PainNCT00369902
The Effect of Acupuncture Treatment on the Perception of Pain and Coping With Pain
An observational study of Pain, run by Sheba Medical Center at 1 site in Israel.
Trial summary
The Purpose of this study is to evaluate whether cognitive and emotional components take part in the positive acupuncture effect on pain. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pain
- What is being tested?
- acupuncture
- Type of treatment
- Surgery or procedure
- How many people
- 41 participants
- Where
- 1 siteIsrael
- Study dates
- May 2006to May 2007
- Phase
- Observational
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 41 consequtive patients with chronic musculosckeletal pain
Who may be able to join
- patients suffering from pain,who are reffered for acupuncture treatment,and consented to participate in this study
Who cannot join
- children under 18 years of age
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Pilot Study on the Effect of Acupuncture Treatment on Pain Perception and on the Ability to Cope With Pain
The Purpose of this study is to evaluate whether cognitive and emotional components take part in the positive acupuncture effect on pain.
Read the detailed description
The effect of acupuncture on pain intensity has been already investigated and confirmed. Recent publication (Pariente J., et a., 2005) indicated that acupuncture may affect midbrain areas, that are associated with cognitive control of pain.
The Pain Self Regulation Model (Levental, 1980)distinguishes between emotional response pain representations and cognitive pain representations. According to this model, emotional and cognitive pain representations leads to a new (cognitive or emotional) evaluation of the pain, that affects its perception and the ability to cope with it (Levental at al., 2001).
This study will try to assess the hypothesis that acupuncture treatment is involved in this process.
The study is designed as pilot study, limited to 45 patients.
- Conditions
- Pain
- Being tested
- acupuncture
- Keywords
- pain, acupuncture
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
acupunctureProcedure or surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Aug 2006 (estimated)
- Study startMay 2006
- Study completionMay 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PainStudies of the same condition, open and under way.
- More trials run by Sheba Medical CenterThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 41 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sheba Medical Center
- Sponsor type
- Other government
- Collaborators
- Assaf-Harofeh Medical Center
- Investigators
- Dorit Gamus, M.D., Ph.D., Principal investigator, Sheba Hospital, Tel Hashomer, ISRAEL
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00369902
- Sponsor's protocol ID
- SHEBA-05-3817-OG-CTIL
- Status last verified
- Jul 2009
- First submitted
- 29 Aug 2006
- Last updated
- 21 Jul 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Jul 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study on the Effect of Acupuncture Treatment on Pain Perception and on the Ability to Cope With Pain
- ClinicalTrials.gov ID
- NCT00369902
- Acronym / sponsor ID
- SHEBA-05-3817-OG-CTIL
- Conditions
- Pain
- Keywords
- pain, acupuncture
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 41 participants (actual)
- Lead sponsor
- Sheba Medical CenterOther government
- Collaborators
- Assaf-Harofeh Medical Center
- Study start
- May 2006
- Study completion
- May 2007 (actual)
- First posted
- 30 Aug 2006 (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.
The Purpose of this study is to evaluate whether cognitive and emotional components take part in the positive acupuncture effect on pain.
Detailed description
The effect of acupuncture on pain intensity has been already investigated and confirmed. Recent publication (Pariente J., et a., 2005) indicated that acupuncture may affect midbrain areas, that are associated with cognitive control of pain.
The Pain Self Regulation Model (Levental, 1980)distinguishes between emotional response pain representations and cognitive pain representations. According to this model, emotional and cognitive pain representations leads to a new (cognitive or emotional) evaluation of the pain, that affects its perception and the ability to cope with it (Levental at al., 2001).
This study will try to assess the hypothesis that acupuncture treatment is involved in this process.
The study is designed as pilot study, limited to 45 patients.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 41 consequtive patients with chronic musculosckeletal pain
Key inclusion criteria (1 listed)
- patients suffering from pain,who are reffered for acupuncture treatment,and consented to participate in this study
Key exclusion criteria (1 listed)
- children under 18 years of age
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 |
|---|---|---|
| acupuncture | Procedure or surgery | – |
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 21 Jul 2009.
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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.
Dorit Gamus, M.D., Ph.D. principal investigator
Sheba Hospital, Tel Hashomer, ISRAEL
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pain, run by Sheba Medical Center at 1 site in Israel.
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 1 inclusion and 1 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: finished, as of the sponsor's last update on 21 Jul 2009. 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 Israel. 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.
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?
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 21 Jul 2009.