Ehlers-Danlos SyndromePhase 2NCT00001966
Mind-Body Therapy for Pain in Ehlers-Danlos Syndrome
A Phase 2 study testing Mind-body therapy in people with Ehlers-Danlos Syndrome and Pain, run by National Human Genome Research Institute (NHGRI) at 1 site in United States.
Trial summary
This study will assess the effectiveness of mind-body therapy in relieving pain in patients with Ehlers-Danlos syndrome. This syndrome is a hereditary condition caused by a connective tissue defect and is often associated with chronic pain poorly controlled by medication or physical therapy. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Ehlers-Danlos Syndrome, Pain
- What is being tested?
- Mind-body therapy
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2000to Jan 2001
- Phase
- Phase 2
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Clinical diagnosis of classical or hypermobile EDS based on history and physical examination by a study investigator.
Subjectively suffer from chronic pain (defined as pain occurring at least weekly).
Must agree to not seek mind-body therapy or other similar interventions outside of this study during the time under investigation.
Able to give informed consent.
No minors (under 18 years of age).
Not currently using formal mind-body or similar therapy for treatment of chronic pain.
No major surgical procedure within 90 days or intending to undergo such a procedure during the time course of this study.
Not decisionally impaired subjects.
No previous diagnosis or hospitalization for a psychotic condition(s). Specifically, no history of illness involving altered perception of reality. Psychiatric diagnoses such as depression or anxiety will not exclude participation.
Trial locations and contacts
1 site in 1 country.
United States1 site
National Human Genome Research Institute (NHGRI)
Bethesda, Maryland, 20892
About this study
Official title: A Pilot Study of Mind-Body Therapy for Chronic Pain in Ehlers-Danlos Syndrome
This study will assess the effectiveness of mind-body therapy in relieving pain in patients with Ehlers-Danlos syndrome. This syndrome is a hereditary condition caused by a connective tissue defect and is often associated with chronic pain poorly controlled by medication or physical therapy. Mind-body therapy comprises various complementary or alternative medicine techniques such as meditation, guided imagery, stress management, and group psychotherapy.
Adult patients with Ehlers-Danlos syndrome who have chronic pain may be eligible for this 4 1/2 [Note: if the symbol is unreadable, it is four and one-half] to 5-month study. Patients not already enrolled in NHGRI's protocol 97-HG-0089 will undergo a history, physical examination, and brief interview before being accepted. Participants will attend 2-hour group sessions of mind-body therapy at NIH each week for at least 10 weeks. They will receive training in meditation, yoga breathing, guided imagery, and stress management in these sessions and will be asked to also practice the treatments at home each day. Patients may continue their regular medications and pain treatment with their private physicians during the course of the study.
Participants will fill out a packet of questionnaires about their pain, health, and quality of life at three intervals: when they enroll in the study, at the end of treatment, and 12 weeks after treatment ends. At these same time intervals, patients will come to NIH for a test of their physical ability to walk and climb stairs. Patients will keep a diary and pain symptoms and medications for 1 week before treatment begins and 1 week after it ends, and will fill out questionnaires about pain during the entire study period.
Read the detailed description
Ehlers-Danlos Syndrome (EDS) encompasses a spectrum of connective tissue diseases thought to result from defects in collagen formation. People with EDS are often affected by chronic, progressive pain poorly responsive to conventional treatment. We propose to investigate the efficacy of mind-body therapy for treatment of chronic pain in Ehlers-Danlos Syndrome. A cohort of adult subjects will be treated with mind-body therapy in a pilot study to assess the efficacy and acceptability of this treatment modality. The primary outcome measure will be change in pain as scored with a standardized inventory. We will also evaluate general health status, psychological variables, medication usage, and physical performance abilities.
- Conditions
- Ehlers-Danlos Syndrome, Pain
- Being tested
- Mind-body therapy
- Keywords
- Adjustment, Alternative, Anxiety, Guided-Imagery, Meditation, Ehlers-Danlos Syndrome
- Medical subject headings
- Ehlers-Danlos Syndrome, Pain, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mind-body therapyDrug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Dec 2002 (estimated)
- Study startJan 2000
- Study completionJan 2001
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Ehlers-Danlos SyndromeStudies 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 2
- Primary purpose
- Treatment
- Enrolment
- 40 participants
Sponsor and investigators
- Lead sponsor
- National Human Genome Research Institute (NHGRI)
- Sponsor type
- US National Institutes of Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00001966
- Sponsor's protocol ID
- 000054
- Other IDs
- 00-HG-0054
- Status last verified
- Jan 2000
- First submitted
- 18 Jan 2000
- Last updated
- 4 Mar 2008
- Results posted
- No
Publications
Ainsworth SR, Aulicino PL. A survey of patients with Ehlers-Danlos syndrome. Clin Orthop Relat Res. 1993 Jan;(286):250-6.
PubMed 8425354Beighton P, De Paepe A, Steinmann B, Tsipouras P, Wenstrup RJ. Ehlers-Danlos syndromes: revised nosology, Villefranche, 1997. Ehlers-Danlos National Foundation (USA) and Ehlers-Danlos Support Group (UK). Am J Med Genet. 1998 Apr 28;77(1):31-7. doi: 10.1002/(sici)1096-8628(19980428)77:13.0.co;2-o.
PubMed 9557891
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study of Mind-Body Therapy for Chronic Pain in Ehlers-Danlos Syndrome
- ClinicalTrials.gov ID
- NCT00001966
- Acronym / sponsor ID
- 000054
- Conditions
- Ehlers-Danlos Syndrome, Pain
- Keywords
- Adjustment, Alternative, Anxiety, Guided-Imagery, Meditation, Ehlers-Danlos Syndrome
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants
- Lead sponsor
- National Human Genome Research Institute (NHGRI)US National Institutes of Health
- Study start
- Jan 2000
- Study completion
- Jan 2001
- First posted
- 10 Dec 2002 (estimated)
- 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.
This study will assess the effectiveness of mind-body therapy in relieving pain in patients with Ehlers-Danlos syndrome. This syndrome is a hereditary condition caused by a connective tissue defect and is often associated with chronic pain poorly controlled by medication or physical therapy. Mind-body therapy comprises various complementary or alternative medicine techniques such as meditation, guided imagery, stress management, and group psychotherapy.
Adult patients with Ehlers-Danlos syndrome who have chronic pain may be eligible for this 4 1/2 [Note: if the symbol is unreadable, it is four and one-half] to 5-month study. Patients not already enrolled in NHGRI's protocol 97-HG-0089 will undergo a history, physical examination, and brief interview before being accepted. Participants will attend 2-hour group sessions of mind-body therapy at NIH each week for at least 10 weeks. They will receive training in meditation, yoga breathing, guided imagery, and stress management in these sessions and will be asked to also practice the treatments at home each day. Patients may continue their regular medications and pain treatment with their private physicians during the course of the study.
Participants will fill out a packet of questionnaires about their pain, health, and quality of life at three intervals: when they enroll in the study, at the end of treatment, and 12 weeks after treatment ends. At these same time intervals, patients will come to NIH for a test of their physical ability to walk and climb stairs. Patients will keep a diary and pain symptoms and medications for 1 week before treatment begins and 1 week after it ends, and will fill out questionnaires about pain during the entire study period.
Detailed description
Ehlers-Danlos Syndrome (EDS) encompasses a spectrum of connective tissue diseases thought to result from defects in collagen formation. People with EDS are often affected by chronic, progressive pain poorly responsive to conventional treatment. We propose to investigate the efficacy of mind-body therapy for treatment of chronic pain in Ehlers-Danlos Syndrome. A cohort of adult subjects will be treated with mind-body therapy in a pilot study to assess the efficacy and acceptability of this treatment modality. The primary outcome measure will be change in pain as scored with a standardized inventory. We will also evaluate general health status, psychological variables, medication usage, and physical performance abilities.
Study design
- Primary purpose
- Treatment
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
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 |
|---|---|---|
| Mind-body therapy | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Mar 2008.
- Background: PubMed 8425354Ainsworth SR, Aulicino PL. A survey of patients with Ehlers-Danlos syndrome. Clin Orthop Relat Res. 1993 Jan;(286):250-6.
- Background: PubMed 9557891Beighton P, De Paepe A, Steinmann B, Tsipouras P, Wenstrup RJ. Ehlers-Danlos syndromes: revised nosology, Villefranche, 1997. Ehlers-Danlos National Foundation (USA) and Ehlers-Danlos Support Group (UK). Am J Med Genet. 1998 Apr 28;77(1):31-7. doi: 10.1002/(sici)1096-8628(19980428)77:13.0.co;2-o.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Mind-body therapy in people with Ehlers-Danlos Syndrome and Pain, run by National Human Genome Research Institute (NHGRI) at 1 site in United States.
The full registered description is in the About this study section and the official record.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Mar 2008. 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 United States. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00001966, which also lists 2 linked publications.
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 4 Mar 2008.