Post-operative PainPhase 3NCT00307892
Traumeel S for Reduction of Post Operative Pain Following Arthroscopy
A Phase 3 study testing Traumeel S: intra-operative irrigation + oral ingestion in people with Post-operative Pain, run by Shaare Zedek Medical Center at 1 site in Israel.
Trial summary
The perception of pain is a complex process that is not yet fully understood. With outpatient knee arthroscopy becoming standard of care, postoperative pain management has become increasingly important in caring for patients. Read more about this study
- Who is it for?
- Ages 18 to 40 years
- Conditions the study is for
- Post-operative Pain
- What is being tested?
- Traumeel S: intra-operative irrigation + oral ingestion
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 98 participants
- Where
- 1 siteIsrael
- Study dates
- Jan 2011to Jan 2012
- 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 40 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Patients of either sex undergoing unilateral arthroscopy for menisectomy or chondroplasty, w/o ligament reconstruction .
- Age 18 - 40 years.
- Meeting none of exclusion criteria.
Who cannot join
- Participation in another clinical trial within 4 weeks prior to enrollment.
- Inability to comply with the study protocol.
- Impossibility to be reached during the whole follow-up period (7 days post operative)
- Refused to give oral consent to the telephone interviews
- Previous arthroscopy on ipsilateral knee.
- Current use of analgesia for any other reason except for the knee complaint.
- Any disease considered to inhibit wound healing (e.g. Diabetes mellitus, Berger, any PVD, DVT).
- Known sensitivity to dipyrone or diclofenac
Trial locations and contacts
1 site in 1 country.
Israel1 site
Dept. of Orthopedic Surgery, Shaare Zedek Medical Center
Jerusalem, 91031
About this study
Official title: A Randomised, Double- Blind, Placebo Controlled, Clinical Trial to Assess the Efficacy of the Homeopathic Medication TRAUMEEL S in Reducing Pain After Arthroscopy
The perception of pain is a complex process that is not yet fully understood. With outpatient knee arthroscopy becoming standard of care, postoperative pain management has become increasingly important in caring for patients. Traumeel S is a homeopathic complex widely used in German-speaking Europe for orthopedic pain and inflammation. It contains a mixture of medicinal plants and minerals, all highly diluted. In some recent studies, Traumeel has shown anti-inflammatory and analgesic activity.
In this study, the efficacy of Traumeel S will be compared with placebo in reducing pain during the first 48 hours after arthroscopy. Also compared will be 6 day pain levels, analgesic consumption, quality of life, post operative knee function, quadriceps atrophy and safety.
The study design is double blind RCT. 98 patients, aged 18-40 and undergoing arthroscopic meniscectomy or chondroplasty will be enrolled in the trial. Patients will be randomized to receive either intraoperative join irrigation with Traumeel S and oral treatment with Traumeel S, or placebo irrigation and oral ingestion. Patients will continue to take active or placebo medication for 6 days. Pain will be recorded daily by the patient in the patient diary using an 11-point numerical rating score (NRS-11. Patients will also record daily consumption of primary and "rescue" analgesics. Range of motion (RoM) will be measured on days 6 and 30 post-operatively, and the Lysholm knee scale and circumference of thigh above patella will be measured at 30 days. All these measures will be compared with baseline. Patients will be contacted daily by the research assistant to encourage compliance and to record their daily NRS and analgesic consumption in the CRF.
- Conditions
- Post-operative Pain
- Being tested
- Traumeel S: intra-operative irrigation + oral ingestion, Placebo
- Keywords
- Homeopathy, Traumeel S, Arthroscopy, Pain management, Post-operative pain following arthroscopy
- Medical subject headings
- Pain, Postoperative, Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Traumeel S: intra-operative irrigation + oral ingestionDrug
homeopathic remedy
PlaceboDrug
placebo remedy
| Study group | Role | What they receive |
|---|---|---|
| A | Active comparator | TRAUMEEL S Receives: Drug: Traumeel S: intra-operative irrigation + oral ingestion |
| B | Placebo comparator | comparable placebo remedy (injection and oral) Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Degree of pain at rest, as recorded daily by the patient and by the study assistant in the CRF, using a 11 point (0-10) numerical rating score (NRS-11), during the first two post operative days.
Measured: 30d
Secondary outcomes (8)
Degree of pain at rest, as recorded daily by the patient and by the study assistant in the CRF, using a 11 point (0-10) numerical rating score (NRS-11), during the six post operative days.
Measured: 30d
Total amount of primary oral analgesic tablets ingested, as reported by the patient and the study assistant in the CRF from Day 0 to Day 5 (six days), using a discrete scale.
Measured: 30d
Number of days on which oral rescue analgesic treatment was required, if any, as reported by the patient and the study assistant in the CRF, from Day 0 to Day 5 (six days) using a discrete scale.
Measured: 6d
Degree of pain upon performance of RoM on days 5 and 30 postoperatively as compared with baseline, using a 11 point (0-10) numerical rating score (NRS), along a discrete scale.
Measured: 30d
Knee function as measured by difference in RoM at 5 and 30 days postoperatively, as compared with baseline, on a continuous scale.
Measured: 30d
Degree of atrophy of quadriceps, as measured by difference in circumference of thigh 15 cm proximal to the upper pole of the patella with knee in full extension on 30 days post-operatively, as compared with baseline, on a continuous scale.
Measured: 30d
Difference in disease-related QoL, as measured by the difference in Lysholm knee score on 30 days post operatively as compared with baseline .
Measured: 30d
Occurrence of adverse events.
Measured: 30d
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Mar 2006 (estimated)
- Study startJan 2011
- Primary completionJan 2012 (estimated)
Why it stopped: Inability to recruit patients
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post-operative 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
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 98 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shaare Zedek Medical Center
- Sponsor type
- University, hospital or other
- Investigators
- Menachem Oberbaum, M.D., Principal investigator, Shaare Zedek Medical Center, Jerusalem, Israel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00307892
- Sponsor's protocol ID
- Arth 06 CTIL
- Status last verified
- Oct 2010
- First submitted
- 27 Mar 2006
- Last updated
- 29 Oct 2010
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomised, Double- Blind, Placebo Controlled, Clinical Trial to Assess the Efficacy of the Homeopathic Medication TRAUMEEL S in Reducing Pain After Arthroscopy
- ClinicalTrials.gov ID
- NCT00307892
- Acronym / sponsor ID
- Arth 06 CTIL
- Conditions
- Post-operative Pain
- Keywords
- Homeopathy, Traumeel S, Arthroscopy, Pain management, Post-operative pain following arthroscopy
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- SuspendedReason stopped: Inability to recruit patients
- Enrolment
- 98 participants (estimated)
- Lead sponsor
- Shaare Zedek Medical CenterUniversity, hospital or other
- Study start
- Jan 2011
- Primary completion
- Jan 2012 (estimated)
- First posted
- 28 Mar 2006 (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.
The perception of pain is a complex process that is not yet fully understood. With outpatient knee arthroscopy becoming standard of care, postoperative pain management has become increasingly important in caring for patients. Traumeel S is a homeopathic complex widely used in German-speaking Europe for orthopedic pain and inflammation. It contains a mixture of medicinal plants and minerals, all highly diluted. In some recent studies, Traumeel has shown anti-inflammatory and analgesic activity.
In this study, the efficacy of Traumeel S will be compared with placebo in reducing pain during the first 48 hours after arthroscopy. Also compared will be 6 day pain levels, analgesic consumption, quality of life, post operative knee function, quadriceps atrophy and safety.
The study design is double blind RCT. 98 patients, aged 18-40 and undergoing arthroscopic meniscectomy or chondroplasty will be enrolled in the trial. Patients will be randomized to receive either intraoperative join irrigation with Traumeel S and oral treatment with Traumeel S, or placebo irrigation and oral ingestion. Patients will continue to take active or placebo medication for 6 days. Pain will be recorded daily by the patient in the patient diary using an 11-point numerical rating score (NRS-11. Patients will also record daily consumption of primary and "rescue" analgesics. Range of motion (RoM) will be measured on days 6 and 30 post-operatively, and the Lysholm knee scale and circumference of thigh above patella will be measured at 30 days. All these measures will be compared with baseline. Patients will be contacted daily by the research assistant to encourage compliance and to record their daily NRS and analgesic consumption in the CRF.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A | Active comparator | Drug: Traumeel S: intra-operative irrigation + oral ingestionTRAUMEEL S |
| B | Placebo comparator | Drug: Placebocomparable placebo remedy (injection and oral) |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Patients of either sex undergoing unilateral arthroscopy for menisectomy or chondroplasty, w/o ligament reconstruction .
- Age 18 - 40 years.
- Meeting none of exclusion criteria.
Key exclusion criteria (8 listed)
- Participation in another clinical trial within 4 weeks prior to enrollment.
- Inability to comply with the study protocol.
- Impossibility to be reached during the whole follow-up period (7 days post operative)
- Refused to give oral consent to the telephone interviews
- Previous arthroscopy on ipsilateral knee.
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 |
|---|---|---|
| Traumeel S: intra-operative irrigation + oral ingestionhomeopathic remedy | Drug | A |
| Placeboplacebo remedy | Drug | B |
Primary outcome
Degree of pain at rest, as recorded daily by the patient and by the study assistant in the CRF, using a 11 point (0-10) numerical rating score (NRS-11), during the first two post operative days.
Time frame: 30d
8 secondary outcomes
Degree of pain at rest, as recorded daily by the patient and by the study assistant in the CRF, using a 11 point (0-10) numerical rating score (NRS-11), during the six post operative days.
Time frame: 30d
Total amount of primary oral analgesic tablets ingested, as reported by the patient and the study assistant in the CRF from Day 0 to Day 5 (six days), using a discrete scale.
Time frame: 30d
Number of days on which oral rescue analgesic treatment was required, if any, as reported by the patient and the study assistant in the CRF, from Day 0 to Day 5 (six days) using a discrete scale.
Time frame: 6d
Degree of pain upon performance of RoM on days 5 and 30 postoperatively as compared with baseline, using a 11 point (0-10) numerical rating score (NRS), along a discrete scale.
Time frame: 30d
Knee function as measured by difference in RoM at 5 and 30 days postoperatively, as compared with baseline, on a continuous scale.
Time frame: 30d
Degree of atrophy of quadriceps, as measured by difference in circumference of thigh 15 cm proximal to the upper pole of the patella with knee in full extension on 30 days post-operatively, as compared with baseline, on a continuous scale.
Time frame: 30d
Difference in disease-related QoL, as measured by the difference in Lysholm knee score on 30 days post operatively as compared with baseline .
Time frame: 30d
Occurrence of adverse events.
Time frame: 30d
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Oct 2010.
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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.
Menachem Oberbaum, M.D. principal investigator
Shaare Zedek Medical Center, Jerusalem, Israel
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 Traumeel S: intra-operative irrigation + oral ingestion in people with Post-operative Pain, run by Shaare Zedek 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 3 inclusion and 8 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: paused, as of the sponsor's last update on 29 Oct 2010. 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. 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?
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?
Degree of pain at rest, as recorded daily by the patient and by the study assistant in the CRF, using a 11 point (0-10) numerical rating score (NRS-11), during the first two post operative days. (time frame: 30d). 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 29 Oct 2010.