Multimodal Imaging and Biospecimen Collection for Low Back Pain (LBPB)
NCT06967363, Not yet recruiting, Peking University Third Hospital
Trial 9
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
| Field | Value | Source |
|---|---|---|
| Title | Multimodal Imaging and Biospecimen Collection for Low Back Pain (LBPB) | ClinicalTrials.gov |
| NCT number | NCT06967363 | ClinicalTrials.gov |
| Status | Not yet recruiting | ClinicalTrials.gov |
| Enrollment | 360 participants, estimated | ClinicalTrials.gov |
| Lead sponsor | Peking University Third Hospital | ClinicalTrials.gov |
| Conditions | Chronic Low Back Pain (CLBP), Acute Low Back Pain, Low Back Pain, Chronic Pain, Acute Pain, Mental Disorders, Sleep Disorder, Fibromyalgia (FM), Nociplastic Pain, Neuropathic Pain, Nonspecific Low Back Pain | ClinicalTrials.gov |
| Interventions | Nerve Block, endoscopic spinal disecetomy, Medication, Psychotherapy | ClinicalTrials.gov |
| First posted | 2025-05-13 | ClinicalTrials.gov |
| Last updated | 2025-05-13 | ClinicalTrials.gov |
Registered outcomes 60
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description | Source |
|---|---|---|---|---|
| Primary | Pain Intensity (Brief Pain Inventory - Short Form) | Baseline; 1 week after treatment; 2 weeks after treatment; 1 month after treatment; 3 months after treatment; 6 months after treatment; 12 months after treatment | Pain intensity will be assessed using the BPI-SF pain severity subscale, consisting of four 0-10 numeric ratings: worst, least, average, and current pain over the past 24 hours. The primary outcome will be the average of these four items. Higher scores indicate greater pain severity. | ClinicalTrials.gov |
| Primary | Pain Interference (Brief Pain Inventory - Short Form) | Time Frame: Baseline; 1 week after treatment; 2 weeks after treatment; 1 month after treatment; 3 months after treatment; 6 months after treatment; 12 months after treatment | Pain interference will be measured using the BPI-SF interference subscale, which includes seven items assessing interference with general activity, mood, walking ability, normal work, relations with others, sleep, and enjoyment of life. Each item is scored on a scale of 0 (does not interfere) to 10 (completely interferes). The mean of the seven items will be reported as the interference score. | ClinicalTrials.gov |
| Secondary | Pain Catastrophizing Scale (PCS) | Time Frame: Baseline; 1 week after treatment; 2 weeks after treatment; 1 month after treatment; 3 months after treatment; 6 months after treatment; 12 months after treatment | The PCS consists of 13 items, each rated on a 0 (not at all) to 4 (all the time) scale. Total scores range from 0 to 52, with higher scores indicating greater pain catastrophizing. The total PCS score will be used as the outcome. | ClinicalTrials.gov |
| Secondary | Pain Coping Strategies Questionnaire | Baseline; 2 weeks after treatment; 1 month after treatment; 3 months after treatment; 6 months after treatment; 12 months after treatment | Use of this scale is designed to measure psychological and behavioral strategies for how individuals cope with chronic pain. Participants need to rate each item on a scale of 0 (never) to 6 (always), depending on the situation. | ClinicalTrials.gov |
| Secondary | Pain Resilience Scale | Baseline; 2 weeks after treatment; 1 month after treatment; 3 months after treatment; 6 months after treatment; 12 months after treatment | This scale is used to assess an individual's mental resilience in response to pain, including the capacity of adaptive, cognitive, affective, and behavioral strategies during the pain experience. Participants need to rate each item on a scale of 0 (never) to 4 (always), depending on the situation. | ClinicalTrials.gov |
| Secondary | Pain Self-efficacy Scale | Baseline; 2 weeks after treatment; 1 month after treatment; 3 months after treatment; 6 months after treatment; 12 months after treatment | This scale is used to assess an individual's confidence in managing pain, with higher scores indicating greater confidence in pain management. Participants need to rate each item on a scale of 0 (never) to 6 (always), depending on the situation. | ClinicalTrials.gov |
| Secondary | Central Sensitization Scale | Baseline; 2 weeks after treatment; 1 month after treatment; 3 months after treatment; 6 months after treatment; 12 months after treatment | This scale is used to comprehensively assess an individual's level of central sensitization, with higher scores indicating a higher level of central sensitization and greater sensitivity to painful stimuli. Participants need to rate each item on a scale of 0 (never) to 4 (always), depending on the situation. | ClinicalTrials.gov |
| Secondary | Brief Family Relationships Scale | Baseline | This scale is used to assess the quality of family relationships and provides insight into the interaction, support, communication, and conflict among family members. Participants need to rate each item on a scale of 0 (Strongly agree) to 6 (Strongly disagree), depending on the situation. | ClinicalTrials.gov |
| Secondary | Family Pain Questionnaire | Baseline | The scale contains 16 questions about pain and pain relief, and each question needs to be scored on a scale of approval, with a scale of 0 to 10 indicating an increase in degree, with higher scores representing greater agreement with the statement. | ClinicalTrials.gov |
| Secondary | Dietary Patterns (Structured Dietary Questionnaire - Food Frequency Component) | Baseline | Dietary patterns will be assessed using a structured dietary questionnaire that includes a food frequency component. Participants report the frequency of consumption of various food groups (e.g., fruits, vegetables, dairy, meats, processed foods) over a defined period. Data will be used to calculate dietary diversity and adherence scores. There is no single summary score; results are used descriptively and for correlation analyses. | ClinicalTrials.gov |
| Secondary | Sensory Threshold and Pain Perception as Assessed by Quantitative Sensory Testing (QST) Using Mechanical and Electrical Stimulation | Baseline; 1 day after treatment; 1 month after treatment; 3 months after treatment; 6 months after treatment; 12 months after treatment | Sensory gain or loss will be assessed using Quantitative Sensory Testing (QST) through both mechanical and electrical stimuli applied to multiple body sites (left leg, right leg, lumbar region, left arm, right arm). Mechanical stimulation will be delivered using Von Frey filaments (0.008g to 300g). The mechanical detection threshold will be recorded in grams. Lower values indicate greater tactile sensitivity. Electrical stimulation will be administered using surface electrodes with adjustable intensity (0-110 volts). The electrical pain threshold will be recorded in volts. Higher voltage indicates a higher pain threshold. Participants will also provide subjective ratings of pain unpleasantness on a Numeric Rating Scale from 0 (no unpleasantness) to 10 (most unpleasant imaginable). | ClinicalTrials.gov |
| Secondary | Quantitative Sensory Testing (Electrical stimulation) | Baseline; 1 day after treatment; 2 weeks after treatment; 1 month after treatment; 3 months after treatment; 6 months after treatment; 12 months after treatment | An electrical stimulation device (STM200) will be used to administer a series of electrical stimulation of different intensities (voltage range 0-100V) to record the sensations corresponding to the different stimulation intensities. The lower the value, the more sensitive the perception. | ClinicalTrials.gov |
| Secondary | Oswestry Disability Index | Baseline; 2 weeks after treatment; 1 month after treatment; 3 months after treatment; 6 months after treatment; 12 months after treatment | The Oswestry Disability Index (ODI) is a validated, self-reported questionnaire used to assess functional disability related to low back pain. It consists of 10 sections measuring limitations in activities such as pain intensity, personal care, lifting, walking, sitting, standing, sleeping, sex life, social life, and traveling. Each section is scored from 0 to 5, resulting in a total score ranging from 0 to 50, which is then converted to a percentage (0%-100%). Higher scores indicate greater disability. | ClinicalTrials.gov |
| Secondary | Health-Related Quality of Life as Assessed by the 36-Item Short Form Health Survey (SF-36) | Baseline; 1 month after treatment; 3 months after treatment; 6 months after treatment; 12 months after treatment | The SF-36 is a validated, self-administered questionnaire that evaluates health-related quality of life across 8 domains: physical functioning, role limitations due to physical health, role limitations due to emotional problems, vitality, emotional well-being, social functioning, bodily pain, and general health perceptions. Scores for each domain range from 0 to 100, with higher scores indicating better health status or functioning. The survey can also be summarized into two component scores: the Physical Component Summary (PCS) and the Mental Component Summary (MCS), both scaled from 0 to 100. | ClinicalTrials.gov |
| Secondary | Pittsburgh Sleep Quality Index | Baseline; 1 month after treatment; 3 months after treatment; 6 months after treatment; 12 months after treatment | This scale mainly assesses subjective sleep in the past month, including sleep duration, sleep efficiency, sleep medication use, and sleep disorders. The total score ranges from 0-21, with higher scores indicating worse sleep quality. | ClinicalTrials.gov |
| Secondary | Polysomnography | Baseline; 1 day after treament; 1 month after treatment; 3 months after treatment; 6 months after treatment; 12 months after treatment | Polysomnography, a device produced by Compumedics, is used to record and analyze physiological indicators of the human body during sleep, including electroencephalography, electrocardiography, electromyography, electrooculography, oral and nasal airflow, blood oxygen saturation, leg movement, right leg movement, pulse rate, etc. | ClinicalTrials.gov |
| Secondary | Insomnia Severity Index | Baseline; 2 weeks after treatment; 1 month after treatment; 3 months after treatment; 6 months after treatment; 12 months after treatment | This scale is used to assess the severity of insomnia symptoms in the past two weeks, including difficulty falling asleep, difficulty maintaining sleep, early waking, and concern about sleep problems. The higher the score, the more serious the insomnia symptoms. | ClinicalTrials.gov |
| Secondary | Hamilton Anxiety Scale | Baseline; 2 weeks after treatment; 1 month after treatment; 3 months after treatment; 6 months after treatment; 12 months after treatment | The Hamilton Anxiety Rating Scale (HAM-A) is a clinician-administered assessment used to measure the severity of a patient's anxiety. It includes 14 items, each assessing a symptom of anxiety (e.g., tension, fears, insomnia, somatic complaints). Each item is scored on a scale from 0 (not present) to 4 (severe), producing a total score ranging from 0 to 56. Higher scores indicate more severe anxiety. Scores can be interpreted as: 0-17: mild severity 18-24: mild to moderate severity 25-30: moderate to severe | ClinicalTrials.gov |
| Secondary | Hamilton Depression Scale | Baseline; 2 weeks after treatment; 1 month after treatment; 3 months after treatment; 6 months after treatment; 12 months after treatment | This scale is used to assess the severity of depressive symptoms. The total score is between 0 and 63. The higher the score, the more severe the depression. | ClinicalTrials.gov |
| Secondary | Patient Health Questionnaire-9 | Baseline; 2 weeks after treatment; 1 month after treatment; 3 months after treatment; 6 months after treatment; 12 months after treatment | This scale is used to self-assess the severity of depressive symptoms. The total score is between 0 and 27. The higher the score, the more severe the depression. | ClinicalTrials.gov |
Outcomes 0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as | Source |
|---|
Results by group 0
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units | Source |
|---|
Participant flow 0
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted | Source |
|---|
Adverse events 0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events | Source |
|---|
Adverse event totals 0
The totals the trial posted for each group.
| Total | Group | Affected | At risk | Source |
|---|
Papers 0
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as | Source |
|---|
Grants 0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years | Source |
|---|
Trial comparisons 0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|
Tests 7
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
| Test | Named as | Source |
|---|---|---|
| Attention Network Test | Secondary outcome | ConductCognition |
| Mnemonic Similarity Task | Secondary outcome | ConductCognition |
| Pain Empathy Task | Secondary outcome | ConductCognition |
| Stroop Color-Word Test | Secondary outcome | ConductCognition |
| Think and No-Think Task | Secondary outcome | ConductCognition |
| Trail Making Test A | Secondary outcome | ConductCognition |
| Trail Making Test B | Secondary outcome | ConductCognition |
Source 5
| Field | Value | Source |
|---|---|---|
| Release | trials-2026-11-12-0.4.0 | ClinicalTrials.gov |
| Release manifest SHA-256 | 0f4a8d8c48aee2a7573ae0fa94ecbeab70c1adbe449bbc95c424bc7d3e97b9d4 | ClinicalTrials.gov |
| Registry capture | 2026-11-12 | ClinicalTrials.gov |
| Results copy, AACT | 2026-03-23 | ClinicalTrials.gov |
| NIH clinical studies file | 2026-11-13 | ClinicalTrials.gov |
Release trials-2026-11-12-0.4.0
ClinicalTrials.gov's posted results, through CTTI's AACT: ClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299 ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
ClinicalTrials.gov: none stated ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
NIH RePORTER's clinical studies and project files: Public domain (NIH RePORTER)