Patients With Axial SpA According to ASAS CriteriaPhase 3NCT05219084
Hip Denervation and Intra-articular Hydration in Damaged Hip in Axial Spondyloarthritis Patients
A Phase 3 study testing hip denervation, intra-articular hydration and Combined group in people with Patients With Axial SpA According to ASAS Criteria and Patients With Unilateral or Bilater Hip Damage According to BASRI Score, run by Sohag University at 1 site in Egypt.
Trial summary
Background: The hip joint is frequently affected in axial spondyloarthritis (SpA) of adults with destructive effects in untreated patients. About 35% of axial SpA patients had either unilateral or bilateral hip arthritis. Destruction is more common with early-onset, active disease, or enthesitis. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Patients With Axial SpA According to ASAS Criteria, Patients With Unilateral or Bilater Hip Damage According to BASRI Score, Age > 18
- What is being tested?
- hip denervation, intra-articular hydration and Combined group
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Dec 2021to 15 Apr 2022
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- age 18 or more
- Axial; SpA fulfilled ASA criteria
- BASRI score grade 3 or 4 for one hip at least
Who cannot join
- patients younger than 18
- Axial; SpA with normal hip or hip involvement less than 3 on BASRI score
Trial locations and contacts
1 site in 1 country.
About this study
Background: The hip joint is frequently affected in axial spondyloarthritis (SpA) of adults with destructive effects in untreated patients. About 35% of axial SpA patients had either unilateral or bilateral hip arthritis. Destruction is more common with early-onset, active disease, or enthesitis.
Objectives: The aim of this study is to evaluate the effect of hip denervation (HD) and intra-articular hydration (IAH) on pain, function score, hip mobility scores in a cohort of axial SpA patients with grade 3 and 4 hip BASRI scores.
- Conditions
- Patients With Axial SpA According to ASAS Criteria, Patients With Unilateral or Bilater Hip Damage According to BASRI Score, Age > 18
- Being tested
- hip denervation, intra-articular hydration, Combined group, Control group
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
hip denervationDrug
Lidocaine 2% 2ml was injected into each genicular nerve
intra-articular hydrationDrug
10 ml; of normal; saline were injected inside the hip joint
Combined groupDrug
hip denervation and intra-articular hydration were conducted together
Control groupDrug
Normal; saline was injected subcutaneously
| Study group | Role | What they receive |
|---|---|---|
| placebo group | Placebo comparator | 5ml of normal; saline-injected subcutaneously Receives: Drug: Control group |
| Hip denervatiopn | Active comparator | Hip denervation with lidocaine 2% to each genicular branch, 2ml at each point Receives: Drug: hip denervation |
| Inra-articular hydration | Active comparator | 10 ml of normal saline injected inside the hip under ultrasound guidance Receives: Drug: intra-articular hydration |
| compined group | Active comparator | hip denervation and intra-articular hydration were conducted together in this group Receives: Drug: Combined group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in visual analogue scale
0 means no pain, 100 means the highest degree of pain
Measured: Baseline , after 4 weeks and after 12 weeks
Change in Harris functional hip score
Pain receives 44 points, function 47 points, range of motion 5 points, and deformity 4 points. Function is subdivided into activities of daily living (14 points) and gait (33 points).
The higher the HHS, the less dysfunction. A total score of <70 is considered a poor result; 70-80 is considered fair, 80-90 is good, and 90-100 is an excellent result
Measured: Baseline, after 4 weeks and after 12 weeks
Change in range of motion of the hip
hip flexion, extension , internal; rotation , external; rotation , abduction , and adduction all were recopreded
Measured: Baseline, after 4 weeks and after 12 weeks
Change in semiquantitative tenderness score
a score from 0-3, 90 means no tenderness and 3 means maximum tenderness
Measured: Baseline, after 4 weeks and after 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Feb 2022
- Study start1 Dec 2021
- Primary completion15 Apr 2022
- Study completion15 Apr 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Patients With Axial SpA According to ASAS CriteriaStudies of the same condition, open and under way.
- More trials run by Sohag 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sohag University
- Sponsor type
- University, hospital or other
- Collaborators
- Suez Canal University
- Responsible party
- Principal investigator, Ahmed Mahrous, Sohag University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05219084
- Sponsor's protocol ID
- SC 250
- Status last verified
- Apr 2022
- First submitted
- 20 Jan 2022
- Last updated
- 3 May 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hip Denervation and Intra-articular Hydration in Damaged Hip in Axial Spondyloarthritis Patients
- ClinicalTrials.gov ID
- NCT05219084
- Acronym / sponsor ID
- SC 250
- Conditions
- Patients With Axial SpA According to ASAS Criteria, Patients With Unilateral or Bilater Hip Damage According to BASRI Score, Age > 18
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Sohag UniversityUniversity, hospital or other
- Collaborators
- Suez Canal University
- Study start
- 1 Dec 2021 (actual)
- Primary completion
- 15 Apr 2022 (actual)
- Study completion
- 15 Apr 2022 (actual)
- First posted
- 1 Feb 2022 (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: The hip joint is frequently affected in axial spondyloarthritis (SpA) of adults with destructive effects in untreated patients. About 35% of axial SpA patients had either unilateral or bilateral hip arthritis. Destruction is more common with early-onset, active disease, or enthesitis.
Objectives: The aim of this study is to evaluate the effect of hip denervation (HD) and intra-articular hydration (IAH) on pain, function score, hip mobility scores in a cohort of axial SpA patients with grade 3 and 4 hip BASRI scores.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| placebo group | Placebo comparator | Drug: Control group5ml of normal; saline-injected subcutaneously |
| Hip denervatiopn | Active comparator | Drug: hip denervationHip denervation with lidocaine 2% to each genicular branch, 2ml at each point |
| Inra-articular hydration | Active comparator | Drug: intra-articular hydration10 ml of normal saline injected inside the hip under ultrasound guidance |
| compined group | Active comparator | Drug: Combined grouphip denervation and intra-articular hydration were conducted together in this group |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- age 18 or more
- Axial; SpA fulfilled ASA criteria
- BASRI score grade 3 or 4 for one hip at least
Key exclusion criteria (2 listed)
- patients younger than 18
- Axial; SpA with normal hip or hip involvement less than 3 on BASRI score
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 |
|---|---|---|
| hip denervationLidocaine 2% 2ml was injected into each genicular nerve | Drug | Hip denervatiopn |
| intra-articular hydration10 ml; of normal; saline were injected inside the hip joint | Drug | Inra-articular hydration |
| Combined grouphip denervation and intra-articular hydration were conducted together | Drug | compined group |
| Control groupNormal; saline was injected subcutaneously | Drug | placebo group |
Primary outcome
Change in visual analogue scale
Time frame: Baseline , after 4 weeks and after 12 weeks
0 means no pain, 100 means the highest degree of pain
Change in Harris functional hip score
Time frame: Baseline, after 4 weeks and after 12 weeks
Pain receives 44 points, function 47 points, range of motion 5 points, and deformity 4 points. Function is subdivided into activities of daily living (14 points) and gait (33 points). The higher the HHS, the less dysfunction. A total score of <70 is considered a poor result; 70-80 is considered fair, 80-90 is good, and 90-100 is an excellent result
Change in range of motion of the hip
Time frame: Baseline, after 4 weeks and after 12 weeks
hip flexion, extension , internal; rotation , external; rotation , abduction , and adduction all were recopreded
Change in semiquantitative tenderness score
Time frame: Baseline, after 4 weeks and after 12 weeks
a score from 0-3, 90 means no tenderness and 3 means maximum tenderness
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 3 May 2022.
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.
The record lists no contact. Use the official record to reach the sponsor.
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 hip denervation, intra-articular hydration and Combined group in people with Patients With Axial SpA According to ASAS Criteria and Patients With Unilateral or Bilater Hip Damage According to BASRI Score, run by Sohag University at 1 site in Egypt.
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 3 inclusion and 2 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 3 May 2022. 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 Egypt. 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. Some participants in this study may receive a placebo. 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?
Change in visual analogue scale (time frame: Baseline , after 4 weeks and after 12 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?
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 3 May 2022.