LI4 Acupuncture for Analgesia in Intrauterine Device Insertion

Acute Pain Clinical Trial

Official title:

Does LI4 Acupuncture Provide an Effective Analgesia During Intrauterine Device

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04963582
• Other study ID #: 08.06.2021/30
• Status: Completed
• Phase: N/A
• Start date: July 5, 2021
• Est. completion date: October 1, 2021

Study information

• Verified date: October 2021
• Source: Nigde Omer Halisdemir University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Pain during IUD insertion is substantially psychologic in origin, responds extremely well to non-pharmacologic interventions. Considering the fact that acupuncture is a modality exerting both psychologic and physiologic effects, the authors presume that acupuncture administration before IUD insertion may have positive effects on pain control. From this point of view, the aim of this study to investigate the effects of LI4 acupuncture administered shortly before IUD insertion on pain perception and discomfort of the women.

Description:

Intrauterine devices (IUDs) are one the most preferred, most effective and reversible contraceptive methods with long term effects. The major drawback of women for IUD use is the pain anticipation during insertion of the device.

Studies using visual analog scale (VAS) demonstrated that pain perception during IUD insertion varied between 2-7 score. Surprisingly there are only limited number of studies on pain management during IUD insertion which is an ambulatory and out-patient gynecologic procedure. Besides the results of present studies contradict with each other. As a result, a standardized protocol is lacking for pain management in IUD insertion [1]. Currently, most of the IUDs are administered in Community Health Centers (CHC) in our country and no modality for pain control is applied before or after IUD insertion. In case of necessity intramuscular or oral analgesic drugs are prescribed.

In a long-standing review on the basics of this issue, it is concluded that the cervical component of pain perception during IUD insertion is psychologic rather than pathologic, is un-responsive to oral non-steroidal anti-inflammatory drugs and could be deducted via psyche-prophylactic methods. similar results were presented with studies undertaken In the advancing years. A recent study demonstrated that verbal inspiration techniques were as effective as oral tramadol for pain management in IUD insertion. Additionally, the effects of anticipation of pain on perception of pain is essential as well. Because in a large scale study, the results showed that one point increments in the VAS for anticipated pain resulted in an increase of pain perception by 19,7%. Therefore, the fact that psychologic, biologic, cognitive, behavioral, emotional and social factors interfere with pain perception is well-known and it is recommended by clinicians that these factors should be taken into consideration in processes of selecting modalities for pain management.

Scientists research for the mechanism of pain control that acupuncture provides. Acupuncture is extremely effective in autonomic nerve regulation. Also, crucial effects of afferent information within somatic nerve fibers on autonomic functions were demonstrated on experimental and clinical studies. Acupuncture relies on biology based physiologic and psychologic mechanisms. It causes both the secretion of oxytocin and endogen opioids that induce functional changes in various organ systems and rhythmic changes in vulnerable tissues via the stimulation of receptors or nerve fibers.

Acupoint LI4 is the most intensely studied, hte most preferred for analgesia and is the most used acupoint in routine daily practice. Studies on pain management in cases of chest tube pain, dental pain or multiple sclerosis were undertaken using LI4.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 72
• Est. completion date: October 1, 2021
• Est. primary completion date: October 1, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 50 Years

Eligibility

Inclusion Criteria:

• Women who wish to use IUD as contraception and who refer to Community Health Center for the procedure of IUD insertion.

Exclusion Criteria:

• Women who use anti-coagulant drugs or who have blood diseases.

• Women with dermatologic lesions on the area of LI4 point location.

• Women with previously diagnosed neurologic diseases.

Related Conditions & MeSH terms

• Acute Pain
• IUD Insertion Complication

Intervention

Procedure:
• Acupuncture
LI4 is located on the dorsum of the hand, midway between the 1st and 2nd metacarpal bones, approximately in the middle of the 2nd metacarpal bone on the radial side. Acupuncture is practiced by using 0,25x25mm sized needles. LI4 point is punctured perpendicularly 2cm in the direction of the palm center.

Locations

Country	Name	City	State
Turkey	Community Health Center	Nigde

Sponsors (1)

Lead Sponsor	Collaborator
Nigde Omer Halisdemir University

Country where clinical trial is conducted

Turkey, 

References & Publications (15)

Abu-Zaid A, Alshahrani MS, Albezrah NA, Miski NT, Abuzaid M, Aboudi SA, Baredwan A, Almadhi N, Baradwan A, Alomar O, Salem H, A Al-Badawi I, Baradwan S. Vaginal dinoprostone versus placebo for pain relief during intrauterine device insertion: a systematic — View Citation

Andersson S, Lundeberg T. Acupuncture--from empiricism to science: functional background to acupuncture effects in pain and disease. Med Hypotheses. 1995 Sep;45(3):271-81. — View Citation

Bracken J, Graham CA. Young women's attitudes towards, and experiences of, long-acting reversible contraceptives. Eur J Contracept Reprod Health Care. 2014 Aug;19(4):276-84. doi: 10.3109/13625187.2014.917623. Epub 2014 Jun 2. — View Citation

Daykan Y, Battino S, Arbib N, Tamir Yaniv R, Schonman R, Klein Z, Pomeranz J, Pomeranz M. Verbal analgesia is as good as oral tramadol prior to intrauterine device (IUD) insertion, among nulliparous women: A randomized controlled trial. Eur J Obstet Gynec — View Citation

Dijkhuizen K, Dekkers OM, Holleboom CA, de Groot CJ, Hellebrekers BW, van Roosmalen GJ, Janssen CA, Helmerhorst FM. Vaginal misoprostol prior to insertion of an intrauterine device: an RCT. Hum Reprod. 2011 Feb;26(2):323-9. doi: 10.1093/humrep/deq348. Epu — View Citation

Dina B, Peipert LJ, Zhao Q, Peipert JF. Anticipated pain as a predictor of discomfort with intrauterine device placement. Am J Obstet Gynecol. 2018 Feb;218(2):236.e1-236.e9. doi: 10.1016/j.ajog.2017.10.017. Epub 2017 Nov 8. — View Citation

Gatchel RJ, Peng YB, Peters ML, Fuchs PN, Turk DC. The biopsychosocial approach to chronic pain: scientific advances and future directions. Psychol Bull. 2007 Jul;133(4):581-624. Review. — View Citation

Goldstuck ND. Pain reduction during and after insertion of an intrauterine contraceptive device. Adv Contracept. 1987 Mar;3(1):25-36. — View Citation

Han JS, Terenius L. Neurochemical basis of acupuncture analgesia. Annu Rev Pharmacol Toxicol. 1982;22:193-220. Review. — View Citation

Hunter TA, Sonalkar S, Schreiber CA, Perriera LK, Sammel MD, Akers AY. Anticipated Pain During Intrauterine Device Insertion. J Pediatr Adolesc Gynecol. 2020 Feb;33(1):27-32. doi: 10.1016/j.jpag.2019.09.007. Epub 2019 Sep 26. — View Citation

Lopez LM, Bernholc A, Zeng Y, Allen RH, Bartz D, O'Brien PA, Hubacher D. Interventions for pain with intrauterine device insertion. Cochrane Database Syst Rev. 2015 Jul 29;(7):CD007373. doi: 10.1002/14651858.CD007373.pub3. Review. — View Citation

Miles SM, Shvartsman K, Dunlow S. Intrauterine lidocaine and naproxen for analgesia during intrauterine device insertion: randomized controlled trial. Contracept Reprod Med. 2019 Sep 10;4:13. doi: 10.1186/s40834-019-0094-0. eCollection 2019. — View Citation

Ngo LL, Ward KK, Mody SK. Ketorolac for Pain Control With Intrauterine Device Placement: A Randomized Controlled Trial. Obstet Gynecol. 2015 Jul;126(1):29-36. doi: 10.1097/AOG.0000000000000912. — View Citation

Origoni M, Leone Roberti Maggiore U, Salvatore S, Candiani M. Neurobiological mechanisms of pelvic pain. Biomed Res Int. 2014;2014:903848. doi: 10.1155/2014/903848. Epub 2014 Jul 8. Review. — View Citation

Ter Riet G, de Craen AJM, de Boer A, Kessels AGH. Is placebo analgesia mediated by endogenous opioids? A systematic review. Pain. 1998 Jun;76(3):273-275. doi: 10.1016/S0304-3959(98)00057-8. Review. — View Citation

* Note: There are 15 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain perception	Pain perception is measured by using 10-point rated Visuel Analog Scale. Zero point in the scale refers to no pain whereas 10 points refers to worst pain experienced by the patient.	At the 3rd minute after IUD insertion is completed
Primary	Pain perception	Pain perception is measured by using 10-point rated Visuel Analog Scale. Zero point in the scale refers to no pain whereas 10 points refers to worst pain experienced by the patient.	At the 10th minute after IUD insertion is completed