Sickle Cell DiseaseOSTEODREPNCT05632289
Osteopathic Manipulation in the Management of Pain Associated With Sickel Cell Disease
A study testing osteopathic manipulative therapy in people with Sickle Cell Disease, run by College Osteopathique de Provence Aix-Marseille at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Sickle Cell Disease
- What is being tested?
- osteopathic manipulative therapy
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 37 participants
- Where
- 1 siteFrance
- Study dates
- Nov 2022to Jan 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Collège Ostéopathique de Provence Aix-Marseille
Marseille, PACA, 13001
Imane Agouti, 033 4 91 38 47 97, imane.agouti@ap-hm.fr
Nicolas Bricot, +33 6 19 02 33 26, nicolas.bricot@cop-osteopathie.fr
About this study
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.
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.
Read more
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.
- Conditions
- Sickle Cell Disease
- Being tested
- osteopathic manipulative therapy, sham osteopathic manipulative therapy
- Keywords
- osteopathic manipulative treatment, sickle cell disease
- Medical subject headings
- Anemia, Sickle Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
osteopathic manipulative therapyOther
osteopathic manipulative therapy : manuel therapy
sham osteopathic manipulative therapyOther
placebo of osteopathic treatment
| Study group | Role | What they receive |
|---|---|---|
| osteopathic treatment | Experimental | Not described Receives: Other: osteopathic manipulative therapy |
| sham of osteopathic treatment | Sham comparator | Not described Receives: Other: sham osteopathic manipulative therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
The consumption of nonopioid and weak opioid analgesics
Analgesic consumption will be assessed by weekly self-questionnaire
Measured: 3 month
Secondary outcomes (2)
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."
Measured: 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.
Measured: 3 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Nov 2022
- Study startNov 2022 (estimated)
- Primary completionNov 2024 (estimated)
- Study completionJan 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sickle Cell DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 37 participants (estimated)
Sponsor and investigators
- Lead sponsor
- College Osteopathique de Provence Aix-Marseille
- Sponsor type
- University, hospital or other
- Collaborators
- University Hospital, Marseille
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05632289
- Sponsor's protocol ID
- COPAixMarseille
- Acronym
- OSTEODREP
- Status last verified
- Nov 2022
- First submitted
- 28 Oct 2022
- Last updated
- 30 Nov 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 30 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT05632289
- Acronym / sponsor ID
- OSTEODREP / COPAixMarseille
- Conditions
- Sickle Cell Disease
- Keywords
- osteopathic manipulative treatment, sickle cell disease
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 37 participants (estimated)
- Lead sponsor
- College Osteopathique de Provence Aix-MarseilleUniversity, hospital or other
- Collaborators
- University Hospital, Marseille
- Study start
- Nov 2022 (estimated)
- Primary completion
- Nov 2024 (estimated)
- Study completion
- Jan 2026 (estimated)
- First posted
- 30 Nov 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| osteopathic treatment | Experimental | Other: osteopathic manipulative therapy |
| sham of osteopathic treatment | Sham comparator | Other: sham osteopathic manipulative therapy |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| osteopathic manipulative therapyosteopathic manipulative therapy : manuel therapy | Other | osteopathic treatment |
| sham osteopathic manipulative therapyplacebo of osteopathic treatment | Other | sham of osteopathic treatment |
Primary outcome
The consumption of nonopioid and weak opioid analgesics
Time frame: 3 month
Analgesic consumption will be assessed by weekly self-questionnaire
2 secondary outcomes
pain assessement
Time frame: 3 month
Perceived stress assessment
Time frame: 3 month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Nov 2022.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Collège Ostéopathique de Provence Aix-Marseille
Marseille, France
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing osteopathic manipulative therapy in people with Sickle Cell Disease, run by College Osteopathique de Provence Aix-Marseille at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 30 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The consumption of nonopioid and weak opioid analgesics (time frame: 3 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Nov 2022.