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

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.

Study Overview

• Status: Completed
• Conditions: Cancer; Myofascial Pain Syndromes
• Intervention / Treatment: Combination product: 1% lidocaine injection in trigger points

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 Type: Interventional
• Enrollment (Actual): 30
• Phase: Phase 3

Contacts and Locations

Study Locations

• Brazil
  • SP
    • Ribeirão Preto, SP, Brazil, 14048900
      • Laís Araujo Dos Santos Vilar

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Participants that

  1. accomplish the Travel and Simons' diagnostic criteria for myofascial pain syndrome,
  2. have pain intensity on visual analog scale of 5 or more,
  3. have performance status on the Karnofsky Performance Status scale of 30 or more.

Exclusion Criteria:

• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 1% lidocaine injection; 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; 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
No Intervention: Control Group; The control group will receive usual care, defined as the treatment for pain prescribed by their assistant doctors.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	7 days
Assessment of quality of life	Assessed by European Organization for Research and Treatment of Cancer Quality of Life Questionnarie Core 15 PAL	7 days

Collaborators and Investigators

• Sponsor: University of Sao Paulo

Publications and helpful links

Helpful Links

• webpage of the Ribeirão Preto Medical School

Study record dates

Study Major Dates

• Study Start (Actual): August 17, 2020
• Primary Completion (Actual): March 19, 2021
• Study Completion (Actual): May 17, 2022

Study Registration Dates

• First Submitted: January 8, 2021
• First Submitted That Met QC Criteria: January 8, 2021
• First Posted (Actual): January 11, 2021

Study Record Updates

• Last Update Posted (Actual): April 25, 2023
• Last Update Submitted That Met QC Criteria: April 22, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Keywords: Palliative care; Cancer Pain; Myofascial Pain Syndromes
• Additional Relevant MeSH Terms: Mental Disorders; Pathologic Processes; Nervous System Diseases; Disease; Musculoskeletal Diseases; Rheumatic Diseases; Muscular Diseases; Neuromuscular Diseases; Syndrome; Fibromyalgia; Somatoform Disorders; Myofascial Pain Syndromes; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Arrhythmia Agents; Central Nervous System Depressants; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Membrane Transport Modulators; Anesthetics, Local; Voltage-Gated Sodium Channel Blockers; Sodium Channel Blockers; Lidocaine
• Other Study ID Numbers: MPS_palliativecancer

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: IPD to be made available after the end of the study protocol
• IPD Sharing Time Frame: After the publication of results of study
• IPD Sharing Access Criteria: Researchers after the review and approval of protocol by the principal investigator
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No