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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
- Source :
- Trials, Vol 19, Iss 1, Pp 1-8 (2018), Trials
- Publication Year :
- 2018
- Publisher :
- BMC, 2018.
-
Abstract
- Background 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. 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/design This 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. Discussion The results of this trial will help to establish the clinical evidence regarding TEA in the treatment of patients with LHIVD. Trial registration ClinicalTrials.gov, NCT03236753. Registered on August 2, 2017. Clinical Research Information Service of the Republic of Korea, KCT0002439. Registered on August 1, 2017. Electronic supplementary material The online version of this article (10.1186/s13063-018-2864-4) contains supplementary material, which is available to authorized users.
- Subjects :
- Male
Time Factors
Acupuncture Therapy
Medicine (miscellaneous)
law.invention
Study Protocol
0302 clinical medicine
Randomized controlled trial
law
Back pain
Medicine
Multicenter Studies as Topic
Pharmacology (medical)
030212 general & internal medicine
Intervertebral Disc
Radiculopathy
Randomized Controlled Trials as Topic
lcsh:R5-920
Lumbar Vertebrae
Middle Aged
Oswestry Disability Index
Treatment Outcome
Lumbar disc herniation
Female
medicine.symptom
lcsh:Medicine (General)
Intervertebral Disc Displacement
Adult
medicine.medical_specialty
Visual analogue scale
03 medical and health sciences
Young Adult
Lumbar
Double-Blind Method
Republic of Korea
Thread-embedding acupuncture
Acupuncture
Humans
Lower back pain
Lumbar herniated intervertebral disc
Aged
Referred pain
business.industry
Recovery of Function
Clinical trial
Physical therapy
Quality of Life
business
Low Back Pain
030217 neurology & neurosurgery
Subjects
Details
- Language :
- English
- ISSN :
- 17456215
- Volume :
- 19
- Issue :
- 1
- Database :
- OpenAIRE
- Journal :
- Trials
- Accession number :
- edsair.doi.dedup.....704ed7b6db28f2146eeed9af08f05044