Clinical trial NCT03494426: Radiofrequency Thoracic Sympathectomy for Chronic Postmastectomy Pain; Randomized Placebo Controlled Study
Official title: Radiofrequency Thoracic Sympathectomy for Chronic Postmastectomy Pain; Randomized Placebo Controlled Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Post-Mastectomy Chronic Pain Syndrome
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2018-04-11
Enrollment: 70
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Postmastectomy pain syndrome (PMPS) is a neuropathic pain that can follow surgical treatment for breast cancer, The antineuropathic medications (antidepressants and anticonvulsants) are disappointing and have low success rate. Continues Radiofrequency lesioning has been reported as treatment for several chronic pain conditions.The concept that the clinical effect of RF was caused by formation of heat had not been challenged. Thermocoagulation of nerve fibers would interfere with the conduction of nociceptive stimuli and pain would be relived. Thoracic sympathectomy has been done for many painful conditions that includes complex regional pain syndrome .It offers the benefit over stellate ganglion block as it blocks the Kuntz fibers that connect to the brachial plexus roots without passing through stellate ganglion.

Detailed description: Postmastectomy pain syndrome (PMPS) is a neuropathic pain that can follow surgical treatment for breast cancer including radical mastectomy, modified radical mastectomy,and segmental mastectomy (lumpectomy) . The pain is distributed in the anterior chest, axilla, and medial and posterior parts of the arm . This pain can be sufficiently severe enough to interfere with sleep and performance of daily activities.

Patients may develop an immobilized arm, which can lead to severe lymph edema, frozen shoulder syndrome, and complex regional pain syndrome. PMPS can result from surgical damage to the intercostobrachial nerve( the lateral cutaneous branch of the second intercostal nerve) that is often resected at mastectomy .

The etiology of persistent pain after mastectomy is unclear, although it is likely multifactorial and may be partially neuropathic in nature . Previous reports of PMPS have suggested a limited number of potential risk factors, which are inconsistent among studies . While surgical factors, including more extensive surgery (mastectomy), axillary lymphnode dissection, and reconstruction have been postulated as important risk factors for chronic pain, many studies do not support this association. Adjuvant treatment, such as radiation, chemotherapy, and hormonal therapy, has also been occasionally associated with persistent pain .

Among demographic factors, younger age correlates with increased incidence of persistent pain in some studies but not others .

The antineuropathic medications (antidepressants and anticonvulsants) are disappointing and have low success rate, also have multiple drawbacks , specifically excessive sedation that affects daily life activities of those patients .

Radiofrequency has been used for interruption of the sympathetic chain to treat intractable pain in the sacral pelvic region or for management of visceral pain and on complex regional pain syndrome.

Radiofrequency has the advantage over surgical resection , in that it is more selective and may cause fewer complications.

Thoracic sympathectomy has been done for many painful conditions that includes complex regional pain syndrome , neuropathic pain of upper limb and it has been done for vasospastic diseases such as Raynaud's phenomenon it offers the benefit over stellate ganglion block as it blocks the Kuntz fibers that connect to the brachial plexus roots without passing through stellate ganglion .

Eligibility criteria: Inclusion Criteria:

* Patients with chronic post-mastectomy pain for at least 6 month post-operative
* Patients with VAS ≥ 5
* Patients on pregabalin dose ≥ 150 mg daily
* Patients treated with more than one line of anti-neuropathic drugs \[e.g. pregabalin+(tricyclic antidepressants or selective serotonin reuptake inhibitors ) or pregabalin+ tramadole\]
* Lymphedema of the upper limb

Exclusion Criteria:

* Patient refusal
* Coagulopathy
* Chest and back deformity hindering procedure impossible
* Infection at the introduction site of the needle

Primary outcomes:
measure: The intensity of pain
timeFrame: up to 3 months after the procedure
Secondary outcomes:
measure: The changes in analgesics consumption
timeFrame: 1 month, 2 month and 3 month post-procedure
measure: The changes in mid-arm circumference
timeFrame: 1 month post- procedure
measure: The changes in post-menopausal hot flashes if it was a pre-procedure complaint
timeFrame: 3 month post- procedure
Other outcomes:
Locations:
city: Assiut
country: Egypt
facility: Madona Misheal Boshra Noman
Study officials:
affiliation: Assiut University
name: Essam E Abd El Hakem, MD
role: STUDY_DIRECTOR
affiliation: Assiut University
name: Ashraf A Mohamed, MD
role: STUDY_DIRECTOR
affiliation: Assiut University
name: Diab F Hetta, MD
role: STUDY_DIRECTOR
References:
citation: Smith WC, Bourne D, Squair J, Phillips DO, Chambers WA. A retrospective cohort study of post mastectomy pain syndrome. Pain. 1999 Oct;83(1):91-5. doi: 10.1016/s0304-3959(99)00076-7.
citation: H. Hoseinzade, A. Mahmoodpoor, D. Agamohammadi, and S. Sanaie, "Comparing the effect of stellate ganglion block and gabapentin on the post mastectomy pain syndrome," Rawal Medical Journal, vol. 33, no. 1, pp. 21-24, 2008.
citation: Andersen KG, Kehlet H. Persistent pain after breast cancer treatment: a critical review of risk factors and strategies for prevention. J Pain. 2011 Jul;12(7):725-46. doi: 10.1016/j.jpain.2010.12.005. Epub 2011 Mar 24.
citation: Jung BF, Ahrendt GM, Oaklander AL, Dworkin RH. Neuropathic pain following breast cancer surgery: proposed classification and research update. Pain. 2003 Jul;104(1-2):1-13. doi: 10.1016/s0304-3959(03)00241-0. No abstract available.
citation: Gartner R, Jensen MB, Nielsen J, Ewertz M, Kroman N, Kehlet H. Prevalence of and factors associated with persistent pain following breast cancer surgery. JAMA. 2009 Nov 11;302(18):1985-92. doi: 10.1001/jama.2009.1568.
citation: Steegers MA, Wolters B, Evers AW, Strobbe L, Wilder-Smith OH. Effect of axillary lymph node dissection on prevalence and intensity of chronic and phantom pain after breast cancer surgery. J Pain. 2008 Sep;9(9):813-22. doi: 10.1016/j.jpain.2008.04.001. Epub 2008 Jun 30.
citation: Carpenter JS, Andrykowski MA, Sloan P, Cunningham L, Cordova MJ, Studts JL, McGrath PC, Sloan D, Kenady DE. Postmastectomy/postlumpectomy pain in breast cancer survivors. J Clin Epidemiol. 1998 Dec;51(12):1285-92. doi: 10.1016/s0895-4356(98)00121-8.
citation: Cohen SP, Sireci A, Wu CL, Larkin TM, Williams KA, Hurley RW. Pulsed radiofrequency of the dorsal root ganglia is superior to pharmacotherapy or pulsed radiofrequency of the intercostal nerves in the treatment of chronic postsurgical thoracic pain. Pain Physician. 2006 Jul;9(3):227-35.
citation: Cahana A, Van Zundert J, Macrea L, van Kleef M, Sluijter M. Pulsed radiofrequency: current clinical and biological literature available. Pain Med. 2006 Sep-Oct;7(5):411-23. doi: 10.1111/j.1526-4637.2006.00148.x.
citation: Guo L, Kubat NJ, Nelson TR, Isenberg RA. Meta-analysis of clinical efficacy of pulsed radio frequency energy treatment. Ann Surg. 2012 Mar;255(3):457-67. doi: 10.1097/SLA.0b013e3182447b5d.