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

Sickle Cell Disease Clinical Trial

— 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.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05632289
• Other study ID #: COPAixMarseille
• Status: Recruiting
• Phase: N/A
• Start date: November 2022
• Est. completion date: January 2026

Study information

• Verified date: November 2022
• Source: College Osteopathique de Provence Aix-Marseille
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 37
• Est. completion date: January 2026
• Est. primary completion date: November 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Anemia, Sickle Cell
• Sickle Cell Disease

Intervention

Other:
• osteopathic manipulative therapy
osteopathic manipulative therapy : manuel therapy
• sham osteopathic manipulative therapy
placebo of osteopathic treatment

Locations

Country	Name	City	State
France	Collège Ostéopathique de Provence Aix-Marseille	Marseille	Paca

Sponsors (2)

Lead Sponsor	Collaborator
College Osteopathique de Provence Aix-Marseille	University Hospital, Marseille

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The consumption of nonopioid and weak opioid analgesics	Analgesic consumption will be assessed by weekly self-questionnaire	3 month
Secondary	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
Secondary	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