NCT03236753

Clinical Research on the Efficacy of Thread-embedding Acupuncture on Herniated Intervertebral Disc of Lumbar Spine

Clinical Research on the Efficacy and Safety of Thread-embedding Acupuncture for Treatment of Herniated Intervertebral Disc of Lumbar Spine; A Multicenter, Randomized, Patient-assessor Blinded, Controlled, Parallel Clinical Trial

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 70 (actual)
• Sponsor: Kyunghee University Medical Center · Academic / Other
• Sex: All
• Age: 19 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

This clinical trial is designed to evaluate the efficacy and safety of thread-embedding acupuncture for treatment of lumbar herniated intervertebral disc (L-HIVD) by assessing pain, function, and quality of life.

Detailed description

Seventy patient between the ages of 19 and 70 with L-HIVD will be recruited by eligibility criteria and randomly allocated to the thread-embedding acupuncture (TEA) group and sham thread-embedding acupuncture (STEA) group. Both groups will receive treatment on predefined 23 acupoints once a week for 8 weeks, and needle with thread removed will be used in STEA group instead of normal TEA. 100 mm visual analogue scale (VAS) for low back pain will be assessed as a primary outcome. Also, 100mm VAS for radiating pain, Oswestry disability index (ODI), Rolland Morris disability questionnaire (RMDQ), EQ-5D-5L and global perceived effect (GPE) will be measured as secondary outcomes. All the outcomes will be assessed at baseline, 4 weeks after screening, treatment end (8 weeks, primary end point) and follow-up sessions (12 and 16 weeks).

Conditions

• Lumbar Disc Herniation

Interventions

Type	Name	Description
PROCEDURE	Thread-embedding Acupuncture (TEA)	The acupoints and size of TEA are as follows: 1. Both EX-B2 of herniated intervertebral disc level, its upper level and its lower level (6 acupoints): perpendicular insertion, 4cm 2. Both BL24: transverse insertion toward L1 level along the erector muscle of spine, 6cm 3. Both BL25: transverse insertion toward iliac crest, 4cm 4. Both BL26: transverse insertion toward L1 level along the erector muscle of spine, 6cm 5. Both BL26: oblique insertion toward iliolumbar ligament, 6cm 6. Both EX-B7: oblique insertion toward gluteus medius muscle, 6cm 7. Both BL28: oblique insertion toward sacroiliac ligament, 6cm 8. Both GB30: perpendicular insertion, 6cm 9. Symptomatic side GB34, BL57 and ST36: oblique insertion toward foot, 4cm
PROCEDURE	Sham Thread-embedding Acupuncture (STEA)	All procedure of STEA group, including acupoints and size of TEA will be same as that of TEA group. However, thread-removed TEA will be used for STEA group instead of normal TEA, and removing procedure of thread will be performed aseptic and secretly for patient-blinding and prevention of infection.

Timeline

• Start date: 2017-08-11
• Primary completion: 2019-06-04
• Completion: 2019-07-30
• First posted: 2017-08-02
• Last updated: 2020-02-06

Locations

4 sites across 1 country: South Korea