Post-Mastectomy Chronic Pain SyndromeNCT03494426
Radiofrequency Thoracic Sympathectomy for Chronic Postmastectomy Pain; Randomized Placebo Controlled Study
A study testing radiofrequency thoracic sympathectomy and pregabalin ,tramadol,and tricyclic antidepressants in people with Post-Mastectomy Chronic Pain Syndrome, run by Assiut University at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Post-Mastectomy Chronic Pain Syndrome
- What is being tested?
- radiofrequency thoracic sympathectomy and pregabalin ,tramadol,and tricyclic antidepressants
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Apr 2018to 1 Jan 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Patient refusal
- Coagulopathy
- Chest and back deformity hindering procedure impossible
- Infection at the introduction site of the needle
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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 .
- Conditions
- Post-Mastectomy Chronic Pain Syndrome
- Being tested
- radiofrequency thoracic sympathectomy, pregabalin ,tramadol,and tricyclic antidepressants
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
radiofrequency thoracic sympathectomyProcedure or surgery
Under fluoroscopic guidance thoracic sympathectomy will be done as follow
- antroposterior view of upper thoracic vertebrae ,cephalo-caudal adjustment of C - arm until aliment of endplates of T2 and T3
- oblique view 20 degree under tunnel view RF 10cm 20G 1mm active tip needle is introduced intimately related to vertebral margin
- the depth of the needle will be determined under lateral fluoroscopic view the needle is advanced step by step hugging the lateral vertebra l margin until the tip of the needle situated at the middle of the vertebral body . RF lesion 2min 80c will be done and needle is rotated 90 degree on both sides and another two lesions will be done at the end of the procedure 2ml of lidocaine and 20mg of triamcinolone will be injected at each level Post procedure analgesic protocol consisted of either increase or decrease, according to intensity of pain by 50 mg pregabalin and 50 mg tramadole and 25 mg tryptazole, individualized for each patient.
pregabalin ,tramadol,and tricyclic antidepressantsDrug
patient will receive anti neuropathic medications
| Study group | Role | What they receive |
|---|---|---|
| interventional group | Experimental | patients will receive Radiofrequency thoracic sympathectomy then will receive pregabalin ,tramadol,and tricyclic antidepressants Receives: Procedure: radiofrequency thoracic sympathectomy; Drug: pregabalin ,tramadol,and tricyclic antidepressants |
| control group | Active comparator | patients will receive pregabalin ,tramadol,and tricyclic antidepressants Receives: Drug: pregabalin ,tramadol,and tricyclic antidepressants |
What is being measured
The primary outcome is the main question the study is designed to answer.
The intensity of pain
The intensity of pain measured by visual analogue score
Measured: up to 3 months after the procedure
Secondary outcomes (3)
The changes in analgesics consumption
The changes in analgesics consumption
Measured: 1 month, 2 month and 3 month post-procedure
The changes in mid-arm circumference
The changes in mid-arm circumference
Measured: 1 month post- procedure
The changes in post-menopausal hot flashes if it was a pre-procedure complaint
The changes in post-menopausal hot flashes if it was a pre-procedure complaint
Measured: 3 month post- procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Apr 2018
- Study start1 Apr 2018
- Primary completion1 Jan 2020
- Study completion1 Jan 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Post-Mastectomy Chronic Pain SyndromeStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Madona M.NOMAN, Assiut University
- Investigators
- Essam E Abd El Hakem, MD, Study director, Assiut UniversityAshraf A Mohamed, MD, Study director, Assiut UniversityDiab F Hetta, MD, Study director, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03494426
- Sponsor's protocol ID
- thoracic sympathectomy
- Status last verified
- Jul 2019
- First submitted
- 4 Apr 2018
- Last updated
- 7 Jan 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 10506676H. 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.
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.
PubMed 21435953Jung 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.
PubMed 12855309Gartner 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.
PubMed 19903919Steegers 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.
PubMed 18585963Carpenter 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.
PubMed 10086821Cohen 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.
PubMed 16886031Cahana 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.
PubMed 17014600Guo 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.
PubMed 22301609
Study at a glance
From the registry record, last updated by the sponsor on 7 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Radiofrequency Thoracic Sympathectomy for Chronic Postmastectomy Pain; Randomized Placebo Controlled Study
- ClinicalTrials.gov ID
- NCT03494426
- Acronym / sponsor ID
- thoracic sympathectomy
- Conditions
- Post-Mastectomy Chronic Pain Syndrome
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Apr 2018 (actual)
- Primary completion
- 1 Jan 2020 (actual)
- Study completion
- 1 Jan 2020 (actual)
- First posted
- 11 Apr 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 .
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| interventional group | Experimental | Procedure: radiofrequency thoracic sympathectomy, Drug: pregabalin ,tramadol,and tricyclic antidepressantspatients will receive Radiofrequency thoracic sympathectomy then will receive pregabalin ,tramadol,and tricyclic antidepressants |
| control group | Active comparator | Drug: pregabalin ,tramadol,and tricyclic antidepressantspatients will receive pregabalin ,tramadol,and tricyclic antidepressants |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (4 listed)
- Patient refusal
- Coagulopathy
- Chest and back deformity hindering procedure impossible
- Infection at the introduction site of the needle
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| radiofrequency thoracic sympathectomyUnder fluoroscopic guidance thoracic sympathectomy will be done as follow 1. antroposterior view of upper thoracic vertebrae ,cephalo-caudal adjustment of C - arm until aliment of endplates of T2 and T3 2. oblique view 20 degree under tunnel view RF 10cm 20G 1mm active tip needle is introduced intimately related to vertebral margin 3. the depth of the needle will be determined under lateral fluoroscopic view the needle is advanced step by step hugging the lateral vertebra l margin until the tip of the needle situated at the middle of the vertebral body . RF lesion 2min 80c will be done and needle is rotated 90 degree on both sides and another two lesions will be done at the end of the procedure 2ml of lidocaine and 20mg of triamcinolone will be injected at each level Post procedure analgesic protocol consisted of either increase or decrease, according to intensity of pain by 50 mg pregabalin and 50 mg tramadole and 25 mg tryptazole, individualized for each patient. | Procedure or surgery | interventional group |
| pregabalin ,tramadol,and tricyclic antidepressantspatient will receive anti neuropathic medications | Drug | control group, interventional group |
Primary outcome
The intensity of pain
Time frame: up to 3 months after the procedure
The intensity of pain measured by visual analogue score
3 secondary outcomes
The changes in analgesics consumption
Time frame: 1 month, 2 month and 3 month post-procedure
The changes in mid-arm circumference
Time frame: 1 month post- procedure
The changes in post-menopausal hot flashes if it was a pre-procedure complaint
Time frame: 3 month post- procedure
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jan 2020.
- Background: PubMed 10506676Smith 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.
- BackgroundH. 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.
- Background: PubMed 21435953Andersen 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.
- Background: PubMed 12855309Jung 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.
- Background: PubMed 19903919Gartner 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.
- Background: PubMed 18585963Steegers 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.
- Background: PubMed 10086821Carpenter 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.
- Background: PubMed 16886031Cohen 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.
- Background: PubMed 17014600Cahana 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.
- Background: PubMed 22301609Guo 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Essam E Abd El Hakem, MD study director
Assiut University
Ashraf A Mohamed, MD study director
Assiut University
Diab F Hetta, MD study director
Assiut University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing radiofrequency thoracic sympathectomy and pregabalin ,tramadol,and tricyclic antidepressants in people with Post-Mastectomy Chronic Pain Syndrome, run by Assiut University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The intensity of pain (time frame: up to 3 months after the procedure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03494426, which also lists 10 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jan 2020; AzTrials last refreshed its copy on 8 Nov 2026.