Lateral Epicondylitis (Tennis Elbow)NCT06597643
The Effect of Adding Deep Friction Massage to Eccentric Training Exercises in Lateral Epicondylitis
A study testing Eccentric Training and Deep Friction Massage in people with Lateral Epicondylitis (Tennis Elbow), run by Cairo University.
Trial summary
Background: Lateral epicondylitis (LE) often benefits from eccentric training exercises, but combining them with deep friction massage (DFM) might enhance outcomes. Objective: To evaluate if adding DFM to eccentric training improves pain, function, wrist extensor strength, and hand grip strength more than eccentric… Read more about this study
- Who is it for?
- Ages 16 to 30 years
- Conditions the study is for
- Lateral Epicondylitis (Tennis Elbow)
- What is being tested?
- Eccentric Training and Deep Friction Massage
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 46 participants
- Where
- No sites listed yet
- Study dates
- 1 Oct 2024to 1 Mar 2025
- 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 16 to 30 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Both gender male and female
- Age from 16 to 30
- Unilateral elbow pain
- Body mass index ranges from 18.5 to 29.9
- Non athletic patient
- Chronic LE don't receive PT for 6 months
Who cannot join
- Any injury or disease around the shoulder, elbow and wrist on the affected side
- Any b local intervention such as injection of steroids 6 month prior to the intervention
- Cervical radiculopathy
- History of fracture of radius, ulna and humerus with resultant deformity of the affected extremity
- Neurological impairments
Trial locations and contacts
No sites are listed yet.
About this study
Background: Lateral epicondylitis (LE) often benefits from eccentric training exercises, but combining them with deep friction massage (DFM) might enhance outcomes.
Objective: To evaluate if adding DFM to eccentric training improves pain, function, wrist extensor strength, and hand grip strength more than eccentric training alone.
Read more
Design: A triple-blinded, randomized controlled trial involving 46 participants aged 16-30 with unilateral LE. Participants will be randomly assigned to receive either eccentric training plus sham massage (Control Group) or eccentric training plus DFM (Experimental Group) over 4 weeks.
Methods: Outcomes will be measured using the Visual Analogue Scale (VAS) for pain, the Disabilities of the Arm, Shoulder, and Hand (DASH) questionnaire for function, a hand-held dynamometer for wrist extensor strength, and a grip dynamometer for hand grip strength.
Blinding: The study is triple-blinded-assessors, statisticians, and participants are unaware of group allocations.
Significance: This study aims to determine if DFM enhances the effectiveness of eccentric training in LE rehabilitation, potentially leading to improved treatment protocols.
Read the detailed description
Background: Lateral epicondylitis (LE), also known as tennis elbow, is an overuse injury of the elbow characterized by pain and functional impairment in the lateral aspect of the elbow. Traditional management strategies often include eccentric training exercises aimed at improving muscle strength and reducing pain. However, the addition of deep friction massage (DFM) to such a regimen might offer additional benefits.
Objective: This study aims to evaluate the impact of combining deep friction massage with eccentric training exercises on pain, functional ability, wrist extensor strength, and hand grip strength in patients with unilateral lateral epicondylitis.
Design: A triple-blinded randomized controlled trial (RCT) will be carried out at the outpatient physical therapy clinic of Pharos University in Alexandria, Egypt. The trial is designed to assess whether the integration of DFM with eccentric training offers superior outcomes compared to eccentric training alone.
Participants: The study will involve 46 patients aged 16 to 30 years, diagnosed with unilateral lateral epicondylitis. Participants will be randomly assigned to one of two groups: Group A (Control) and Group B (Experimental). Inclusion criteria include unilateral elbow pain, a BMI between 18.5 and 29.9, and chronic LE not treated with physical therapy in the past six months. Exclusion criteria include significant injuries or diseases affecting the shoulder, elbow, or wrist, recent local steroid injections, cervical radiculopathy, and neurological impairments.
Interventions:
Control Group (Group A): Participants will receive eccentric training exercises and sham massage. The eccentric training regimen includes three exercises: eccentric wrist extension with dumbbells, eccentric wrist extension with a twist-bar, and eccentric supination with an elastic band. Sham massage will be used to maintain blinding.
Experimental Group (Group B): Participants will receive the same eccentric training exercises as Group A, plus deep friction massage (DFM). DFM will be applied to the extensor carpi radialis brevis tendon at the site of the common extensor origin, with firm pressure applied perpendicular to the tendon for 5 minutes before each exercise session.
Outcome Measures:
Pain: Assessed using the Visual Analogue Scale (VAS), which allows patients to rate pain intensity on a 100 mm line ranging from \"no pain\" to \"worst pain.\" Function: Evaluated using the Disabilities of the Arm, Shoulder, and Hand (DASH) questionnaire, which includes 30 items measuring both function and symptoms in upper limb activities. Scores range from 0 (no disability) to 100 (severe disability).
Wrist Extensor Strength: Measured with a hand-held dynamometer, quantifying the maximum isometric strength of wrist extensors.
Hand Grip Strength: Assessed using a Jamar grip dynamometer, recording the maximum grip strength in kilograms.
Blinding and Randomization: The study will use a triple-blinding approach. Research assistants conducting assessments will be blinded to group allocations, as will the statisticians analyzing the data. Participants will also be unaware of their group assignment. Randomization will be achieved using an online random number generator to ensure unbiased group assignment.
Significance: This study seeks to determine if combining deep friction massage with eccentric training provides additional benefits over eccentric training alone in terms of pain reduction, functional improvement, and strength enhancement in patients with lateral epicondylitis. The results could inform more effective rehabilitation strategies for this common condition.
- Conditions
- Lateral Epicondylitis (Tennis Elbow)
- Being tested
- Eccentric Training, Deep Friction Massage
- Keywords
- Lateral Epicondylitis, Eccentric Training, Deep Friction Massage (DFM, Wrist Extensor Strength
- Medical subject headings
- Tennis Elbow
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Eccentric TrainingOther
Exercise 1: Eccentric Wrist Extension with Dumbbell
Position: Seated, elbow extended, wrist maximally extended.
Action:
Lower: Slowly flex the wrist for 30 seconds. Return: Use the opposite hand to bring wrist back to extension. Load: Increase weight based on 10 Repetition Maximum (10RM). Exercise 2: Eccentric Wrist Extension with Twist-Bar
Position: Hold Flex Bar with involved hand in extension.
Action:
Twist: Rotate the bar with the non-involved hand while keeping the involved wrist extended.
Untwist: Allow the wrist to flex slowly. Exercise 3: Eccentric Supination with Elastic Band
Position: Anchor band, elbow flexed to 90°.
Action:
Supinate: Rotate forearm with palm up. Flex: Slowly rotate to palm down, then return
Deep Friction MassageOther
The patient will sit on a chair while holding a pillow. DFM will be performed in perpendicular direction to the Extensor carpi radialis brevis tendon the site of the application will be on the upper attachment of the common extensor origin (palpated one cm distal to the lateral epicondyle of the humerus) for 5 minutes. Using the thumb, Firm pressure will be applied to compress the extensor tendons, their origins, and the musculotendinous junctions between the underlying bone and the fingertips. This pressure will be maintained while the therapist applies DFM in the direction of their fingers,
| Study group | Role | What they receive |
|---|---|---|
| Control Group | Active comparator | Twenty-one patients will be assigned to group A, who will receive eccentric exercise program in addition to sham massage in the form of skin rubbing for patient blinding. for a total of 12 treatment sessions (3 sessions per week) for 4 weeks 3 sets of 15 repetitions, it takes 5 seconds to complete each repetition and between each set there is 30 seconds of rest Receives: Other: Eccentric Training |
| Experimental Group | Experimental | Twenty-one patients will be assigned to group B who will receive the same exercises as in control group (eccentric training exercises) in addition to deep friction massage (DFM) for a total of 12 treatment sessions (3 sessions per week) for 4 weeks. Before starting the exercises DFM will be performed. The patient will sit on a chair while holding a pillow. DFM will be performed in perpendicular direction to the Extensor carpi radialis brevis tendon the site of the application will be on the upper attachment of the common extensor origin (palpated one cm distal to the lateral epicondyle of the humerus) for 5 minutes. Using the thumb, Firm pressure will be applied to compress the extensor tendons, their origins, and the musculotendinous junctions between the underlying bone and the fingertips. This pressure will be maintained while the therapist applies DFM in the direction of their fingers, Receives: Other: Eccentric Training; Other: Deep Friction Massage |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual Analogue Scale
is used to measure the pain which is represented from (0) grade to (10) grade, with zero means no pain and ten means intolerable pain, The subjects were asked to indicate the level of pain by placing a dash at the appropriate level on the 10 cm horizontal line
Measured: 4 weeks
Secondary outcomes (3)
-Disability of the Arm, Shoulder and Hand questionnaire Arabic version
It is a 30-item; self-report questionnaire designed to assess the patient's health status. The items indicate the degree of difficulty in performing different physical activities (21 items), the severity of each of the symptoms of pain, activity-related pain, tingling, weakness and stiffness (5 items) and the impact of the problem on social, work, sleep and self-image (4 items). Each item has 5 response options. Scores range from 0 (no disability) to 100 (most severe disability)
Measured: 4 weeks
Hand-held Dynamometer
for measuring wrist extensor strength, it is a sensitive, objective and affordable device
Measured: 4 weeks
-Jamar grip dynamometer
for measuring hand grip strength, it is an accurate and quantifiable assessment tool
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2024
- Study start1 Oct 2024 (estimated)
- Primary completion1 Mar 2025 (estimated)
- Study completion1 Mar 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Lateral Epicondylitis (Tennis Elbow)Studies of the same condition, open and under way.
- More trials run by Cairo 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
- 46 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mai Mohamed Abdelkader Abdallah, Cairo University
- Investigators
- Enas Fawzy yousef, Phd, Study chair, Cairo UniversityMai Mohamed Abdelkader, PhD, Study director, Pharos university in alexanderiasherif Hamdy Zawam, PhD, Study director, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06597643
- Sponsor's protocol ID
- P.T.REC/012/005344
- Status last verified
- Sep 2024
- First submitted
- 10 Sep 2024
- Last updated
- 19 Sep 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Vieira CS, Pack A, Roberts K, Davis AR. A pilot study of levonorgestrel concentrations and bleeding patterns in women with epilepsy using a levonorgestrel IUD and treated with antiepileptic drugs. Contraception. 2019 Apr;99(4):251-255. doi: 10.1016/j.contraception.2018.11.018. Epub 2018 Dec 4.
PubMed 30529085Libby AM, Pace W, Bryan C, Anderson HO, Ellis SL, Allen RR, Brandt E, Huebschmann AG, West D, Valuck RJ. Comparative effectiveness research in DARTNet primary care practices: point of care data collection on hypoglycemia and over-the-counter and herbal use among patients diagnosed with diabetes. Med Care. 2010 Jun;48(6 Suppl):S39-44. doi: 10.1097/MLR.0b013e3181ddc7b0.
PubMed 20473193Pietrini V, Pavesi G, Andreetta F. Miller Fisher syndrome with positivity of anti-GAD antibodies. Clin Neurol Neurosurg. 2013 Nov;115(11):2399-400. doi: 10.1016/j.clineuro.2013.09.002. Epub 2013 Sep 16. No abstract available.
PubMed 24094904
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Adding Deep Friction Massage to Eccentric Training Exercises in Lateral Epicondylitis
- ClinicalTrials.gov ID
- NCT06597643
- Acronym / sponsor ID
- P.T.REC/012/005344
- Conditions
- Lateral Epicondylitis (Tennis Elbow)
- Keywords
- Lateral Epicondylitis, Eccentric Training, Deep Friction Massage (DFM, Wrist Extensor Strength
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 46 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Oct 2024 (estimated)
- Primary completion
- 1 Mar 2025 (estimated)
- Study completion
- 1 Mar 2025 (estimated)
- First posted
- 19 Sep 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.
Background: Lateral epicondylitis (LE) often benefits from eccentric training exercises, but combining them with deep friction massage (DFM) might enhance outcomes.
Objective: To evaluate if adding DFM to eccentric training improves pain, function, wrist extensor strength, and hand grip strength more than eccentric training alone.
Design: A triple-blinded, randomized controlled trial involving 46 participants aged 16-30 with unilateral LE. Participants will be randomly assigned to receive either eccentric training plus sham massage (Control Group) or eccentric training plus DFM (Experimental Group) over 4 weeks.
Methods: Outcomes will be measured using the Visual Analogue Scale (VAS) for pain, the Disabilities of the Arm, Shoulder, and Hand (DASH) questionnaire for function, a hand-held dynamometer for wrist extensor strength, and a grip dynamometer for hand grip strength.
Blinding: The study is triple-blinded-assessors, statisticians, and participants are unaware of group allocations.
Significance: This study aims to determine if DFM enhances the effectiveness of eccentric training in LE rehabilitation, potentially leading to improved treatment protocols.
Detailed description
Background: Lateral epicondylitis (LE), also known as tennis elbow, is an overuse injury of the elbow characterized by pain and functional impairment in the lateral aspect of the elbow. Traditional management strategies often include eccentric training exercises aimed at improving muscle strength and reducing pain. However, the addition of deep friction massage (DFM) to such a regimen might offer additional benefits.
Objective: This study aims to evaluate the impact of combining deep friction massage with eccentric training exercises on pain, functional ability, wrist extensor strength, and hand grip strength in patients with unilateral lateral epicondylitis.
Design: A triple-blinded randomized controlled trial (RCT) will be carried out at the outpatient physical therapy clinic of Pharos University in Alexandria, Egypt. The trial is designed to assess whether the integration of DFM with eccentric training offers superior outcomes compared to eccentric training alone.
Participants: The study will involve 46 patients aged 16 to 30 years, diagnosed with unilateral lateral epicondylitis. Participants will be randomly assigned to one of two groups: Group A (Control) and Group B (Experimental). Inclusion criteria include unilateral elbow pain, a BMI between 18.5 and 29.9, and chronic LE not treated with physical therapy in the past six months. Exclusion criteria include significant injuries or diseases affecting the shoulder, elbow, or wrist, recent local steroid injections, cervical radiculopathy, and neurological impairments.
Interventions:
Control Group (Group A): Participants will receive eccentric training exercises and sham massage. The eccentric training regimen includes three exercises: eccentric wrist extension with dumbbells, eccentric wrist extension with a twist-bar, and eccentric supination with an elastic band. Sham massage will be used to maintain blinding.
Experimental Group (Group B): Participants will receive the same eccentric training exercises as Group A, plus deep friction massage (DFM). DFM will be applied to the extensor carpi radialis brevis tendon at the site of the common extensor origin, with firm pressure applied perpendicular to the tendon for 5 minutes before each exercise session.
Outcome Measures:
Pain: Assessed using the Visual Analogue Scale (VAS), which allows patients to rate pain intensity on a 100 mm line ranging from \"no pain\" to \"worst pain.\" Function: Evaluated using the Disabilities of the Arm, Shoulder, and Hand (DASH) questionnaire, which includes 30 items measuring both function and symptoms in upper limb activities. Scores range from 0 (no disability) to 100 (severe disability).
Wrist Extensor Strength: Measured with a hand-held dynamometer, quantifying the maximum isometric strength of wrist extensors.
Hand Grip Strength: Assessed using a Jamar grip dynamometer, recording the maximum grip strength in kilograms.
Blinding and Randomization: The study will use a triple-blinding approach. Research assistants conducting assessments will be blinded to group allocations, as will the statisticians analyzing the data. Participants will also be unaware of their group assignment. Randomization will be achieved using an online random number generator to ensure unbiased group assignment.
Significance: This study seeks to determine if combining deep friction massage with eccentric training provides additional benefits over eccentric training alone in terms of pain reduction, functional improvement, and strength enhancement in patients with lateral epicondylitis. The results could inform more effective rehabilitation strategies for this common condition.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control Group | Active comparator | Other: Eccentric TrainingTwenty-one patients will be assigned to group A, who will receive eccentric exercise program in addition to sham massage in the form of skin rubbing for patient blinding. for a total of 12 treatment sessions (3 sessions per week) for 4 weeks 3 sets of 15 repetitions, it takes 5 seconds to complete each repetition and between each set there is 30 seconds of rest |
| Experimental Group | Experimental | Other: Eccentric Training, Other: Deep Friction MassageTwenty-one patients will be assigned to group B who will receive the same exercises as in control group (eccentric training exercises) in addition to deep friction massage (DFM) for a total of 12 treatment sessions (3 sessions per week) for 4 weeks. Before starting the exercises DFM will be performed. The patient will sit on a chair while holding a pillow. DFM will be performed in perpendicular direction to the Extensor carpi radialis brevis tendon the site of the application will be on the upper attachment of the common extensor origin (palpated one cm distal to the lateral epicondyle of the humerus) for 5 minutes. Using the thumb, Firm pressure will be applied to compress the extensor tendons, their origins, and the musculotendinous junctions between the underlying bone and the fingertips. This pressure will be maintained while the therapist applies DFM in the direction of their fingers, |
Who may qualify
- Ages
- 16 to 30 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (6 listed)
- Both gender male and female
- Age from 16 to 30
- Unilateral elbow pain
- Body mass index ranges from 18.5 to 29.9
- Non athletic patient
Key exclusion criteria (5 listed)
- Any injury or disease around the shoulder, elbow and wrist on the affected side
- Any b local intervention such as injection of steroids 6 month prior to the intervention
- Cervical radiculopathy
- History of fracture of radius, ulna and humerus with resultant deformity of the affected extremity
- Neurological impairments
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 |
|---|---|---|
| Eccentric TrainingExercise 1: Eccentric Wrist Extension with Dumbbell Position: Seated, elbow extended, wrist maximally extended. Action: Lower: Slowly flex the wrist for 30 seconds. Return: Use the opposite hand to bring wrist back to extension. Load: Increase weight based on 10 Repetition Maximum (10RM). Exercise 2: Eccentric Wrist Extension with Twist-Bar Position: Hold Flex Bar with involved hand in extension. Action: Twist: Rotate the bar with the non-involved hand while keeping the involved wrist extended. Untwist: Allow the wrist to flex slowly. Exercise 3: Eccentric Supination with Elastic Band Position: Anchor band, elbow flexed to 90°. Action: Supinate: Rotate forearm with palm up. Flex: Slowly rotate to palm down, then return | Other | Control Group, Experimental Group |
| Deep Friction MassageThe patient will sit on a chair while holding a pillow. DFM will be performed in perpendicular direction to the Extensor carpi radialis brevis tendon the site of the application will be on the upper attachment of the common extensor origin (palpated one cm distal to the lateral epicondyle of the humerus) for 5 minutes. Using the thumb, Firm pressure will be applied to compress the extensor tendons, their origins, and the musculotendinous junctions between the underlying bone and the fingertips. This pressure will be maintained while the therapist applies DFM in the direction of their fingers, | Other | Experimental Group |
Primary outcome
Visual Analogue Scale
Time frame: 4 weeks
is used to measure the pain which is represented from (0) grade to (10) grade, with zero means no pain and ten means intolerable pain, The subjects were asked to indicate the level of pain by placing a dash at the appropriate level on the 10 cm horizontal line
3 secondary outcomes
-Disability of the Arm, Shoulder and Hand questionnaire Arabic version
Time frame: 4 weeks
Hand-held Dynamometer
Time frame: 4 weeks
-Jamar grip dynamometer
Time frame: 4 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2024.
- Results publication: PubMed 30529085Vieira CS, Pack A, Roberts K, Davis AR. A pilot study of levonorgestrel concentrations and bleeding patterns in women with epilepsy using a levonorgestrel IUD and treated with antiepileptic drugs. Contraception. 2019 Apr;99(4):251-255. doi: 10.1016/j.contraception.2018.11.018. Epub 2018 Dec 4.
- Results publication: PubMed 20473193Libby AM, Pace W, Bryan C, Anderson HO, Ellis SL, Allen RR, Brandt E, Huebschmann AG, West D, Valuck RJ. Comparative effectiveness research in DARTNet primary care practices: point of care data collection on hypoglycemia and over-the-counter and herbal use among patients diagnosed with diabetes. Med Care. 2010 Jun;48(6 Suppl):S39-44. doi: 10.1097/MLR.0b013e3181ddc7b0.
- Results publication: PubMed 24094904Pietrini V, Pavesi G, Andreetta F. Miller Fisher syndrome with positivity of anti-GAD antibodies. Clin Neurol Neurosurg. 2013 Nov;115(11):2399-400. doi: 10.1016/j.clineuro.2013.09.002. Epub 2013 Sep 16. No abstract available.
- Lateral epicondylitis: a review of pathology and management. The bone \& joint journalLink provided by the sponsor.
- Lateral Elbow Tendinopathy: Development of a Pathophysiology-Based Treatment AlgorithmLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided
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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.
Enas Fawzy yousef, Phd study chair
Cairo University
Mai Mohamed Abdelkader, PhD study director
Pharos university in alexanderia
sherif Hamdy Zawam, PhD study director
Cairo University
Questions about this trial
What is this clinical trial studying?
A study testing Eccentric Training and Deep Friction Massage in people with Lateral Epicondylitis (Tennis Elbow), run by Cairo University.
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 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: status not confirmed, as of the sponsor's last update on 19 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Nada Bahnasy Zenbaa, B.Sc. (929-435-8403, nada.bahnasy@pua.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual Analogue Scale (time frame: 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06597643, which also lists 3 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 19 Sep 2024.