Efficacy of Myofascial Pain Syndrome Treatment in Patients With Cancer in Palliative Care

NCT04703803 | Completed Phase 3

• 1 other identifier: MPS_palliativecancer
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Myofascial Pain Syndromes; Cancer

Keywords

Myofascial Pain Syndromes; Cancer Pain; Palliative care

Outcome Measures

Primary Outcomes (1)

• 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.

  72 hours and 7 days

Secondary Outcomes (4)

• Change in pain threshold measurement

  72 hours and 7 days

• Change in number of analgesic drugs in use

  72 hours and 7 days

• Assessment of depression and anxiety simptoms

  7 days

• Assessment of quality of life

  7 days

Study Arms (2)

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

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.

Interventions

1% lidocaine injection in trigger points COMBINATION_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

1% lidocaine injection

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Sao Paulo: lead

Study Sites (1)

Laís Araujo Dos Santos Vilar

Ribeirão Preto, São Paulo, 14048900, Brazil

Location

Related Publications (1)

• 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.

  PMID: 38484328 DERIVED

Related Links

• Webpage of the Ribeirão Preto Medical School

MeSH Terms

Conditions

Myofascial Pain Syndromes; Neoplasms; Cancer Pain

Interventions

Lidocaine

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: A member of the research team who doesn´t know whether the participant is in the intervention or control group will be responsible for the reassessment (after 72 hours and 1 week) to measure the outcomes
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: Randomized, comparative, single-blinded interventional study

Study Record Dates

• First Submitted: January 8, 2021
• First Posted: January 11, 2021
• Study Start: August 17, 2020
• Primary Completion: March 19, 2021
• Study Completion: May 17, 2022
• Last Updated: April 25, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: After the publication of results of study
• Access Criteria: Researchers after the review and approval of protocol by the principal investigator

Locations

BR (1)