---
title: Paraspinal Muscle Degeneration, Bone Mass and Clinical Outcomes in Patients With Lumbar Degenerative Diseases
nct_id: NCT05190289
overall_status: UNKNOWN
sponsor: Peking University Third Hospital
study_type: OBSERVATIONAL
primary_condition: Degenerative Lumbar Spinal Stenosis
countries: China
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT05190289.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT05190289"
ct_last_update_post_date: 2022-01-13
last_seen_at: "2026-05-12T06:03:25.585Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# Paraspinal Muscle Degeneration, Bone Mass and Clinical Outcomes in Patients With Lumbar Degenerative Diseases

**Official Title:** The Relationship Between Paraspinal Muscle Degeneration and Bone Mass and Clinical Outcomes After Surgery in Patients With Lumbar Degenerative Diseases

**NCT ID:** [NCT05190289](https://clinicaltrials.gov/study/NCT05190289)

## Key Facts

- **Status:** UNKNOWN
- **Study Type:** OBSERVATIONAL
- **Target Enrollment:** 600
- **Lead Sponsor:** Peking University Third Hospital
- **Conditions:** Degenerative Lumbar Spinal Stenosis, Degenerative Scoliosis
- **Start Date:** 2021-04-03
- **Completion Date:** 2022-09-30
- **CT.gov Last Update:** 2022-01-13

## Brief Summary

This study was a retrospective study. The investigators intended to review the preoperative paraspinal muscle imaging data of patients with lumbar spinal stenosis and degenerative scoliosis treated in hospital, and follow up the symptoms, quality of life and surgical complications at 1 year and at the last follow-up. The aims were: (1) to explore the correlation between paraspinal muscle imaging parameters and clinical outcomes; (2) based on the postoperative functional scores and the presence of complications, to explore the best combination of imaging parameters for predictive value of prognosis; (3) to evaluate the consistency between different measurement methods, and improve the standardized paraspinal muscle imaging assessment; (4) Combining the characteristics of individual bone mass and paravertebral muscle (functional and imaging assessment), to explore the correlation between bone loss and paravertebral muscle degeneration; (5) to explore a muscle-bone mass assessment system that could reflect the prognosis of patients.

## Detailed Description

This study was a retrospective study. The investigators intended to review the preoperative paraspinal muscle imaging data of patients with lumbar spinal stenosis and degenerative scoliosis treated in our hospital, and follow up the symptoms, quality of life and surgical complications at 1 year and at the last follow-up. The aims were: (1) to explore the correlation between paraspinal muscle imaging parameters and clinical outcomes; (2) based on the postoperative functional scores and the presence of complications, to explore the best combination of imaging parameters for predictive value of prognosis; (3) to evaluate the consistency between different measurement methods, and improve the standardized paraspinal muscle imaging assessment; (4) Combining the characteristics of individual bone mass and paravertebral muscle (functional and imaging assessment), to explore the correlation between bone loss and paravertebral muscle degeneration; (5) to explore a muscle-bone mass assessment system that could reflect the prognosis of patients.

The investigators intended to review the patients who underwent posterior surgery for degenerative lumbar diseases from January 2010 to December 2019.

1. To review the patients who underwent posterior surgery in orthopedic department for degenerative scoliosis. The inclusion criteria were: (1) above the age of 45; (2) satisfy at least one of the following criteria: cobb angle \> 10°, sagittal vertical axis (SVA) \> 5cm, pelvic tilt (PT) \> 25°, or thoracic kyphosis (TK) \> 60°. The exclusion criteria were: (1) with a history of arthritic tumor or neuromuscular disease (2) with a history of spinal surgery.
2. To review the patients who underwent posterior surgery in orthopedic department for lumbar spinal stenosis. The inclusion criteria were: (1) above the age of 45; (2) diagnosis of lumbar spinal stenosis. The exclusion criteria were: (1) with a history of arthritic tumor or neuromuscular disease (2) with a history of spinal surgery.

## Eligibility

- **Minimum age:** 45 Years
- **Sex:** ALL

```
Inclusion Criteria:

* Underwent posterior surgery for degenerative scoliosis;
* Above the age of 45;
* Satisfy at least one of the following criteria: cobb angle \> 10°, sagittal vertical axis \> 5cm, pelvic tilt \> 25°, or thoracic kyphosis \> 60°.

Exclusion Criteria:

* Underwent posterior surgery for lumbar spinal stenosis;
* Above the age of 45;
* Diagnosis of lumbar spinal stenosis.
```

## Arms

- **Compared Group** — Patients without inferior clinical outcomes
- **Case Group** — Patients with inferior clinical outcomes

## Interventions

- **Pre-existing degenerative factors of paraspinal muscles and bone mass** (OTHER) — Pre-existing degenerative factors of paraspinal muscles, including muscle atrophy and fat infiltration; bone mass

## Primary Outcomes

- **Disability** _(time frame: 12 months; through study completion, an average of 3 years)_ — The Oswestry Disability Index (ODI) (0-100, high score indicates severer disability) is used to assess disability.
- **Low Back pain** _(time frame: 12 months; through study completion, an average of 3 years)_ — The Visual Analog Scale (VAS) (0-10, high score indicates more pain) is used to evaluate leg pain.
- **Leg pain** _(time frame: 12 months; through study completion, an average of 3 years)_ — The Visual Analog Scale (VAS) (0-10, high score indicates more pain) is used to evaluate leg pain.
- **Sagittal balance** _(time frame: 12 months; through study completion, an average of 3 years)_ — Sagittal balance is evaluated by anteroposterior and lateral X-ray of the whole spine at the standing position.
- **Bone nonunion** _(time frame: 12 months; through study completion, an average of 3 years)_ — Bone nonunion was evaluated by dynamic X-ray. Bone nonunion was defined as 1) there was no continued bone fusion mass at any fusion segment; 2) any motion (greater than 3 mm or 3°) on flexion/ extension plain radiographs.
- **Screw loosening** _(time frame: 12 months; through study completion, an average of 3 years)_ — Screw loosening was evaluated on spine radiograph or CT. Screw loosening was defined when a 1mm or wider circumferential radiolucent line around the pedicle screw was confirmed.
- **Proximal junctional kyphosis** _(time frame: 12 months; through study completion, an average of 3 years)_ — Proximal junctional angle (PJA) was determined by the sagittal angle subtended by the inferior endplate of the uppermost instrumented vertebra (UIV) and the superior end plate of the vertebrae two levels above the UIV (UIV + 2). The definition of proximal junctional kyphosis (PJK) was PJA 10 or greater and at least 10 greater than the corresponding preoperative measurement.
- **Proximal scoliosis progression** _(time frame: 12 months; through study completion, an average of 3 years)_ — The proximal scoliosis progression (PSP) was defined as the disc wedging increased 10 degrees from postoperative to two-year follow up on the AP radiograph.

## Locations (1)

- Peking University Third Hospital, Beijing, Beijing Municipality, China — _RECRUITING_

## Recent Field Changes (last 30 days)

- `status.overallStatus` — added _(2026-05-12)_
- `status.primaryCompletionDate` — added _(2026-05-12)_
- `status.completionDate` — added _(2026-05-12)_
- `status.lastUpdatePostDate` — added _(2026-05-12)_
- `design.enrollmentCount` — added _(2026-05-12)_
- `eligibility.criteria` — added _(2026-05-12)_
- `eligibility.minAge` — added _(2026-05-12)_
- `eligibility.sex` — added _(2026-05-12)_
- `outcomes.primary` — added _(2026-05-12)_
- `armsInterventions.arms` — added _(2026-05-12)_
- `armsInterventions.interventions` — added _(2026-05-12)_
- `sponsor.lead` — added _(2026-05-12)_
- `results.hasResults` — added _(2026-05-12)_
- `locations.peking university third hospital|beijing|beijing municipality|china` — added _(2026-05-12)_

---

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