Information-motivation-behavior Skills ModelNCT07883785
Application of Chain Management Based on the IMB Model in Patients With Kinesiophobia Following Lumbar Fusion Surgery
A study testing Basic Postoperative Care and chain management based on the Information-Motivation-Behavioral Skills model in people with Information-motivation-behavior Skills Model, run by Jiawei Jiang at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Information-motivation-behavior Skills Model
- What is being tested?
- Basic Postoperative Care and chain management based on the Information-Motivation-Behavioral Skills model
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 104 participants
- Where
- 1 siteChina
- Study dates
- 1 Feb 2024to 1 Oct 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Concomitant other lumbar spine-related medical history and inability to perform functional exercises
- Malignancy or concomitant damage to important organs such as the brain, heart, and lungs
- Cognitive impairment
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Affiliated 2 Hospital of Nantong University, Nantong, Jiangsu 0513
Nantong, Jiangsu
Qin Xuan, 15189406162, 1061867253@qq.com
About this study
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.
- Being tested
- Basic Postoperative Care, chain management based on the Information-Motivation-Behavioral Skills model
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Basic Postoperative CareBehavioural
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.
chain management based on the Information-Motivation-Behavioral Skills modelBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| The control group | Active comparator | The control group received routine nursing intervention Receives: Behavioral: Basic Postoperative Care |
| The intervention group | Experimental | 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. Receives: Behavioral: chain management based on the Information-Motivation-Behavioral Skills model |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: The TSK scores were collected at baseline and at 1 months, and 6 months post-intervention.
Secondary outcomes (2)
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.
Measured: The NRS scores were collected at baseline and at 1 months, and 6 months post-intervention.
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.
Measured: The NRS scores were collected at baseline and at 1 months, and 6 months post-intervention.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Oct 2026
- Study start1 Feb 2024
- Primary completion1 Feb 2028 (estimated)
- Study completion1 Oct 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Information-motivation-behavior Skills ModelStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 104 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jiawei Jiang
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Jiawei Jiang, Affiliated 2 Hospital of Nantong University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07883785
- Sponsor's protocol ID
- QinXuan
- Status last verified
- Oct 2026
- First submitted
- 14 Oct 2026
- Last updated
- 20 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Application of Chain Management Based on the IMB Model in Patients With Kinesiophobia Following Lumbar Fusion Surgery
- ClinicalTrials.gov ID
- NCT07883785
- Acronym / sponsor ID
- QinXuan
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 104 participants (estimated)
- Lead sponsor
- Jiawei JiangUniversity, hospital or other
- Study start
- 1 Feb 2024 (actual)
- Primary completion
- 1 Feb 2028 (estimated)
- Study completion
- 1 Oct 2028 (estimated)
- First posted
- 20 Oct 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| The control group | Active comparator | Behavioral: Basic Postoperative CareThe control group received routine nursing intervention |
| The intervention group | Experimental | Behavioral: chain management based on the Information-Motivation-Behavioral Skills modelThe 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (3 listed)
- Concomitant other lumbar spine-related medical history and inability to perform functional exercises
- Malignancy or concomitant damage to important organs such as the brain, heart, and lungs
- Cognitive impairment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Basic Postoperative CarePostoperative: 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. | Behavioural | The control group |
| chain management based on the Information-Motivation-Behavioral Skills modelThe 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. | Behavioural | The intervention group |
Primary outcome
Tampa Scale for Kinesiophobia
Time frame: The TSK scores were collected at baseline and at 1 months, and 6 months post-intervention.
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.
2 secondary outcomes
NRS Score
Time frame: The NRS scores were collected at baseline and at 1 months, and 6 months post-intervention.
the Oswestry Disability Index，ODI
Time frame: The NRS scores were collected at baseline and at 1 months, and 6 months post-intervention.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Oct 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Basic Postoperative Care and chain management based on the Information-Motivation-Behavioral Skills model in people with Information-motivation-behavior Skills Model, run by Jiawei Jiang at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 20 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Qin Xuan (15189406162, 1061867253@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Tampa Scale for Kinesiophobia (time frame: The TSK scores were collected at baseline and at 1 months, and 6 months post-intervention.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Oct 2026.