Chronic Tension-Type HeadacheNCT03133884
Acupuncture for Patients With Chronic Tension-type Headache
A study testing acupuncture and superficial acupuncture in people with Chronic Tension-Type Headache, run by Chengdu University of Traditional Chinese Medicine at 1 site in China.
Trial summary
Two hundred and eighteen patients with chronic tension-type headache(CTTH) will be randomly assigned to an experimental group (acupuncture) and a control group (superficial acupuncture) in a 1:1 ratio. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Chronic Tension-Type Headache
- What is being tested?
- acupuncture and superficial acupuncture
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 218 participants
- Where
- 1 siteChina
- Study dates
- Jun 2016to 10 Sep 2019
- 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
- Meeting the diagnostic criteria of CTTH in the international classification of headache disorders, 3rd edition (beta version) (ICHD-III beta);
- Aged 18-65 years;
- Having the ability of understanding and completing the headache dairy;
- Volunteering to this study and able to provide written informed consent.
Who cannot join
- Not suffering tension-type headache during the pervious 3 months;
- Taking any prophylactic headache medication during the previous one month;
- Headache due to organic disorders (e.g. subarachnoid hemorrhage, cerebral hemorrhage, cerebral embolism, cerebral thrombosis, vascular malformation, arthritis, hypertension, arteriosclerosis);
- Having serious diseases of the heart, liver, kidney or other organs;
- In pregnancy or lactation, or planning to be pregnant in 6 months;
- In unconsciousness, or having psychosis;
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- Having bleeding disorders or getting infectious;
- Unwilling to take parts in this study or with low compliance;
- Addicted to smoking, alcohol or drugs;
- Taking parts in other clinical studies at the same time.
Trial locations and contacts
1 site in 1 country.
China1 site
Chengdu University of Traditional Chinese Medicine
Chengdu, Sichuan, 610075
About this study
Official title: Acupuncture for Patients With Chronic Tension-type Headache : a Randomized Controlled Trial
Two hundred and eighteen patients with chronic tension-type headache(CTTH) will be randomly assigned to an experimental group (acupuncture) and a control group (superficial acupuncture) in a 1:1 ratio. Participants in both groups will receive 20 sessions of acupuncture over 8 weeks, and the same acupoints will be selected in acupuncture treatments.The study cycle will last 36 weeks, including a 4-week baseline period, a 8-week treatment period and a 24-week follow-up period. And the primary outcome will be measured at the end of 16th week. While, the secondary outcomes will be measured at the baseline, the 4th, 8th,12th,16th,20th,24th,28th and 32nd week after randomization.After each treatment, participants will finish the Massachusetts General Hospital (MGH) Acupuncture Sensation Scale (MASS) to evaluate deqi sensations.
Read the detailed description
This is a clinical randomized controlled trial (RCT). According to the pervious study, 218 patients, who meet the diagnostic criteria of CTTH in the international classification of headache disorders, 3rd edition (beta version) (ICHD-III beta), will be recruited in this study. And these participants will be randomly assigned to 2groups with acupuncture treatment or superficial acupuncture treatment through central randomization in a 1:1 ratio.
The total observation period will last 36 weeks, including a 4-week baseline period, a 8-week treatment period and a 24-week follow-up period. The central randomization will be performed after the baseline period, and participants will receive 20 sessions of intervention over 8 weeks ( 3 sessions per week in the first 4 weeks and 2 sessions per week in the following 4 weeks).
The same acupoints, named Fengchi (GB20), Taiyang (EX-HN5), Baihui (DU20), Hegu (LI4) and Taichong (LR3) on both sides, will be punctured by filiform needles. However, manipulation methods will be different. In acupuncture group, the needles will be inserted into the acupoints, of which the depths will be adjusted to the standard permissible layers.Then even reinforcing-reducing technique will be performed on the needles until achieving deqi sensation.The needles will be retained for 30 minutes in each session and manipulated twice every 10 minutes with intermittent stimulation. Each manipulation will last for 30 seconds. While, in superficial group, the selected acupoints will be punctured superficially by the depth of 1-3 mm, and the needles will be retained for 30 minutes without any manipulation.
Within 5 minutes after withdrawing needles of each session, participants in three acupuncture groups will finish the Massachusetts General Hospital (MGH) Acupuncture Sensation Scale (MASS).
Most of the curative outcomes will be collected from the headache dairy which is filled by participants. And the primary outcome will be measured at the end of 16th week. While, the secondary outcomes will be measured at the baseline, the 4th, 8th,12th,16th,20th,24th,28th and 32nd week after randomization.
- Conditions
- Chronic Tension-Type Headache
- Being tested
- acupuncture, superficial acupuncture
- Keywords
- chronic tension-type headache, acupuncture, Deqi
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
acupunctureOther
The needles will be inserted into the acupoints and the depths will be adjusted to the standard permissible layers, then even reinforcing-reducing technique will be performed on the needles until achieving deqi sensation.The needles will be retained for 30 minutes in each session and manipulated twice every 10 minutes with intermittent stimulation. Each manipulation will last for 30 seconds.
superficial acupunctureOther
The selected acupoints will be punctured superficially by the depth of 1-3 mm, and the needles will be retained for 30 minutes without any manipulation.
| Study group | Role | What they receive |
|---|---|---|
| Acupuncture | Experimental | The needles will be inserted into the acupoints and the depths will be adjusted to the standard permissible layers, then even reinforcing-reducing technique will be performed on the needles until achieving deqi sensation.The needles will be retained for 30 minutes in each session and manipulated twice every 10 minutes with intermittent stimulation. Each manipulation will last for 20 seconds. Receives: Other: acupuncture |
| Superficial acupuncture | Other | The selected acupoints will be punctured superficially by the depth of 1-3 mm, and the needles will be retained for 30 minutes without any manipulation. Receives: Other: superficial acupuncture |
What is being measured
The primary outcome is the main question the study is designed to answer.
Responder rate
The responder rate is defined as >50% reduction in the number of headache days per four week
Measured: 16 weeks after randomization
Secondary outcomes (7)
The number of days with headache
Measured: at baseline before randomization, 4, 8, 12, 16, 20, 24, 28 and 32 weeks after randomization
The mean pain intensity of tension-type headache during 4 weeks
Using a visual analogue scale from 0-10, 0 defined as no pain and 10 defined as an unbearable pain.
Measured: at baseline before randomization, 4, 8, 12, 16, 20, 24, 28 and 32 weeks after randomization
The rate of medication intake during 4 weeks
Measured: at baseline before randomization, 4, 8, 12, 16, 20, 24, 28 and 32 weeks after randomization
Evaluation of quality of life
The 36-item short from health survey (SF-36)
Measured: at baseline before randomization, 4, 8, 12, 16, 20, 24, 28 and 32 weeks after randomization
Evaluation of anxiety state
Hamilton anxiety scale (HAMA)
Measured: at baseline before randomization, 4, 8, 12, 16, 20, 24, 28 and 32 weeks after randomization
Evaluation of depression state
Hamilton depression scale (HAMD)
Measured: at baseline before randomization, 4, 8, 12, 16, 20, 24, 28 and 32 weeks after randomization
Evaluation of needling sensation
the Massachusetts General Hospital (MGH) Acupuncture Sensation Scale (MASS)
Measured: Within 5 minutes after withdrawing needles of each acupuncture session
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Apr 2017
- Study startJun 2016
- Primary completionJun 2019
- Study completion10 Sep 2019
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 Chronic Tension-Type HeadacheStudies 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
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 218 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chengdu University of Traditional Chinese Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ying Li, PhD, Study chair, Chengdu University of Traditional Chinese Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03133884
- Sponsor's protocol ID
- 2016HH0007
- Status last verified
- Sep 2019
- First submitted
- 22 Mar 2017
- Last updated
- 19 Sep 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Zheng H, Gao T, Zheng QH, Lu LY, Hou TH, Zhang SS, Zhou SY, Hao XY, Wang L, Zhao L, Liang FR, Li Y. Acupuncture for Patients With Chronic Tension-Type Headache: A Randomized Controlled Trial. Neurology. 2022 Oct 3;99(14):e1560-e1569. doi: 10.1212/WNL.0000000000200670.
PubMed 35732505Lu L, Zheng H, Zheng Q, Hao X, Zhou S, Zhang S, Wei T, Gao T, Duan D, Zhao L, Li N, Li Y. The long-term effect of acupuncture for patients with chronic tension-type headache: study protocol for a randomized controlled trial. Trials. 2017 Oct 3;18(1):453. doi: 10.1186/s13063-017-2188-9.
PubMed 28974247
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acupuncture for Patients With Chronic Tension-type Headache : a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03133884
- Acronym / sponsor ID
- 2016HH0007
- Conditions
- Chronic Tension-Type Headache
- Keywords
- chronic tension-type headache, acupuncture, Deqi
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 218 participants (actual)
- Lead sponsor
- Chengdu University of Traditional Chinese MedicineUniversity, hospital or other
- Study start
- Jun 2016 (actual)
- Primary completion
- Jun 2019 (actual)
- Study completion
- 10 Sep 2019 (actual)
- First posted
- 28 Apr 2017 (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.
Two hundred and eighteen patients with chronic tension-type headache(CTTH) will be randomly assigned to an experimental group (acupuncture) and a control group (superficial acupuncture) in a 1:1 ratio. Participants in both groups will receive 20 sessions of acupuncture over 8 weeks, and the same acupoints will be selected in acupuncture treatments.The study cycle will last 36 weeks, including a 4-week baseline period, a 8-week treatment period and a 24-week follow-up period. And the primary outcome will be measured at the end of 16th week. While, the secondary outcomes will be measured at the baseline, the 4th, 8th,12th,16th,20th,24th,28th and 32nd week after randomization.After each treatment, participants will finish the Massachusetts General Hospital (MGH) Acupuncture Sensation Scale (MASS) to evaluate deqi sensations.
Detailed description
This is a clinical randomized controlled trial (RCT). According to the pervious study, 218 patients, who meet the diagnostic criteria of CTTH in the international classification of headache disorders, 3rd edition (beta version) (ICHD-III beta), will be recruited in this study. And these participants will be randomly assigned to 2groups with acupuncture treatment or superficial acupuncture treatment through central randomization in a 1:1 ratio.
The total observation period will last 36 weeks, including a 4-week baseline period, a 8-week treatment period and a 24-week follow-up period. The central randomization will be performed after the baseline period, and participants will receive 20 sessions of intervention over 8 weeks ( 3 sessions per week in the first 4 weeks and 2 sessions per week in the following 4 weeks).
The same acupoints, named Fengchi (GB20), Taiyang (EX-HN5), Baihui (DU20), Hegu (LI4) and Taichong (LR3) on both sides, will be punctured by filiform needles. However, manipulation methods will be different. In acupuncture group, the needles will be inserted into the acupoints, of which the depths will be adjusted to the standard permissible layers.Then even reinforcing-reducing technique will be performed on the needles until achieving deqi sensation.The needles will be retained for 30 minutes in each session and manipulated twice every 10 minutes with intermittent stimulation. Each manipulation will last for 30 seconds. While, in superficial group, the selected acupoints will be punctured superficially by the depth of 1-3 mm, and the needles will be retained for 30 minutes without any manipulation.
Within 5 minutes after withdrawing needles of each session, participants in three acupuncture groups will finish the Massachusetts General Hospital (MGH) Acupuncture Sensation Scale (MASS).
Most of the curative outcomes will be collected from the headache dairy which is filled by participants. And the primary outcome will be measured at the end of 16th week. While, the secondary outcomes will be measured at the baseline, the 4th, 8th,12th,16th,20th,24th,28th and 32nd week after randomization.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Acupuncture | Experimental | Other: acupunctureThe needles will be inserted into the acupoints and the depths will be adjusted to the standard permissible layers, then even reinforcing-reducing technique will be performed on the needles until achieving deqi sensation.The needles will be retained for 30 minutes in each session and manipulated twice every 10 minutes with intermittent stimulation. Each manipulation will last for 20 seconds. |
| Superficial acupuncture | Other | Other: superficial acupunctureThe selected acupoints will be punctured superficially by the depth of 1-3 mm, and the needles will be retained for 30 minutes without any manipulation. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Meeting the diagnostic criteria of CTTH in the international classification of headache disorders, 3rd edition (beta version) (ICHD-III beta);
- Aged 18-65 years;
- Having the ability of understanding and completing the headache dairy;
- Volunteering to this study and able to provide written informed consent.
Key exclusion criteria (10 listed)
- Not suffering tension-type headache during the pervious 3 months;
- Taking any prophylactic headache medication during the previous one month;
- Headache due to organic disorders (e.g. subarachnoid hemorrhage, cerebral hemorrhage, cerebral embolism, cerebral thrombosis, vascular malformation, arthritis, hypertension, arteriosclerosis);
- Having serious diseases of the heart, liver, kidney or other organs;
- In pregnancy or lactation, or planning to be pregnant in 6 months;
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 |
|---|---|---|
| acupunctureThe needles will be inserted into the acupoints and the depths will be adjusted to the standard permissible layers, then even reinforcing-reducing technique will be performed on the needles until achieving deqi sensation.The needles will be retained for 30 minutes in each session and manipulated twice every 10 minutes with intermittent stimulation. Each manipulation will last for 30 seconds. | Other | Acupuncture |
| superficial acupunctureThe selected acupoints will be punctured superficially by the depth of 1-3 mm, and the needles will be retained for 30 minutes without any manipulation. | Other | Superficial acupuncture |
Primary outcome
Responder rate
Time frame: 16 weeks after randomization
The responder rate is defined as >50% reduction in the number of headache days per four week
7 secondary outcomes
The number of days with headache
Time frame: at baseline before randomization, 4, 8, 12, 16, 20, 24, 28 and 32 weeks after randomization
The mean pain intensity of tension-type headache during 4 weeks
Time frame: at baseline before randomization, 4, 8, 12, 16, 20, 24, 28 and 32 weeks after randomization
The rate of medication intake during 4 weeks
Time frame: at baseline before randomization, 4, 8, 12, 16, 20, 24, 28 and 32 weeks after randomization
Evaluation of quality of life
Time frame: at baseline before randomization, 4, 8, 12, 16, 20, 24, 28 and 32 weeks after randomization
Evaluation of anxiety state
Time frame: at baseline before randomization, 4, 8, 12, 16, 20, 24, 28 and 32 weeks after randomization
Evaluation of depression state
Time frame: at baseline before randomization, 4, 8, 12, 16, 20, 24, 28 and 32 weeks after randomization
Evaluation of needling sensation
Time frame: Within 5 minutes after withdrawing needles of each acupuncture session
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 19 Sep 2019.
- Derived from this study: PubMed 35732505Zheng H, Gao T, Zheng QH, Lu LY, Hou TH, Zhang SS, Zhou SY, Hao XY, Wang L, Zhao L, Liang FR, Li Y. Acupuncture for Patients With Chronic Tension-Type Headache: A Randomized Controlled Trial. Neurology. 2022 Oct 3;99(14):e1560-e1569. doi: 10.1212/WNL.0000000000200670.
- Derived from this study: PubMed 28974247Lu L, Zheng H, Zheng Q, Hao X, Zhou S, Zhang S, Wei T, Gao T, Duan D, Zhao L, Li N, Li Y. The long-term effect of acupuncture for patients with chronic tension-type headache: study protocol for a randomized controlled trial. Trials. 2017 Oct 3;18(1):453. doi: 10.1186/s13063-017-2188-9.
- 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.
Ying Li, PhD study chair
Chengdu University of Traditional Chinese Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing acupuncture and superficial acupuncture in people with Chronic Tension-Type Headache, run by Chengdu University of Traditional Chinese Medicine 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 4 inclusion and 10 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 19 Sep 2019. 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?
Responder rate (time frame: 16 weeks after randomization). 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 NCT03133884, 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 19 Sep 2019.