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Comparative Evaluation of Osteopathy Treatment Efficacy in Pain Support After Breast Surgery in Oncology (OSTEOPATHIE)

Primary Purpose

Breast Cancer

Status
Terminated
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
OSTEOPATHY + conventional analgesic treatments
Conventional analgesic treatments
Sponsored by
Centre Leon Berard
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Breast Cancer focused on measuring Osteopathy, Breast cancer, Pain

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  • woman >= 18 years
  • pain (median VAS >=3 on the week prior to inclusion)
  • mastectomy or tumorectomy with axillary dissection <= 12 months
  • PS <=2
  • able to write, understand and read French
  • signed informed consent

Exclusion Criteria:

  • no pain
  • immediate breast reconstruction
  • history of cognitive or psychiatric troubles

Sites / Locations

  • Centre Leon Berard

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

osteopathy + conventional analgesic treatments

conventional analgesic treatments

Arm Description

Outcomes

Primary Outcome Measures

Efficacy of the osteopathy treatment on pain
Pain is assessed by means of visual analogic scale (from 0 to 10 points). A decrease of 2 points after 3 months is expected.

Secondary Outcome Measures

Full Information

First Posted
July 21, 2011
Last Updated
June 26, 2015
Sponsor
Centre Leon Berard
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1. Study Identification

Unique Protocol Identification Number
NCT01403168
Brief Title
Comparative Evaluation of Osteopathy Treatment Efficacy in Pain Support After Breast Surgery in Oncology
Acronym
OSTEOPATHIE
Official Title
Comparative Evaluation of Osteopathy Treatment Efficacy in Pain Support After Breast Surgery in Oncology
Study Type
Interventional

2. Study Status

Record Verification Date
June 2015
Overall Recruitment Status
Terminated
Why Stopped
Recruitment difficulties
Study Start Date
April 2011 (undefined)
Primary Completion Date
April 2014 (Actual)
Study Completion Date
April 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Leon Berard

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
This is an open, prospective, controlled, randomized, comparative study with 2 arms. The purpose of the study is to assess the efficacy of osteopathy after breast surgery. 80 patients will be enrolled, 40 per arm. Patients will be randomized at inclusion and will be followed during one year.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer
Keywords
Osteopathy, Breast cancer, Pain

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
28 (Actual)

8. Arms, Groups, and Interventions

Arm Title
osteopathy + conventional analgesic treatments
Arm Type
Experimental
Arm Title
conventional analgesic treatments
Arm Type
Placebo Comparator
Intervention Type
Other
Intervention Name(s)
OSTEOPATHY + conventional analgesic treatments
Intervention Description
5 sessions for osteopathy are planned and will start in the 15 days following the enrollment. The conventional analgesic treatments will be administered in the 15 days following the enrollment.
Intervention Type
Other
Intervention Name(s)
Conventional analgesic treatments
Intervention Description
These treatments will be administered in the 15 days following the enrollment. Dose and frequence will depend on patients.
Primary Outcome Measure Information:
Title
Efficacy of the osteopathy treatment on pain
Description
Pain is assessed by means of visual analogic scale (from 0 to 10 points). A decrease of 2 points after 3 months is expected.
Time Frame
3 months

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: woman >= 18 years pain (median VAS >=3 on the week prior to inclusion) mastectomy or tumorectomy with axillary dissection <= 12 months PS <=2 able to write, understand and read French signed informed consent Exclusion Criteria: no pain immediate breast reconstruction history of cognitive or psychiatric troubles
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gisele CHVETZOFF, MD
Organizational Affiliation
Centre Leon Berard
Official's Role
Principal Investigator
Facility Information:
Facility Name
Centre Leon Berard
City
LYON Cedex 08
ZIP/Postal Code
69373
Country
France

12. IPD Sharing Statement

Citations:
PubMed Identifier
12351281
Citation
Fassoulaki A, Patris K, Sarantopoulos C, Hogan Q. The analgesic effect of gabapentin and mexiletine after breast surgery for cancer. Anesth Analg. 2002 Oct;95(4):985-91, table of contents. doi: 10.1097/00000539-200210000-00036.
Results Reference
background
PubMed Identifier
1637663
Citation
Ivens D, Hoe AL, Podd TJ, Hamilton CR, Taylor I, Royle GT. Assessment of morbidity from complete axillary dissection. Br J Cancer. 1992 Jul;66(1):136-8. doi: 10.1038/bjc.1992.230.
Results Reference
background
PubMed Identifier
12855309
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.
Results Reference
background
PubMed Identifier
17371770
Citation
Labreze L, Dixmerias-Iskandar F, Monnin D, Bussieres E, Delahaye E, Bernard D, Lakdja F. [Postmastectomy pain syndrome evidence based guidelines and decision trees]. Bull Cancer. 2007 Mar;94(3):275-85. French.
Results Reference
background
PubMed Identifier
12218520
Citation
Dirks J, Fredensborg BB, Christensen D, Fomsgaard JS, Flyger H, Dahl JB. A randomized study of the effects of single-dose gabapentin versus placebo on postoperative pain and morphine consumption after mastectomy. Anesthesiology. 2002 Sep;97(3):560-4. doi: 10.1097/00000542-200209000-00007.
Results Reference
background
PubMed Identifier
8740607
Citation
Eija K, Tiina T, J NP. Amitriptyline effectively relieves neuropathic pain following treatment of breast cancer. Pain. 1996 Feb;64(2):293-302. doi: 10.1016/0304-3959(95)00138-7.
Results Reference
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PubMed Identifier
17038030
Citation
Attal N, Cruccu G, Haanpaa M, Hansson P, Jensen TS, Nurmikko T, Sampaio C, Sindrup S, Wiffen P; EFNS Task Force. EFNS guidelines on pharmacological treatment of neuropathic pain. Eur J Neurol. 2006 Nov;13(11):1153-69. doi: 10.1111/j.1468-1331.2006.01511.x.
Results Reference
background
PubMed Identifier
8838907
Citation
Vick DA, McKay C, Zengerle CR. The safety of manipulative treatment: review of the literature from 1925 to 1993. J Am Osteopath Assoc. 1996 Feb;96(2):113-5. doi: 10.7556/jaoa.1996.96.2.113.
Results Reference
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PubMed Identifier
12041633
Citation
Ernst E. Manipulation of the cervical spine: a systematic review of case reports of serious adverse events, 1995-2001. Med J Aust. 2002 Apr 15;176(8):376-80. doi: 10.5694/j.1326-5377.2002.tb04459.x.
Results Reference
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PubMed Identifier
12532139
Citation
Licht PB, Christensen HW, Hoilund-Carlsen PF. Is cervical spinal manipulation dangerous? J Manipulative Physiol Ther. 2003 Jan;26(1):48-52. doi: 10.1067/mmt.2003.42.
Results Reference
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PubMed Identifier
10541511
Citation
Vickers A, Zollman C. ABC of complementary medicine. The manipulative therapies: osteopathy and chiropractic. BMJ. 1999 Oct 30;319(7218):1176-9. doi: 10.1136/bmj.319.7218.1176. No abstract available.
Results Reference
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PubMed Identifier
15083985
Citation
Noll DR, Degenhardt BF, Stuart M, McGovern R, Matteson M. Effectiveness of a sham protocol and adverse effects in a clinical trial of osteopathic manipulative treatment in nursing home patients. J Am Osteopath Assoc. 2004 Mar;104(3):107-13. No abstract available.
Results Reference
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PubMed Identifier
17122030
Citation
Hayes NM, Bezilla TA. Incidence of iatrogenesis associated with osteopathic manipulative treatment of pediatric patients. J Am Osteopath Assoc. 2006 Oct;106(10):605-8.
Results Reference
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Comparative Evaluation of Osteopathy Treatment Efficacy in Pain Support After Breast Surgery in Oncology

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