PainNCT06760559
Does Pre-injection Local Anesthesia Affect Experienced Pain During Intra-articular Hip Injections.
An observational study of Pain and Injection, run by Tel-Aviv Sourasky Medical Center at 1 site in Israel.
Trial summary
Intra-articular hip injections are commonly used for diagnostic and therapeutic purposes but are often associated with patient anxiety and fear. The disparity between anticipated and experienced pain during these injections, as well as the role of pre-injection local anesthesia in pain modulation, remains unclear. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Pain, Injection, Prevention
- What is being tested?
- Intra-articular corticosteroid injection
- Type of treatment
- Injection or infusion, Surgery or procedure
- How many people
- 60 participants
- Where
- 1 siteIsrael
- Study dates
- 3 Jan 2021to 2 Jan 2022
- How long will I take part?
- 2 Days
- Phase
- Observational
- 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 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients undergoing first-time intra-articular hip injection as indicated by an orthopedic surgeon either for diagnostic (e.g. lidocaine test, arthrography) and/or therapeutic (steroid injection for osteoarthritis) purposes.
Who may be able to join
- Patients undergoing a first-time intra-articular hip injection as indicated by an orthopedic surgeon.
- Indications for injection include:
- Diagnostic purposes (e.g., lidocaine test, arthrography)
- Therapeutic purposes (e.g., steroid injection for osteoarthritis)
- Participants must be 18 years of age or older.
- No previous hip joint injections.
- Ability to fill in the survey questionnaire.
Who cannot join
- Patients under 18 years of age.
- Patients with a known history of hypersensitivity or allergy to the injectant material (e.g., local anesthetics, steroids).
- Patients lacking the ability to sign informed consent or complete a survey questionnaire.
- Patients with previous hip joint injections, due to the potential for recalling prior pain experienced.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Pain Scores Following Intrarticular Injections
Intra-articular hip injections are commonly used for diagnostic and therapeutic purposes but are often associated with patient anxiety and fear. The disparity between anticipated and experienced pain during these injections, as well as the role of pre-injection local anesthesia in pain modulation, remains unclear.
This study investigates the difference between anticipated and experienced pain during intra-articular hip injections. In addition, the study examines the impact of pre-injection local anesthesia in 60 prospectively recruited patients, some of whom received pre-injection local anesthesia while others did not. These study findings provide valuable insights into experienced pain during intra-articular hip injections, which can be applied to improve patient experiences and treatment compliance.
Read the detailed description
- Identification of patients in the outpatient clinic and completion of the questionnaires will be carried out by the principal investigator and sub-investigators in the clinic.
- Data processing will be conducted by physicians holding an MD certification.
- The type of study is prospective.
- Data collection will be performed using the medical records of Tel Aviv Medical Center Hospital only, covering the years 2021 and 2022.
- Demographic data will be collected, including gender, year of birth, age, diagnosis, indication for injection, and previous treatments. Clinical data will include underlying diseases, side of injection, complications, indications, and follow-up time.
- Conditions
- Pain, Injection, Prevention, Assessment
- Being tested
- Intra-articular corticosteroid injection
- Keywords
- pain, injection, intra-articular, expectation, compliance
- Medical subject headings
- Pain, Patient Compliance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intra-articular corticosteroid injectionProcedure or surgery
Also called Local anasthesia
Intra-articular hip injections with and without local anastesia and questionnaire about pain and anxiety related to the procedure was administered before and after the injection to the study and control groups.
| Study group | Role | What they receive |
|---|---|---|
| Pre-injection superficial local anesthesia prior to Intra-articular corticosteroid injection | Not described Receives: Procedure: Intra-articular corticosteroid injection | |
| Patients without pre-injection local anesthesia prior to Intra-articular corticosteroid injection | Not described Receives: Procedure: Intra-articular corticosteroid injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Numeric rating scales (NRS) scores
Numeric rating scales (NRS) scores were measured before and after an injection in both, study and control groups to determine the anticipated pain compared to experienced pain after Intra-articular hip injection with or without local anasthesia.
Measured: Questionnaire was given before the injection for anticipated pain evaluation and additional influencing factors on pain perception prior to injection and right after the injection for actual experienced pain.
Secondary outcomes (1)
Beck Anxiety Inventory (BAI) and fear of injections
Correlation of BAI scores and other injection-related factors including fear of pain, needle visualization, needle size, and prior injection experiences to pre-injection anticipated pain.
Measured: Questionnaire was given before the injection for anticipated pain evaluation,Beck Anxiety Inventory (BAI) and additional influencing factors on pain perception prior to injection.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jan 2025
- Study start3 Jan 2021
- Primary completion2 Jan 2022
- Study completion2 Jan 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PainStudies 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 60 participants (actual)
- Target duration
- 2 Days
Sponsor and investigators
- Lead sponsor
- Tel-Aviv Sourasky Medical Center
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Ehud Rath, Professor, Study director, Tel Aviv Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06760559
- Sponsor's protocol ID
- TLV-0674-21
- Status last verified
- Jan 2025
- First submitted
- 31 Dec 2024
- Last updated
- 22 Jan 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Due to medical confidentiality
Study at a glance
From the registry record, last updated by the sponsor on 22 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pain Scores Following Intrarticular Injections
- ClinicalTrials.gov ID
- NCT06760559
- Acronym / sponsor ID
- TLV-0674-21
- Conditions
- Pain, Injection, Prevention, Assessment
- Keywords
- pain, injection, intra-articular, expectation, compliance
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Tel-Aviv Sourasky Medical CenterOther government
- Study start
- 3 Jan 2021 (actual)
- Primary completion
- 2 Jan 2022 (actual)
- Study completion
- 2 Jan 2022 (actual)
- First posted
- 7 Jan 2025 (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.
Intra-articular hip injections are commonly used for diagnostic and therapeutic purposes but are often associated with patient anxiety and fear. The disparity between anticipated and experienced pain during these injections, as well as the role of pre-injection local anesthesia in pain modulation, remains unclear.
This study investigates the difference between anticipated and experienced pain during intra-articular hip injections. In addition, the study examines the impact of pre-injection local anesthesia in 60 prospectively recruited patients, some of whom received pre-injection local anesthesia while others did not. These study findings provide valuable insights into experienced pain during intra-articular hip injections, which can be applied to improve patient experiences and treatment compliance.
Detailed description
- Identification of patients in the outpatient clinic and completion of the questionnaires will be carried out by the principal investigator and sub-investigators in the clinic.
- Data processing will be conducted by physicians holding an MD certification.
- The type of study is prospective.
- Data collection will be performed using the medical records of Tel Aviv Medical Center Hospital only, covering the years 2021 and 2022.
- Demographic data will be collected, including gender, year of birth, age, diagnosis, indication for injection, and previous treatments. Clinical data will include underlying diseases, side of injection, complications, indications, and follow-up time.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 2 Days
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pre-injection superficial local anesthesia prior to Intra-articular corticosteroid injection | – | Procedure: Intra-articular corticosteroid injection |
| Patients without pre-injection local anesthesia prior to Intra-articular corticosteroid injection | – | Procedure: Intra-articular corticosteroid injection |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients undergoing first-time intra-articular hip injection as indicated by an orthopedic surgeon either for diagnostic (e.g. lidocaine test, arthrography) and/or therapeutic (steroid injection for osteoarthritis) purposes.
Key inclusion criteria (7 listed)
- Patients undergoing a first-time intra-articular hip injection as indicated by an orthopedic surgeon.
- Indications for injection include:
- Diagnostic purposes (e.g., lidocaine test, arthrography)
- Therapeutic purposes (e.g., steroid injection for osteoarthritis)
- Participants must be 18 years of age or older.
Key exclusion criteria (4 listed)
- Patients under 18 years of age.
- Patients with a known history of hypersensitivity or allergy to the injectant material (e.g., local anesthetics, steroids).
- Patients lacking the ability to sign informed consent or complete a survey questionnaire.
- Patients with previous hip joint injections, due to the potential for recalling prior pain experienced.
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 |
|---|---|---|
| Intra-articular corticosteroid injectionAlso: Local anasthesiaIntra-articular hip injections with and without local anastesia and questionnaire about pain and anxiety related to the procedure was administered before and after the injection to the study and control groups. | Procedure or surgery | Patients without pre-injection local anesthesia prior to Intra-articular corticosteroid injection, Pre-injection superficial local anesthesia prior to Intra-articular corticosteroid injection |
Primary outcome
Numeric rating scales (NRS) scores
Time frame: Questionnaire was given before the injection for anticipated pain evaluation and additional influencing factors on pain perception prior to injection and right after the injection for actual experienced pain.
Numeric rating scales (NRS) scores were measured before and after an injection in both, study and control groups to determine the anticipated pain compared to experienced pain after Intra-articular hip injection with or without local anasthesia.
1 secondary outcome
Beck Anxiety Inventory (BAI) and fear of injections
Time frame: Questionnaire was given before the injection for anticipated pain evaluation,Beck Anxiety Inventory (BAI) and additional influencing factors on pain perception prior to injection.
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 Jan 2025.
- Individual participant dataSharing planned: No. Due to medical confidentiality
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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.
Ehud Rath, Professor study director
Tel Aviv Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pain and Injection, run by Tel-Aviv Sourasky Medical Center at 1 site in Israel.
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 7 inclusion and 4 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 Jan 2025. 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 Israel. 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 rating scales (NRS) scores (time frame: Questionnaire was given before the injection for anticipated pain evaluation and additional influencing factors on pain perception prior to injection and right after the injection for actual experienced pain.). 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 22 Jan 2025.