NCT01403168

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
28

participants targeted

Target at below P25 for not_applicable breast-cancer

Timeline
Completed

Started Apr 2011

Typical duration for not_applicable breast-cancer

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2011

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

July 21, 2011

Completed
6 days until next milestone

First Posted

Study publicly available on registry

July 27, 2011

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2014

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2015

Completed
Last Updated

June 29, 2015

Status Verified

June 1, 2015

Enrollment Period

3 years

First QC Date

July 21, 2011

Last Update Submit

June 26, 2015

Conditions

Breast Cancer

Keywords

OsteopathyBreast cancerPain

Outcome Measures

Primary Outcomes (1)

  • 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.

    3 months

Study Arms (2)

osteopathy + conventional analgesic treatments

EXPERIMENTAL
Other: OSTEOPATHY + conventional analgesic treatments

conventional analgesic treatments

PLACEBO COMPARATOR
Other: Conventional analgesic treatments

Interventions

OSTEOPATHY + conventional analgesic treatmentsOTHER

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.

osteopathy + conventional analgesic treatments
Conventional analgesic treatmentsOTHER

These treatments will be administered in the 15 days following the enrollment. Dose and frequence will depend on patients.

conventional analgesic treatments

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • woman \>= 18 years
  • mastectomy or tumorectomy with axillary dissection \<= 12 months
  • PS \<=2
  • able to write, understand and read French
  • signed informed consent

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centre Leon Berard

Lyon, 69373, France

Location

Related Publications (13)

  • 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.

    PMID: 12351281BACKGROUND

  • 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.

    PMID: 1637663BACKGROUND

  • 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.

    PMID: 12855309BACKGROUND

  • 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.

    PMID: 17371770BACKGROUND

  • 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.

    PMID: 12218520BACKGROUND

  • 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.

    PMID: 8740607BACKGROUND

  • 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.

    PMID: 17038030BACKGROUND

  • 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.

    PMID: 8838907BACKGROUND

  • 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.

    PMID: 12041633BACKGROUND

  • 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.

    PMID: 12532139BACKGROUND

  • 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.

    PMID: 10541511BACKGROUND

  • 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.

    PMID: 15083985BACKGROUND

  • 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.

    PMID: 17122030BACKGROUND

MeSH Terms

Conditions

Breast NeoplasmsPain

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue DiseasesNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Gisele CHVETZOFF, MD

    Centre Leon Berard

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 21, 2011

First Posted

July 27, 2011

Study Start

April 1, 2011

Primary Completion

April 1, 2014

Study Completion

April 1, 2015

Last Updated

June 29, 2015

Record last verified: 2015-06

Locations

FR(1)