Analgesic Efficacy of Pulsed Radiofrequency in Non-cyclic Mastalgia
Condition: Breast Fibroadenoma
MeSH terms: Fibroadenoma; Mastodynia
Study type: Interventional
Phase: Phase 2

Summary: 
      Background: Breast pain, mastalgia or mastodynia, is recognized as an organic benign breast
      disease. Mastalgia may be bilateral, may be in only one breast or part of one breast, and may
      radiate to the axilla and down the medial aspect of the upper arm. This study aimed to
      evaluate the additional pulsed radiofrequency of 2nd , 3rd and 4th thoracic dorsal root
      ganglia to the routine regimen treatment of mastalgia tamoxifen 10 mg daily may improve
      breast pain severity and quality of life.

      Method: Patients was randomly classified into two groups:Group A (n=13): they was received
      Tamoxifen 10 mg daily. Group B (n=13): they was received Tamoxifen 10 mg daily and pulsed
      radiofrequency of 2nd , 3rd and 4th thoracic dorsal root ganglia. The following parameters
      were monitored: Primary outcome: VAS after injection and at interval two weeks, 1, 2 and 3
      months after injection. Secondary outcome:1-Immediate complications for ex. Hematoma,
      neurological deficits or respiratory insufficiency (dyspnea or pneumothorax).2-Need for
      analgesic intake was recorded.3-Side effect of Tamoxifen as nausea, vomiting, hot flashes and
      dizziness.4-Quality of life (The American Chronic Pain Association's Quality of life scale).
    

Detailed description: 
      Introduction:

      Breast pain, mastalgia or mastodynia, is recognized as an organic benign breast disease . It
      can be severe enough to cause disturbances in normal quality of life rating which leads to
      disorders in sexual, physical, and social activities. When compared with other conditions, it
      will be similar to chronic cancer pain in the mean pain-index .

      Breast pain is classified into three main categories: cyclical, non-cyclical and
      extra-mammary mastalgia. Cyclical pain is the commonest and it has a temporal association
      with the menstrual cycle. Pain characteristically starts in the days before menstruation and
      gradually increases. It tends to subside once menstruation has started and often disappears
      after a few days. Pain in these women usually abates after the menopause. These factors
      suggest a hormonal aetiology, high level of estrogen, low level of progesterone, and
      imbalance in estrogen to progesterone ratio are assumed among its causes, as well.
      Furthermore, many women associate the onset and resolution of cyclical mastalgia with a
      hormonal event, such as pregnancy or taking the oral contraceptive pill .

      In contrast, there is no relationship to the menstrual cycle with non-cyclical mastalgia.
      Non-cyclic breast pain may result from pregnancy, mastitis, trauma, thrombophlebitis,
      macrocysts, psychologic disturbance, benign tumors, or cancer. However, only a minority of
      breast pain is explained by these conditions. Most non-cyclic breast pain arises for unknown
      reasons. Typically, it presents at a later age; most women are in the fourth or fifth decade
      of life at diagnosis. Many women are postmenopausal at onset of symptoms. Unfortunately, the
      course of both cyclical and non-cyclical mastalgia may be long and last many years.

      The origin of extra-mammary pain is variable. Referred pain from cardiac, pulmonary and
      gastrointestinal causes, such as angina, pneumonia and oesophagitis, respectively, need to be
      excluded. A common cause of extra-mammary mastalgia arises from inflammation of the
      costochondral junctions of the chest wall (Tietze's disease). This condition usually resolves
      with rest and non-steroidal anti-inflammatory drugs .

      Mastalgia may be bilateral, may be in only one breast or part of one breast, and may radiate
      to the axilla and down the medial aspect of the upper arm. The affected breast is often
      extremely tender to touch and pain may be accompanied by swelling and congestion.

      A variety of medical therapies such as non-steroidal anti-inflammatory drugs (NSAIDs),
      vitamin B2, B6, E and C, diuretics, progesterone, thyroxin, Tamoxifen, Bromocriptine,
      Danazol, and plant extracts like evening primrose oil (EPO) and vitexagnus castus have been
      recommended for treatment of mastalgia. Unfortunately, Non-cyclic mastalgia responds poorly
      to medical treatment.

      Psychological reassurance and active life style play a role to decrease the pain and low-fat,
      high-carbohydrate diet can also effect an improvement.

      the female breast supplied its innervation from the anterior and lateral cutaneous branches
      of the second to the sixth intercostal nerves .

      Tamoxifen is one of the medical treatment of mastalgia and considered as a first medication
      line. Tamoxifen 10 mg daily is effective in the treatment of mastalgia. It has side effects
      commonly observed in short-term treatment as weight gain, nausea, hot flashes (10%), bloating
      (5% or less), menstrual irregularity, amenorrhea (10%) and vaginal dryness. Thromboembolic is
      a rare but serious side effects of tamoxifen so it is contraindicated in women with a history
      of thromboembolic disease.

      Pulsed radiofrequency (PRF) has recently been developed with widely usage by pain
      practitioners as alternative therapeutic technique for relief of chronic pain .

      In our study, the investigators aim that the additional pulsed radiofrequency of 2nd , 3rd
      and 4th thoracic dorsal root ganglia to the routine regimen treatment of mastalgia tamoxifen
      10 mg daily may improve breast pain severity and quality of life.

      Our proposal: Is to find that pulsed radiofrequency of 2nd , 3rd and 4th thoracic dorsal root
      ganglia may improve breast pain severity and quality of life.

      Aim of the work: This study aimed to evaluate the efficacy of additional pulsed
      radiofrequency (2nd , 3rd and 4th thoracic dorsal root ganglia) to the routine regimen
      treatment of mastalgia tamoxifen 10 mg daily.

      Hypothesis: Management of non cyclic mastalgia is a challenging issue needing more
      appropriate method to reach the best result.

      Recharge Gap: To our knowledge, there is a no researches discuss this issue and how to manage
      it in best way.

      Patients and methods:

      After approval of the local ethics committee (Mansoura university), twenty six patients
      complain from non-cyclic mastalgia aged from 18 to 60 with VAS > 4 was enrolled in this
      prospective study who were recruited from outpatient pain clinic in Oncology Center Mansoura
      University.

      Sample size:

      It was assessed using G-power analysis. Assuming α (type I error) = 0.05 and β (type II
      error) = 0.2 (power = 80 %) and effect size (δ) = 0.6 yielded a total sample size of 26.

      Patients was randomly classified into two groups:

      Group A (n=13): they was received Tamoxifen 10 mg daily. Group B (n=13): they was received
      Tamoxifen 10 mg daily and pulsed radiofrequency of 2nd , 3rd and 4th thoracic dorsal root
      ganglia.

      Exclusion criteria: cyclical mastalgia, extra-mammary mastalgia patients refusal, suspicion
      of malignancy, acute inflammatory breast conditions, presence of polycystic ovarian diseases
      or cervical hyperplasia, pregnant patients and patients during lactation period, coagulopathy
      disorder, sepsis at the side of injection, history of thromboembolic disease, mental disorder
      and who was not willing or cannot finish the whole study, disturbed anatomy (congenital,
      traumatic, and postsurgical), which increase the intervention difficulty.

      All patients in group B will inform about the procedure and its possible consequences.
      Written informed consent was obtained from all patients before the procedure.

      Technique:

      An intravenous cannula was inserted and secured. All suitable resuscitation equipment and
      drugs will available. Vital signs, heart rate, blood pressure and oxygen saturation will
      monitored throughout the procedure and up to 1 hour after the block performance.

      Resuscitation equipment must be readily available including endotracheal tubes of different
      sizes, ambu bag, ventilator, druges eg. atropine and adrenaline.

      The procedures were performed on a 64 MDCT scanner (Brilliance 64-Philips). The CT
      acquisition parameters were 200 mAs, 120 kVp, 512 × 512 matrix, 1.172 pitches, 64 × 0.625 mm
      section collimation, and 4 mm slice thickness.

      Patients were lying prone. First, a level of T2, 3, 4 disc was detected then the target 2nd,
      3rd and 4th thoracic nerve roots were identified. After marking the entry points, adequate
      sterilization of the skin was achieved using bovidone iodine then the skin was anasthesied by
      2 ml lidocaine 2% at each entry point. The Baileys radio frequency (RF) 22G, 10 cm, sharp
      needles with 10 mm active tip was introduced to face the 2nd, 3rd and 4th thoracic nerve
      roots. If the lung or the pleura are within the needle path injection of saline in order to
      push the lung or the pleura away from the field.

      When confirm the place of the needles tips, the sensory and motor stimulations were done by
      the RF generator to get sensory paresthesia along T2, T3 and T4 dermatomes at 0.4-0.8 V and
      intercostal fasciculation were obtained at double the sensory amplitude.

      The PRF course was carried out at 42°C for 120 s twice at each level followed by injection of
      1 ml lidocaine 2% and 1 ml dexamethasone 4 mg at each level.

      After intervention, All patients were transferred to a recovery room for observation and
      record any complication.
    

Intervention name(s): pulsed radiofrequency of 2nd , 3rd and 4th thoracic dorsal root ganglia.; Tamoxifen
Intervention type(s): Other; Drug
Intervention description(s): Patients were lying prone. Firstly, T2, 3, 4 disc level was detected then the target 2nd, 3rd and 4th thoracic nerve roots were identified. After marking the entry points, adequate sterilization of the skin was achieved using bovidone iodine then the skin was anasthesied by 2 ml lidocaine 2% at each entry point. The Baileys radio frequency (RF) 22G, 10 cm, sharp needles with 10 mm active tip was introduced to face the 2nd, 3rd and 4th thoracic nerve roots.The PRF course was carried out at 42°C for 120 s twice at each level followed by injection of 1 ml lidocaine 2% and 1 ml dexamethasone 4 mg at each level.; received Tamoxifen 10 mg daily
Intervention MeSH terms: Tamoxifen
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: pulsed radiofrequency, non-cyclic mastalgia