Clinical trial · Interventional
Trigger Point Injections for Post-Mastectomy Pain Syndrome
Trigger Point Injections for Post-Mastectomy Pain Syndrome: A Double-Blind Randomized Controlled Trial With Intention-to-Treat Analysis
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
| Myofascial Pain Syndrome | — | UNRESOLVED | — |
| Post-mastectomy Pain Syndrome | — | UNRESOLVED | — |
| Trigger Point Pain, Myofascial | — | UNRESOLVED | — |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Comprehensive Rehabilitation program | Other | — | UNRESOLVED |
| Subcutaneous saline injection | Procedure | — | UNRESOLVED |
| Trigger point injection | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Active
- 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.
- interventionNames
- Procedure: Trigger point injection
- Other: Comprehensive Rehabilitation program
- type
- SHAM_COMPARATOR
- label
- Placebo
- 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.
- interventionNames
- Procedure: Subcutaneous saline injection
- Other: Comprehensive Rehabilitation program
Primary outcomes (5)
Eligibility
Eligibility (as posted)
- Sex
- All
Show eligibility criteria text
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.
References
Publications (1)
- BACKGROUNDWisotzky 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