AcupunctureNCT02959346
Acupuncture in Postoperative Pain Control for Minimal Invasive Thoracoscopic Surgery Patients
A study testing Acupuncture in people with Acupuncture and Pain Control, run by China Medical University Hospital at 1 site in Taiwan.
Trial summary
Minimal invasive thoracoscopic surgery has been used widely for common thoracic diseases in recent years. Patients who received thoracoscopic surgery recovered much quickly and returned to their daily life sooner because of small operation wound and less invasion. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Acupuncture, Pain Control, Randomized Controlled Trial
- What is being tested?
- Acupuncture
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 siteTaiwan
- Study dates
- Dec 2016to Oct 2017
- 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 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age more than 20-year-old
- Both male and female patients
- Nationality: Republic of China (R.O.C., Taiwan)
- Who received thoracoscopic surgery for benign lung tumor/disease, metastatic lung tumor, primary lung cancer, mediastinal tumor
Who cannot join
- Abnormal function of coagulation
- Platelet count less than 20 x 10^3/mm^3
- International normalized ratio (INR) more than 2.5
- Severe comorbidity, for example central vascular, cardiovascular disease, liver/renal failure
- Who would not cooperate in access, or express appropriately
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
Division of thoracic surgery, China medical university hospital
Taichung, 404
Ting Yu Lu, MD, +886-975682784, seawindss@hotmail.com
About this study
Official title: Investigate the Efficacy of Acupuncture in Postoperative Pain Control for Minimal Invasive Thoracoscopic Surgery Patients
Minimal invasive thoracoscopic surgery has been used widely for common thoracic diseases in recent years. Patients who received thoracoscopic surgery recovered much quickly and returned to their daily life sooner because of small operation wound and less invasion. However, operative pain was still an important factor, which might contribute to several post-operative complications.
In daily practice, patients received oral/intravenous form non-steroidal anti-inflammatory drugs and opioid agents, or patient-controlled analgesia for post operative pain control. However, some side effects were observed occasionally.
Read more
The role of acupuncture in post-operative pain control was frequently discussed in recent research. The main mechanisms of acupuncture in pain control were (1) to stimulate the release of endogenous opioid and (2) to block TRPV1 receptor.
The randomized controlled trial arranged by Gary Deng and his colleagues in 2008, was the first clinical trial investigated the role of acupuncture in post-operative pain control for traditional thoracotomy patients. However, there was no further research about the role of acupuncture applied to minimal invasive thoracoscopic surgery.
Thus, the aim of this randomized controlled trial was to investigate the role of acupuncture in post-operative pain control for minimal invasive thoracoscopic surgery patients. In order to deliver a safe and effective way in pain control, and to save medical cost and promote quality of patient care.
- Being tested
- Sham Acupuncture, Acupuncture
- Keywords
- Minimal invasive thoracoscopic surgery, Pain control, Acupuncture, Randomized controlled trial
- Medical subject headings
- Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sham AcupunctureProcedure or surgery
Procedure:
Sham Acupuncture(ipisilateral side, 0.3cun, No needle sensation (de qi) was elicited) Sham acupuncture will be applied by inserting acupuncture needle into acupoints(1cm away from the true acupoint):upper limb: Waiguan TE5; lower limb: Zusanli ST36.
All procedures were carried out to a depth of 0.5 cm with disposable needles measuring 0.16 mm in diameter (40-gauge) and 12.7 mm in length (Yu Kuang, Taipei, Taiwan).
Acupuncture treatment will consist of one session per day and consecutive three days after thoracoscopic surgery.
AcupunctureProcedure or surgery
Procedure:
Acupuncture(ipisilateral side, the needling depth decided by whether patients feel De qi, neutral supplementation and draining) Acupuncture will be applied by inserting acupuncture needle into acupoints: Zhigou TE6, Shousanli LI10, Hegu LI4, Neiguan PC6, Houxi SI3; lower limb: Biguan ST31, Fushe SP13, Zulinqi GB41; axillary area(Remove Needles right away after De qi): Yuanye GB22, Jiquan HT1; local area(Remove Needles right away after De qi): ashi point close to the pain area.
The other needles will be left for 20 minutes and then removed. All procedures were carried out with disposable needles measuring 0.25 mm in diameter (32-gauge) and 44 mm in length (Yu Kuang, Taipei, Taiwan).
Acupuncture treatment will consist of one session per day and consecutive three days after thoracoscopic surgery.
| Study group | Role | What they receive |
|---|---|---|
| Sham Acupuncture | Sham comparator | After recruitment, participants will be randomized to receive acupuncture or sham acupuncture treatment. In the sham acupuncture group, participants will receive sham acupuncture. Receives: Procedure: Sham Acupuncture |
| Acupuncture | Experimental | After recruitment, participants will be randomized to receive acupuncture or sham acupuncture treatment. In the acupuncture group, participants will receive acupuncture. Receives: Procedure: Acupuncture |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline pain scale at post operative day 2, after intervention
- Pain, as assessed by Numeric Rating Scale, NRS
- Measure at post-operative day 1, 9AM, before intervention; and post-operative day 2, 5PM, after intervention
- accompanied with rest, deep breath, cough and change posture by left and right decubitus
Measured: measure at post-operative day 1, 9AM, before intervention; and post-operative day 2, 5PM, after intervention
Secondary outcomes (4)
Opioid dosage
- Routine pain control was given with oral form acetaminophen (500mg, at every 9AM, 1PM, 5PM and 9PM)
- Additional Morphine was given for intolerable pain (0.05mg/kg, intramuscular injection)
- Additional Ketorolac was given for intolerable pain after morphine used (15mg, intramuscular injection)
- Avoid patient controlled analgesia (PCA) using
Measured: injection times of morphine or ketorolac would be recorded during whole admission, an average of 7 days
Von Frey hair Test
- Pain, as assessed by von Frey hair Test at each wound sites
- Measure at post-operative day 1, 9AM, before intervention; and post-operative day 2, 5PM, after intervention
Measured: measure at post-operative day 1, 9AM, before intervention; and post-operative day 2, 5PM, after intervention
Vital signs
- Measure at every 9AM, 1PM, 5PM and 9PM
- Including blood pressure, heart rate, breath rate, body temperature
Measured: measure during whole admission, an average of 7 days
Questionnaire
- Including quality control of acupuncture, discomfort and satisfaction during whole admission, an average of 7 days
Measured: measure before discharge, an average at post operative day 5
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Nov 2016 (estimated)
- Study startDec 2016
- Primary completionJun 2017 (estimated)
- Study completionOct 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (16)Papers the sponsor has linked to this study.
- Other trials for AcupunctureStudies of the same condition, open and under way.
- More trials run by China Medical University HospitalThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- China Medical University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ting Yu Lu, MD, Principal investigator, Division of thoracic surgery, China medical university hospital, Taiwan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02959346
- Sponsor's protocol ID
- CMUH105-REC2-097
- Status last verified
- Dec 2016
- First submitted
- 3 Nov 2016
- Last updated
- 12 Dec 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Leaver HA, Craig SR, Yap PL, Walker WS. Lymphocyte responses following open and minimally invasive thoracic surgery. Eur J Clin Invest. 2000 Mar;30(3):230-8. doi: 10.1046/j.1365-2362.2000.00622.x.
PubMed 10692000Rizk NP, Ghanie A, Hsu M, Bains MS, Downey RJ, Sarkaria IS, Finley DJ, Adusumilli PS, Huang J, Sima CS, Burkhalter JE, Park BJ, Rusch VW. A prospective trial comparing pain and quality of life measures after anatomic lung resection using thoracoscopy or thoracotomy. Ann Thorac Surg. 2014 Oct;98(4):1160-6. doi: 10.1016/j.athoracsur.2014.05.028. Epub 2014 Jul 31.
PubMed 25086945Mulder DS. Pain management principles and anesthesia techniques for thoracoscopy. Ann Thorac Surg. 1993 Sep;56(3):630-2. doi: 10.1016/0003-4975(93)90933-9.
PubMed 8379756Kim JA, Kim TH, Yang M, Gwak MS, Kim GS, Kim MJ, Cho HS, Sim WS. Is intravenous patient controlled analgesia enough for pain control in patients who underwent thoracoscopy? J Korean Med Sci. 2009 Oct;24(5):930-5. doi: 10.3346/jkms.2009.24.5.930. Epub 2009 Sep 23.
PubMed 19794994Lin JG, Chen WL. Acupuncture analgesia: a review of its mechanisms of actions. Am J Chin Med. 2008;36(4):635-45. doi: 10.1142/S0192415X08006107.
PubMed 18711761Lu KW, Hsu CK, Hsieh CL, Yang J, Lin YW. Probing the Effects and Mechanisms of Electroacupuncture at Ipsilateral or Contralateral ST36-ST37 Acupoints on CFA-induced Inflammatory Pain. Sci Rep. 2016 Feb 24;6:22123. doi: 10.1038/srep22123.
PubMed 26906464Wang B, Tang J, White PF, Naruse R, Sloninsky A, Kariger R, Gold J, Wender RH. Effect of the intensity of transcutaneous acupoint electrical stimulation on the postoperative analgesic requirement. Anesth Analg. 1997 Aug;85(2):406-13. doi: 10.1097/00000539-199708000-00029.
PubMed 9249122Kotani N, Hashimoto H, Sato Y, Sessler DI, Yoshioka H, Kitayama M, Yasuda T, Matsuki A. Preoperative intradermal acupuncture reduces postoperative pain, nausea and vomiting, analgesic requirement, and sympathoadrenal responses. Anesthesiology. 2001 Aug;95(2):349-56. doi: 10.1097/00000542-200108000-00015.
PubMed 11506105Langenbach MR, Aydemir-Dogruyol K, Issel R, Sauerland S. Randomized sham-controlled trial of acupuncture for postoperative pain control after stapled haemorrhoidopexy. Colorectal Dis. 2012 Aug;14(8):e486-91. doi: 10.1111/j.1463-1318.2012.02984.x.
PubMed 22330010Sim CK, Xu PC, Pua HL, Zhang G, Lee TL. Effects of electroacupuncture on intraoperative and postoperative analgesic requirement. Acupunct Med. 2002 Aug;20(2-3):56-65. doi: 10.1136/aim.20.2-3.56.
PubMed 12216602Lin JG, Lo MW, Wen YR, Hsieh CL, Tsai SK, Sun WZ. The effect of high and low frequency electroacupuncture in pain after lower abdominal surgery. Pain. 2002 Oct;99(3):509-514. doi: 10.1016/S0304-3959(02)00261-0.
PubMed 12406527Wang RR, Tronnier V. Effect of acupuncture on pain management in patients before and after lumbar disc protrusion surgery--a randomized control study. Am J Chin Med. 2000;28(1):25-33. doi: 10.1142/S0192415X00000052.
PubMed 10794114Ward U, Nilsson UG. Acupuncture for postoperative pain in day surgery patients undergoing arthroscopic shoulder surgery. Clin Nurs Res. 2013 Feb;22(1):130-6. doi: 10.1177/1054773812454136. Epub 2012 Jul 27.
PubMed 22843248Coura LE, Manoel CH, Poffo R, Bedin A, Westphal GA. Randomised, controlled study of preoperative electroacupuncture for postoperative pain control after cardiac surgery. Acupunct Med. 2011 Mar;29(1):16-20. doi: 10.1136/aim.2010.003251.
PubMed 21383391Gilbey P, Bretler S, Avraham Y, Sharabi-Nov A, Ibrgimov S, Luder A. Acupuncture for posttonsillectomy pain in children: a randomized, controlled study. Paediatr Anaesth. 2015 Jun;25(6):603-9. doi: 10.1111/pan.12621. Epub 2015 Feb 7.
PubMed 25661270
Study at a glance
From the registry record, last updated by the sponsor on 12 Dec 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigate the Efficacy of Acupuncture in Postoperative Pain Control for Minimal Invasive Thoracoscopic Surgery Patients
- ClinicalTrials.gov ID
- NCT02959346
- Acronym / sponsor ID
- CMUH105-REC2-097
- Keywords
- Minimal invasive thoracoscopic surgery, Pain control, Acupuncture, Randomized controlled trial
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- China Medical University HospitalUniversity, hospital or other
- Study start
- Dec 2016
- Primary completion
- Jun 2017 (estimated)
- Study completion
- Oct 2017 (estimated)
- First posted
- 9 Nov 2016 (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.
Minimal invasive thoracoscopic surgery has been used widely for common thoracic diseases in recent years. Patients who received thoracoscopic surgery recovered much quickly and returned to their daily life sooner because of small operation wound and less invasion. However, operative pain was still an important factor, which might contribute to several post-operative complications.
In daily practice, patients received oral/intravenous form non-steroidal anti-inflammatory drugs and opioid agents, or patient-controlled analgesia for post operative pain control. However, some side effects were observed occasionally.
The role of acupuncture in post-operative pain control was frequently discussed in recent research. The main mechanisms of acupuncture in pain control were (1) to stimulate the release of endogenous opioid and (2) to block TRPV1 receptor.
The randomized controlled trial arranged by Gary Deng and his colleagues in 2008, was the first clinical trial investigated the role of acupuncture in post-operative pain control for traditional thoracotomy patients. However, there was no further research about the role of acupuncture applied to minimal invasive thoracoscopic surgery.
Thus, the aim of this randomized controlled trial was to investigate the role of acupuncture in post-operative pain control for minimal invasive thoracoscopic surgery patients. In order to deliver a safe and effective way in pain control, and to save medical cost and promote quality of patient care.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sham Acupuncture | Sham comparator | Procedure: Sham AcupunctureAfter recruitment, participants will be randomized to receive acupuncture or sham acupuncture treatment. In the sham acupuncture group, participants will receive sham acupuncture. |
| Acupuncture | Experimental | Procedure: AcupunctureAfter recruitment, participants will be randomized to receive acupuncture or sham acupuncture treatment. In the acupuncture group, participants will receive acupuncture. |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age more than 20-year-old
- Both male and female patients
- Nationality: Republic of China (R.O.C., Taiwan)
- Who received thoracoscopic surgery for benign lung tumor/disease, metastatic lung tumor, primary lung cancer, mediastinal tumor
Key exclusion criteria (5 listed)
- Abnormal function of coagulation
- Platelet count less than 20 x 10^3/mm^3
- International normalized ratio (INR) more than 2.5
- Severe comorbidity, for example central vascular, cardiovascular disease, liver/renal failure
- Who would not cooperate in access, or express appropriately
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 |
|---|---|---|
| Sham AcupunctureProcedure: Sham Acupuncture(ipisilateral side, 0.3cun, No needle sensation (de qi) was elicited) Sham acupuncture will be applied by inserting acupuncture needle into acupoints(1cm away from the true acupoint):upper limb: Waiguan TE5; lower limb: Zusanli ST36. All procedures were carried out to a depth of 0.5 cm with disposable needles measuring 0.16 mm in diameter (40-gauge) and 12.7 mm in length (Yu Kuang, Taipei, Taiwan). Acupuncture treatment will consist of one session per day and consecutive three days after thoracoscopic surgery. | Procedure or surgery | Sham Acupuncture |
| AcupunctureProcedure: Acupuncture(ipisilateral side, the needling depth decided by whether patients feel De qi, neutral supplementation and draining) Acupuncture will be applied by inserting acupuncture needle into acupoints: Zhigou TE6, Shousanli LI10, Hegu LI4, Neiguan PC6, Houxi SI3; lower limb: Biguan ST31, Fushe SP13, Zulinqi GB41; axillary area(Remove Needles right away after De qi): Yuanye GB22, Jiquan HT1; local area(Remove Needles right away after De qi): ashi point close to the pain area. The other needles will be left for 20 minutes and then removed. All procedures were carried out with disposable needles measuring 0.25 mm in diameter (32-gauge) and 44 mm in length (Yu Kuang, Taipei, Taiwan). Acupuncture treatment will consist of one session per day and consecutive three days after thoracoscopic surgery. | Procedure or surgery | Acupuncture |
Primary outcome
Change from baseline pain scale at post operative day 2, after intervention
Time frame: measure at post-operative day 1, 9AM, before intervention; and post-operative day 2, 5PM, after intervention
1. Pain, as assessed by Numeric Rating Scale, NRS 2. Measure at post-operative day 1, 9AM, before intervention; and post-operative day 2, 5PM, after intervention 3. accompanied with rest, deep breath, cough and change posture by left and right decubitus
4 secondary outcomes
Opioid dosage
Time frame: injection times of morphine or ketorolac would be recorded during whole admission, an average of 7 days
Von Frey hair Test
Time frame: measure at post-operative day 1, 9AM, before intervention; and post-operative day 2, 5PM, after intervention
Vital signs
Time frame: measure during whole admission, an average of 7 days
Questionnaire
Time frame: measure before discharge, an average at post operative day 5
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Dec 2016.
- Background: PubMed 10692000Leaver HA, Craig SR, Yap PL, Walker WS. Lymphocyte responses following open and minimally invasive thoracic surgery. Eur J Clin Invest. 2000 Mar;30(3):230-8. doi: 10.1046/j.1365-2362.2000.00622.x.
- Background: PubMed 25086945Rizk NP, Ghanie A, Hsu M, Bains MS, Downey RJ, Sarkaria IS, Finley DJ, Adusumilli PS, Huang J, Sima CS, Burkhalter JE, Park BJ, Rusch VW. A prospective trial comparing pain and quality of life measures after anatomic lung resection using thoracoscopy or thoracotomy. Ann Thorac Surg. 2014 Oct;98(4):1160-6. doi: 10.1016/j.athoracsur.2014.05.028. Epub 2014 Jul 31.
- Background: PubMed 8379756Mulder DS. Pain management principles and anesthesia techniques for thoracoscopy. Ann Thorac Surg. 1993 Sep;56(3):630-2. doi: 10.1016/0003-4975(93)90933-9.
- Background: PubMed 19794994Kim JA, Kim TH, Yang M, Gwak MS, Kim GS, Kim MJ, Cho HS, Sim WS. Is intravenous patient controlled analgesia enough for pain control in patients who underwent thoracoscopy? J Korean Med Sci. 2009 Oct;24(5):930-5. doi: 10.3346/jkms.2009.24.5.930. Epub 2009 Sep 23.
- Background: PubMed 18711761Lin JG, Chen WL. Acupuncture analgesia: a review of its mechanisms of actions. Am J Chin Med. 2008;36(4):635-45. doi: 10.1142/S0192415X08006107.
- Background: PubMed 26906464Lu KW, Hsu CK, Hsieh CL, Yang J, Lin YW. Probing the Effects and Mechanisms of Electroacupuncture at Ipsilateral or Contralateral ST36-ST37 Acupoints on CFA-induced Inflammatory Pain. Sci Rep. 2016 Feb 24;6:22123. doi: 10.1038/srep22123.
- Background: PubMed 9249122Wang B, Tang J, White PF, Naruse R, Sloninsky A, Kariger R, Gold J, Wender RH. Effect of the intensity of transcutaneous acupoint electrical stimulation on the postoperative analgesic requirement. Anesth Analg. 1997 Aug;85(2):406-13. doi: 10.1097/00000539-199708000-00029.
- Background: PubMed 11506105Kotani N, Hashimoto H, Sato Y, Sessler DI, Yoshioka H, Kitayama M, Yasuda T, Matsuki A. Preoperative intradermal acupuncture reduces postoperative pain, nausea and vomiting, analgesic requirement, and sympathoadrenal responses. Anesthesiology. 2001 Aug;95(2):349-56. doi: 10.1097/00000542-200108000-00015.
- Background: PubMed 22330010Langenbach MR, Aydemir-Dogruyol K, Issel R, Sauerland S. Randomized sham-controlled trial of acupuncture for postoperative pain control after stapled haemorrhoidopexy. Colorectal Dis. 2012 Aug;14(8):e486-91. doi: 10.1111/j.1463-1318.2012.02984.x.
- Background: PubMed 12216602Sim CK, Xu PC, Pua HL, Zhang G, Lee TL. Effects of electroacupuncture on intraoperative and postoperative analgesic requirement. Acupunct Med. 2002 Aug;20(2-3):56-65. doi: 10.1136/aim.20.2-3.56.
- Background: PubMed 12406527Lin JG, Lo MW, Wen YR, Hsieh CL, Tsai SK, Sun WZ. The effect of high and low frequency electroacupuncture in pain after lower abdominal surgery. Pain. 2002 Oct;99(3):509-514. doi: 10.1016/S0304-3959(02)00261-0.
- Background: PubMed 10794114Wang RR, Tronnier V. Effect of acupuncture on pain management in patients before and after lumbar disc protrusion surgery--a randomized control study. Am J Chin Med. 2000;28(1):25-33. doi: 10.1142/S0192415X00000052.
- 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.
Ting Yu Lu, MD principal investigator
Division of thoracic surgery, China medical university hospital, Taiwan
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 in people with Acupuncture and Pain Control, run by China Medical University Hospital at 1 site in Taiwan.
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 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: status not confirmed, as of the sponsor's last update on 12 Dec 2016. 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 Taiwan. 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.
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 Ting Yu Lu, MD (+886-975682784, seawindss@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline pain scale at post operative day 2, after intervention (time frame: measure at post-operative day 1, 9AM, before intervention; and post-operative day 2, 5PM, after intervention). 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 NCT02959346, which also lists 16 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 12 Dec 2016.