Trigger Point Injections for Post-Mastectomy Pain Syndrome
Primary Purpose
Post-mastectomy Pain Syndrome, Myofascial Pain Syndrome, Trigger Point Pain, Myofascial
Status
Active
Phase
Phase 2
Locations
Brazil
Study Type
Interventional
Intervention
Trigger point injection
Subcutaneous saline injection
Comprehensive Rehabilitation program
Sponsored by
About this trial
This is an interventional treatment trial for Post-mastectomy Pain Syndrome
Eligibility Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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.
Sites / Locations
- Hospital de Câncer de Barretos
- Instituto do Câncer do Estado de São Paulo
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Sham Comparator
Arm Label
Active
Placebo
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
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.
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.
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.
Pressure Pain Threshold (PPT)
Pressure Pain Threshold (PPT) at bilateral latissimus dorsi, levator scapulae, trapezius superior, infraspinatus, pectoralis major, serratus anterior. Difference from baseline
Pressure Pain Threshold
Pressure Pain Threshold (PPT) at bilateral latissimus dorsi, levator scapulae, trapezius superior, infraspinatus, pectoralis major, serratus anterior. Difference from baseline
Secondary Outcome Measures
Visual Numeric Scale (VNS) for pain in 1 month
Mean difference of Pain between groups from baseline,assessed by the Visual Numeric Scale (VNS, 0-10), in which higher scores represent higher pain intensity.
Short-Form McGill Pain Questionnaire (SF-MPQ) - total score, sensorial and affective scale
Short-Form McGill Pain Questionnaire - total score, sensorial and affective scale. Mean difference between groups from baseline. Higher values represent higher pain intensity
Short-Form McGill Pain Questionnaire (SF-MPQ) - total score, sensorial and affective scale
Short-Form McGill Pain Questionnaire - total score, sensorial and affective scale. Mean difference between groups from baseline. Higher values represent higher pain intensity
Neuropathic Pain Symptom Inventory (NPSI)
Neuropathic Pain Symptom Inventory . Mean difference between groups from baseline. Higher values represent more symptoms of neuropathic pain.
Neuropathic Pain Symptom Inventory (NPSI)
Neuropathic Pain Symptom Inventory . Mean difference between groups from baseline. Higher values represent more symptoms of neuropathic pain.
Disabilities of the Arm, Shoulder and Hand Questionnaire (DASH)
Disabilities of the Arm, Shoulder and Hand Questionnaire (DASH). Mean difference between groups from baseline. Higher values represent lower functionality.
Disabilities of the Arm, Shoulder and Hand Questionnaire (DASH)
Disabilities of the Arm, Shoulder and Hand Questionnaire (DASH). Mean difference between groups from baseline. Higher values represent lower functionality.
Shoulder range of motion (ROM)
Range of motion (ROM) of affected shoulder, for abduction and external rotation. Mean difference between groups from baseline.
Shoulder range of motion (ROM)
Range of motion (ROM) of affected shoulder, for abduction and external rotation. Mean difference between groups from baseline.
Percentage of patients with at least 30% improvement of pain as per VNS scores (VNS30%)
Percentage of patients with at least 30% improvement of pain as per VAS scores (VAS30%). Mean difference between groups.
Percentage of patients with at least 30% improvement of pain as per VNS scores (VNS30%)
Percentage of patients with at least 30% improvement of pain as per VAS scores (VAS30%). Mean difference between groups.
Percentage of patients with at least 50% improvement of pain as per VNS scores (VNS50%)
Percentage of patients with at least 50% improvement of pain as per VAS scores (VAS30%). Mean difference between groups.
Percentage of patients with at least 50% improvement of pain as per VNS scores (VNS50%)
Percentage of patients with at least 50% improvement of pain as per VAS scores (VAS30%). Mean difference between groups.
Adverse events
Number of participants with adverse events. Mean difference between groups.
Adverse events
Number of participants with adverse events. Mean difference between groups.
Pain medication
Use of pain medication. Classified as "Increased", "Decreased", "Stable" or "Non-applicable" . Mean difference between groups.
Pain medication
Use of pain medication. Classified as "Increased", "Decreased", "Stable" or "Non-applicable" . Mean difference between groups.
Full Information
NCT ID
NCT04267315
First Posted
January 29, 2020
Last Updated
October 13, 2023
Sponsor
Instituto do Cancer do Estado de São Paulo
Collaborators
Hospital de Câncer de Barretos
1. Study Identification
Unique Protocol Identification Number
NCT04267315
Brief Title
Trigger Point Injections for Post-Mastectomy Pain Syndrome
Official Title
Trigger Point Injections for Post-Mastectomy Pain Syndrome: A Double-Blind Randomized Controlled Trial With Intention-to-Treat Analysis
Study Type
Interventional
2. Study Status
Record Verification Date
October 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
January 3, 2020 (Actual)
Primary Completion Date
November 30, 2023 (Anticipated)
Study Completion Date
February 15, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Instituto do Cancer do Estado de São Paulo
Collaborators
Hospital de Câncer de Barretos
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
Detailed Description
INTRODUCTION: 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. Trigger point injections (TPI) are classically used for the treatment of myofascial pain in other etiologies. However, there are no controlled trials assessing the efficacy of TPI in the treatment of PMPS
OBJECTIVE: Assess the efficacy of TPI in patients with PMPS, when associated with a comprehensive rehabilitation program and pain management.
METHODS: Double-blind randomized controlled trial with intention-to-treat analysis. Both groups will undergo standard of care delivered by Physiatrist blinded to group allocation. Active group will undergo TPI with 1% lidocaine in each identified trigger-point, weekly, for three consecutive weeks. Control group will undergo subcutaneous saline injection superficial to the same trigger points, with the same frequency and number of sessions. Primary outcome is the mean difference between groups for pain levels, as assessed by Visual Numeric Scale (VNS), from baseline to 3 months after the procedure.
STATISTICAL ANALYSIS: Difference between groups at baseline, one and three months after injection, using Analysis of Covariance (ANCOVA) for the following outcomes: VNS; Presence of active trigger points, Pressure pain threshold (PPT); Short-Form McGill Pain Questionnaire (SF-MPQ); Neuropathic Pain Symptom Inventory (NPSI); Disabilities of the Arm, Shoulder and Hand Questionnaire (DASH); Range of motion (ROM) of affected shoulder, for abduction and external rotation; adverse events; use of pain medication.
Total sample size is 120. Alpha=5%, power=80%.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Post-mastectomy Pain Syndrome, Myofascial Pain Syndrome, Trigger Point Pain, Myofascial, Breast Cancer
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Model Description
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
Masking
ParticipantCare ProviderOutcomes Assessor
Masking Description
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.
Allocation
Randomized
Enrollment
72 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Active
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Placebo
Arm Type
Sham Comparator
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
Trigger point injection
Intervention Description
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).
Intervention Type
Procedure
Intervention Name(s)
Subcutaneous saline injection
Intervention Description
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).
Intervention Type
Other
Intervention Name(s)
Comprehensive Rehabilitation program
Intervention Description
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.
Primary Outcome Measure Information:
Title
Visual Numeric Scale (VNS) for pain in 3 months
Description
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.
Time Frame
3 months
Title
Trigger-points
Description
Number of active trigger-points in the assessed muscles (latissimus dorsi, levator scapulae, trapezius superior, infraspinatus, pectoralis major, serratus anterior). Mean difference between groups.
Time Frame
1 month
Title
Trigger-points
Description
Number of active trigger-points in the assessed muscles (latissimus dorsi, levator scapulae, trapezius superior, infraspinatus, pectoralis major, serratus anterior). Mean difference between groups.
Time Frame
3 months
Title
Pressure Pain Threshold (PPT)
Description
Pressure Pain Threshold (PPT) at bilateral latissimus dorsi, levator scapulae, trapezius superior, infraspinatus, pectoralis major, serratus anterior. Difference from baseline
Time Frame
1 month
Title
Pressure Pain Threshold
Description
Pressure Pain Threshold (PPT) at bilateral latissimus dorsi, levator scapulae, trapezius superior, infraspinatus, pectoralis major, serratus anterior. Difference from baseline
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Visual Numeric Scale (VNS) for pain in 1 month
Description
Mean difference of Pain between groups from baseline,assessed by the Visual Numeric Scale (VNS, 0-10), in which higher scores represent higher pain intensity.
Time Frame
1 month
Title
Short-Form McGill Pain Questionnaire (SF-MPQ) - total score, sensorial and affective scale
Description
Short-Form McGill Pain Questionnaire - total score, sensorial and affective scale. Mean difference between groups from baseline. Higher values represent higher pain intensity
Time Frame
1 month
Title
Short-Form McGill Pain Questionnaire (SF-MPQ) - total score, sensorial and affective scale
Description
Short-Form McGill Pain Questionnaire - total score, sensorial and affective scale. Mean difference between groups from baseline. Higher values represent higher pain intensity
Time Frame
3 months
Title
Neuropathic Pain Symptom Inventory (NPSI)
Description
Neuropathic Pain Symptom Inventory . Mean difference between groups from baseline. Higher values represent more symptoms of neuropathic pain.
Time Frame
1 month.
Title
Neuropathic Pain Symptom Inventory (NPSI)
Description
Neuropathic Pain Symptom Inventory . Mean difference between groups from baseline. Higher values represent more symptoms of neuropathic pain.
Time Frame
3 months
Title
Disabilities of the Arm, Shoulder and Hand Questionnaire (DASH)
Description
Disabilities of the Arm, Shoulder and Hand Questionnaire (DASH). Mean difference between groups from baseline. Higher values represent lower functionality.
Time Frame
1 month
Title
Disabilities of the Arm, Shoulder and Hand Questionnaire (DASH)
Description
Disabilities of the Arm, Shoulder and Hand Questionnaire (DASH). Mean difference between groups from baseline. Higher values represent lower functionality.
Time Frame
3 months
Title
Shoulder range of motion (ROM)
Description
Range of motion (ROM) of affected shoulder, for abduction and external rotation. Mean difference between groups from baseline.
Time Frame
1 month
Title
Shoulder range of motion (ROM)
Description
Range of motion (ROM) of affected shoulder, for abduction and external rotation. Mean difference between groups from baseline.
Time Frame
3 months
Title
Percentage of patients with at least 30% improvement of pain as per VNS scores (VNS30%)
Description
Percentage of patients with at least 30% improvement of pain as per VAS scores (VAS30%). Mean difference between groups.
Time Frame
1 month
Title
Percentage of patients with at least 30% improvement of pain as per VNS scores (VNS30%)
Description
Percentage of patients with at least 30% improvement of pain as per VAS scores (VAS30%). Mean difference between groups.
Time Frame
3 months
Title
Percentage of patients with at least 50% improvement of pain as per VNS scores (VNS50%)
Description
Percentage of patients with at least 50% improvement of pain as per VAS scores (VAS30%). Mean difference between groups.
Time Frame
1 month
Title
Percentage of patients with at least 50% improvement of pain as per VNS scores (VNS50%)
Description
Percentage of patients with at least 50% improvement of pain as per VAS scores (VAS30%). Mean difference between groups.
Time Frame
3 months
Title
Adverse events
Description
Number of participants with adverse events. Mean difference between groups.
Time Frame
1 month
Title
Adverse events
Description
Number of participants with adverse events. Mean difference between groups.
Time Frame
3 months
Title
Pain medication
Description
Use of pain medication. Classified as "Increased", "Decreased", "Stable" or "Non-applicable" . Mean difference between groups.
Time Frame
1 months
Title
Pain medication
Description
Use of pain medication. Classified as "Increased", "Decreased", "Stable" or "Non-applicable" . Mean difference between groups.
Time Frame
3 months
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Christina May Moran de Brito, MD, PhD
Organizational Affiliation
Instituto do Câncer do Estado de São Paulo
Official's Role
Study Director
Facility Information:
Facility Name
Hospital de Câncer de Barretos
City
Barretos
State/Province
São Paulo
Country
Brazil
Facility Name
Instituto do Câncer do Estado de São Paulo
City
São Paulo
Country
Brazil
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
27912994
Citation
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.
Results Reference
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Trigger Point Injections for Post-Mastectomy Pain Syndrome
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