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Osteopathic Manipulation in the Management of Pain Associated With Sickel Cell Disease (OSTEODREP)

Primary Purpose

Sickle Cell Disease

Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
osteopathic manipulative therapy
sham osteopathic manipulative therapy
Sponsored by
College Osteopathique de Provence Aix-Marseille
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Sickle Cell Disease focused on measuring osteopathic manipulative treatment, sickle cell disease

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: patients with major sickle cell syndrome Suffering from acute or chronic pain Aged over 18 and legally responsible The informed consent of the patients will be collected Exclusion Criteria: Pregnant or breastfeeding women Patients who underwent surgery in the 6 months prior to inclusion Patients with known medical contraindications to osteopathic manipulations: vertebral compression, severe osteoporosis, progressive osteonecrosis and not treated with a prosthesis Patients with acute stroke Patients with cerebral arteriovenous malformation or cerebral aneurysm Patients participating in another interventional clinical research protocol

Sites / Locations

  • Collège Ostéopathique de Provence Aix-MarseilleRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

osteopathic treatment

sham of osteopathic treatment

Arm Description

Outcomes

Primary Outcome Measures

The consumption of nonopioid and weak opioid analgesics
Analgesic consumption will be assessed by weekly self-questionnaire

Secondary Outcome Measures

pain assessement
Pain assessment will be performed using the Visual Analog Scale score. The visual analog scale (VAS) is a validated, subjective measure for acute and chronic pain. Scores are recorded by making a handwritten mark on a 10-cm line that represents a continuum between "no pain" and "worst pain."
Perceived stress assessment
The degree of stress will be measured using the Perceived Stress Scale (PSS). The Perceived Stress Scale (PSS-10) is a 10-item questionnaire originally developed by Cohen et al. (1983) widely used to assess stress levels in young people and adults aged 12 and above. It is a measure of the degree to which situations in one's life are appraised as stressful. Items were designed to tap how unpredictable, uncontrollable, and overloaded respondents find their lives.

Full Information

First Posted
October 28, 2022
Last Updated
November 18, 2022
Sponsor
College Osteopathique de Provence Aix-Marseille
Collaborators
University Hospital, Marseille
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1. Study Identification

Unique Protocol Identification Number
NCT05632289
Brief Title
Osteopathic Manipulation in the Management of Pain Associated With Sickel Cell Disease
Acronym
OSTEODREP
Official Title
Effects of Osteopathic Treatment in Combination With Usual Care in the Management of Pain Associated With Sickle Cell Disease: A Randomized Controlled Trial.
Study Type
Interventional

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Recruiting
Study Start Date
November 2022 (Anticipated)
Primary Completion Date
November 2024 (Anticipated)
Study Completion Date
January 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
College Osteopathique de Provence Aix-Marseille
Collaborators
University Hospital, Marseille

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Background: Sickle cell disease is the most common monogenic disease in the world caused by a mutation in the β-globin gene which creates abnormal hemoglobin called HbS. This polymer deforms the erythrocyte, making it more fragile and less flexible, thus leading to the occlusion of small blood vessels. This obstruction is the cause of painful vaso-occlusive crises and ischemia-reperfusion phenomena. Patients with sickle cell disease undergo major acute and chronic pain responsible for a significant deterioration in their quality of life and a significant consumption of analgesics, often daily, sometimes with the development of addictive behavior. Improved analgesic management was associated with improved disease prognosis. Several studies have shown the effectiveness of the osteopathic approach in the management of chronic pain. Our hypothesis is that the association with the standard treatment of osteopathy sessions could improve but also prevent the chronic pain frequent in patients with sickle cell disease. Objectives: Our main objective is to study the effectiveness of an osteopathic treatment in adult sickle cell patients with chronic pain on the reduction of the consumption of level I and II analgesics at 3 months (D90 +/- 15 days). Methods/Experimental design: This is a single-blind prospective randomized controlled monocentric study. The study population will be composed of 37 sickle cell patients aged over 18 years. The patients included will be allocated into two groups: one group will receive the osteopathic treatment and the 2nd group will receive the "placebo" treatment. Analgesic consumption will be assessed by weekly self- questionnaire. The evaluation of the pain will be carried out by the visual analogue scale (VAS). The degree of stress will be measured using the Perceived Stress Scale (PSS). Patients will receive an osteopathic treatment or a "placebo" treatment, one session every 4 weeks for 12 weeks with a total of 3 sessions per patient. The duration of each session is 45 minutes. Pain and stress assessments will be done before each session. A final evaluation will be carried out 3 months after the end of the osteopathic or "placebo" treatment. Data analysis will be performed using SPSS version 17.0 software. The significance threshold will be set at 0.05. This is the first protocol that aims to evaluate, with scientific rigor, the impact of the osteopathic approach in the management of pain in patients with sickle cell disease.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sickle Cell Disease
Keywords
osteopathic manipulative treatment, sickle cell disease

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
37 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
osteopathic treatment
Arm Type
Experimental
Arm Title
sham of osteopathic treatment
Arm Type
Sham Comparator
Intervention Type
Other
Intervention Name(s)
osteopathic manipulative therapy
Intervention Description
osteopathic manipulative therapy : manuel therapy
Intervention Type
Other
Intervention Name(s)
sham osteopathic manipulative therapy
Intervention Description
placebo of osteopathic treatment
Primary Outcome Measure Information:
Title
The consumption of nonopioid and weak opioid analgesics
Description
Analgesic consumption will be assessed by weekly self-questionnaire
Time Frame
3 month
Secondary Outcome Measure Information:
Title
pain assessement
Description
Pain assessment will be performed using the Visual Analog Scale score. The visual analog scale (VAS) is a validated, subjective measure for acute and chronic pain. Scores are recorded by making a handwritten mark on a 10-cm line that represents a continuum between "no pain" and "worst pain."
Time Frame
3 month
Title
Perceived stress assessment
Description
The degree of stress will be measured using the Perceived Stress Scale (PSS). The Perceived Stress Scale (PSS-10) is a 10-item questionnaire originally developed by Cohen et al. (1983) widely used to assess stress levels in young people and adults aged 12 and above. It is a measure of the degree to which situations in one's life are appraised as stressful. Items were designed to tap how unpredictable, uncontrollable, and overloaded respondents find their lives.
Time Frame
3 month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: patients with major sickle cell syndrome Suffering from acute or chronic pain Aged over 18 and legally responsible The informed consent of the patients will be collected Exclusion Criteria: Pregnant or breastfeeding women Patients who underwent surgery in the 6 months prior to inclusion Patients with known medical contraindications to osteopathic manipulations: vertebral compression, severe osteoporosis, progressive osteonecrosis and not treated with a prosthesis Patients with acute stroke Patients with cerebral arteriovenous malformation or cerebral aneurysm Patients participating in another interventional clinical research protocol
Facility Information:
Facility Name
Collège Ostéopathique de Provence Aix-Marseille
City
Marseille
State/Province
Paca
ZIP/Postal Code
13001
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Imane Agouti
Phone
033 4 91 38 47 97
Email
imane.agouti@ap-hm.fr
First Name & Middle Initial & Last Name & Degree
Nicolas Bricot
Phone
+33 6 19 02 33 26
Email
nicolas.bricot@cop-osteopathie.fr
First Name & Middle Initial & Last Name & Degree
Estelle Jean-Mignard, MD

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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Osteopathic Manipulation in the Management of Pain Associated With Sickel Cell Disease

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