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.
Highlights
A lumbar herniated intervertebral disc (LHIVD) is a common problem that usually causes lower back pain and neurological symptoms that manifest as radiating pain
Several recent randomized clinical trials (RCTs) have reported that thread-embedding acupuncture (TEA) has a more favorable therapeutic effect on LHIVD than other types of acupuncture or other treatments, the evidence remains limited because these trials used poor assessment methods and had a high risk of bias [14]
TEA has been reported to have beneficial effects on musculoskeletal diseases such as ankylosing spondylitis [33], chronic pelvic pain [34], and cervical spondylosis [35], and a review study on the use of TEA to treat LHIVD reported that 17 RCTs had positive results
Summary
A 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. These studies were of low quality and there is little clinical evidence for the effectiveness of TEA in this regard. A lumbar herniated intervertebral disc (LHIVD) is a common problem leading to lower back pain and neurological symptoms, including radiating pain in the lower extremities [1]. Several recent randomized clinical trials (RCTs) have reported that TEA has a more favorable therapeutic effect on LHIVD than other types of acupuncture or other treatments, the evidence remains limited because these trials used poor assessment methods and had a high risk of bias [14]
Talk to us
Join us for a 30 min session where you can share your feedback and ask us any queries you have