FibromyalgiaNCT05228990
Pilot Study of Warm Acupuncture in Treatment of Cold-sensitive Fibromyalgia Syndrome
A study testing warm acupunctrue in people with Fibromyalgia, run by Guang'anmen Hospital of China Academy of Chinese Medical Sciences at 1 site in China.
Trial summary
Non-pharmaceutical therapies, such as acupuncture, hydrotherapy, and meditative exercises (such as Qigong (including Tai Chi and Ba-Duan-Jin), have been shown to reduce pain and improve physical function. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Fibromyalgia
- What is being tested?
- warm acupunctrue
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 38 participants
- Where
- 1 siteChina
- Study dates
- 14 Feb 2022to 31 Dec 2023
- 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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Meet the 1990 American College of Rheumatology (ACR) Research Classification Criteria for fibromyalgia;
- Be over 18 years of age;
- The type and dose of drugs used for fibromyalgia should be stable for at least 2 weeks;
- The VAS score of item 10 (sensitivity to cold) in FIQR scale ≧4 points;
- Sign informed consent.
Who cannot join
- Patients suffering from systemic or local acute infectious diseases;
- Patients with severe visceral diseases or physical weakness who cannot tolerate acupuncture treatment;
- Pregnant women.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Clinical Study on Efficacy and Safety of Warm Acupuncture in Treatment of Cold-sensitive Fibromyalgia Syndrome
Non-pharmaceutical therapies, such as acupuncture, hydrotherapy, and meditative exercises (such as Qigong (including Tai Chi and Ba-Duan-Jin), have been shown to reduce pain and improve physical function. The management recommendations of fibromyalgia issued by the European Union, Canada, Germany and Israel have all affirmed the "first-line" role of Non-pharmaceutical therapy. Because of its good efficacy and safety, acupuncture therapy has been recommended in the management guidelines and has broad application prospects. Warm acupuncture is a therapy combining acupuncture and moxibustion, which is widely used in the treatment of various painful diseases in China, especially for cold-sensitive patients . This study aims to observe the safety and effectiveness of warm acupuncture in the treatment of cold-sensitive fibromyalgia patients, in order to provide a more alternative non-drug therapy for this particular type of patients with fibromyalgia .
- Conditions
- Fibromyalgia
- Being tested
- warm acupunctrue
- Keywords
- Fibromyalgia, cold-sensitive, needle warming moxibustion, randomized controlled trial, warm acupunctrue
- Medical subject headings
- Fibromyalgia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
warm acupunctrueDevice
Also called warm needling method, needle warming moxibustion, acupuncture with warmed needle
The sterile acupuncture needle (0.3mm×40mm) is taken, and the acupuncture needle is vertically inserted into the corresponding depth of the acupoint. After the needle is transported to "get qi", moxibustion will be added at acupoints. The moxibustion distance is about 3cm from the skin, and the local temperature is warm and the patient felt comfortable with the skin. Replace it after burning out. During the acupuncture treatment, in order to avoid burns, it is necessary to strictly control the distance between moxibustion and skin. In the supine position, cardboard should be placed between moxibustion and skin to prevent burns, and ashes should be removed after moxibustion is completely burned. The needle is left for 20 minutes.
| Study group | Role | What they receive |
|---|---|---|
| Warm acupuncture - observation group | Experimental | Sequence A: Participants will receive warm acupuncture for 20 minutes twice a week for eight weeks.
Sequence B: Patients will be observed without any intervention for eight weeks. Receives: Device: warm acupunctrue |
| Observation - warm acupuncture group | Experimental | Sequence A: Patients will be observed without any intervention for eight weeks. Sequence B: Participants will receive warm acupuncture for 20 minutes twice a week for eight weeks. Receives: Device: warm acupunctrue |
What is being measured
The primary outcome is the main question the study is designed to answer.
The change of the VAS score for item 10 (susceptibility to cold) of the modified fibromyalgia Impact Questionnaire from baseline.
range from 0 to 10 cm with higher score indicating more sensitive to cold.
Measured: Baseline, week4, week8, week12, week16
Secondary outcomes (10)
The change of the revised Fibromyalgia Impact Questionnaire (FIQR) from baseline
A self-administered questionnaire with 10 subscales, measuring fibromyalgia symptoms and function domains. FIQR total score ranges from 0 to 100, with higher scores indicating more severe symptoms.
Measured: Baseline, week4, week8, week12, week16
The change of the Visual Analogue Scale (VAS) for pain from baseline.
Pain VAS, range, 0 to 10 cm, where higher scores indicated the perceived pain to be more severe.
Measured: Baseline, week4, week8, week12, week16
The change of the Multidimensional Fatigue Inventory-20 (MFI-20) from baseline.
The Multidimensional Fatigue Inventory-20 (MFI-20) measures fatigue severity. The MFI-20 total score ranges from 0 to 80, with higher scores indicate more severe fatigue.
Measured: Baseline, week4, week8, week12, week16
The change of the Perceived Stress Scale (PSS) from baseline.
The Perceived Stress Scale (PSS) is for measuring the perception of stress and The Perceived Stress Scale (PSS) is for measuring the perception of stress and current levels of experienced stress. Scores range from 0 to 56, with higher total score indicating a greater degree of symptom severity
Measured: Baseline, week4, week8, week12, week16
The change of the Hamilton Anxiety Scale（HAMA） from baseline.
he Hamilton Anxiety Scale is used to assess the severity of anxiety symptoms and consists of 14 items, with higher scores indicating greater anxiety
Measured: Baseline, week4, week8, week12, week16
The change of the Beck II Depression Inventory (BDI) from baseline.
The Beck II Depression Inventory (BDI) assesses the severity of depressive symptoms. Scores range from 0 to 39, with higher scores indicate a greater degree of depression severity.
Measured: Baseline, week4, week8, week12, week16
The change of the Short Form-36 Health Status Questionnaire (SF-36) from baseline.
The Short Form-36 Health Status Questionnaire (SF-36), which measured health-related quality of life (range, 0 to 100, with higher scores indicating better perceived health status
Measured: Baseline, week4, week8, week12, week16
The change of the Minimum Mental State Examination(MMSE) from baseline.
The Minimum Mental State Examination(MMSE) scores range from 0 to 30, with higher scores indicating better cognitive function
Measured: Baseline, week4, week8, week12, week16
The change of the Pittsburgh Sleep Quality Index (PSQI) from baseline.
Scores on the Pittsburgh Sleep Quality Index (PSQI) range from 0 to 21, with higher scores indicating worse sleep quality.
Measured: Baseline, week4, week8, week12, week16
Global Impression of Change (PGIC) questionnaire evaluated at week 16.
A questionnaire determine any change in overall symptom status from the beginning of the study to its conclusion (score range, 1 [very much improved] to 7 [very much worse).
Measured: week16
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2022
- Study start14 Feb 2022
- Primary completion30 Nov 2023
- Study completion31 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for FibromyalgiaStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- Guang'anmen Hospital of China Academy of Chinese Medical Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Juan Jiao, Guang'anmen Hospital of China Academy of Chinese Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05228990
- Sponsor's protocol ID
- CI2021A015
- Status last verified
- Feb 2024
- First submitted
- 25 Jan 2022
- Last updated
- 21 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Study on Efficacy and Safety of Warm Acupuncture in Treatment of Cold-sensitive Fibromyalgia Syndrome
- ClinicalTrials.gov ID
- NCT05228990
- Acronym / sponsor ID
- CI2021A015
- Conditions
- Fibromyalgia
- Keywords
- Fibromyalgia, cold-sensitive, needle warming moxibustion, randomized controlled trial, warm acupunctrue
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 38 participants (actual)
- Lead sponsor
- Guang'anmen Hospital of China Academy of Chinese Medical SciencesUniversity, hospital or other
- Study start
- 14 Feb 2022 (actual)
- Primary completion
- 30 Nov 2023 (actual)
- Study completion
- 31 Dec 2023 (actual)
- First posted
- 8 Feb 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.
Non-pharmaceutical therapies, such as acupuncture, hydrotherapy, and meditative exercises (such as Qigong (including Tai Chi and Ba-Duan-Jin), have been shown to reduce pain and improve physical function. The management recommendations of fibromyalgia issued by the European Union, Canada, Germany and Israel have all affirmed the "first-line" role of Non-pharmaceutical therapy. Because of its good efficacy and safety, acupuncture therapy has been recommended in the management guidelines and has broad application prospects. Warm acupuncture is a therapy combining acupuncture and moxibustion, which is widely used in the treatment of various painful diseases in China, especially for cold-sensitive patients . This study aims to observe the safety and effectiveness of warm acupuncture in the treatment of cold-sensitive fibromyalgia patients, in order to provide a more alternative non-drug therapy for this particular type of patients with fibromyalgia .
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Warm acupuncture - observation group | Experimental | Device: warm acupunctrueSequence A: Participants will receive warm acupuncture for 20 minutes twice a week for eight weeks. Sequence B: Patients will be observed without any intervention for eight weeks. |
| Observation - warm acupuncture group | Experimental | Device: warm acupunctrueSequence A: Patients will be observed without any intervention for eight weeks. Sequence B: Participants will receive warm acupuncture for 20 minutes twice a week for eight weeks. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Meet the 1990 American College of Rheumatology (ACR) Research Classification Criteria for fibromyalgia;
- Be over 18 years of age;
- The type and dose of drugs used for fibromyalgia should be stable for at least 2 weeks;
- The VAS score of item 10 (sensitivity to cold) in FIQR scale ≧4 points;
- Sign informed consent.
Key exclusion criteria (3 listed)
- Patients suffering from systemic or local acute infectious diseases;
- Patients with severe visceral diseases or physical weakness who cannot tolerate acupuncture treatment;
- Pregnant women.
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 |
|---|---|---|
| warm acupunctrueAlso: warm needling method, needle warming moxibustion, acupuncture with warmed needleThe sterile acupuncture needle (0.3mm×40mm) is taken, and the acupuncture needle is vertically inserted into the corresponding depth of the acupoint. After the needle is transported to "get qi", moxibustion will be added at acupoints. The moxibustion distance is about 3cm from the skin, and the local temperature is warm and the patient felt comfortable with the skin. Replace it after burning out. During the acupuncture treatment, in order to avoid burns, it is necessary to strictly control the distance between moxibustion and skin. In the supine position, cardboard should be placed between moxibustion and skin to prevent burns, and ashes should be removed after moxibustion is completely burned. The needle is left for 20 minutes. | Device | Observation - warm acupuncture group, Warm acupuncture - observation group |
Primary outcome
The change of the VAS score for item 10 (susceptibility to cold) of the modified fibromyalgia Impact Questionnaire from baseline.
Time frame: Baseline, week4, week8, week12, week16
range from 0 to 10 cm with higher score indicating more sensitive to cold.
10 secondary outcomes
The change of the revised Fibromyalgia Impact Questionnaire (FIQR) from baseline
Time frame: Baseline, week4, week8, week12, week16
The change of the Visual Analogue Scale (VAS) for pain from baseline.
Time frame: Baseline, week4, week8, week12, week16
The change of the Multidimensional Fatigue Inventory-20 (MFI-20) from baseline.
Time frame: Baseline, week4, week8, week12, week16
The change of the Perceived Stress Scale (PSS) from baseline.
Time frame: Baseline, week4, week8, week12, week16
The change of the Hamilton Anxiety Scale（HAMA） from baseline.
Time frame: Baseline, week4, week8, week12, week16
The change of the Beck II Depression Inventory (BDI) from baseline.
Time frame: Baseline, week4, week8, week12, week16
The change of the Short Form-36 Health Status Questionnaire (SF-36) from baseline.
Time frame: Baseline, week4, week8, week12, week16
The change of the Minimum Mental State Examination(MMSE) from baseline.
Time frame: Baseline, week4, week8, week12, week16
The change of the Pittsburgh Sleep Quality Index (PSQI) from baseline.
Time frame: Baseline, week4, week8, week12, week16
Global Impression of Change (PGIC) questionnaire evaluated at week 16.
Time frame: week16
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 Oct 2024.
- Individual participant dataSharing planned: No
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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 study testing warm acupunctrue in people with Fibromyalgia, run by Guang'anmen Hospital of China Academy of Chinese Medical Sciences at 1 site in China.
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 3 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 Oct 2024. 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 China. 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.
What does the primary outcome measure?
The change of the VAS score for item 10 (susceptibility to cold) of the modified fibromyalgia Impact Questionnaire from baseline. (time frame: Baseline, week4, week8, week12, week16). 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 21 Oct 2024.