AzTrials
AzTrials

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.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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

Other trials in Mexico

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

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 groups in NCT03794505
Study groupRoleWhat they receive
Shoulder infiltrationActive comparatorShoulder 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 blockExperimentalSuprascapular 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.

  1. Pain before

    visual analogue scale

    Measured: VAS before intervention

  2. Pain 2 months after

    Visual analogue scale 2 months after procedure

    Measured: VAS 2 months after

  3. Pain 6 months after

    Visual analogue scale 6 months after procedure

    Measured: VAS 6 months after

Secondary outcomes (3)

  1. Quality of life before procedure

    SF12v2 Health related quality of life before procedure

    Measured: SF12v2 before procedure

  2. Quality of life 2 months after procedure

    SF12v2 Health related quality of life 2 months after

    Measured: SF12v2 2 months after

  3. 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.

  1. First posted7 Jan 2019
  2. Study start1 Apr 2018
  3. Primary completion30 Aug 2018
  4. Study completion30 Aug 2018

Resources

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)
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

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?

On the ClinicalTrials.gov record for NCT03794505.

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.

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