Trigger Point Injections for Post-Mastectomy Pain Syndrome

NCT04267315 | Unknown Phase 2

• 1 other identifier: 1474/19
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 2

Brief Summary

Post-Mastectomy Pain Syndrome (PMPS) is a chronic pain that persists for more than three months after a surgical breast procedure. It has 11-70% incidence in patients that underwent a breast surgery. It consists of mixed pain, frequently associated with myofascial pain, an specific type of muscular pain. Trigger point injections (TPI) are classically used for the treatment of myofascial pain in other painful conditions. However, there are no controlled trials assessing the efficacy of TPI in the treatment of PMPS. The intervention objective is to assess the efficacy of TPI in patients with PMPS, when associated with a comprehensive rehabilitation program and pain management.

Conditions

Post-mastectomy Pain Syndrome; Myofascial Pain Syndrome; Trigger Point Pain, Myofascial; Breast Cancer

Outcome Measures

Primary Outcomes (5)

• Visual Numeric Scale (VNS) for pain in 3 months

  Mean difference of Pain between groups from baseline to 3 months(T3m), assessed by the Visual Numeric Scale (VNS, 0-10), in which higher scores represent higher pain intensity.

  3 months

• Trigger-points

  Number of active trigger-points in the assessed muscles (latissimus dorsi, levator scapulae, trapezius superior, infraspinatus, pectoralis major, serratus anterior). Mean difference between groups.

  1 month

• Trigger-points

  Number of active trigger-points in the assessed muscles (latissimus dorsi, levator scapulae, trapezius superior, infraspinatus, pectoralis major, serratus anterior). Mean difference between groups.

  3 months

• Pressure Pain Threshold (PPT)

  Pressure Pain Threshold (PPT) at bilateral latissimus dorsi, levator scapulae, trapezius superior, infraspinatus, pectoralis major, serratus anterior. Difference from baseline

  1 month

• Pressure Pain Threshold

  Pressure Pain Threshold (PPT) at bilateral latissimus dorsi, levator scapulae, trapezius superior, infraspinatus, pectoralis major, serratus anterior. Difference from baseline

  3 months

Secondary Outcomes (17)

• Visual Numeric Scale (VNS) for pain in 1 month

  1 month

• Short-Form McGill Pain Questionnaire (SF-MPQ) - total score, sensorial and affective scale

  1 month

• Short-Form McGill Pain Questionnaire (SF-MPQ) - total score, sensorial and affective scale

  3 months

• Neuropathic Pain Symptom Inventory (NPSI)

  1 month.

• Neuropathic Pain Symptom Inventory (NPSI)

  3 months

Study Arms (2)

Active

ACTIVE COMPARATOR

3 weekly sessions of TPI. Participants will undergo 1mL injections of 1% lidocaine in the muscles identified with either active or latent trigger points at the initial assessment. The same muscles will be injected at all procedures.

Procedure: Trigger point injection; Other: Comprehensive Rehabilitation program

Placebo

SHAM COMPARATOR

3 weekly sessions of subcutaneous saline injections. Participants will undergo 0.2mL subcutaneous saline injections superficial to the trigger points identified at initial assessment. The same superficial sites will be injected in all procedures.

Procedure: Subcutaneous saline injection; Other: Comprehensive Rehabilitation program

Interventions

Trigger point injection PROCEDURE

1mL injections of 1% lidocaine in the muscles identified active trigger points at the day of intervention (pectoralis major, serratus anterior, levator scapulae, latissimus dorsi, infraspinatus).

Active

Subcutaneous saline injection PROCEDURE

0.2mL subcutaneous saline injections superficial to the muscles identified with active trigger points at the day of intervention (pectoralis major, serratus anterior, levator scapulae, latissimus dorsi, infraspinatus).

Placebo

Comprehensive Rehabilitation program OTHER

Patients in both groups will undergo standard of care rehabilitation delivered by a Physiatrist, which may include Physical Therapy, Occupational Therapy, Exercise Physiologist, Rehabilitation Nurse, Psychologist, as per Physiatrist's prescription. Both the comprehensive rehabilitation program and pain medications will continue to be managed by participant's Physiatrist, who will be blinded to patient's allocation. The researchers will be responsible for TPI and for data collection.

Active; Placebo

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Breast cancer patients.
• PMPS diagnosis, as per Wisotzky et col.
• Pain \> 3 months over breast, chest wall or shoulder ipsilateral to surgery.
• Pain Visual analog Scale (VAS) ≥4.
• At least one active trigger point in the following muscles: pectoralis major, superior trapezius, serratus anterior, levator scapularis, latissimus dorsi, infraspinatus

You may not qualify if:

• Current radiation therapy or time since completion \< 3months.
• Allergy to lidocaine or other local anesthetics
• Active infection over injection sites
• Unavailability to be at the hospital during study intervention.

Sponsors & Collaborators

• Instituto do Cancer do Estado de São Paulo: lead
• Hospital de Câncer de Barretos: collaborator

Study Sites (2)

Hospital de Câncer de Barretos

Barretos, São Paulo, Brazil

Location

Instituto do Câncer do Estado de São Paulo

São Paulo, Brazil

Location

Related Publications (1)

• Wisotzky E, Hanrahan N, Lione TP, Maltser S. Deconstructing Postmastectomy Syndrome: Implications for Physiatric Management. Phys Med Rehabil Clin N Am. 2017 Feb;28(1):153-169. doi: 10.1016/j.pmr.2016.09.003.

  PMID: 27912994 BACKGROUND

MeSH Terms

Conditions

Myofascial Pain Syndromes; Breast Neoplasms

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Christina May Moran de Brito, MD, PhD

  Instituto do Câncer do Estado de São Paulo

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Masking Details: Patients will be randomized as they enter the study (T0). Only one of the researchers will have access to the randomization list. The researcher responsible for the procedure will receive an email at the day of the first injection, informing of the participant's allocation group. The outcomes assessor, patient, attending Physiatrist and the Rehabilitation team will be blinded to the patient's allocation group until the end of the study. Only the researcher the performed the TPI, and the researcher responsible for the allocation list will have access to that information.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Double-blind randomized controlled trial comparing the efficacy of TPI + standard of care (ACTIVE) versus sham TPI + standard of care(PLACEBO), with an intention-to-treat analysis

Study Record Dates

• First Submitted: January 29, 2020
• First Posted: February 12, 2020
• Study Start: January 3, 2020
• Primary Completion: November 30, 2023
• Study Completion: February 15, 2024
• Last Updated: October 16, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share

Locations

BR (2)