degenerative joint disease. Knee OA patients sometimes report episodes of knee instability that limit their ADLs. The episodes of instability are similar to those reported in knee ligament injuries. It is believed that modifications of interventions that are used to promote knee stability in knee ligament injuries can be used in knee OA to enhance knee stability and function. The purpose of this study will be to determine the effects of agility and perturbation-based training in addition to routine physical therapy on pain, function, quality of life and disability in knee osteoarthritis.
Read the detailed description
A Randomized Clinical Trial will be conducted at Al Syed Touqeer Altaf Surgical Hospital through a convenience sampling technique on 26 patients, which will be allocated using computer-generated randomization into two groups. Group A will be treated with agility and perturbation training techniques in addition to the same routine physical therapy as Group B, and Group B will receive only routine physical therapy. Outcome measures will be conducted through NPRS, WOMAC, SF-36, and KOS-ADLs questionnaires. All the outcome measures will be assessed pre and post-treatment, and the assessor will be blind. Frequency of the treatment will be 3 sessions per week for 4 weeks. Data will be analyzed using SPSS software version 25.
- Conditions
- Knee Osteoarthritis
- Being tested
- Routine Physical Therapy
- Keywords
- pain, function, quality of life
- 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.
Routine Physical TherapyOther
Group B: Routine physical therapy Group that includes:
- Calf Stretching
- Hamstring Stretching
- Prone Quadriceps Stretching
- Long-Sitting Knee Flexion and Extension
- Quadriceps setting
- Supine Straight Leg Raises
- Prone Hip Extensions
- Standing Hamstring Curls With Cuff Weights
- Standing Calf Raises
- Treadmill Walking
- Mobilization techniques
| Study group | Role | What they receive |
|---|---|---|
| Agility and perturbation training group | Experimental | Group A will receive agility and perturbation training techniques in addition to the same routine physical therapy as Group B.
The Agility training exercises include:
* Side Stepping
* Braiding Activities
* Front and Back Crossover Steps During Forward Ambulation
* Multiple Changes in Direction During Walking on Therapist Command
The perturbation training exercises include:
* Double-Leg Foam Balance Activity
* Tilt board Balance Training
* Rollerboard and Platform Perturbations Receives: Other: Routine Physical Therapy |
| Routine physical therapy | Active comparator | Group B: Routine physical therapy Group that includes:
* Calf Stretching
* Hamstring Stretching
* Prone Quadriceps Stretching
* Long-Sitting Knee Flexion and Extension
* Quadriceps setting
* Supine Straight Leg Raises
* Prone Hip Extensions
* Standing Hamstring Curls With Cuff Weights
* Standing Calf Raises
* Treadmill Walking
* Mobilization techniques Receives: Other: Routine Physical Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Numeric pain rate scale (NPRS)
Numeric pain rate scale will be used to quantify patient level of pain. The Numeric Pain Rating Scale (NPRS) is a subjective measure in which individuals rate their pain on an eleven-point numerical scale. The common format is a horizontal bar or line. Although various iterations exist, the most commonly used is the 11-item NPRS. The 11-point numeric scale ranges from (no pain at all) to 10 (worst imaginable pain) i.e. higher scores indicating greater pain intensity. High test-retest reliability has been observed in both literate and illiterate patients with rheumatoid arthritis (r = 0.96 and 0.95, respectively) before and after medical consultation. For construct validity, the NPRS was shown to be highly correlated with the VAS in patients with rheumatic and other chronic pain conditions (pain>6 months): correlations range from 0.86 to 0.95.
Measured: upto 4 weeks
Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)
Patients' knee function and stiffness will be measured through the Western Ontario and McMaster Universities Arthritis Index (WOMAC) . It is a self-administered questionnaire consisting of 24 items divided into 3 subscales; Pain-5 items, Stiffness-2 items, Physical Function-17 items .
WOMAC Index was developed in 1982 at Western Ontario and McMaster Universities. WOMAC is available in over 65 languages and has been linguistically validated. 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.
Measured: upto 4 weeks
SF-36 (Short form)
36-Item Short Form Survey (SF-36) will be used to assess the quality of life. (SF-36) is an outcome measure instrument that is often used, a well-researched, self-reported measure of health. It stems from a study called the Medical Outcomes Study, which is an objective measure of quality of life. It comprises 36 questions that cover eight domains of health. The 36 questions on the SF-36 are meant to reflect 8 domains of health, including physical functioning, physical role, pain, general health, vitality, social function, emotional role, and mental health.Possible scores range from 0 to 100, with higher scores representing better health status.
Measured: upto 4 weeks
Knee Outcome Survey Activities of Daily Living KOS-ADLS
Knee outcome survey ADLS will be used to measure disability. The ADLS is a 14 item scale that queries patients about how their knee symptoms effect their ability to perform general daily activities (6 items) as well as how their knee condition effects their ability to perform specific functional tasks (8 items). Each item is scored 0-5 with 5 indicating "no difficulty" and 0 representing "unable to perform". The highest possible score is 70. The scores of all items are summed, divided by 70, and then multiplied by 100 to give an overall ADLS percent rating. Higher percentages reflect higher levels of functional ability.
The ADLS demonstrated high test-retest reliability in 52 subjects with knee pathology. The ICC score for test-retest reliability over a 24 hour period was .97. Construct validity was determined through correlations with the Lysholm Knee Scale (r = .78 to .86).
Measured: upto 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jun 2024
- Study start30 Jun 2024
- Primary completion30 Sep 2024
- Study completion10 Oct 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)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
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Maryam Ijaz, MSPT*, Principal investigator, Riphah International University,Lahore
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06460662
- Sponsor's protocol ID
- REC/RCR & AHS/23/0193 Maryam
- Status last verified
- Oct 2024
- First submitted
- 11 Jun 2024
- Last updated
- 15 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Lange AK, Vanwanseele B, Fiatarone Singh MA. Strength training for treatment of osteoarthritis of the knee: a systematic review. Arthritis Rheum. 2008 Oct 15;59(10):1488-94. doi: 10.1002/art.24118.
PubMed 18821647Hicks-Little CA, Peindl RD, Hubbard-Turner TJ, Cordova ML. The Relationship Between Early-Stage Knee Osteoarthritis and Lower-Extremity Alignment, Joint Laxity, and Subjective Scores of Pain, Stiffness, and Function. J Sport Rehabil. 2016 Aug;25(3):213-8. doi: 10.1123/jsr.2014-0170. Epub 2016 Jul 21.
PubMed 27445119Michael JW, Schluter-Brust KU, Eysel P. The epidemiology, etiology, diagnosis, and treatment of osteoarthritis of the knee. Dtsch Arztebl Int. 2010 Mar;107(9):152-62. doi: 10.3238/arztebl.2010.0152. Epub 2010 Mar 5.
PubMed 20305774Samson DJ, Grant MD, Ratko TA, Bonnell CJ, Ziegler KM, Aronson N. Treatment of primary and secondary osteoarthritis of the knee. Evid Rep Technol Assess (Full Rep). 2007 Sep;(157):1-157.
PubMed 18088162Collins NJ, Hart HF, Mills KAG. Osteoarthritis year in review 2018: rehabilitation and outcomes. Osteoarthritis Cartilage. 2019 Mar;27(3):378-391. doi: 10.1016/j.joca.2018.11.010. Epub 2018 Dec 7.
PubMed 30529739Zhang W, Moskowitz RW, Nuki G, Abramson S, Altman RD, Arden N, Bierma-Zeinstra S, Brandt KD, Croft P, Doherty M, Dougados M, Hochberg M, Hunter DJ, Kwoh K, Lohmander LS, Tugwell P. OARSI recommendations for the management of hip and knee osteoarthritis, part I: critical appraisal of existing treatment guidelines and systematic review of current research evidence. Osteoarthritis Cartilage. 2007 Sep;15(9):981-1000. doi: 10.1016/j.joca.2007.06.014. Epub 2007 Aug 27.
PubMed 17719803Jamtvedt G, Dahm KT, Christie A, Moe RH, Haavardsholm E, Holm I, Hagen KB. Physical therapy interventions for patients with osteoarthritis of the knee: an overview of systematic reviews. Phys Ther. 2008 Jan;88(1):123-36. doi: 10.2522/ptj.20070043. Epub 2007 Nov 6.
PubMed 17986496Zhang W, Moskowitz RW, Nuki G, Abramson S, Altman RD, Arden N, Bierma-Zeinstra S, Brandt KD, Croft P, Doherty M, Dougados M, Hochberg M, Hunter DJ, Kwoh K, Lohmander LS, Tugwell P. OARSI recommendations for the management of hip and knee osteoarthritis, Part II: OARSI evidence-based, expert consensus guidelines. Osteoarthritis Cartilage. 2008 Feb;16(2):137-62. doi: 10.1016/j.joca.2007.12.013.
PubMed 18279766
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Agility and Perturbation Based Training in Addition to Routine Physical Therapy on Pain, Function and Quality of Life in Patients With Knee Osteoarthritis
- ClinicalTrials.gov ID
- NCT06460662
- Acronym / sponsor ID
- REC/RCR & AHS/23/0193 Maryam
- Conditions
- Knee Osteoarthritis
- Keywords
- pain, function, quality of life
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 30 Jun 2024 (actual)
- Primary completion
- 30 Sep 2024 (actual)
- Study completion
- 10 Oct 2024 (actual)
- First posted
- 14 Jun 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.
Osteoarthritis is a degenerative joint disease. Knee OA patients sometimes report episodes of knee instability that limit their ADLs. The episodes of instability are similar to those reported in knee ligament injuries. It is believed that modifications of interventions that are used to promote knee stability in knee ligament injuries can be used in knee OA to enhance knee stability and function. The purpose of this study will be to determine the effects of agility and perturbation-based training in addition to routine physical therapy on pain, function, quality of life and disability in knee osteoarthritis.
Detailed description
A Randomized Clinical Trial will be conducted at Al Syed Touqeer Altaf Surgical Hospital through a convenience sampling technique on 26 patients, which will be allocated using computer-generated randomization into two groups. Group A will be treated with agility and perturbation training techniques in addition to the same routine physical therapy as Group B, and Group B will receive only routine physical therapy. Outcome measures will be conducted through NPRS, WOMAC, SF-36, and KOS-ADLs questionnaires. All the outcome measures will be assessed pre and post-treatment, and the assessor will be blind. Frequency of the treatment will be 3 sessions per week for 4 weeks. Data will be analyzed using SPSS software version 25.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Agility and perturbation training group | Experimental | Other: Routine Physical TherapyGroup A will receive agility and perturbation training techniques in addition to the same routine physical therapy as Group B. The Agility training exercises include: * Side Stepping * Braiding Activities * Front and Back Crossover Steps During Forward Ambulation * Multiple Changes in Direction During Walking on Therapist Command The perturbation training exercises include: * Double-Leg Foam Balance Activity * Tilt board Balance Training * Rollerboard and Platform Perturbations |
| Routine physical therapy | Active comparator | Other: Routine Physical TherapyGroup B: Routine physical therapy Group that includes: * Calf Stretching * Hamstring Stretching * Prone Quadriceps Stretching * Long-Sitting Knee Flexion and Extension * Quadriceps setting * Supine Straight Leg Raises * Prone Hip Extensions * Standing Hamstring Curls With Cuff Weights * Standing Calf Raises * Treadmill Walking * Mobilization techniques |
Who may qualify
- Ages
- 50 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Both male and female.
- Subjects with Kellgren and Lawrence grade II and III osteoarthritis.
- OA diagnosed subjects according to American College of Rheumatology ACR criteria;
Key exclusion criteria (9 listed)
- Ligament or meniscal injury around the knee.
- Suffering from acute synovitis
- Neuromuscular disorders.
- Cognitive impairments.
- Required use of an assistive device for ambulation.
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 |
|---|---|---|
| Routine Physical TherapyGroup B: Routine physical therapy Group that includes: * Calf Stretching * Hamstring Stretching * Prone Quadriceps Stretching * Long-Sitting Knee Flexion and Extension * Quadriceps setting * Supine Straight Leg Raises * Prone Hip Extensions * Standing Hamstring Curls With Cuff Weights * Standing Calf Raises * Treadmill Walking * Mobilization techniques | Other | Agility and perturbation training group, Routine physical therapy |
Primary outcome
Numeric pain rate scale (NPRS)
Time frame: upto 4 weeks
Numeric pain rate scale will be used to quantify patient level of pain. The Numeric Pain Rating Scale (NPRS) is a subjective measure in which individuals rate their pain on an eleven-point numerical scale. The common format is a horizontal bar or line. Although various iterations exist, the most commonly used is the 11-item NPRS. The 11-point numeric scale ranges from (no pain at all) to 10 (worst imaginable pain) i.e. higher scores indicating greater pain intensity. High test-retest reliability has been observed in both literate and illiterate patients with rheumatoid arthritis (r = 0.96 and 0.95, respectively) before and after medical consultation. For construct validity, the NPRS was shown to be highly correlated with the VAS in patients with rheumatic and other chronic pain conditions (pain>6 months): correlations range from 0.86 to 0.95.
Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)
Time frame: upto 4 weeks
Patients' knee function and stiffness will be measured through the Western Ontario and McMaster Universities Arthritis Index (WOMAC) . It is a self-administered questionnaire consisting of 24 items divided into 3 subscales; Pain-5 items, Stiffness-2 items, Physical Function-17 items . WOMAC Index was developed in 1982 at Western Ontario and McMaster Universities. WOMAC is available in over 65 languages and has been linguistically validated. 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.
SF-36 (Short form)
Time frame: upto 4 weeks
36-Item Short Form Survey (SF-36) will be used to assess the quality of life. (SF-36) is an outcome measure instrument that is often used, a well-researched, self-reported measure of health. It stems from a study called the Medical Outcomes Study, which is an objective measure of quality of life. It comprises 36 questions that cover eight domains of health. The 36 questions on the SF-36 are meant to reflect 8 domains of health, including physical functioning, physical role, pain, general health, vitality, social function, emotional role, and mental health.Possible scores range from 0 to 100, with higher scores representing better health status.
Knee Outcome Survey Activities of Daily Living KOS-ADLS
Time frame: upto 4 weeks
Knee outcome survey ADLS will be used to measure disability. The ADLS is a 14 item scale that queries patients about how their knee symptoms effect their ability to perform general daily activities (6 items) as well as how their knee condition effects their ability to perform specific functional tasks (8 items). Each item is scored 0-5 with 5 indicating "no difficulty" and 0 representing "unable to perform". The highest possible score is 70. The scores of all items are summed, divided by 70, and then multiplied by 100 to give an overall ADLS percent rating. Higher percentages reflect higher levels of functional ability. The ADLS demonstrated high test-retest reliability in 52 subjects with knee pathology. The ICC score for test-retest reliability over a 24 hour period was .97. Construct validity was determined through correlations with the Lysholm Knee Scale (r = .78 to .86).
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 15 Oct 2024.
- Background: PubMed 18821647Lange AK, Vanwanseele B, Fiatarone Singh MA. Strength training for treatment of osteoarthritis of the knee: a systematic review. Arthritis Rheum. 2008 Oct 15;59(10):1488-94. doi: 10.1002/art.24118.
- Background: PubMed 27445119Hicks-Little CA, Peindl RD, Hubbard-Turner TJ, Cordova ML. The Relationship Between Early-Stage Knee Osteoarthritis and Lower-Extremity Alignment, Joint Laxity, and Subjective Scores of Pain, Stiffness, and Function. J Sport Rehabil. 2016 Aug;25(3):213-8. doi: 10.1123/jsr.2014-0170. Epub 2016 Jul 21.
- Background: PubMed 20305774Michael JW, Schluter-Brust KU, Eysel P. The epidemiology, etiology, diagnosis, and treatment of osteoarthritis of the knee. Dtsch Arztebl Int. 2010 Mar;107(9):152-62. doi: 10.3238/arztebl.2010.0152. Epub 2010 Mar 5.
- Background: PubMed 18088162Samson DJ, Grant MD, Ratko TA, Bonnell CJ, Ziegler KM, Aronson N. Treatment of primary and secondary osteoarthritis of the knee. Evid Rep Technol Assess (Full Rep). 2007 Sep;(157):1-157.
- Background: PubMed 30529739Collins NJ, Hart HF, Mills KAG. Osteoarthritis year in review 2018: rehabilitation and outcomes. Osteoarthritis Cartilage. 2019 Mar;27(3):378-391. doi: 10.1016/j.joca.2018.11.010. Epub 2018 Dec 7.
- Background: PubMed 17719803Zhang W, Moskowitz RW, Nuki G, Abramson S, Altman RD, Arden N, Bierma-Zeinstra S, Brandt KD, Croft P, Doherty M, Dougados M, Hochberg M, Hunter DJ, Kwoh K, Lohmander LS, Tugwell P. OARSI recommendations for the management of hip and knee osteoarthritis, part I: critical appraisal of existing treatment guidelines and systematic review of current research evidence. Osteoarthritis Cartilage. 2007 Sep;15(9):981-1000. doi: 10.1016/j.joca.2007.06.014. Epub 2007 Aug 27.
- Background: PubMed 17986496Jamtvedt G, Dahm KT, Christie A, Moe RH, Haavardsholm E, Holm I, Hagen KB. Physical therapy interventions for patients with osteoarthritis of the knee: an overview of systematic reviews. Phys Ther. 2008 Jan;88(1):123-36. doi: 10.2522/ptj.20070043. Epub 2007 Nov 6.
- Background: PubMed 18279766Zhang W, Moskowitz RW, Nuki G, Abramson S, Altman RD, Arden N, Bierma-Zeinstra S, Brandt KD, Croft P, Doherty M, Dougados M, Hochberg M, Hunter DJ, Kwoh K, Lohmander LS, Tugwell P. OARSI recommendations for the management of hip and knee osteoarthritis, Part II: OARSI evidence-based, expert consensus guidelines. Osteoarthritis Cartilage. 2008 Feb;16(2):137-62. doi: 10.1016/j.joca.2007.12.013.
- 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.
Maryam Ijaz, MSPT* principal investigator
Riphah International University,Lahore
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Routine Physical 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 6 inclusion and 9 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 15 Oct 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 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?
Numeric pain rate scale (NPRS) (time frame: upto 4 weeks). 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 NCT06460662, which also lists 8 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 15 Oct 2024.