Osteoarthritis Trapezial-metacarpal JointNCT01783262
The Role of Extracorporeal Shock Wave Therapy in the Treatment of Trapezial-Metacarpal Osteoarthritis. A Double Blind Randomized Controlled Study.
A study testing Extracorporeal shock wave therapy STORZ MEDICAL Modulith SLK in people with Osteoarthritis Trapezial-metacarpal Joint, run by University of Roma La Sapienza at 1 site in Italy.
Trial summary
Evaluate if extracorporeal shock wave therapy is more effective than sham treatment in patients with trapezial-metacarpal osteoarthritis in pain relief and functional improvement. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Osteoarthritis Trapezial-metacarpal Joint
- What is being tested?
- Extracorporeal shock wave therapy STORZ MEDICAL Modulith SLK
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- Not given
- Where
- 1 siteItaly
- Study dates
- Dec 2009to Jun 2011
- Phase
- Interventional
- 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
- Adult, Older adult
Who may be able to join
- according to the Eaton et al. classification the inclusion criteria involved those patients with stage III, participants had to have a history 6 months of pain and they were 18 years of age or older. Exclusion criteria were also the presence of degenerative or non-degenerative neurologic conditions, in which pain perception is altered, a history of coagulopathy, cancer, cardiac pacemaker, calcaneal fracture, and pregnancy.
Who cannot join
- Exclusion criteria were also the presence of degenerative or non-degenerative neurologic conditions, in which pain perception is altered, a history of coagulopathy, cancer, cardiac pacemaker, calcaneal fracture, and pregnancy.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Role of Extracorporeal Shock Wave Therapy in the Treatment of Trapezial-Metacarpal Osteoarthritis.
Evaluate if extracorporeal shock wave therapy is more effective than sham treatment in patients with trapezial-metacarpal osteoarthritis in pain relief and functional improvement.
- Being tested
- Extracorporeal shock wave therapy STORZ MEDICAL Modulith SLK, Device: Sham extracorporeal shock wave therapy STORZ MEDICAL Modulith SLK
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Extracorporeal shock wave therapy STORZ MEDICAL Modulith SLKDevice
an energy level of 0.09 mJ/mm2, 2400 pulses once a week for 4 weeks.
Device: Sham extracorporeal shock wave therapy STORZ MEDICAL Modulith SLKDevice
Also called an energy level of 0.09 mJ/mm2, 2400 pulses once a week for 4 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Extracorporeal shock wave therapy | Active comparator | an energy level of 0.09 mJ/mm2, 2400 pulses once a week for 4 weeks. Receives: Device: Extracorporeal shock wave therapy STORZ MEDICAL Modulith SLK |
| sham extracorporeal shock wave therapy | Placebo comparator | The second grouop of patients received 0.04 mJ/mm2, 2400 pulses once a week for 4 weeks. Receives: Device: Device: Sham extracorporeal shock wave therapy STORZ MEDICAL Modulith SLK |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual Analogue Scale
It is a horizontal line, 10 cm in length with 0 cm labeled "no pain" and 10 cm labeled "worst pain I have ever had". The patient marks on the line the point that they feel represents their perception of their current state
Measured: The change in the mean Visual Analogic Scale scores from baseline to 3 and 6 months after the intervention
Duruöz Hand Index (DHI)
is a self-report questionnaire which measures hand functional ability detecting how much difficulty the patient has performing eighteen daily tasks of living in reference to hand function. Each item is scored from 0 (performed without difficulty) to 5 (impossible to do). A total score is obtained by adding the scores of all questions (range 0-90). A higher score indicates greater disability. It was found that this scale is reliable and valid in patients with osteoarthritis
Measured: The change in the mean of DHI at 3 and 6 months follow up
Disabilities of the Arm, Shoulder, and Hand questionnaire
It is a 30-item scale that addresses difficulty in performing various physical activities that require upper extremity function (physical function, 21 items); symptoms of pain, activity-related pain, tingling, weakness, and stiffness (pain symptoms, 5 items); or impact of disability and symptoms on social activities, work, sleep, and psychological well-being (emotional and social function, 4 items). The score ranges from 0 to 100, where 0 disability and 100 most severe disability.
Measured: The changes in mean at 3 and 6 months follow up
Secondary outcomes (1)
grip and pinch tests
The measure of strength by hand grip and pinch tests, for continuous variables that were measured in kilograms with a standard dynamometer
Measured: The change in mean at 3 and 6 months follow up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Feb 2013 (estimated)
- Study startDec 2009
- Primary completionJun 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Osteoarthritis Trapezial-metacarpal JointStudies of the same condition, open and under way.
- More trials run by University of Roma La SapienzaThe 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
Sponsor and investigators
- Lead sponsor
- University of Roma La Sapienza
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Francesco Ioppolo, University of Roma La Sapienza
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01783262
- Sponsor's protocol ID
- Interventional Study Design
- Status last verified
- Jan 2013
- First submitted
- 29 Jan 2013
- Last updated
- 4 Feb 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Feb 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of Extracorporeal Shock Wave Therapy in the Treatment of Trapezial-Metacarpal Osteoarthritis.
- ClinicalTrials.gov ID
- NCT01783262
- Acronym / sponsor ID
- Interventional Study Design
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- University of Roma La SapienzaUniversity, hospital or other
- Study start
- Dec 2009
- Primary completion
- Jun 2011 (actual)
- First posted
- 4 Feb 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.
Evaluate if extracorporeal shock wave therapy is more effective than sham treatment in patients with trapezial-metacarpal osteoarthritis in pain relief and functional improvement.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Extracorporeal shock wave therapy | Active comparator | Device: Extracorporeal shock wave therapy STORZ MEDICAL Modulith SLKan energy level of 0.09 mJ/mm2, 2400 pulses once a week for 4 weeks. |
| sham extracorporeal shock wave therapy | Placebo comparator | Device: Device: Sham extracorporeal shock wave therapy STORZ MEDICAL Modulith SLKThe second grouop of patients received 0.04 mJ/mm2, 2400 pulses once a week for 4 weeks. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- according to the Eaton et al. classification the inclusion criteria involved those patients with stage III, participants had to have a history 6 months of pain and they were 18 years of age or older. Exclusion criteria were also the presence of degenerative or non-degenerative neurologic conditions, in which pain perception is altered, a history of coagulopathy, cancer, cardiac pacemaker, calcaneal fracture, and pregnancy.
Key exclusion criteria (1 listed)
- Exclusion criteria were also the presence of degenerative or non-degenerative neurologic conditions, in which pain perception is altered, a history of coagulopathy, cancer, cardiac pacemaker, calcaneal fracture, and pregnancy.
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 |
|---|---|---|
| Extracorporeal shock wave therapy STORZ MEDICAL Modulith SLKan energy level of 0.09 mJ/mm2, 2400 pulses once a week for 4 weeks. | Device | Extracorporeal shock wave therapy |
| Device: Sham extracorporeal shock wave therapy STORZ MEDICAL Modulith SLKAlso: an energy level of 0.09 mJ/mm2, 2400 pulses once a week for 4 weeks. | Device | sham extracorporeal shock wave therapy |
Primary outcome
Visual Analogue Scale
Time frame: The change in the mean Visual Analogic Scale scores from baseline to 3 and 6 months after the intervention
It is a horizontal line, 10 cm in length with 0 cm labeled "no pain" and 10 cm labeled "worst pain I have ever had". The patient marks on the line the point that they feel represents their perception of their current state
Duruöz Hand Index (DHI)
Time frame: The change in the mean of DHI at 3 and 6 months follow up
is a self-report questionnaire which measures hand functional ability detecting how much difficulty the patient has performing eighteen daily tasks of living in reference to hand function. Each item is scored from 0 (performed without difficulty) to 5 (impossible to do). A total score is obtained by adding the scores of all questions (range 0-90). A higher score indicates greater disability. It was found that this scale is reliable and valid in patients with osteoarthritis
Disabilities of the Arm, Shoulder, and Hand questionnaire
Time frame: The changes in mean at 3 and 6 months follow up
It is a 30-item scale that addresses difficulty in performing various physical activities that require upper extremity function (physical function, 21 items); symptoms of pain, activity-related pain, tingling, weakness, and stiffness (pain symptoms, 5 items); or impact of disability and symptoms on social activities, work, sleep, and psychological well-being (emotional and social function, 4 items). The score ranges from 0 to 100, where 0 disability and 100 most severe disability.
1 secondary outcome
grip and pinch tests
Time frame: The change in mean at 3 and 6 months follow up
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 4 Feb 2013.
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 study testing Extracorporeal shock wave therapy STORZ MEDICAL Modulith SLK in people with Osteoarthritis Trapezial-metacarpal Joint, run by University of Roma La Sapienza at 1 site in Italy.
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 1 inclusion and 1 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 4 Feb 2013. 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 Italy. 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.
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?
Visual Analogue Scale (time frame: The change in the mean Visual Analogic Scale scores from baseline to 3 and 6 months after the 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 4 Feb 2013.