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

Effects of Osteopathic Treatment in Combination With Usual Care in the Management of Pain Associated With Sickle Cell Disease: A Randomized Controlled Trial.

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.

Study Overview

• Status: Recruiting
• Conditions: Sickle Cell Disease
• Intervention / Treatment: Other: osteopathic manipulative therapy; Other: sham osteopathic manipulative therapy

• Study Type: Interventional
• Enrollment (Anticipated): 37
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Paca
    • Marseille, Paca, France, 13001
      • Recruiting
      • Collège Ostéopathique de Provence Aix-Marseille
      • Contact: Imane Agouti; Phone Number: 033 4 91 38 47 97; Email: imane.agouti@ap-hm.fr
      • Contact: Nicolas Bricot; Phone Number: +33 6 19 02 33 26; Email: nicolas.bricot@cop-osteopathie.fr
      • Principal Investigator: Estelle JEAN-MIGNARD, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 63 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: osteopathic treatment	Other: osteopathic manipulative therapy; osteopathic manipulative therapy : manuel therapy
Sham Comparator: sham of osteopathic treatment	Other: sham osteopathic manipulative therapy; placebo of osteopathic treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The consumption of nonopioid and weak opioid analgesics	Analgesic consumption will be assessed by weekly self-questionnaire	3 month

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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."	3 month
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.	3 month

Collaborators and Investigators

• Sponsor: College Osteopathique de Provence Aix-Marseille
• Collaborators: University Hospital, Marseille

Study record dates

Study Major Dates

• Study Start (Anticipated): November 1, 2022
• Primary Completion (Anticipated): November 1, 2024
• Study Completion (Anticipated): January 1, 2026

Study Registration Dates

• First Submitted: October 28, 2022
• First Submitted That Met QC Criteria: November 18, 2022
• First Posted (Actual): November 30, 2022

Study Record Updates

• Last Update Posted (Actual): November 30, 2022
• Last Update Submitted That Met QC Criteria: November 18, 2022
• Last Verified: November 1, 2022

More Information

Terms related to this study

• Keywords: sickle cell disease; osteopathic manipulative treatment
• Additional Relevant MeSH Terms: Hematologic Diseases; Genetic Diseases, Inborn; Anemia; Anemia, Hemolytic, Congenital; Anemia, Hemolytic; Hemoglobinopathies; Anemia, Sickle Cell
• Other Study ID Numbers: COPAixMarseille

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No