Myofascial Pain SyndromesPhase 3NCT04703803
Efficacy of Myofascial Pain Syndrome Treatment in Patients With Cancer in Palliative Care
A Phase 3 study testing 1% lidocaine injection in trigger points in people with Myofascial Pain Syndromes and Cancer, run by University of Sao Paulo at 1 site in Brazil.
Trial summary
Palliative Care is active holistic care offered to people who are in intense suffering related to their health, resulting from a serious life-threatening illness, with a focus on improving the quality of life. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Myofascial Pain Syndromes, Cancer
- What is being tested?
- 1% lidocaine injection in trigger points
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteBrazil
- Study dates
- 17 Aug 2020to 17 May 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 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Participants that
- accomplish the Travel and Simons' diagnostic criteria for myofascial pain syndrome,
- have pain intensity on visual analog scale of 5 or more,
- have performance status on the Karnofsky Performance Status scale of 30 or more.
Who cannot join
- Use of high dose anticoagulants (RNI above the therapeutic range);
- Patients with hemorrhagic diathesis;
- Patients with moderate to severe dementia syndrome;
- Patients with diagnosis of acute confusional state during the follow-up;
- Occurrence of clinical complication or intervention that could compromise the reevaluation of pain in the following days (for example, undergoing a surgical procedure or nerve block) or death.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Treatment of Myofascial Pain Syndrome With Lidocaine Injection in Patients With Cancer in Palliative Care: a Randomized Clinical Trial
Palliative Care is active holistic care offered to people who are in intense suffering related to their health, resulting from a serious life-threatening illness, with a focus on improving the quality of life. Among the symptoms that cause suffering, physical pain has a prominent role in terms of prevalence and impact on well-being, especially in the subgroup of patients with terminal cancer. Myofascial Pain Syndrome may be one of the components of pain in cancer patients in palliative care. However, the literature is scarce in defining the prevalence of this condition in this population, and there is no evidence of the benefit of needling treatment with 1% lidocaine in these patients until now. The objectives of this study are to determinate the prevalence of myofascial pain syndrome and to evaluate the effectiveness of myofascial pain treatment with 1% lidocaine injection in reducing pain in palliative cancer patients, comparing it with a control group in usual care.
Read the detailed description
This is a clinical trial designed as a comparative, randomized, single-blinded intervention study. Patients will be recruited from wards and radiotherapy sector of the Ribeirão Preto Clinical Hospital - Ribeirão Preto Medical School, University of São Paulo (FMRP-USP). Initially, patients aged 50 years or older with cancer in palliative care will be evaluated to assess the prevalence of myofascial pain syndrome using Travel and Simons' diagnostic criteria and for the following variables: demographic characteristics, functional status (Palliative Performance Scale), pain intensity (visual analog scale and pain threshold measurement with a pressure gauge), prognostic score (Palliative Prognosis Score), depression and anxiety (Hospital Anxiety and Depression Scale), quality of life (European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 15 PAL) and analgesic drugs in use. The participants that (1) accomplish the Travel and Simons' diagnostic criteria for myofascial pain syndrome, (2) have performance status on the Karnofsky scale of 30 or more, and (3) have pain intensity on visual analog scale of 5 or more will be randomized for the clinical trial. The sample size calculation resulted in 15 participants for each group, totaling a sample composed of 30 patients. The intervention group will be submitted to the trigger point injection procedure with 1% lidocaine, and the control group will receive usual care, defined as the treatment for pain prescribed by their assistant doctors. Both groups will be reevaluated after 72 hours and 1 week after the procedure. In the analysis statistics, chi-square test (or Fisher's exact test) will be used to evaluate categorical variables. For the comparison between the groups at each moment (before and after intervention) will be used the linear mixed effects model. The significance level established was <0.05. SAS Statistical Software (version 9.3; SAS Institute, Inc. Cary , NC) will be used for the analysis.
- Conditions
- Myofascial Pain Syndromes, Cancer
- Being tested
- 1% lidocaine injection in trigger points
- Keywords
- Myofascial Pain Syndromes, Cancer Pain, Palliative care
- Medical subject headings
- Myofascial Pain Syndromes, Neoplasms, Cancer Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
1% lidocaine injection in trigger pointsCombination product
The trigger point injection procedure with 1% lidocaine will be e (the sum of all needled trigger points will have a maximum of 10 ml), in a single intervention
| Study group | Role | What they receive |
|---|---|---|
| 1% lidocaine injection | Experimental | The intervention group will be submitted to the trigger point injection procedure with 1% lidocaine (the sum of all needled trigger points will have a maximum of 10 ml), in a single intervention Receives: Combination Product: 1% lidocaine injection in trigger points |
| Control Group | No intervention | The control group will receive usual care, defined as the treatment for pain prescribed by their assistant doctors. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in pain intensity
Assessed by Visual Analogic Scale (0 to 10). This evaluation will be collected at baseline, after 72 hours and after 7 days in follow-up.
Measured: 72 hours and 7 days
Secondary outcomes (4)
Change in pain threshold measurement
Assessed with a pressure gauge (Kg). This evaluation will be collected at baseline, after 72 hours and after 7 days in follow-up.
Measured: 72 hours and 7 days
Change in number of analgesic drugs in use
Evaluation of the number of drugs in use, if there was an increase, reduction or maintenance of the number and doses of analgesic drugs comparing to the baseline.
Measured: 72 hours and 7 days
Assessment of depression and anxiety simptoms
Assessed by Hospital Anxiety and Depression Scale- scores ranged from 0 to 21 for anxiety and 0 to 21 for depression. Higher scores mean worse outcome.
Measured: 7 days
Assessment of quality of life
Assessed by European Organization for Research and Treatment of Cancer Quality of Life Questionnarie Core 15 PAL
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2021
- Study start17 Aug 2020
- Primary completion19 Mar 2021
- Study completion17 May 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Myofascial Pain SyndromesStudies of the same condition, open and under way.
- More trials run by University of Sao PauloThe 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
- Model description
- Randomized, comparative, single-blinded interventional study
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nereida Kilza da Costa Lima, University of Sao Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04703803
- Sponsor's protocol ID
- MPS_palliativecancer
- Status last verified
- Apr 2023
- First submitted
- 8 Jan 2021
- Last updated
- 25 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: IPD to be made available after the end of the study protocol
Publications
Santos-Vilar LAD, Freitas-Passos IF, Rossi BM, Blauth FG, Pontes VCB, Moriguti JC, Riberto M, Lima NKDC. Lidocaine Needling in Myofascial Pain Syndrome for Palliative Oncologic Care: A Randomized Clinical Study. J Palliat Med. 2024 Jul;27(7):888-894. doi: 10.1089/jpm.2023.0641. Epub 2024 Mar 14.
PubMed 38484328
Study at a glance
From the registry record, last updated by the sponsor on 25 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment of Myofascial Pain Syndrome With Lidocaine Injection in Patients With Cancer in Palliative Care: a Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT04703803
- Acronym / sponsor ID
- MPS_palliativecancer
- Conditions
- Myofascial Pain Syndromes, Cancer
- Keywords
- Myofascial Pain Syndromes, Cancer Pain, Palliative care
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- University of Sao PauloUniversity, hospital or other
- Study start
- 17 Aug 2020 (actual)
- Primary completion
- 19 Mar 2021 (actual)
- Study completion
- 17 May 2022 (actual)
- First posted
- 11 Jan 2021 (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.
Palliative Care is active holistic care offered to people who are in intense suffering related to their health, resulting from a serious life-threatening illness, with a focus on improving the quality of life. Among the symptoms that cause suffering, physical pain has a prominent role in terms of prevalence and impact on well-being, especially in the subgroup of patients with terminal cancer. Myofascial Pain Syndrome may be one of the components of pain in cancer patients in palliative care. However, the literature is scarce in defining the prevalence of this condition in this population, and there is no evidence of the benefit of needling treatment with 1% lidocaine in these patients until now. The objectives of this study are to determinate the prevalence of myofascial pain syndrome and to evaluate the effectiveness of myofascial pain treatment with 1% lidocaine injection in reducing pain in palliative cancer patients, comparing it with a control group in usual care.
Detailed description
This is a clinical trial designed as a comparative, randomized, single-blinded intervention study. Patients will be recruited from wards and radiotherapy sector of the Ribeirão Preto Clinical Hospital - Ribeirão Preto Medical School, University of São Paulo (FMRP-USP). Initially, patients aged 50 years or older with cancer in palliative care will be evaluated to assess the prevalence of myofascial pain syndrome using Travel and Simons' diagnostic criteria and for the following variables: demographic characteristics, functional status (Palliative Performance Scale), pain intensity (visual analog scale and pain threshold measurement with a pressure gauge), prognostic score (Palliative Prognosis Score), depression and anxiety (Hospital Anxiety and Depression Scale), quality of life (European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 15 PAL) and analgesic drugs in use. The participants that (1) accomplish the Travel and Simons' diagnostic criteria for myofascial pain syndrome, (2) have performance status on the Karnofsky scale of 30 or more, and (3) have pain intensity on visual analog scale of 5 or more will be randomized for the clinical trial. The sample size calculation resulted in 15 participants for each group, totaling a sample composed of 30 patients. The intervention group will be submitted to the trigger point injection procedure with 1% lidocaine, and the control group will receive usual care, defined as the treatment for pain prescribed by their assistant doctors. Both groups will be reevaluated after 72 hours and 1 week after the procedure. In the analysis statistics, chi-square test (or Fisher's exact test) will be used to evaluate categorical variables. For the comparison between the groups at each moment (before and after intervention) will be used the linear mixed effects model. The significance level established was <0.05. SAS Statistical Software (version 9.3; SAS Institute, Inc. Cary , NC) will be used for the analysis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized, comparative, single-blinded interventional study
| Arm | Type | Receives |
|---|---|---|
| 1% lidocaine injection | Experimental | Combination Product: 1% lidocaine injection in trigger pointsThe intervention group will be submitted to the trigger point injection procedure with 1% lidocaine (the sum of all needled trigger points will have a maximum of 10 ml), in a single intervention |
| Control Group | No intervention | –The control group will receive usual care, defined as the treatment for pain prescribed by their assistant doctors. |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Participants that
Key exclusion criteria (5 listed)
- Use of high dose anticoagulants (RNI above the therapeutic range);
- Patients with hemorrhagic diathesis;
- Patients with moderate to severe dementia syndrome;
- Patients with diagnosis of acute confusional state during the follow-up;
- Occurrence of clinical complication or intervention that could compromise the reevaluation of pain in the following days (for example, undergoing a surgical procedure or nerve block) or death.
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 |
|---|---|---|
| 1% lidocaine injection in trigger pointsThe trigger point injection procedure with 1% lidocaine will be e (the sum of all needled trigger points will have a maximum of 10 ml), in a single intervention | Combination product | 1% lidocaine injection |
Primary outcome
Change in pain intensity
Time frame: 72 hours and 7 days
Assessed by Visual Analogic Scale (0 to 10). This evaluation will be collected at baseline, after 72 hours and after 7 days in follow-up.
4 secondary outcomes
Change in pain threshold measurement
Time frame: 72 hours and 7 days
Change in number of analgesic drugs in use
Time frame: 72 hours and 7 days
Assessment of depression and anxiety simptoms
Time frame: 7 days
Assessment of quality of life
Time frame: 7 days
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 25 Apr 2023.
- Derived from this study: PubMed 38484328Santos-Vilar LAD, Freitas-Passos IF, Rossi BM, Blauth FG, Pontes VCB, Moriguti JC, Riberto M, Lima NKDC. Lidocaine Needling in Myofascial Pain Syndrome for Palliative Oncologic Care: A Randomized Clinical Study. J Palliat Med. 2024 Jul;27(7):888-894. doi: 10.1089/jpm.2023.0641. Epub 2024 Mar 14.
- Webpage of the Ribeirão Preto Medical SchoolLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. IPD to be made available after the end of the study protocol
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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.
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 1% lidocaine injection in trigger points in people with Myofascial Pain Syndromes and Cancer, run by University of Sao Paulo at 1 site in Brazil.
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 4 inclusion and 5 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 25 Apr 2023. 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 Brazil. 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.
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 pain intensity (time frame: 72 hours and 7 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04703803, which also lists 1 linked publication.
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 25 Apr 2023.