A novel and minimally invasive surgery termed Percutaneous-transpedicular Injection of Polymethylmethacrylate into the Intervertebral vacuum space (PIPI) for chronic and disabling low back pain associated with de novo degenerative lumbar scoliosis in the elderly: a prospective single-center cohort study

A novel and minimally invasive surgery termed Percutaneous-transpedicular Injection of Polymethylmethacrylate into the Intervertebral vacuum space (PIPI) for chronic and disabling low back pain associated with de novo degenerative lumbar scoliosis in the elderly: a prospective single-center cohort study - Prospective cohort study of a targeted operative therapy for low back pain associated with de novo degenerative lumbar scoliosis in the elderly.

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000016127

Enrollment

162

Registered

2015-01-06

Start date

2000-08-01

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Degenerative lumbar scoliosis

Interventions

PIPI Non-operative treatment

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1) De novo degenerative lumbar scoliosis with a Cobb angle >=10 degrees 2) Degenerative lumbar scoliosis patients aged >=65 years 3) Low back pain (LBP) lasted for >6 months with an intensity of VAS >50 points on a 0 to 100-point visual analogue scale (VAS), with 0 and 100 denoting no and maximal pain, respectively 4) Intervertebral vacuum phenomenon on coronal reconstructed CT 5) Vertebral bone marrow edema on coronal gadolinium-contrasted T1- or T2-weighed fat-saturated images 6) Locations of bone marrow edema in the spine consistent with those of lumbar tender points

Exclusion criteria

Exclusion criteria: 1) Osteoporosis or lumbar vertebral density <70% of that of the young adult mean as determined by dual-energy x-ray absorptiometry 2) Infectious disease 3) Tumorous conditions of the spine 4) History of lumbar surgery 5) Leg length discrepancy due to hip or knee joint disease 6) LBP alleviated by facet joint anesthetic injections 7) Disoriented or did not complete the screening questionnaire

Design outcomes

Primary

Measure	Time frame
1) Visual analogue scale (VAS) for low back pain 2) Oswestry disability index 3) Bone marrow edema on MRI	—

Countries

Japan

Contacts

Public ContactYoshinori Fujimoto

JA Hiroshima General Hospital Dept. of Orthopaedic Surgery

skydog1018@m6.dion.ne.jp+81-829-36-311

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026