PeriarthritisPhase 3NCT01807962
Local Injection Under US Control in GTPS.
A Phase 3 study testing rapidocain and bethametsaone and sterile saline in people with Periarthritis and Bursitis, run by Stephane Genevay at 1 site in Switzerland.
Trial summary
We hypothesize that local ultrasound guided injection with corticosteroid and local anaesthetic are effective on the symptoms of GTPS. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Periarthritis, Bursitis
- What is being tested?
- rapidocain and bethametsaone and sterile saline
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 46 participants
- Where
- 1 siteSwitzerland
- Study dates
- Nov 2011to Dec 2015
- 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
- Patients complaining of lateral hip pain for more than 1 month.
- NRS lateral hip pain score ≥ 4 in the preceding week.
- Failure of another "standard" treatment:
- Physiotherapy: local therapy or a stretching program, or
- Analgesic treatment (minimum of 5 days of consecutive therapy, including, but not limited to, NSAIDs).
- Typical lateral hip pain reproduced by palpation of the greater trochanter
Who cannot join
- Age younger than 18 years old
- Concomitant local surgical intervention for tumours, infection or fracture, based on clinical history and physical examination
- Previous ipsilateral prosthetic hip surgery
- Scheduled ipsilateral hip surgery within 3 months
- Fibromyalgia (diagnosis established by a rheumatologist)
- Flair of chronic inflammatory joint disease (as defined by a rheumatologist)
Show all 20Show fewer
- Skin lesions at the injection site
- Allergy to one of the studied drugs
- Anticoagulation with internal normalized ration (INR) >3
- Blood coagulation disorder, such as haemophilia.
- Serious and uncontrolled psychiatric disease (as assessed by the clinician as a contraindication for steroid)
- Other contraindications to steroid use, such as:
- uncontrolled diabetes (non-fasting blood glucose > 10 mmol/L)
- unstable hypertension (systolic pressure > 160mmHg or diastolic pressure > 100mmHg), or
- open or closed angle glaucoma.
- Requirement for systemic steroids (including steroid injections) or dose modification of disease modifying anti-rheumatic drugs during the preceding three months. Oral corticosteroids (< 10mg / day of Prednisone or equivalent) will be permitted providing that the dose has been stable for 4 weeks prior to inclusion and that the patient is expected to remain on the baseline dose for the duration of the study.
- Presence of a pacemaker or other metallic object that constitutes a CI to MRI, or severe claustrophobia
- Pregnant women (according to a pregnancy test) or nursing (breastfeeding) mothers.
- Unwillingness or inability to give informed consent.
- Unavailability for follow-up
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomised Double Blind Controlled Trial of Injection of Local Anaesthetic and Corticosteroid Under Ultrasound Control in the Greater Trochanteric Pain Syndrome.
We hypothesize that local ultrasound guided injection with corticosteroid and local anaesthetic are effective on the symptoms of GTPS.
Read the detailed description
The greater trochanteric pain syndrome (GTPS) is a frequent soft tissue syndrome which is often not recognised by medical practitioners. Currently, there is no validated definition of this syndrome and it is classically defined as pain and tenderness in the region of the greater trochanter that may radiate down to the postero-lateral aspect of the thigh and may mimic nerve root compression.
The prevalence of GTPS amongst adult patients referred to a spine clinic for chronic low back pain (LBP) has been reported to be 20-35%. In addition to pain, GTPS induces functional disability which at times may profoundly interfere with patients' daily activities. The diagnosis of GTPS is suspected in a patient complaining of lateral hip pain. The reproduction of typical pain on palpation of the posterior part of the greater trochanter is the only well recognised clinical sign, although other clinical signs have been described. As is frequently the case with these type of syndromes, the physiopathology of GTPS is probably a mixture of several musculoskeletal problems, among which trochanteric bursitis and gluteus medius (GMe) tendinosis are the most frequently cited.
MRI studies have demonstrated GMe tendinosis or tears in patients with GTPS and MRI is used as the gold standard for the diagnosis of GTPS in many studies. Musculoskeletal ultrasound (US) is of increasing interest among rheumatologists. It readily demonstrates soft tissue lesions, fluid collections, allows dynamic examination and the undertaking of ultrasound guided procedures. GMe and gluteus minus (GMi) tendinopathy or tears as well as bursitis can be clearly demonstrated by ultrasound and US may guide steroid injection for the treatment of GMe tendinopathy. However, to date no study has compared the utility of MRI compared to US.
There are very few well-performed studies regarding the treatment of GTPS. Although poorly studied, analgesics and non steroidal anti-inflammatory drugs (NSAIDs) are often used as first line therapy. The duration of therapy required with these oral agents is unknown and there are significant potential side-effects from these treatments. The vast majority of patients referred to secondary or tertiary centres have failed these oral therapies. Some authors advocate physiotherapy (massage or stretching) but once again, there is no strong evidence to support this approach. Thus, most patients are treated with an injection of a combination of steroids and local anaesthetic. However, there is no convincing evidence in the literature that this practice is effective.
The use of musculoskeletal ultrasound (US) has been shown to improve the accuracy of corticosteroid injections for many joints and extra-articular structures such as bursa and tendon sheaths. Although small observational studies have suggested that local corticosteroid injection may be effective in the short term, no prospective controlled study has been carried out to establish the efficacy of this common intervention.
- Conditions
- Periarthritis, Bursitis
- Being tested
- rapidocain and bethametsaone, sterile saline
- Keywords
- Injections, Subcutaneous, Cortisone, Anesthetics, Local
- Medical subject headings
- Periarthritis, Bursitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
rapidocain and bethametsaoneDrug
Also called diprophos, lidocaine
lidocaine (Rapidocain(R)): 4ml of 1% Lidocaine
bethametasone (Diprophos): 1ml ampoule (containing 5mg/ml dipropionate de betamethasone and 2mg/ml phosphate disodique de betamethasone)
sterile salineDrug
Also called NaCl
Placebo = 5ml of sterile saline solution
| Study group | Role | What they receive |
|---|---|---|
| rapidocain and bethametsaone | Active comparator | Rapidocain and Bethametsaone :
Lidocaine (Rapidocain(R)): 4ml of 1% Lidocaine Bethametasone (Diprophos): 1ml ampoule (containing 5mg/ml dipropionate de bétaméthasone and 2mg/ml phosphate disodique de bétaméthasone) Receives: Drug: rapidocain and bethametsaone |
| sterile saline | Placebo comparator | Placebo arm with 5ml of sterile saline (NaCl) solution Receives: Drug: sterile saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
The efficacy of ultrasound-guided injection with corticosteroid and local anaesthetic for GTPS.
Difference in pain intensity in the lateral hip region at 4 weeks between the 2 treatment groups, as measured by a NRS. Because the timing of the response to an infiltration is not well established we plan to examine pain both at 4 weeks, as well as longitudinally over 4 weeks(evolution of pain over time).
Measured: 4 weeks
Secondary outcomes (8)
Number of "responders"
Number of "responders" (defined as a reduction in NRS ≥ 1.5)at 4 weeks and at 6 months.
Measured: 4 weeks
Number of patients with "low residual disease activity"
Number of patients with "low residual disease activity" (defined as NRS
≤ 2.0)at 4 weeks and at 6 months.
Measured: 4 weeks
PGI patient
Patient Global Assessment
Measured: 4 weeks
Lumbar spine function
Lumbar spine function measured with the Oswestry questionnaire at 4 weeks and at 6 months
Measured: 4 weeks
Hip joint function
Hip joint function (Womac questionnaire)at 4 weeks and 6 months
Measured: 4 weeks
QoL
Quality of life (SF-12)at 4 weeks and 6 months
Measured: 4 weeks
Requirement for oral analgesics
Recording patient requirements for analgesics at weekly intervals following the intervention
Measured: 4 weeks
Side effects of the intervention
Clinical side effects - patients will be questioned specifically with respect to certain side-effects potentially linked to the injection technique and /or the injected substances. Any other side-effects cited by the patient will be recorded appropriately.
Ultrasound-measured side-effects: hematoma, GMe or GMi tear, tendinosis or calcification post-intervention that had not been visualised on the initial US prior to the first injection.
Measured at 4 weeks and at 6 months
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 posted8 Mar 2013 (estimated)
- Study startNov 2011
- Primary completionDec 2015
- Study completionDec 2015
Why it stopped: Slower than planned recruitement
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PeriarthritisStudies 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
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stephane Genevay
- Sponsor type
- University, hospital or other
- Collaborators
- University Hospital, Geneva
- Responsible party
- Sponsor-investigator, Stephane Genevay, University Hospital, Geneva
- Investigators
- Stephane Genevay, MD, Principal investigator, University Hospital, Geneva
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01807962
- Sponsor's protocol ID
- CE 10-213
- Status last verified
- Jun 2017
- First submitted
- 7 Mar 2013
- Last updated
- 8 Jun 2017
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 8 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomised Double Blind Controlled Trial of Injection of Local Anaesthetic and Corticosteroid Under Ultrasound Control in the Greater Trochanteric Pain Syndrome.
- ClinicalTrials.gov ID
- NCT01807962
- Acronym / sponsor ID
- CE 10-213
- Conditions
- Periarthritis, Bursitis
- Keywords
- Injections, Subcutaneous, Cortisone, Anesthetics, Local
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Slower than planned recruitement
- Enrolment
- 46 participants (actual)
- Lead sponsor
- Stephane GenevayUniversity, hospital or other
- Collaborators
- University Hospital, Geneva
- Study start
- Nov 2011
- Primary completion
- Dec 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 8 Mar 2013 (estimated)
- 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.
We hypothesize that local ultrasound guided injection with corticosteroid and local anaesthetic are effective on the symptoms of GTPS.
Detailed description
The greater trochanteric pain syndrome (GTPS) is a frequent soft tissue syndrome which is often not recognised by medical practitioners. Currently, there is no validated definition of this syndrome and it is classically defined as pain and tenderness in the region of the greater trochanter that may radiate down to the postero-lateral aspect of the thigh and may mimic nerve root compression.
The prevalence of GTPS amongst adult patients referred to a spine clinic for chronic low back pain (LBP) has been reported to be 20-35%. In addition to pain, GTPS induces functional disability which at times may profoundly interfere with patients' daily activities. The diagnosis of GTPS is suspected in a patient complaining of lateral hip pain. The reproduction of typical pain on palpation of the posterior part of the greater trochanter is the only well recognised clinical sign, although other clinical signs have been described. As is frequently the case with these type of syndromes, the physiopathology of GTPS is probably a mixture of several musculoskeletal problems, among which trochanteric bursitis and gluteus medius (GMe) tendinosis are the most frequently cited.
MRI studies have demonstrated GMe tendinosis or tears in patients with GTPS and MRI is used as the gold standard for the diagnosis of GTPS in many studies. Musculoskeletal ultrasound (US) is of increasing interest among rheumatologists. It readily demonstrates soft tissue lesions, fluid collections, allows dynamic examination and the undertaking of ultrasound guided procedures. GMe and gluteus minus (GMi) tendinopathy or tears as well as bursitis can be clearly demonstrated by ultrasound and US may guide steroid injection for the treatment of GMe tendinopathy. However, to date no study has compared the utility of MRI compared to US.
There are very few well-performed studies regarding the treatment of GTPS. Although poorly studied, analgesics and non steroidal anti-inflammatory drugs (NSAIDs) are often used as first line therapy. The duration of therapy required with these oral agents is unknown and there are significant potential side-effects from these treatments. The vast majority of patients referred to secondary or tertiary centres have failed these oral therapies. Some authors advocate physiotherapy (massage or stretching) but once again, there is no strong evidence to support this approach. Thus, most patients are treated with an injection of a combination of steroids and local anaesthetic. However, there is no convincing evidence in the literature that this practice is effective.
The use of musculoskeletal ultrasound (US) has been shown to improve the accuracy of corticosteroid injections for many joints and extra-articular structures such as bursa and tendon sheaths. Although small observational studies have suggested that local corticosteroid injection may be effective in the short term, no prospective controlled study has been carried out to establish the efficacy of this common intervention.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| rapidocain and bethametsaone | Active comparator | Drug: rapidocain and bethametsaoneRapidocain and Bethametsaone : Lidocaine (Rapidocain(R)): 4ml of 1% Lidocaine Bethametasone (Diprophos): 1ml ampoule (containing 5mg/ml dipropionate de bétaméthasone and 2mg/ml phosphate disodique de bétaméthasone) |
| sterile saline | Placebo comparator | Drug: sterile salinePlacebo arm with 5ml of sterile saline (NaCl) solution |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Patients complaining of lateral hip pain for more than 1 month.
- NRS lateral hip pain score ≥ 4 in the preceding week.
- Failure of another "standard" treatment:
- Typical lateral hip pain reproduced by palpation of the greater trochanter
Key exclusion criteria (20 listed)
- Age younger than 18 years old
- Concomitant local surgical intervention for tumours, infection or fracture, based on clinical history and physical examination
- Previous ipsilateral prosthetic hip surgery
- Scheduled ipsilateral hip surgery within 3 months
- Fibromyalgia (diagnosis established by a rheumatologist)
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 |
|---|---|---|
| rapidocain and bethametsaoneAlso: diprophos, lidocainelidocaine (Rapidocain(R)): 4ml of 1% Lidocaine bethametasone (Diprophos): 1ml ampoule (containing 5mg/ml dipropionate de betamethasone and 2mg/ml phosphate disodique de betamethasone) | Drug | rapidocain and bethametsaone |
| sterile salineAlso: NaClPlacebo = 5ml of sterile saline solution | Drug | sterile saline |
Primary outcome
The efficacy of ultrasound-guided injection with corticosteroid and local anaesthetic for GTPS.
Time frame: 4 weeks
Difference in pain intensity in the lateral hip region at 4 weeks between the 2 treatment groups, as measured by a NRS. Because the timing of the response to an infiltration is not well established we plan to examine pain both at 4 weeks, as well as longitudinally over 4 weeks(evolution of pain over time).
8 secondary outcomes
Number of "responders"
Time frame: 4 weeks
Number of patients with "low residual disease activity"
Time frame: 4 weeks
PGI patient
Time frame: 4 weeks
Lumbar spine function
Time frame: 4 weeks
Hip joint function
Time frame: 4 weeks
QoL
Time frame: 4 weeks
Requirement for oral analgesics
Time frame: 4 weeks
Side effects of the intervention
Time frame: 4 weeks
Results and safety
The study was stopped early (reason given: Slower than planned recruitement). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jun 2017.
- Individual participant dataSharing planned: Undecided
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.
Stephane Genevay, MD principal investigator
University Hospital, Geneva
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 rapidocain and bethametsaone and sterile saline in people with Periarthritis and Bursitis, run by Stephane Genevay at 1 site in Switzerland.
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 20 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: stopped early, as of the sponsor's last update on 8 Jun 2017. 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 Switzerland. 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 was stopped early (reason given: Slower than planned recruitement). Results are not available in the source record.
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?
The efficacy of ultrasound-guided injection with corticosteroid and local anaesthetic for GTPS. (time frame: 4 weeks). 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 Jun 2017.