Adjacent Segment DegenerationNCT07396051
Rehabilitation Exercise Against Complications in High-risk Elderly After Lumbar Fusion(REACH)
A study testing Postoperative Multimodal Rehabilitation Program in people with Adjacent Segment Degeneration and Multimodal Rehabilitation, run by Xuanwu Hospital, Beijing at 3 sites in China.
Trial summary
This is a prospective, randomized controlled trial aimed at evaluating whether a structured multimodal rehabilitation program can delay or reduce the occurrence of adjacent segment degeneration (ASDeg) in frail elderly patients after short-segment lumbar fusion surgery. Read more about this study
- Who is it for?
- Ages 75 years and older
- Conditions the study is for
- Adjacent Segment Degeneration, Multimodal Rehabilitation, Lumber Fusion
- What is being tested?
- Postoperative Multimodal Rehabilitation Program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 212 participants
- Where
- 3 sitesChina
- Study dates
- 25 Jan 2026to 1 Mar 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 75 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Age ≥ 75 years.
- Classified as "frail" according to the Fried frailty phenotype.
- Scheduled for first-time, posterior short-segment (1-2 levels) lumbar instrumented fusion surgery.
- Willing and able to provide written informed consent and complete the 2-year follow-up.
Who cannot join
- History of previous lumbar spine surgery.
- Lumbar pathology due to tumor, trauma, infection, or congenital deformity.
- Comorbidities with a severe impact on prognosis or ability to participate in rehabilitation (e.g., severe cardiopulmonary disease, advanced dementia).
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
China3 sites, 3 recruiting
- Recruiting
Beijing Friendship Hospital
Beijing, Beijing Municipality, 10053
Yang Yong, PhD., 18310031517, yrz0116@163.com
- Recruiting
Peking University First Hospital, Beijing, Beijing 10034
Beijing, Beijing Municipality, 10053
Li Chunde, PhD., 13699188306, lichunde@vip.sina.com
- Recruiting
Xuanwu Hospital, Capital Medical University
Beijing, Beijing Municipality, 10053
Lu Shibao, PhD., +8618310031517, 1831327488@qq.com
About this study
Official title: A Randomized Controlled Trial of Multimodal Rehabilitation Versus Standard Care on Adjacent Segment Degeneration in Frail Elderly Patients Undergoing Short-Segment Lumbar Fusion
This is a prospective, randomized controlled trial aimed at evaluating whether a structured multimodal rehabilitation program can delay or reduce the occurrence of adjacent segment degeneration (ASDeg) in frail elderly patients after short-segment lumbar fusion surgery.
Read the detailed description
- Rationale and Scientific Background Adjacent segment degeneration (ASDeg) represents a major determinant of long-term clinical success after lumbar fusion. In frail older adults (≥75 years, Fried phenotype), the risk is theorized to be amplified due to age-related sarcopenia, osteopenia, diminished healing capacity, and compensatory biomechanical overload. While Enhanced Recovery After Surgery (ERAS) protocols address acute perioperative stress, they do not provide a targeted, long-term strategy to modify the underlying biological and biomechanical progression toward ASD. This trial is grounded on the hypothesis that a structured, multimodal rehabilitation program, initiated after the initial bone-soft tissue healing phase (12 weeks), can enhance paraspinal muscular endurance, improve global sagittal alignment, increase bone density, and mitigate systemic frailty. This multisystem approach aims to decelerate the degenerative cascade at adjacent segments compared to standard care alone.
- Intervention Design and Theoretical Framework Timing Rationale: The intervention commencement at 12 weeks postoperatively is deliberately chosen to avoid interference with initial osseous fusion and wound healing, while capitalizing on the phase of maximal functional plasticity and patient engagement in recovery. Multimodal Components: The program integrates three evidence-based components supervised by a physiotherapist: Progressive Resistance \& Stabilization Training: Targets deep spinal stabilizers and global movers to restore functional strength and reduce segmental strain. Neuromotor \& Balance Re-education: Addresses age-related proprioceptive decline to improve movement efficiency and reduce fall risk. Pain Neuroscience Education \& Activity Pacing: Aims to modify maladaptive pain behaviors and fear-avoidance beliefs, promoting sustained engagement. Adherence Strategy \& Measurement: Adherence is not merely recorded but is actively managed as a modifiable process variable. The weekly Likert-scale tracking (via phone/app) serves as both a measurement tool and a behavioral prompt. The >70% adherence threshold (cumulative score >135/196) is based on prior rehabilitation efficacy studies, defining a minimum "dose" for expected biological effect. Illustrated manuals and periodic in-person sessions ensure correct technique and gradual progression, addressing a key limitation of unsupervised home exercise.
- Outcome Selection and Measurement Rationale Primary Outcome Justification: Time to ASD (in days) was selected over a simple binary incidence rate because it is a time-to-event measure that captures both the occurrence and the timing of degeneration, providing greater statistical power and clinical relevance regarding the delay of disease. Secondary Outcome Triangulation: The combination of patient-reported outcomes (VAS, ODI), physician-assessed function (JOA), objective physiological measures (BMD, Fried score), and radiographic biomechanics (PI-LL, SVA) allows for a comprehensive evaluation of treatment effect across the domains of symptoms, function, biology, and structure. This aligns with the multifactorial nature of both frailty and ASD.
- Methodological Rigor and Design Considerations Randomization \& Blinding: 1:1 block randomization will be performed by an independent statistician using sealed envelopes. While participants and treating therapists cannot be blinded to group assignment, all outcome assessors (radiologists evaluating ASD, researchers collecting PROs) will remain blinded to minimize assessment bias. Handling Expected Challenges in a Frail Population: The protocol includes explicit strategies for managing common issues: 1) Flexible follow-up modes (clinic, phone, app) to reduce dropout; 2) LOCF imputation for missing data specified a priori in the statistical plan; and 3) Adverse event monitoring specifically for rehabilitation-related musculoskeletal complaints. Sample Size Consideration: The 20% inflation for attrition is conservative but justified for this older, frail population over a 2-year follow-up. Sensitivity analyses (e.g., per-protocol, complier-average causal effect models) are pre-planned to assess the robustness of findings to deviations from the protocol and variable adherence.
- Anticipated Impact and Mechanistic Exploration This trial is designed to establish not only whether the intervention works (efficacy) but also to generate hypotheses on how it works. By correlating changes in muscular performance (via functional tests), frailty status, and sagittal alignment with the primary ASD outcome, the study aims to explore potential mediators of treatment effect. The findings are expected to inform the development of a standardized, reproducible rehabilitation protocol tailored to the high-risk frail elderly spine surgery population.
- Being tested
- Postoperative Multimodal Rehabilitation Program
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Postoperative Multimodal Rehabilitation ProgramBehavioural
All subjects independently completed the training program postoperatively. During follow-up, two physical therapists were responsible for arranging and designing the training sessions for the next phase. The therapists possessed equivalent levels of clinical experience. Based on clinical experience, scientific knowledge, and personal conviction, the therapists were confident that they provided the best treatment plan for the patients. To ensure consistency in treatment implementation throughout the study, fidelity checks were conducted at the end of each treatment session and course, in accordance with the cognitive-behavioral therapy and exercise training implementation manual. After enrollment, patients did not receive other treatments (such as physical therapy or nerve block), and the use of major pharmacological agents was prohibited, except for the allowance of mild analgesics and non-steroidal anti-inflammatory drugs.
| Study group | Role | What they receive |
|---|---|---|
| Routine Care Group | No intervention | All patients in this group undergo standard Enhanced Recovery After Surgery (ERAS) protocols tailored for frail individuals, which encompass optimization of nutrition, pain management, early mobilization, and other evidence-based perioperative measures. |
| Multimodal Rehabilitation Group | Experimental | This group receives a supervised, structured, and progressive multimodal rehabilitation program in addition to the standard perioperative Enhanced Recovery After Surgery (ERAS) care and initial home exercise guidance. Receives: Behavioral: Postoperative Multimodal Rehabilitation Program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to Adjacent Segment Degeneration (ASDeg)
The number of days from the surgery date to the radiographic diagnosis of ASDeg. For participants who do not develop ASD during the study, the data will be censored at 730 days (2 years postoperatively). This measure is used to compare the intervention and control groups.
Measured: From surgery date up to 2 years postoperatively (730 days).
Secondary outcomes (4)
Comprehensive Complication Index
The Comprehensive Complication Index (CCI) is based on the complication grading by the Clavien-Dindo Classification and captures every complication that occurred after an intervention. Postoperative complications were recorded to 90-day after surgery (definitions provided in supplementary table 1) and scored by severity using the Clavien-Dindo classification. The CCI was derived from these scores using the CCI calculator available online (http://www.assessurgery.com). Previous studies have validated the CCI as a measure of postoperative morbidity, suggesting that it offers a more comprehensive and sensitive endpoint for surgical research compared to traditional morbidity measures, such as the overall rate of complications or the rate of severe complications.
Measured: Preoperative; immediately postoperative; and at 12, 24, 48, 60, 72, and 96 weeks postoperatively.
Oswestry disability index
Oswestry disability index (0 - 100 points, a higher total score reflects higher disability) for lumbar surgery.
Measured: Preoperative; immediately postoperative; and at 12, 24, 48, 60, 72, and 96 weeks postoperatively.
Leg Pain Visual Analog Scale (VAS) Score
Patient-reported intensity of leg pain (radicular pain) measured on Visual Analog Scale (VAS), where 0 represents "no pain" and 10 represents "worst imaginable pain".
Measured: Preoperative; immediately postoperative; and at 12, 24, 48, 60, 72, and 96 weeks postoperatively.
Japanese Orthopaedic Association (JOA) Score for Low Back Pain
Clinician-assessed lumbar spine function measured by the Japanese Orthopaedic Association (JOA) score. Higher scores indicate better function.
Measured: Preoperative; immediately postoperative; and at 12, 24, 48, 60, 72, and 96 weeks postoperatively.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2026
- Study start25 Jan 2026 (estimated)
- Primary completion1 Mar 2028 (estimated)
- Study completion1 Mar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Adjacent Segment DegenerationStudies of the same condition, open and under way.
- More trials run by Xuanwu Hospital, BeijingThe sponsor's other registered studies.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 212 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Xuanwu Hospital, Beijing
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07396051
- Sponsor's protocol ID
- Xuanwu-REACH
- Status last verified
- Jan 2026
- First submitted
- 2 Feb 2026
- Last updated
- 17 Feb 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Gillis C, Ljungqvist O, Carli F. Prehabilitation, enhanced recovery after surgery, or both? A narrative review. Br J Anaesth. 2022 Mar;128(3):434-448. doi: 10.1016/j.bja.2021.12.007. Epub 2022 Jan 7.
PubMed 35012741Dindo D, Demartines N, Clavien PA. Classification of surgical complications: a new proposal with evaluation in a cohort of 6336 patients and results of a survey. Ann Surg. 2004 Aug;240(2):205-13. doi: 10.1097/01.sla.0000133083.54934.ae.
PubMed 15273542Parker SG, McCue P, Phelps K, McCleod A, Arora S, Nockels K, Kennedy S, Roberts H, Conroy S. What is Comprehensive Geriatric Assessment (CGA)? An umbrella review. Age Ageing. 2018 Jan 1;47(1):149-155. doi: 10.1093/ageing/afx166.
PubMed 29206906Whittle AK, Kalsi T, Babic-Illman G, Wang Y, Fields P, Ross PJ, Maisey NR, Hughes S, Kwan W, Harari D. A comprehensive geriatric assessment screening questionnaire (CGA-GOLD) for older people undergoing treatment for cancer. Eur J Cancer Care (Engl). 2017 Sep;26(5). doi: 10.1111/ecc.12509. Epub 2016 May 1.
PubMed 27132979Karsy M, Chan AK, Mummaneni PV, Virk MS, Bydon M, Glassman SD, Foley KT, Potts EA, Shaffrey CI, Shaffrey ME, Coric D, Asher AL, Knightly JJ, Park P, Fu KM, Slotkin JR, Haid RW, Wang M, Bisson EF. Outcomes and Complications With Age in Spondylolisthesis: An Evaluation of the Elderly From the Quality Outcomes Database. Spine (Phila Pa 1976). 2020 Jul 15;45(14):1000-1008. doi: 10.1097/BRS.0000000000003441.
PubMed 32097272Martin BI, Mirza SK, Spina N, Spiker WR, Lawrence B, Brodke DS. Trends in Lumbar Fusion Procedure Rates and Associated Hospital Costs for Degenerative Spinal Diseases in the United States, 2004 to 2015. Spine (Phila Pa 1976). 2019 Mar 1;44(5):369-376. doi: 10.1097/BRS.0000000000002822.
PubMed 30074971Rivier C, Shen GH. In the rat, endogenous nitric oxide modulates the response of the hypothalamic-pituitary-adrenal axis to interleukin-1 beta, vasopressin, and oxytocin. J Neurosci. 1994 Apr;14(4):1985-93. doi: 10.1523/JNEUROSCI.14-04-01985.1994.
PubMed 8158253Kassebaum DG, Judkins MP, Griswold HE. Stress electrocardiography in the evaluation of surgical revascularization of the heart. Circulation. 1969 Sep;40(3):297-313. doi: 10.1161/01.cir.40.3.297. No abstract available.
PubMed 5810888
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Trial of Multimodal Rehabilitation Versus Standard Care on Adjacent Segment Degeneration in Frail Elderly Patients Undergoing Short-Segment Lumbar Fusion
- ClinicalTrials.gov ID
- NCT07396051
- Acronym / sponsor ID
- Xuanwu-REACH
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 212 participants (estimated)
- Lead sponsor
- Xuanwu Hospital, BeijingUniversity, hospital or other
- Study start
- 25 Jan 2026 (estimated)
- Primary completion
- 1 Mar 2028 (estimated)
- Study completion
- 1 Mar 2028 (estimated)
- First posted
- 9 Feb 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 is a prospective, randomized controlled trial aimed at evaluating whether a structured multimodal rehabilitation program can delay or reduce the occurrence of adjacent segment degeneration (ASDeg) in frail elderly patients after short-segment lumbar fusion surgery.
Detailed description
- Rationale and Scientific Background Adjacent segment degeneration (ASDeg) represents a major determinant of long-term clinical success after lumbar fusion. In frail older adults (≥75 years, Fried phenotype), the risk is theorized to be amplified due to age-related sarcopenia, osteopenia, diminished healing capacity, and compensatory biomechanical overload. While Enhanced Recovery After Surgery (ERAS) protocols address acute perioperative stress, they do not provide a targeted, long-term strategy to modify the underlying biological and biomechanical progression toward ASD. This trial is grounded on the hypothesis that a structured, multimodal rehabilitation program, initiated after the initial bone-soft tissue healing phase (12 weeks), can enhance paraspinal muscular endurance, improve global sagittal alignment, increase bone density, and mitigate systemic frailty. This multisystem approach aims to decelerate the degenerative cascade at adjacent segments compared to standard care alone.
- Intervention Design and Theoretical Framework Timing Rationale: The intervention commencement at 12 weeks postoperatively is deliberately chosen to avoid interference with initial osseous fusion and wound healing, while capitalizing on the phase of maximal functional plasticity and patient engagement in recovery. Multimodal Components: The program integrates three evidence-based components supervised by a physiotherapist: Progressive Resistance \& Stabilization Training: Targets deep spinal stabilizers and global movers to restore functional strength and reduce segmental strain. Neuromotor \& Balance Re-education: Addresses age-related proprioceptive decline to improve movement efficiency and reduce fall risk. Pain Neuroscience Education \& Activity Pacing: Aims to modify maladaptive pain behaviors and fear-avoidance beliefs, promoting sustained engagement. Adherence Strategy \& Measurement: Adherence is not merely recorded but is actively managed as a modifiable process variable. The weekly Likert-scale tracking (via phone/app) serves as both a measurement tool and a behavioral prompt. The >70% adherence threshold (cumulative score >135/196) is based on prior rehabilitation efficacy studies, defining a minimum "dose" for expected biological effect. Illustrated manuals and periodic in-person sessions ensure correct technique and gradual progression, addressing a key limitation of unsupervised home exercise.
- Outcome Selection and Measurement Rationale Primary Outcome Justification: Time to ASD (in days) was selected over a simple binary incidence rate because it is a time-to-event measure that captures both the occurrence and the timing of degeneration, providing greater statistical power and clinical relevance regarding the delay of disease. Secondary Outcome Triangulation: The combination of patient-reported outcomes (VAS, ODI), physician-assessed function (JOA), objective physiological measures (BMD, Fried score), and radiographic biomechanics (PI-LL, SVA) allows for a comprehensive evaluation of treatment effect across the domains of symptoms, function, biology, and structure. This aligns with the multifactorial nature of both frailty and ASD.
- Methodological Rigor and Design Considerations Randomization \& Blinding: 1:1 block randomization will be performed by an independent statistician using sealed envelopes. While participants and treating therapists cannot be blinded to group assignment, all outcome assessors (radiologists evaluating ASD, researchers collecting PROs) will remain blinded to minimize assessment bias. Handling Expected Challenges in a Frail Population: The protocol includes explicit strategies for managing common issues: 1) Flexible follow-up modes (clinic, phone, app) to reduce dropout; 2) LOCF imputation for missing data specified a priori in the statistical plan; and 3) Adverse event monitoring specifically for rehabilitation-related musculoskeletal complaints. Sample Size Consideration: The 20% inflation for attrition is conservative but justified for this older, frail population over a 2-year follow-up. Sensitivity analyses (e.g., per-protocol, complier-average causal effect models) are pre-planned to assess the robustness of findings to deviations from the protocol and variable adherence.
- Anticipated Impact and Mechanistic Exploration This trial is designed to establish not only whether the intervention works (efficacy) but also to generate hypotheses on how it works. By correlating changes in muscular performance (via functional tests), frailty status, and sagittal alignment with the primary ASD outcome, the study aims to explore potential mediators of treatment effect. The findings are expected to inform the development of a standardized, reproducible rehabilitation protocol tailored to the high-risk frail elderly spine surgery population.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Routine Care Group | No intervention | –All patients in this group undergo standard Enhanced Recovery After Surgery (ERAS) protocols tailored for frail individuals, which encompass optimization of nutrition, pain management, early mobilization, and other evidence-based perioperative measures. |
| Multimodal Rehabilitation Group | Experimental | Behavioral: Postoperative Multimodal Rehabilitation ProgramThis group receives a supervised, structured, and progressive multimodal rehabilitation program in addition to the standard perioperative Enhanced Recovery After Surgery (ERAS) care and initial home exercise guidance. |
Who may qualify
- Ages
- 75 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (4 listed)
- Age ≥ 75 years.
- Classified as "frail" according to the Fried frailty phenotype.
- Scheduled for first-time, posterior short-segment (1-2 levels) lumbar instrumented fusion surgery.
- Willing and able to provide written informed consent and complete the 2-year follow-up.
Key exclusion criteria (3 listed)
- History of previous lumbar spine surgery.
- Lumbar pathology due to tumor, trauma, infection, or congenital deformity.
- Comorbidities with a severe impact on prognosis or ability to participate in rehabilitation (e.g., severe cardiopulmonary disease, advanced dementia).
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 |
|---|---|---|
| Postoperative Multimodal Rehabilitation ProgramAll subjects independently completed the training program postoperatively. During follow-up, two physical therapists were responsible for arranging and designing the training sessions for the next phase. The therapists possessed equivalent levels of clinical experience. Based on clinical experience, scientific knowledge, and personal conviction, the therapists were confident that they provided the best treatment plan for the patients. To ensure consistency in treatment implementation throughout the study, fidelity checks were conducted at the end of each treatment session and course, in accordance with the cognitive-behavioral therapy and exercise training implementation manual. After enrollment, patients did not receive other treatments (such as physical therapy or nerve block), and the use of major pharmacological agents was prohibited, except for the allowance of mild analgesics and non-steroidal anti-inflammatory drugs. | Behavioural | Multimodal Rehabilitation Group |
Primary outcome
Time to Adjacent Segment Degeneration (ASDeg)
Time frame: From surgery date up to 2 years postoperatively (730 days).
The number of days from the surgery date to the radiographic diagnosis of ASDeg. For participants who do not develop ASD during the study, the data will be censored at 730 days (2 years postoperatively). This measure is used to compare the intervention and control groups.
4 secondary outcomes
Comprehensive Complication Index
Time frame: Preoperative; immediately postoperative; and at 12, 24, 48, 60, 72, and 96 weeks postoperatively.
Oswestry disability index
Time frame: Preoperative; immediately postoperative; and at 12, 24, 48, 60, 72, and 96 weeks postoperatively.
Leg Pain Visual Analog Scale (VAS) Score
Time frame: Preoperative; immediately postoperative; and at 12, 24, 48, 60, 72, and 96 weeks postoperatively.
Japanese Orthopaedic Association (JOA) Score for Low Back Pain
Time frame: Preoperative; immediately postoperative; and at 12, 24, 48, 60, 72, and 96 weeks postoperatively.
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 17 Feb 2026.
- Background: PubMed 35012741Gillis C, Ljungqvist O, Carli F. Prehabilitation, enhanced recovery after surgery, or both? A narrative review. Br J Anaesth. 2022 Mar;128(3):434-448. doi: 10.1016/j.bja.2021.12.007. Epub 2022 Jan 7.
- Background: PubMed 15273542Dindo D, Demartines N, Clavien PA. Classification of surgical complications: a new proposal with evaluation in a cohort of 6336 patients and results of a survey. Ann Surg. 2004 Aug;240(2):205-13. doi: 10.1097/01.sla.0000133083.54934.ae.
- Background: PubMed 29206906Parker SG, McCue P, Phelps K, McCleod A, Arora S, Nockels K, Kennedy S, Roberts H, Conroy S. What is Comprehensive Geriatric Assessment (CGA)? An umbrella review. Age Ageing. 2018 Jan 1;47(1):149-155. doi: 10.1093/ageing/afx166.
- Background: PubMed 27132979Whittle AK, Kalsi T, Babic-Illman G, Wang Y, Fields P, Ross PJ, Maisey NR, Hughes S, Kwan W, Harari D. A comprehensive geriatric assessment screening questionnaire (CGA-GOLD) for older people undergoing treatment for cancer. Eur J Cancer Care (Engl). 2017 Sep;26(5). doi: 10.1111/ecc.12509. Epub 2016 May 1.
- Background: PubMed 32097272Karsy M, Chan AK, Mummaneni PV, Virk MS, Bydon M, Glassman SD, Foley KT, Potts EA, Shaffrey CI, Shaffrey ME, Coric D, Asher AL, Knightly JJ, Park P, Fu KM, Slotkin JR, Haid RW, Wang M, Bisson EF. Outcomes and Complications With Age in Spondylolisthesis: An Evaluation of the Elderly From the Quality Outcomes Database. Spine (Phila Pa 1976). 2020 Jul 15;45(14):1000-1008. doi: 10.1097/BRS.0000000000003441.
- Background: PubMed 30074971Martin BI, Mirza SK, Spina N, Spiker WR, Lawrence B, Brodke DS. Trends in Lumbar Fusion Procedure Rates and Associated Hospital Costs for Degenerative Spinal Diseases in the United States, 2004 to 2015. Spine (Phila Pa 1976). 2019 Mar 1;44(5):369-376. doi: 10.1097/BRS.0000000000002822.
- Background: PubMed 8158253Rivier C, Shen GH. In the rat, endogenous nitric oxide modulates the response of the hypothalamic-pituitary-adrenal axis to interleukin-1 beta, vasopressin, and oxytocin. J Neurosci. 1994 Apr;14(4):1985-93. doi: 10.1523/JNEUROSCI.14-04-01985.1994.
- Background: PubMed 5810888Kassebaum DG, Judkins MP, Griswold HE. Stress electrocardiography in the evaluation of surgical revascularization of the heart. Circulation. 1969 Sep;40(3):297-313. doi: 10.1161/01.cir.40.3.297. No abstract available.
- 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.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Postoperative Multimodal Rehabilitation Program in people with Adjacent Segment Degeneration and Multimodal Rehabilitation, run by Xuanwu Hospital, Beijing at 3 sites 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 17 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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 Lu Shibao, MD. (18310031517, 1831327488@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to Adjacent Segment Degeneration (ASDeg) (time frame: From surgery date up to 2 years postoperatively (730 days).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07396051, which also lists 8 linked publications.
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 17 Feb 2026.