Ignite Creation Date:
2024-05-06 @ 2:26 PM
Last Modification Date:
2024-10-26 @ 1:31 PM
Study NCT ID:
NCT04319510
Status:
RECRUITING
Last Update Posted:
2023-11-22
First Post:
2020-03-20
Brief Title:
Supportive Effects of Craniosacral Therapy for Female Patients With Breast Cancer and Their Partners
Sponsor:
Universität Duisburg-Essen
Organization:
Universität Duisburg-Essen
Study Overview
Official Title:
Supportive Effects of Craniosacral Therapy for Female Patients With Breast Cancer and Their Partners a Randomized Controlled Trial
Status:
RECRUITING
Status Verified Date:
2023-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
CRANIO4US
Brief Summary:
Craniosacral Therapy CST is a non-manipulative very gentle manual treatment method that aims to release restrictions of the fasciae and regulate the arousal of the sympathetic nervous system which is often increased in chronically ill patients Initial randomized trials support CSTs efficacy and effectiveness in reducing symptoms of patients with psychosomatic and chronic pain disorders To date there is no trial investigating the effectiveness of CST as a supportive strategy for enhancing cancer-related quality of life in women with breast cancer In clinical practice therapists also report alleviating as well as regulating effects of simple CST self-help techniques offered to patients within a group concept
Within the recent study a CST treatment and self-help protocol for women after curative therapy of breast cancer was developed and shall be tested against a waiting list control group The first group will receive 24 units of CST treatment in a 11 setting with a certified craniosacral therapist over 12 weeks The second group will receive 24 units of group training in CST self-help techniques offered by a certified craniosacral therapist over 12 weeks They will be reassessed after 12 and 26 weeks 6 months after randomization The third group will wait for 26 weeks and will receive no specific study intervention After 26 weeks patients of the third group were offered to take part in two individual CST interventions and the CST self-help training For all groups treatment as usual is allowed
Within the recent study a CST treatment and self-help protocol for women after curative therapy of breast cancer was developed and shall be tested against a waiting list control group The first group will receive 24 units of CST treatment in a 11 setting with a certified craniosacral therapist over 12 weeks The second group will receive 24 units of group training in CST self-help techniques offered by a certified craniosacral therapist over 12 weeks They will be reassessed after 12 and 26 weeks 6 months after randomization The third group will wait for 26 weeks and will receive no specific study intervention After 26 weeks patients of the third group were offered to take part in two individual CST interventions and the CST self-help training For all groups treatment as usual is allowed
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None