Temporomandibular Joint DisordersNCT02324712
Cytokine and Growth Factor Changes and Correlation With Clinical Outcomes Following Acupuncture for TMD
A study testing Acupuncture in people with Temporomandibular Joint Disorders, run by University of North Carolina, Chapel Hill.
Trial summary
Purpose: 1) To investigate differences in pro-inflammatory and anti-inflammatory cytokines and growth factors in the circulating blood (and cytokine levels only in saliva) of patients with chronic temporomandibular disorder (TMD) before and after acupuncture; 2) To determine differences in cytokine profiles between… Read more about this study
- Who is it for?
- Ages 18 to 64 years
- Conditions the study is for
- Temporomandibular Joint Disorders
- What is being tested?
- Acupuncture
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Start not givento Feb 2016
- 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 64 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Signed, informed consent; females and males aged 18-64; planning on living in the area for the next 2 months; fluent in written and spoken English;
- Myofascial pain with referral diagnosed according to TMD diagnostic criteria (Schiffman et al. 2014):
- pain in the temporalis and masseter muscles report of familiar pain with palpation of the two muscles report of pain at a site beyond the boundary of the muscle being palpated.
Who cannot join
- Traumatic facial injury or surgery on the face or jaw; currently receiving orthodontic treatment;
- Systemic inflammatory disorders such as lupus, kidney failure or renal dialysis, heart disease or heart failure, chronic respiratory disease, hypertension, un- controlled diabetes, epilepsy or seizures
- Hyperthyroidism; chemotherapy or radiation therapy; trigeminal neuralgia; cluster headache;
- Drug or alcohol abuse; active or uncontrolled psychiatric disorders or recent (within 6 months) psychiatric hospitalization; pending pension or worker's claim/litigation; previous experience with acupuncture for TMD
- Current use of NSAIDS and/or steroidal medications.
About this study
Purpose: 1) To investigate differences in pro-inflammatory and anti-inflammatory cytokines and growth factors in the circulating blood (and cytokine levels only in saliva) of patients with chronic temporomandibular disorder (TMD) before and after acupuncture; 2) To determine differences in cytokine profiles between real and sham acupuncture in circulating blood of patients with chronic TMD; and 3) To explore correlations between these changes and clinical outcomes.
Participants: Patients with chronic TMD pain recruited through the University of North Carolina-Chapel Hill (UNC-CH) Orofacial Pain Clinic.
Procedures (methods): Participants will complete a self-administered questionnaire assessing TMD-related comorbidity. During the initial visit, study examiners will record clinical characteristics of muscles and joints of the head, neck and body according to newly recommended diagnostic criteria (DC) for TMD. Clinical outcomes include a pain index (computed from numeric rating scales) of masseter, temporalis and the supplemental painful muscles, and patient-reported symptoms (using the Measure Yourself Medical Outcome Profile; MYMOP) and pain intensity (using the Pain Scale). Blood (5 cc) will be taken before and after acupuncture treatments. Participants will self-collect pre-treatment and post-treatment saliva samples. Patients will receive 4 acupuncture treatments, once per week for 4 weeks. The primary outcome measure is change in IL-8 levels in circulating blood and saliva after 4 weeks of real acupuncture compared with sham acupuncture. Secondary outcome measures include comparing changes in levels of nerve growth factor (NGF), tumor necrosis factor-alpha (TNFα),vascular endothelial growth factor (VEGF), platelet-derived growth factor (PDGF), basic fibroblast growth factor (bFGF), and IL-1α, IL-2, IL-4, IL-6 and IL-10, before and after real acupuncture at Week 1 compared with sham acupuncture and before and after real acupuncture at Week 4 compared with sham acupuncture. The exploratory outcome measure is correlation between changes in cytokine levels and clinical variables after 4 weeks of real acupuncture compared with 4 weeks of sham acupuncture.
Read the detailed description
Temporomandibular disorder (TMD) is known to be the second most frequent musculoskeletal pain condition following low back pain. According to the NIDCR, TMD affects 5%-12% of the population at an annual cost estimated at 4 billion dollars in the US. Recent studies that have investigated acupuncture as a treatment for musculoskeletal pain have reported various results. Several meta-analyses and systematic reviews of randomized controlled trials suggest that acupuncture treatment improves TMD-related pain. Its mechanism of action in improving TMD pain, however, is largely unclear.
Elevated levels of pro-inflammatory cytokines, e.g., MCP-1 and IL-8 have been found in circulating blood of patients with TMD. Upregulated pro-inflammatory cytokine levels have been correlated with greater sensitivity to pain evoking stimuli. Abnormalities in levels of pro-inflammatory cytokines are often accompanied by alterations in levels of anti-inflammatory cytokines, e.g., IL-1ra, which are associated with reductions in pain and inflammation. The effects of acupuncture on pro- and anti-inflammatory cytokines, growth factors, and clinical pain and function have not been reported in a prospective cohort of TMD patients at multiple time points in the clinical setting. The proposed mechanistic study seeks to ascertain if acupuncture compared to sham acupuncture produces measurable changes in circulating pro- and anti-inflammatory cytokines and growth factors in a manner that is associated with patient self-reports of pain and function over a 4-week treatment period. Cytokine and growth factor levels will be measured in blood and saliva; saliva will be used to measure cytokine levels only.
- Conditions
- Temporomandibular Joint Disorders
- Being tested
- Acupuncture, Sham Acupuncture
- Medical subject headings
- Temporomandibular Joint Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AcupunctureDevice
Acupuncture using standard stainless steel acupuncture needles inserted into intramuscular tissue for 20 minutes
Sham AcupunctureDevice
Acupuncture using non-penetrating Park Sham Needles for 20 minutes
| Study group | Role | What they receive |
|---|---|---|
| Acupuncture | Active comparator | Acupuncture treatment for TMD Receives: Device: Acupuncture |
| Sham Acupuncture | Sham comparator | Acupuncture treatment for TMD using the non-penetrating Park Sham Acupuncture Device Receives: Device: Sham Acupuncture |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in cytokine IL-8 levels in circulating blood and saliva after 4 weeks of real acupuncture compared with 4 weeks of sham acupuncture.
Measured: Baseline, 4 weeks
Secondary outcomes (22)
Change in patient-reported symptoms on the Measure Yourself Medical Outcome Profile (MYMOP; a 1-page paper questionnaire) after 4 weeks of real acupuncture compared with 4 weeks of sham acupuncture.
Measured: Baseline, 4 weeks
Change in patient-reported pain intensity on the Pain Scale (a 1-page paper questionnaire) after 4 weeks of real acupuncture compared with 4 weeks of sham acupuncture.
Measured: Baseline, 4 weeks
Change in cytokine MCP-1 levels in circulating blood and saliva after 4 weeks of real acupuncture compared with 4 weeks of sham acupuncture.
Measured: Baseline, 4 weeks
Change in cytokine IL-1ra levels in circulating blood and saliva after 4 weeks of real acupuncture compared with 4 weeks of sham acupuncture.
Measured: Baseline, 4 weeks
Change in cytokine IL-2 levels in circulating blood and saliva prior to and after real acupuncture compared with sham acupuncture at study Week 1.
Measured: Week 1
Change in cytokine IL-4 levels in circulating blood and saliva prior to and after real acupuncture compared with sham acupuncture at study Week 1.
Measured: Week 1
Change in cytokine IL-6 levels in circulating blood and saliva prior to and after real acupuncture compared with sham acupuncture at study Week 1.
Measured: Week 1
Change in cytokine IL-10 levels in circulating blood and saliva prior to and after real acupuncture compared with sham acupuncture at study Week 1.
Measured: Week 1
Change in cytokine IL-2 levels in circulating blood and saliva prior to and after real acupuncture compared with sham acupuncture at study Week 4.
Measured: Week 4
Change in cytokine IL-4 levels in circulating blood and saliva prior to and after real acupuncture compared with sham acupuncture at study Week 4.
Measured: Week 4
Change in cytokine IL-6 levels in circulating blood and saliva prior to and after real acupuncture compared with sham acupuncture at study Week 4.
Measured: Week 4
Change in cytokine IL-10 levels in circulating blood and saliva prior to and after real acupuncture compared with sham acupuncture at study Week 4.
Measured: Week 4
Change in nerve growth factor (NGF) levels in circulating blood prior to and after real acupuncture compared with sham acupuncture at study Week 1.
Measured: Week 1
Change in vascular endothelial growth factor (VEGF) levels in circulating blood prior to and after real acupuncture compared with sham acupuncture at study Week 1.
Measured: Week 1
Change in platelet-derived growth factor (PDGF) levels in circulating blood prior to and after real acupuncture compared with sham acupuncture at study Week 1.
Measured: Week 1
Change in basic fibroblast growth factor (bFGF) levels in circulating blood prior to and after real acupuncture compared with sham acupuncture at study Week 1.
Measured: Week 1
Change in tumor necrosis factor alpha (TNFa) levels in circulating blood prior to and after real acupuncture compared with sham acupuncture at study Week 1.
Measured: Week 1
Change in nerve growth factor (NGF) levels in circulating blood prior to and after real acupuncture compared with sham acupuncture at study Week 4.
Measured: Week 4
Change in vascular endothelial growth factor (VEGF) levels in circulating blood prior to and after real acupuncture compared with sham acupuncture at study Week 4.
Measured: Week 4
Change in platelet-derived growth factor (PDGF) levels in circulating blood prior to and after real acupuncture compared with sham acupuncture at study Week 4.
Measured: Week 4
Change in basic fibroblast growth factor (bFGF) levels in circulating blood prior to and after real acupuncture compared with sham acupuncture at study Week 4.
Measured: Week 4
Change in tumor necrosis factor alpha (TNFa) levels in circulating blood prior to and after real acupuncture compared with sham acupuncture at study Week 4.
Measured: Week 4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Dec 2014 (estimated)
- Primary completionFeb 2016
Why it stopped: PI relocated to another institution; study may be resubmitted at a later date.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Temporomandibular Joint DisordersStudies of the same condition, open and under way.
- More trials run by University of North Carolina, Chapel HillThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of North Carolina, Chapel Hill
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jongbae (Jay) Park, KMD, PhD, Principal investigator, University of North Carolina, Chapel Hill
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02324712
- Sponsor's protocol ID
- 14-0919
- Status last verified
- Feb 2016
- First submitted
- 19 Dec 2014
- Last updated
- 23 Feb 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Cho SH, Whang WW. Acupuncture for temporomandibular disorders: a systematic review. J Orofac Pain. 2010 Spring;24(2):152-62.
PubMed 20401353La Touche R, Goddard G, De-la-Hoz JL, Wang K, Paris-Alemany A, Angulo-Diaz-Parreno S, Mesa J, Hernandez M. Acupuncture in the treatment of pain in temporomandibular disorders: a systematic review and meta-analysis of randomized controlled trials. Clin J Pain. 2010 Jul-Aug;26(6):541-50. doi: 10.1097/AJP.0b013e3181e2697e.
PubMed 20551730Slade GD, Conrad MS, Diatchenko L, Rashid NU, Zhong S, Smith S, Rhodes J, Medvedev A, Makarov S, Maixner W, Nackley AG. Cytokine biomarkers and chronic pain: association of genes, transcription, and circulating proteins with temporomandibular disorders and widespread palpation tenderness. Pain. 2011 Dec;152(12):2802-2812. doi: 10.1016/j.pain.2011.09.005. Epub 2011 Oct 14.
PubMed 22000099
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cytokine and Growth Factor Changes and Correlation With Clinical Outcomes Following Acupuncture for TMD
- ClinicalTrials.gov ID
- NCT02324712
- Acronym / sponsor ID
- 14-0919
- Conditions
- Temporomandibular Joint Disorders
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: PI relocated to another institution; study may be resubmitted at a later date.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of North Carolina, Chapel HillUniversity, hospital or other
- Primary completion
- Feb 2016 (actual)
- First posted
- 24 Dec 2014 (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.
Purpose: 1) To investigate differences in pro-inflammatory and anti-inflammatory cytokines and growth factors in the circulating blood (and cytokine levels only in saliva) of patients with chronic temporomandibular disorder (TMD) before and after acupuncture; 2) To determine differences in cytokine profiles between real and sham acupuncture in circulating blood of patients with chronic TMD; and 3) To explore correlations between these changes and clinical outcomes.
Participants: Patients with chronic TMD pain recruited through the University of North Carolina-Chapel Hill (UNC-CH) Orofacial Pain Clinic.
Procedures (methods): Participants will complete a self-administered questionnaire assessing TMD-related comorbidity. During the initial visit, study examiners will record clinical characteristics of muscles and joints of the head, neck and body according to newly recommended diagnostic criteria (DC) for TMD. Clinical outcomes include a pain index (computed from numeric rating scales) of masseter, temporalis and the supplemental painful muscles, and patient-reported symptoms (using the Measure Yourself Medical Outcome Profile; MYMOP) and pain intensity (using the Pain Scale). Blood (5 cc) will be taken before and after acupuncture treatments. Participants will self-collect pre-treatment and post-treatment saliva samples. Patients will receive 4 acupuncture treatments, once per week for 4 weeks. The primary outcome measure is change in IL-8 levels in circulating blood and saliva after 4 weeks of real acupuncture compared with sham acupuncture. Secondary outcome measures include comparing changes in levels of nerve growth factor (NGF), tumor necrosis factor-alpha (TNFα),vascular endothelial growth factor (VEGF), platelet-derived growth factor (PDGF), basic fibroblast growth factor (bFGF), and IL-1α, IL-2, IL-4, IL-6 and IL-10, before and after real acupuncture at Week 1 compared with sham acupuncture and before and after real acupuncture at Week 4 compared with sham acupuncture. The exploratory outcome measure is correlation between changes in cytokine levels and clinical variables after 4 weeks of real acupuncture compared with 4 weeks of sham acupuncture.
Detailed description
Temporomandibular disorder (TMD) is known to be the second most frequent musculoskeletal pain condition following low back pain. According to the NIDCR, TMD affects 5%-12% of the population at an annual cost estimated at 4 billion dollars in the US. Recent studies that have investigated acupuncture as a treatment for musculoskeletal pain have reported various results. Several meta-analyses and systematic reviews of randomized controlled trials suggest that acupuncture treatment improves TMD-related pain. Its mechanism of action in improving TMD pain, however, is largely unclear.
Elevated levels of pro-inflammatory cytokines, e.g., MCP-1 and IL-8 have been found in circulating blood of patients with TMD. Upregulated pro-inflammatory cytokine levels have been correlated with greater sensitivity to pain evoking stimuli. Abnormalities in levels of pro-inflammatory cytokines are often accompanied by alterations in levels of anti-inflammatory cytokines, e.g., IL-1ra, which are associated with reductions in pain and inflammation. The effects of acupuncture on pro- and anti-inflammatory cytokines, growth factors, and clinical pain and function have not been reported in a prospective cohort of TMD patients at multiple time points in the clinical setting. The proposed mechanistic study seeks to ascertain if acupuncture compared to sham acupuncture produces measurable changes in circulating pro- and anti-inflammatory cytokines and growth factors in a manner that is associated with patient self-reports of pain and function over a 4-week treatment period. Cytokine and growth factor levels will be measured in blood and saliva; saliva will be used to measure cytokine levels only.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Acupuncture | Active comparator | Device: AcupunctureAcupuncture treatment for TMD |
| Sham Acupuncture | Sham comparator | Device: Sham AcupunctureAcupuncture treatment for TMD using the non-penetrating Park Sham Acupuncture Device |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Signed, informed consent; females and males aged 18-64; planning on living in the area for the next 2 months; fluent in written and spoken English;
- Myofascial pain with referral diagnosed according to TMD diagnostic criteria (Schiffman et al. 2014):
- pain in the temporalis and masseter muscles report of familiar pain with palpation of the two muscles report of pain at a site beyond the boundary of the muscle being palpated.
Key exclusion criteria (5 listed)
- Traumatic facial injury or surgery on the face or jaw; currently receiving orthodontic treatment;
- Systemic inflammatory disorders such as lupus, kidney failure or renal dialysis, heart disease or heart failure, chronic respiratory disease, hypertension, un- controlled diabetes, epilepsy or seizures
- Hyperthyroidism; chemotherapy or radiation therapy; trigeminal neuralgia; cluster headache;
- Drug or alcohol abuse; active or uncontrolled psychiatric disorders or recent (within 6 months) psychiatric hospitalization; pending pension or worker's claim/litigation; previous experience with acupuncture for TMD
- Current use of NSAIDS and/or steroidal medications.
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 |
|---|---|---|
| AcupunctureAcupuncture using standard stainless steel acupuncture needles inserted into intramuscular tissue for 20 minutes | Device | Acupuncture |
| Sham AcupunctureAcupuncture using non-penetrating Park Sham Needles for 20 minutes | Device | Sham Acupuncture |
Primary outcome
Change in cytokine IL-8 levels in circulating blood and saliva after 4 weeks of real acupuncture compared with 4 weeks of sham acupuncture.
Time frame: Baseline, 4 weeks
22 secondary outcomes
Change in patient-reported symptoms on the Measure Yourself Medical Outcome Profile (MYMOP; a 1-page paper questionnaire) after 4 weeks of real acupuncture compared with 4 weeks of sham acupuncture.
Time frame: Baseline, 4 weeks
Change in patient-reported pain intensity on the Pain Scale (a 1-page paper questionnaire) after 4 weeks of real acupuncture compared with 4 weeks of sham acupuncture.
Time frame: Baseline, 4 weeks
Change in cytokine MCP-1 levels in circulating blood and saliva after 4 weeks of real acupuncture compared with 4 weeks of sham acupuncture.
Time frame: Baseline, 4 weeks
Change in cytokine IL-1ra levels in circulating blood and saliva after 4 weeks of real acupuncture compared with 4 weeks of sham acupuncture.
Time frame: Baseline, 4 weeks
Change in cytokine IL-2 levels in circulating blood and saliva prior to and after real acupuncture compared with sham acupuncture at study Week 1.
Time frame: Week 1
Change in cytokine IL-4 levels in circulating blood and saliva prior to and after real acupuncture compared with sham acupuncture at study Week 1.
Time frame: Week 1
Change in cytokine IL-6 levels in circulating blood and saliva prior to and after real acupuncture compared with sham acupuncture at study Week 1.
Time frame: Week 1
Change in cytokine IL-10 levels in circulating blood and saliva prior to and after real acupuncture compared with sham acupuncture at study Week 1.
Time frame: Week 1
Change in cytokine IL-2 levels in circulating blood and saliva prior to and after real acupuncture compared with sham acupuncture at study Week 4.
Time frame: Week 4
Change in cytokine IL-4 levels in circulating blood and saliva prior to and after real acupuncture compared with sham acupuncture at study Week 4.
Time frame: Week 4
Change in cytokine IL-6 levels in circulating blood and saliva prior to and after real acupuncture compared with sham acupuncture at study Week 4.
Time frame: Week 4
Change in cytokine IL-10 levels in circulating blood and saliva prior to and after real acupuncture compared with sham acupuncture at study Week 4.
Time frame: Week 4
Change in nerve growth factor (NGF) levels in circulating blood prior to and after real acupuncture compared with sham acupuncture at study Week 1.
Time frame: Week 1
Change in vascular endothelial growth factor (VEGF) levels in circulating blood prior to and after real acupuncture compared with sham acupuncture at study Week 1.
Time frame: Week 1
Change in platelet-derived growth factor (PDGF) levels in circulating blood prior to and after real acupuncture compared with sham acupuncture at study Week 1.
Time frame: Week 1
Change in basic fibroblast growth factor (bFGF) levels in circulating blood prior to and after real acupuncture compared with sham acupuncture at study Week 1.
Time frame: Week 1
Change in tumor necrosis factor alpha (TNFa) levels in circulating blood prior to and after real acupuncture compared with sham acupuncture at study Week 1.
Time frame: Week 1
Change in nerve growth factor (NGF) levels in circulating blood prior to and after real acupuncture compared with sham acupuncture at study Week 4.
Time frame: Week 4
Change in vascular endothelial growth factor (VEGF) levels in circulating blood prior to and after real acupuncture compared with sham acupuncture at study Week 4.
Time frame: Week 4
Change in platelet-derived growth factor (PDGF) levels in circulating blood prior to and after real acupuncture compared with sham acupuncture at study Week 4.
Time frame: Week 4
Change in basic fibroblast growth factor (bFGF) levels in circulating blood prior to and after real acupuncture compared with sham acupuncture at study Week 4.
Time frame: Week 4
Change in tumor necrosis factor alpha (TNFa) levels in circulating blood prior to and after real acupuncture compared with sham acupuncture at study Week 4.
Time frame: Week 4
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Feb 2016.
- Background: PubMed 20401353Cho SH, Whang WW. Acupuncture for temporomandibular disorders: a systematic review. J Orofac Pain. 2010 Spring;24(2):152-62.
- Background: PubMed 20551730La Touche R, Goddard G, De-la-Hoz JL, Wang K, Paris-Alemany A, Angulo-Diaz-Parreno S, Mesa J, Hernandez M. Acupuncture in the treatment of pain in temporomandibular disorders: a systematic review and meta-analysis of randomized controlled trials. Clin J Pain. 2010 Jul-Aug;26(6):541-50. doi: 10.1097/AJP.0b013e3181e2697e.
- Background: PubMed 22000099Slade GD, Conrad MS, Diatchenko L, Rashid NU, Zhong S, Smith S, Rhodes J, Medvedev A, Makarov S, Maixner W, Nackley AG. Cytokine biomarkers and chronic pain: association of genes, transcription, and circulating proteins with temporomandibular disorders and widespread palpation tenderness. Pain. 2011 Dec;152(12):2802-2812. doi: 10.1016/j.pain.2011.09.005. Epub 2011 Oct 14.
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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.
Jongbae (Jay) Park, KMD, PhD principal investigator
University of North Carolina, Chapel Hill
Questions about this trial
What is this clinical trial studying?
A study testing Acupuncture in people with Temporomandibular Joint Disorders, run by University of North Carolina, Chapel Hill.
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 3 inclusion and 5 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: withdrawn, as of the sponsor's last update on 23 Feb 2016. Status can change between updates, so confirm with the study contact before making plans.
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.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
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?
Change in cytokine IL-8 levels in circulating blood and saliva after 4 weeks of real acupuncture compared with 4 weeks of sham acupuncture. (time frame: Baseline, 4 weeks). 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 NCT02324712, which also lists 3 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 23 Feb 2016; AzTrials last refreshed its copy on 6 Nov 2026.