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RecruitingNCT07883785Updated Oct 20, 2026

Application of Chain Management Based on the IMB Model in Patients With Kinesiophobia Following Lumbar Fusion Surgery

An interventional study of Basic Postoperative Care and chain management based on the Information-Motivation-Behavioral Skills model in Information-motivation-behavior Skills Model, sponsored by Jiawei Jiang. Recruiting at 1 site in China. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2026-10-20.

Sponsored by Jiawei Jiang · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 2 years 8 months after the study started (first participant enrolled Feb 2024, registered Oct 2026).
  • Started Feb 2024; still recruiting 2 years 9 months later.
Updated Oct 20, 2026Newly registeredGo to Updates ↓
Phase
Not applicable
Study type
Interventional
Enrollment
104
Allocation
Non-randomized
Ages
18 Years to 65 Years
Sex
All
01

Study summary

This study aims to investigate the application effect of chain management based on the Information-Motivation-Behavioral Skills (IMB) model in patients with kinesiophobia after lumbar fusion surgery. The intervention is designed to provide IMB model-based chain management, with routine nursing intervention as the control, and to evaluate the degree of kinesiophobia (TSK), pain intensity (NRS), lumbar function (ODI), and spinal posture indicators (trunk deviation angle, pelvic torsion angle, and the sum of the maximum left and right vertebral rotation angles) at different time points before and after the intervention. The ultimate objectives are to reduce the level of kinesiophobia, relieve pain, improve lumbar stability and lumbar function, and promote postoperative rehabilitation in patients after lumbar fusion surgery.

02

Conditions studied

  • Information-motivation-behavior Skills Model

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03

In context

Behavior

1,573 studies on the registry are indexed under Behavior; 313 are open to participants now.

This study's planned enrollment of 104 is below the median of 120 across 1,197 interventional studies indexed under Behavior.

Browse Behavior studies →

Lead sponsor

Jiawei Jiang is the lead sponsor of 6 studies on the registry; 5 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Confirmed diagnosis of degenerative spinal disease
  • First-time treatment with posterior lumbar decompression and interbody fusion, with stable vital signs after surgery
  • Age ≥18 years
  • TSK (Tampa Scale of Kinesiophobia) score >37 within 48 h after surgery

Exclusion criteria

Exclusion Criteria:

  • Concomitant other lumbar spine-related medical history and inability to perform functional exercises
  • or concomitant damage to important organs such as the brain, heart, and lungs
  • Cognitive impairment
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Cancer (malignancy)

Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.

Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
104 participants (estimated)

Study arms

  • Active comparator
    The control group

    The control group received routine nursing intervention

    Behavioral: Basic Postoperative Care

  • Experimental
    The intervention group

    The experimental group received IMB model-based chain management for kinesiophobia after lumbar fusion surgery, delivered by a multidisciplinary team. It included daily kinesiophobia assessment, early warning, chain responses, rehabilitation and analgesia adjustment, psychological intervention, and continuous postoperative assessment-intervention-reassessment.

    Behavioral: chain management based on the Information-Motivation-Behavioral Skills model

Interventions

  • BehavioralBasic Postoperative Care

    Postoperative: Primary nurses provided disease and surgery education, guided pain self-assessment, assisted logrolling (every 2 h), and taught ankle pump exercises (3-4 times/day, 20-30 sets each time) to prevent DVT and straight leg raising (3 times/day, 5 min each time) to prevent nerve root adhesion. After drain removal, patients were taught brace wearing, standing posture correction, and gait/balance training.Discharge: A discharge education sheet was provided, instructing patients to avoid bending, weight-bearing, prolonged sitting, and cold exposure, and to lie on a firm mattress. At 3 weeks postoperatively, lumbar and back muscle exercises were taught.After discharge: Routine telephone follow-ups were conducted at 1 and 3 months, and patients were reminded to return for follow-up on time.

  • Behavioralchain management based on the Information-Motivation-Behavioral Skills model

    The intervention group received IMB model-based chain management for kinesiophobia after lumbar fusion. A 9-member multidisciplinary team (spine surgery, rehabilitation, psychology, pain) was formed to implement the protocol, adjust rehabilitation and analgesia, provide cognitive behavioral intervention, and collect data. During hospitalization, daily assessment triggered chain responses for refusal to move after 3 days, increased catastrophizing, pain NRS≥4 with fear, or failure to meet activity goals for 2 days. Responses included rehabilitation adjustment, psychological intervention within 24h, and analgesia adjustment. The vertical chain used the postoperative timeline (assessment-intervention-reassessment), with visual materials for older or less educated patients.

06

What researchers measure

Primary outcomes

  1. Tampa Scale for Kinesiophobia

    Kinesiophobia was assessed using a scale containing 17 items. A 4-point Likert scoring method was used, with each item scored from 0 to 4, and the total score ranging from 17 to 68. Higher scores indicate a more significant pathological fear of movement.

    Time frame: The TSK scores were collected at baseline and at 1 months, and 6 months post-intervention.

Secondary outcomes

  1. NRS Score

    Postoperative pain was assessed using the Numerical Rating Scale (NRS), with a total score ranging from 0 to 10, where 0 indicates no pain, 1-3 indicates mild pain, 4-6 indicates moderate pain, 7-9 indicates severe pain, and 10 indicates excruciating pain.

    Time frame: The NRS scores were collected at baseline and at 1 months, and 6 months post-intervention.

  2. the Oswestry Disability Index,ODI

    The scale includes 10 items, such as pain intensity, self-care, lifting, walking, and sitting. Each item is scored on a 6-point Likert scale (0-5). The total score = actual score / 50 (highest possible score) × 100%. Higher scores indicate more severe functional disability.

    Time frame: The NRS scores were collected at baseline and at 1 months, and 6 months post-intervention.

07

Study locations

1 of 1 sites recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

1 registry update since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Feb 2024 (actual). Primary completion is estimated for Feb 2028, 48 months after the start.

Of 741 non-industry interventional studies with no phase under Behavior, half reached primary completion within 14 months of starting (the median), counting those still running; a quarter within 5 and three quarters within 32. This study's planned 48 months is above that.

Counting every sponsor, half of 757 studies reached it within 13 months; a quarter within 5 and three quarters within 32.

How these figures are worked out, and which studies are left out of them.

Registered
Oct 14, 2026
First posted
Oct 20, 2026
StartActual
Feb 1, 2024
Primary completionEst.
Feb 1, 2028
CompletionEst.
Oct 1, 2028
Last update
Oct 20, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Registered
First appeared on the registry. No changes since
Oct 20, 2026
Show all 1 update
  1. Oct 20, 2026
    First appeared on the registry

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07883785
Lead sponsor
Jiawei Jiang
Responsible party
Jiawei Jiang (Attending Physician, Affiliated 2 Hospital of Nantong University) — Sponsor-investigator
First posted
Oct 20, 2026
Start date
Feb 1, 2024
Primary completion
Feb 1, 2028 (estimated)
Completion
Oct 1, 2028 (estimated)
Last update
Oct 20, 2026

Study contacts

Qin Xuan
Contact
1061867253@qq.com
15189406162

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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