Chronic Fatigue Syndrome.Phase 2/3AV/ASNCT01907711
Clinical Trial to Evaluate the Effectiveness of Acupuncture as a Treatment in Patients Diagnosed With CFS.
A Phase 2/3 study testing Acupuncture. in people with Chronic Fatigue Syndrome. and Muscular Diseases., run by Hospital Vall d'Hebron at 2 sites in Spain.
Trial summary
background: The Chronic Fatigue Syndrome (CFS) presents many disturbances multidimensional affect holistically to people who have the disease and current management of fatigue, pain, anxiety, depression and sleep disturbances present in this clinical entity is unsatisfactory. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Chronic Fatigue Syndrome., Muscular Diseases., Cognitive Impairment
- What is being tested?
- Acupuncture.
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 2 sitesSpain
- Study dates
- Feb 2013to Oct 2014
- Phase
- Phase 2/3
- 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 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients must meet each of the following criteria for admission to the study:
- Patients of both sexes.
- Aged between 18 and 70 years.
- Patients diagnosed as having chronic fatigue syndrome according to the diagnostic criteria Fukuda.
- Patients who have previously given their informed consent for participation in the study.
Who cannot join
- -Patients who have had prior treatment with acupuncture.
- Pregnant or lactating.
- Women of childbearing potential not using an effective contraceptive method according to medical criteria.
- Terminal clinical condition.
- History of allergy and / or hypersensitivity to the acupuncture needles.
- Patients who are on anticoagulant therapy.
Show all 11Show fewer
- Use of investigational agents or not registered in the 30 days prior to study entry.
- Patients who are participating in another clinical trial of the same or different nature in the last 30 days prior to inclusion.
- Any individual who, in the opinion of the investigator, may not be able to follow instructions or make a good filling of the therapeutic regimen.
- Subjects who do not grant written consent to participate in the study.
- Labor litigation for reasons of participation in the clinical trial of CFS.
Trial locations and contacts
2 sites in 1 country.
Jimenez C Gutierrez, Nurse contact
Alegre J Martín, Doctor contact
Spain2 sites, 2 recruiting
- Recruiting
HValldhebron
Barcelona, Barcelona, 08035
Jiménez C Gutiérrez, Nurse, conxitajg@gmail.com
Alegre J Martín, Doctor, 18502jam@gmail.com
- Recruiting
HValldhebron
Barcelona, Barcelona, 08035
Jimenez C Gutierrez, Nurse, conxitajg@gmail.com
Alegre J Martin, Doctor
About this study
Official title: Clinical Trial, Randomized, Controlled, Parallel, to Evaluate the Effectiveness of Acupuncture as a Treatment in Patients Diagnosed With Chronic Fatigue Syndrome.
background: The Chronic Fatigue Syndrome (CFS) presents many disturbances multidimensional affect holistically to people who have the disease and current management of fatigue, pain, anxiety, depression and sleep disturbances present in this clinical entity is unsatisfactory.
Hypothesis:
Read more
The hypothesis of this essay is to contrast that acupuncture is more useful than placebo.
The investigators suggest the use of a clinical study protocol (PEC), randomized, placebo-controlled, acupuncture technique, aimed at increasing the patient's sense of well-being, relief of pain and stiffness, acupuncture is effective to reduce fatigue, anxiety, depression and sleep disorders in patients diagnosed with CFS.
Read the detailed description
Headline Goal.
Evaluate the effectiveness of true acupuncture (AV) compared to placebo-acupuncture or sham acupuncture (AS) in improving symptoms of patients diagnosed with CFS.
Specific objectives:
- To assess whether, in patients diagnosed with Chronic Fatigue Syndrome, AV treatment, compared to AS, is associated with a reduction in fatigue as measured by the scale FIS (Fatigue impact Scale).
- Check the reduction of pain in patients diagnosed with CFS, following treatment with AS versus AV as measured by the McGill.
- To verify the decrease in the use of analgesics in patients diagnosed with CFS, after treatment with the AV versus AS, by counting these drugs.
- Evaluate reducing anxiety in patients diagnosed with CFS, following treatment with AS AV against measured by HAD scale.
- Assess whether, in patients diagnosed with CFS, treatment with AV compared to AS, is associated with a reduction in depressive symptoms, as measured by the HAD scale.
- To assess the improvement in sleep quality in patients diagnosed with CFS, after treatment with AV compared to the AS, as measured by the Pittsburgh scale.
- Check the quality improvement of health-related life (HRQOL) in patients diagnosed with CFS, after treatment with AV compared to the AS, as measured by the SF-36 (Short Form-36).
Methodology.
Design.
Pilot clinical trial randomized, parallel group, placebo-controlled simulated acupuncture, single-center, prospective, patient and assessor blind. 1:1 randomized trial, the principal investigator unknown randomization to the time the patient is randomized.
Primary endpoint. Scores on the fatigue impact scale (FIS) after treatment with two acupuncture techniques.
Study population and total number of patients. After signing the informed consent, we included 60 patients diagnosed with CFS, 30 in the intervention group (IG) of real acupuncture and 30 in the control group (CG) of sham acupuncture, applying an individualized treatment plan customized according energy assessment of each patient.
Duration of treatment. 4 months.
Relevance.
This pilot study can demonstrate the effectiveness of acupuncture as a treatment for the symptoms of CFS. The reduction in fatigue, anxiety, depression, pain and reduction in the intake of analgesics with improved sleep quality, after treatment with real acupuncture technique, i results in increased quality of life for the patient suffering from CFS.
Inclusion criteria.
- Patients must meet each of the following criteria for admission to the study:
- Patients of both sexes.
- Aged between 18 and 70 years.
- Patients diagnosed as having chronic fatigue syndrome according to the diagnostic criteria Fukuda.
- Patients who have previously given their informed consent for participation in the study.
Exclusion criteria.
- Patients who have had prior treatment with acupuncture.
- Pregnant or lactating.
- Women of childbearing potential not using an effective contraceptive method according to medical criteria.
- Terminal clinical condition.
- History of allergy and / or hypersensitivity to the acupuncture needles.
- Patients who are on anticoagulant therapy.
- Use of investigational agents not registered in the 30 days prior to study entry.
- Patients who are participating in another clinical trial of the same or different nature in the last 30 days prior to inclusion.
- Any individual who, in the opinion of the investigator, may not be able to follow instructions or make a good filling of the therapeutic regimen.
- Subjects who do not grant written consent to participate in the study.
- Labor litigation for reasons of participation in the clinical trial of CFS.
- Conditions
- Chronic Fatigue Syndrome., Muscular Diseases., Cognitive Impairment, Sleep Disturbances, Pain.
- Being tested
- Acupuncture.
- Keywords
- Acupuncture., Fatigue syndrome chronic., Sleep disturbances., Pain., Cognitive impairment.
- Medical subject headings
- Fatigue Syndrome, Chronic, Muscular Diseases, Cognitive Dysfunction, Parasomnias, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Acupuncture.Device
Also called Assurance in manufacturing. EN ISO9001., Registration No.: 60007186 DD 0001., Notified under No 0197 to the EC Commission.
Who tried the insertion and manipulation between 8 - 12 needles with guide applied at different points of the body, individually selected and customized, after the insertion, the acupoint stimulation is done through manipulation of de needle sleeve to achieve at each point the sensation known as "De Qi".
| Study group | Role | What they receive |
|---|---|---|
| Sham Acupuncture. | Sham comparator | That through the center of the guide tube is inserted blunt rod, producing the sensation of a prick in each of the eight points that are not acupuncture points. No intervention is a completely inert as it involves some type of peripheral stimulus, but the technique is closer to a placebo and offers interesting option from a methodologic al point of view showing and ability to mimic real acupuncture The points are not used acupuncture points but are fictional points. The patient should remáis lying prone during the 20 minutes of the session, so the placebo technique remains hidden. Every five minutes the acupuncturist will repeat the action in the corresponding eigh points. Receives: Device: Acupuncture. |
| True acupuncture | Active comparator | The AV is an energy balance treatment with the aim of restoring health and well-being of the patient. Since each patient may have moré than three diagnoses of Traditional Chinese Medicine, will undertake a Major effort of synthesis of acupuncture points for treatment in a session, use the AV 8 - 12 needles, are held in place for 20 minutes with bidirectional rotation of the sleeve needle for one minute every five minutes (a total of four rotations for session). And in the AS 8 tube rod guides with blunt tip for 20 minutes. The same time be devoted to the patients in each treatment group similar, the time requested for the period of pre and post-treatment will be identical in all cases. Receives: Device: Acupuncture. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fatigue, asses the scale fatigue FÍS. • Fatigue: Scores on the fatigue impact scale (FIS) after treatment with two acupuncture techniques
first visit,13 visit, 6 months and 1 year
Measured: one year
Secondary outcomes (4)
• Pain scale (McGill) (MPQ)
first visit, 13th visit, 6 months and one year
Measured: one year
Sleep quality (Pittsburgh) scale (PSQI)
first visit, 13th visit, 6 months and one year
Measured: one year
Quality of life scale (ST-36)
first visit, 13th visit, 6 months and one year
Measured: one year
Anxiety and depression scale HAD.
first visit, 13th visit, 6 months and one year
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jul 2013 (estimated)
- Study startFeb 2013
- Primary completionJan 2014 (estimated)
- Study completionOct 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Chronic Fatigue Syndrome.Studies 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 2/3
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospital Vall d'Hebron
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Conchita Jimenez Gutierrez, Hospital Vall d'Hebron
- Investigators
- Jimenez Gutierrez, Nurse, Principal investigator, Hospital Vall d'Hebron
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01907711
- Sponsor's protocol ID
- AV/AS
- Other IDs
- COIB. PR - 2725/12
- Acronym
- AV/AS
- Status last verified
- Aug 2013
- First submitted
- 27 Jun 2013
- Last updated
- 29 Aug 2013
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Vas J, Mendez C, Perea-Milla E. Acupuncture vs Streitberger needle in knee osteoarthritis - an RCT. BMJ 2004;329:1216-219. Vas J, Modesto M, Aguilar I, Santos-Rey K, Benitez- Parejo N, Rivas-Ruiz F: Effects of acupuncture on patients with fibromyalgia: study protocol of a multicentre randomized controlled trial. Trials 2011;12:59. Wang T, Zhan Q, Xue X, Yeung A. A systematic review of acunpunture and Moxibustion treatment for chronic fatigue syndrome in China. Am J Chin Med 2008;36:1-24. Wang JJ, Song YJ, Wu ZC, Chu XO, Wang XH, Wang XJ, et al. A meta analysis on randomized controlled trials of acupuncture treatment of chronic fatigue syndrome. Zhen Ci Yan Jiu 2009;34:421-8.
Study at a glance
From the registry record, last updated by the sponsor on 29 Aug 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Trial, Randomized, Controlled, Parallel, to Evaluate the Effectiveness of Acupuncture as a Treatment in Patients Diagnosed With Chronic Fatigue Syndrome.
- ClinicalTrials.gov ID
- NCT01907711
- Acronym / sponsor ID
- AV/AS / AV/AS
- Conditions
- Chronic Fatigue Syndrome., Muscular Diseases., Cognitive Impairment, Sleep Disturbances, Pain.
- Keywords
- Acupuncture., Fatigue syndrome chronic., Sleep disturbances., Pain., Cognitive impairment.
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Hospital Vall d'HebronUniversity, hospital or other
- Study start
- Feb 2013
- Primary completion
- Jan 2014 (estimated)
- Study completion
- Oct 2014 (estimated)
- First posted
- 25 Jul 2013 (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.
background: The Chronic Fatigue Syndrome (CFS) presents many disturbances multidimensional affect holistically to people who have the disease and current management of fatigue, pain, anxiety, depression and sleep disturbances present in this clinical entity is unsatisfactory.
Hypothesis:
The hypothesis of this essay is to contrast that acupuncture is more useful than placebo.
The investigators suggest the use of a clinical study protocol (PEC), randomized, placebo-controlled, acupuncture technique, aimed at increasing the patient's sense of well-being, relief of pain and stiffness, acupuncture is effective to reduce fatigue, anxiety, depression and sleep disorders in patients diagnosed with CFS.
Detailed description
Headline Goal.
Evaluate the effectiveness of true acupuncture (AV) compared to placebo-acupuncture or sham acupuncture (AS) in improving symptoms of patients diagnosed with CFS.
Specific objectives:
- To assess whether, in patients diagnosed with Chronic Fatigue Syndrome, AV treatment, compared to AS, is associated with a reduction in fatigue as measured by the scale FIS (Fatigue impact Scale).
- Check the reduction of pain in patients diagnosed with CFS, following treatment with AS versus AV as measured by the McGill.
- To verify the decrease in the use of analgesics in patients diagnosed with CFS, after treatment with the AV versus AS, by counting these drugs.
- Evaluate reducing anxiety in patients diagnosed with CFS, following treatment with AS AV against measured by HAD scale.
- Assess whether, in patients diagnosed with CFS, treatment with AV compared to AS, is associated with a reduction in depressive symptoms, as measured by the HAD scale.
- To assess the improvement in sleep quality in patients diagnosed with CFS, after treatment with AV compared to the AS, as measured by the Pittsburgh scale.
- Check the quality improvement of health-related life (HRQOL) in patients diagnosed with CFS, after treatment with AV compared to the AS, as measured by the SF-36 (Short Form-36).
Methodology.
Design.
Pilot clinical trial randomized, parallel group, placebo-controlled simulated acupuncture, single-center, prospective, patient and assessor blind. 1:1 randomized trial, the principal investigator unknown randomization to the time the patient is randomized.
Primary endpoint. Scores on the fatigue impact scale (FIS) after treatment with two acupuncture techniques.
Study population and total number of patients. After signing the informed consent, we included 60 patients diagnosed with CFS, 30 in the intervention group (IG) of real acupuncture and 30 in the control group (CG) of sham acupuncture, applying an individualized treatment plan customized according energy assessment of each patient.
Duration of treatment. 4 months.
Relevance.
This pilot study can demonstrate the effectiveness of acupuncture as a treatment for the symptoms of CFS. The reduction in fatigue, anxiety, depression, pain and reduction in the intake of analgesics with improved sleep quality, after treatment with real acupuncture technique, i results in increased quality of life for the patient suffering from CFS.
Inclusion criteria.
- Patients must meet each of the following criteria for admission to the study:
- Patients of both sexes.
- Aged between 18 and 70 years.
- Patients diagnosed as having chronic fatigue syndrome according to the diagnostic criteria Fukuda.
- Patients who have previously given their informed consent for participation in the study.
Exclusion criteria.
- Patients who have had prior treatment with acupuncture.
- Pregnant or lactating.
- Women of childbearing potential not using an effective contraceptive method according to medical criteria.
- Terminal clinical condition.
- History of allergy and / or hypersensitivity to the acupuncture needles.
- Patients who are on anticoagulant therapy.
- Use of investigational agents not registered in the 30 days prior to study entry.
- Patients who are participating in another clinical trial of the same or different nature in the last 30 days prior to inclusion.
- Any individual who, in the opinion of the investigator, may not be able to follow instructions or make a good filling of the therapeutic regimen.
- Subjects who do not grant written consent to participate in the study.
- Labor litigation for reasons of participation in the clinical trial of CFS.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sham Acupuncture. | Sham comparator | Device: Acupuncture.That through the center of the guide tube is inserted blunt rod, producing the sensation of a prick in each of the eight points that are not acupuncture points. No intervention is a completely inert as it involves some type of peripheral stimulus, but the technique is closer to a placebo and offers interesting option from a methodologic al point of view showing and ability to mimic real acupuncture The points are not used acupuncture points but are fictional points. The patient should remáis lying prone during the 20 minutes of the session, so the placebo technique remains hidden. Every five minutes the acupuncturist will repeat the action in the corresponding eigh points. |
| True acupuncture | Active comparator | Device: Acupuncture.The AV is an energy balance treatment with the aim of restoring health and well-being of the patient. Since each patient may have moré than three diagnoses of Traditional Chinese Medicine, will undertake a Major effort of synthesis of acupuncture points for treatment in a session, use the AV 8 - 12 needles, are held in place for 20 minutes with bidirectional rotation of the sleeve needle for one minute every five minutes (a total of four rotations for session). And in the AS 8 tube rod guides with blunt tip for 20 minutes. The same time be devoted to the patients in each treatment group similar, the time requested for the period of pre and post-treatment will be identical in all cases. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients must meet each of the following criteria for admission to the study:
- Patients of both sexes.
- Aged between 18 and 70 years.
- Patients diagnosed as having chronic fatigue syndrome according to the diagnostic criteria Fukuda.
- Patients who have previously given their informed consent for participation in the study.
Key exclusion criteria (11 listed)
- -Patients who have had prior treatment with acupuncture.
- Pregnant or lactating.
- Women of childbearing potential not using an effective contraceptive method according to medical criteria.
- Terminal clinical condition.
- History of allergy and / or hypersensitivity to the acupuncture needles.
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.Also: Assurance in manufacturing. EN ISO9001., Registration No.: 60007186 DD 0001., Notified under No 0197 to the EC Commission.Who tried the insertion and manipulation between 8 - 12 needles with guide applied at different points of the body, individually selected and customized, after the insertion, the acupoint stimulation is done through manipulation of de needle sleeve to achieve at each point the sensation known as "De Qi". | Device | Sham Acupuncture., True acupuncture |
Primary outcome
Fatigue, asses the scale fatigue FÍS. • Fatigue: Scores on the fatigue impact scale (FIS) after treatment with two acupuncture techniques
Time frame: one year
first visit,13 visit, 6 months and 1 year
4 secondary outcomes
• Pain scale (McGill) (MPQ)
Time frame: one year
Sleep quality (Pittsburgh) scale (PSQI)
Time frame: one year
Quality of life scale (ST-36)
Time frame: one year
Anxiety and depression scale HAD.
Time frame: one year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Aug 2013.
- Results publicationVas J, Mendez C, Perea-Milla E. Acupuncture vs Streitberger needle in knee osteoarthritis - an RCT. BMJ 2004;329:1216-219. Vas J, Modesto M, Aguilar I, Santos-Rey K, Benitez- Parejo N, Rivas-Ruiz F: Effects of acupuncture on patients with fibromyalgia: study protocol of a multicentre randomized controlled trial. Trials 2011;12:59. Wang T, Zhan Q, Xue X, Yeung A. A systematic review of acunpunture and Moxibustion treatment for chronic fatigue syndrome in China. Am J Chin Med 2008;36:1-24. Wang JJ, Song YJ, Wu ZC, Chu XO, Wang XH, Wang XJ, et al. A meta analysis on randomized controlled trials of acupuncture treatment of chronic fatigue syndrome. Zhen Ci Yan Jiu 2009;34:421-8.
- Valle Hebrón institut de recerca.org. Barcelona. Spain.Link provided by the sponsor.
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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.
Jimenez C Gutierrez, Nurse contact
Alegre J Martín, Doctor contact
Jimenez Gutierrez, Nurse principal investigator
Hospital Vall d'Hebron
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Acupuncture. in people with Chronic Fatigue Syndrome. and Muscular Diseases., run by Hospital Vall d'Hebron at 2 sites in Spain.
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 5 inclusion and 11 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 29 Aug 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Spain. 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.
What does this combined 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.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Contact Jimenez C Gutierrez, Nurse (conxitajg@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fatigue, asses the scale fatigue FÍS. • Fatigue: Scores on the fatigue impact scale (FIS) after treatment with two acupuncture techniques (time frame: one year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01907711, which also lists 1 linked publication.
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 29 Aug 2013.