Shoulder ArthritisPhase 3NCT03794505
Quality of Life and Pain With Infiltration or Suprascapular Nerve Block in Glenohumeral Arthirtis
A Phase 3 study testing Methylprednisolone Acetate, Lidocaine 2% Injectable Solution and Ropivacaine HCl Inj 7.5 MG/ML in people with Shoulder Arthritis, run by Instituto Mexicano del Seguro Social at 1 site in Mexico.
Trial summary
Efficacy in pain and health related quality of life of suprascapular nerve block ultrasound guided and glenohumeral infiltration in glenohumeral arthritis Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Shoulder Arthritis
- What is being tested?
- Methylprednisolone Acetate, Lidocaine 2% Injectable Solution and Ropivacaine HCl Inj 7.5 MG/ML
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteMexico
- Study dates
- 1 Apr 2018to 30 Aug 2018
- Phase
- Phase 3
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- IMSS affiliated
- Glenohumeral arthritis diagnosed
Who cannot join
- Previusly treatment for the same disease
- No follow up
- Dead
Trial locations and contacts
1 site in 1 country.
Mexico1 site
Department of Orthopedics, UMAE "Dr. Victorio de la Fuente Narváez" IMSS-UNAM. Ciudad de México, México
Mexico City, Gustavo A Madero, 07760
About this study
Official title: Health Related Quality of Life and Pain Managment Using Infiltration or Suprascapular Nerve Block Ultrasound Guided in Patients With Glenohumeral Arthirtis
Efficacy in pain and health related quality of life of suprascapular nerve block ultrasound guided and glenohumeral infiltration in glenohumeral arthritis
Read the detailed description
To describe the efficacy in pain management and health related quality of life of suprascapular nerve block ultrasound guided and glenohumeral infiltration in patients with glenohumeral arthritis
- Conditions
- Shoulder Arthritis
- Being tested
- Methylprednisolone Acetate, Lidocaine 2% Injectable Solution, Ropivacaine HCl Inj 7.5 MG/ML
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Methylprednisolone AcetateDrug
Also called depo-medrol 40 mg
depo-medrol 40 mg
Lidocaine 2% Injectable SolutionDrug
Also called xilocaine
2ml of 2% lidocaine
Ropivacaine HCl Inj 7.5 MG/MLDrug
Also called Ropivacaine
25 mg
| Study group | Role | What they receive |
|---|---|---|
| Shoulder infiltration | Active comparator | Shoulder infiltration using 2 ml of Lidocaine 2% Injectable Solution and methylprednisolone acetate 40 mg Receives: Drug: Methylprednisolone Acetate; Drug: Lidocaine 2% Injectable Solution |
| Suprascapular nerve block | Experimental | Suprascapular nerve block ultrasound guided using 25 mg of Ropivacaine HCl Inj 7.5 MG/ML and methylprednisolone acetate 40 mg Receives: Drug: Methylprednisolone Acetate; Drug: Ropivacaine HCl Inj 7.5 MG/ML |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain before
visual analogue scale
Measured: VAS before intervention
Pain 2 months after
Visual analogue scale 2 months after procedure
Measured: VAS 2 months after
Pain 6 months after
Visual analogue scale 6 months after procedure
Measured: VAS 6 months after
Secondary outcomes (3)
Quality of life before procedure
SF12v2 Health related quality of life before procedure
Measured: SF12v2 before procedure
Quality of life 2 months after procedure
SF12v2 Health related quality of life 2 months after
Measured: SF12v2 2 months after
Quality of life 6 months after procedure
SF12v2 Health related quality of life 6 months after
Measured: SF12v2 6 months after
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jan 2019
- Study start1 Apr 2018
- Primary completion30 Aug 2018
- Study completion30 Aug 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Shoulder ArthritisStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Instituto Mexicano del Seguro Social
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Luis Alonso Calderon Cordova, Instituto Mexicano del Seguro Social
- Investigators
- Luis Alonso Calderon Cordova, MD, Principal investigator, IMSS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03794505
- Sponsor's protocol ID
- F-2018-3401-056
- Status last verified
- Jan 2019
- First submitted
- 3 Jan 2019
- Last updated
- 8 Jan 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Health Related Quality of Life and Pain Managment Using Infiltration or Suprascapular Nerve Block Ultrasound Guided in Patients With Glenohumeral Arthirtis
- ClinicalTrials.gov ID
- NCT03794505
- Acronym / sponsor ID
- F-2018-3401-056
- Conditions
- Shoulder Arthritis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Instituto Mexicano del Seguro SocialOther government
- Study start
- 1 Apr 2018 (actual)
- Primary completion
- 30 Aug 2018 (actual)
- Study completion
- 30 Aug 2018 (actual)
- First posted
- 7 Jan 2019 (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.
Efficacy in pain and health related quality of life of suprascapular nerve block ultrasound guided and glenohumeral infiltration in glenohumeral arthritis
Detailed description
To describe the efficacy in pain management and health related quality of life of suprascapular nerve block ultrasound guided and glenohumeral infiltration in patients with glenohumeral arthritis
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Shoulder infiltration | Active comparator | Drug: Methylprednisolone Acetate, Drug: Lidocaine 2% Injectable SolutionShoulder infiltration using 2 ml of Lidocaine 2% Injectable Solution and methylprednisolone acetate 40 mg |
| Suprascapular nerve block | Experimental | Drug: Methylprednisolone Acetate, Drug: Ropivacaine HCl Inj 7.5 MG/MLSuprascapular nerve block ultrasound guided using 25 mg of Ropivacaine HCl Inj 7.5 MG/ML and methylprednisolone acetate 40 mg |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- IMSS affiliated
- Glenohumeral arthritis diagnosed
Key exclusion criteria (3 listed)
- Previusly treatment for the same disease
- No follow up
- Dead
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 |
|---|---|---|
| Methylprednisolone AcetateAlso: depo-medrol 40 mgdepo-medrol 40 mg | Drug | Shoulder infiltration, Suprascapular nerve block |
| Lidocaine 2% Injectable SolutionAlso: xilocaine2ml of 2% lidocaine | Drug | Shoulder infiltration |
| Ropivacaine HCl Inj 7.5 MG/MLAlso: Ropivacaine25 mg | Drug | Suprascapular nerve block |
Primary outcome
Pain before
Time frame: VAS before intervention
visual analogue scale
Pain 2 months after
Time frame: VAS 2 months after
Visual analogue scale 2 months after procedure
Pain 6 months after
Time frame: VAS 6 months after
Visual analogue scale 6 months after procedure
3 secondary outcomes
Quality of life before procedure
Time frame: SF12v2 before procedure
Quality of life 2 months after procedure
Time frame: SF12v2 2 months after
Quality of life 6 months after procedure
Time frame: SF12v2 6 months after
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 8 Jan 2019.
- 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.
Luis Alonso Calderon Cordova, MD principal investigator
IMSS
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Methylprednisolone Acetate, Lidocaine 2% Injectable Solution and Ropivacaine HCl Inj 7.5 MG/ML in people with Shoulder Arthritis, run by Instituto Mexicano del Seguro Social at 1 site in Mexico.
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 2 inclusion and 3 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 8 Jan 2019. 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 Mexico. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 before (time frame: VAS before intervention). 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 8 Jan 2019; AzTrials last refreshed its copy on 8 Nov 2026.