Clinical research on the efficacy and safety of thread-embedding acupuncture for treatment of herniated intervertebral disc of the lumbar spine: a protocol for a multicenter, randomized, patient–assessor blinded, controlled, parallel, clinical trial

Abstract

BackgroundA lumbar herniated intervertebral disc (LHIVD) is a common problem that usually causes lower back pain and neurological symptoms that manifest as radiating pain. Several studies have reported that thread-embedding acupuncture (TEA) is effective in the treatment of LHIVD. However, these studies were of low quality and there is therefore little clinical evidence for the effectiveness of TEA in this regard. The aim of the present study is to establish the clinical evidence regarding the efficacy and safety of TEA in the treatment of pain, function, and quality of life in patients with LHIVD. The study uses a rigorously designed, full-scale, randomized clinical trial (RCT) protocol.Method/designThis is a multicenter, randomized, patient–assessor blinded, sham-controlled trial with two parallel arms. Seventy patients with LHIVD who have lower back pain more severe than 40 mm on the 100-mm visual analogue scale (VAS), and who are aged 19–70 years, will be recruited and randomly allocated to a TEA group and sham TEA (STEA) group. Both groups will receive treatment on 23 predefined acupoints once a week for eight weeks; needles with the thread removed will be used in the STEA group, while normal TEA will be employed in the TEA group. Changes in the 100-mm VAS for lower back pain after eight weeks will be assessed as the primary outcome. Furthermore, the 100-mm VAS for radiating pain, Oswestry Disability Index, Roland–Morris disability questionnaire, EuroQol 5 Dimensions 5 Levels, and global perceived effect will be measured and analyzed as secondary outcomes. All outcomes will be assessed at baseline and at 4, 8, 12, and 16 weeks after screening.DiscussionThe results of this trial will help to establish the clinical evidence regarding TEA in the treatment of patients with LHIVD.Trial registrationClinicalTrials.gov, NCT03236753. Registered on August 2, 2017.Clinical Research Information Service of the Republic of Korea, KCT0002439. Registered on August 1, 2017.Electronic supplementary materialThe online version of this article (10.1186/s13063-018-2864-4) contains supplementary material, which is available to authorized users.

Thread-Embedding Acupuncture for the Treatment of Shoulder Instability: Protocol for a Randomized, Controlled, Patient-Assessor Blinded Pilot Study

“…Previous studies have shown that the embedded thread, which is gradually absorbed into the body, causes a long-term therapeutic effect through mechanical and chemical stimulation at the treatment site. 26 In this trial, a STEA needle without the thread will be set as the control intervention, with reference to previous studies 22,27,28 to confirm only the effect of the embedded thread, excluding the stimulation effect of needle insertion. Additionally, to confirm the long-term maintenance effect, 8 weeks of follow-up assessment will be conducted after the end of treatment sessions.…”

An Economic Evaluation of Thread Embedding Acupuncture for the Treatment of Lumbar Herniated Intervertebral Disc in a Randomized Controlled Clinical Trial

“…This RCT had approval from the Institutional Review Boards of the institutions involved (KHUHGD: KHNMCOH 2016-09-006, KHUMC: 161216-HR-006, DUBOH: 2016-0012, DKMHDHU: DHUMC-D16015-PRO-02) [12].…”

“…In the RCT [12], participants were selected by the following criteria; (1) men or women aged 19 to 70 years; (2) patients whose magnetic resonance image or computed tomography image showed a severe bulging abnormality in the lumbar spine and corresponding symptoms of radiating pain; (3) patients who complained of low back pain and indicated more than 40 mm on the 100 mm VAS; and (4) patients who voluntarily participated and agreed to give signed informed consent, after hearing the details of the clinical trial.…”

“…In the RCT [12], there were 35 participants who met the inclusion criteria and were randomly assigned to a group. The study was powered to 80%, considering a dropout rate of 20%.…”

“…An economic evaluation of LHIVD treatment was reported, however, it was limited to a comparison between surgical and non-surgical treatments [11]. A randomized controlled clinical trial was conducted to examine the basis for the use of TEA in the treatment of LHIVD [12]. In this current study, an economic evaluation of TEA was conducted concurrently with a clinical trial to assess the economic feasibility of TEA as a treatment for LHIVD.…”