Trial · NCT07125027
Registered outcomes37
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 20 of 37
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Recruitment Proportion | End of study | The proportion of patients contacted who consent to screening |
| Primary | Retention | End of study | Retention will be assessed by tracking the percentage of participants who complete their primary endpoint visit |
| Primary | Client Satisfaction Questionnaire | Week 4, Week 8, Week 20 | Intervention Satisfaction. Min = 8, Max = 32. Higher score = greater satisfaction. |
| Primary | Adherence | End of study | The proportion of participants completing at least 5 intervention sessions |
| Primary | Adverse Events | End of study | The frequency and severity of adverse events (AEs) and serious adverse events (SAEs) occurring during the study. |
| Primary | Intervention Satisfaction | Week 4, Week 8 | Satisfaction will be measured using the Client Satisfaction Questionnaire (CSQ-8). The CSQ-8 is a self-report measure designed to assess satisfaction with health services. |
| Secondary | Oswestry Disability Index | Week 0, Week 4, Week 8, Week 20 | Activities of daily living. Min = 0%, Max = 100%. Higher score = worse outcomes. |
| Secondary | painDETECT Questionnaire | Week 0, Week 4, Week 8, Week 20 | Neuropathic Pain. Min = -1, Max = 38. Higher score = worse outcomes. |
| Secondary | Visual Analog Scale | Daily | Pain Intensity. Min = 0, Max = 10. Higher score = worse pain |
| Secondary | Complex Medical Symptoms Inventory | Week 0, Week 4, Week 8, Week 20 | A questionnaire to assess pain hypersensitivity and allodynia. The CMSI inquires about participants' pain experiences specifically related to hypersensitivity and allodynia to discern whether an individual may experience central sensitization. Currently, no direct measures of self-reported nociplastic pain exist, thus measures of central sensitization can be used as surrogate measures for this construct. The CSI has previously been shown to have strong test-retest reliability in chronic pain patients. |
| Secondary | Nociplastic Pain Questionnaire | Week 0, Week 4, Week 8, Week 20 | The NPQ is a screening tool designed to identify characteristics of nociplastic pain, which arises from altered nociception without clear evidence of tissue damage or somatosensory system disease. The NPQ assesses symptoms such as widespread pain, fatigue, sleep disturbance, and cognitive difficulties, helping to differentiate nociplastic pain from nociceptive and neuropathic pain mechanisms. |
| Secondary | Patient Global Impression of Change | Week 0, Week 4, Week 8, Week 20 | The PGIC is a single-item, patient-reported outcome measure that captures a participant's overall perception of improvement or decline in health status since the start of an intervention. Rated on a 7-point Likert scale ranging from "very much improved" to "very much worse," the PGIC provides a global assessment of treatment effectiveness from the patient's perspective. |
| Secondary | Healthcare Utilization Changes | Week 4, Week 8, Week 20 | This questionnaire will assess whether participants have changed their use or plans for use of pain medication, injection, nerve ablation, or surgery as a result of participation in the study. |
| Secondary | The Pain, Enjoyment of Life and General Activity (PEG-3) | Week 0, Week 4, Week 8, Week 20 | The PEG-3 is a brief, 3-item measure derived from the Brief Pain Inventory that assesses pain intensity and its impact on enjoyment of life and general activity. Each item is rated on a 0-10 scale, with higher scores indicating greater pain-related interference. The PEG-3 is a validated tool commonly used in both clinical and research settings to monitor pain outcomes efficiently. |
| Secondary | Tampa Scale of Kinesiophobia (TSK-11) | Week 0, Week 4, Week 8, Week 20 | A questionnaire to assess fear of movement. The TSK-11 is designed to assess the presence of fear of movement. This measure has previously been validated in populations of patients with chronic non-specific low back pain and shown to have good reliability. |
| Secondary | Pain Catastrophizing Scale (PCS) | Week 0, Week 4, Week 8, Week 20 | A questionnaire to assess pain catastrophizing and rumination. The PCS is ubiquitously used to assess pain catastrophizing via its subscales: helplessness, rumination, and magnification. It has primarily been used and validated in patients with low back pain. |
| Secondary | PROMIS Self-Efficacy for Managing Symptoms 8a | Week 0, Week 4, Week 8, Week 20 | The PROMIS Self-Efficacy for Managing Symptoms 8a is an 8-item patient-reported measure assessing an individual's confidence in managing symptoms related to their health conditions. It evaluates domains such as controlling symptoms, performing tasks despite symptoms, and coping with the impact of symptoms on daily life. Higher scores indicate greater self-efficacy in symptom management. This tool helps capture patients' perceived ability to handle their health challenges and is useful for tailoring interventions and tracking progress in clinical research. |
| Secondary | PROMIS Ability to Participate in Social Roles | Week 0, Week 4, Week 8, Week 20 | A questionnaire to assess social participation. The ability to participate in social roles questionnaire is a PROMIS measure designed to evaluate the impact of a condition on social engagement. It has previously been validated with an additional questionnaire, satisfaction with participation in social activities. |
| Secondary | PROMIS Sleep Disturbance 6a + Sleep Duration Question | Week 0, Week 4, Week 8, Week 20 | This is a validated patient-reported outcome measure assessing perceived sleep quality and disturbances over the past 7 days. The 6-item Sleep Disturbance short form (6a) evaluates aspects such as difficulty falling asleep, staying asleep, and overall sleep satisfaction, while an additional question captures average sleep duration. Scores provide insight into sleep problems that may affect health and functioning. |
| Secondary | Whole Person Health Index (WPHI) | Week 0, Week 4, Week 8, Week 20 | The WPHI is a simple self-report survey tool that provides a comprehensive snapshot of a person's health. The WPHI can serve as an anchor or reference point for connecting diverse health data, all while keeping the individual's personal health perspective at its core. The WPHI is based on nine questions developed and validated through a collaboration between the National Center for Complementary and Integrative Health (NCCIH) and the National Center for Health Statistics/Centers for Disease Control and Prevention. |
Source ClinicalTrials.govtrials-2026-11-12-0.4.0
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.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.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this list from software.
Twenty rows a page, as JSON. No key.
GET https://conductscience.org/api/trials/v1/NCT07125027/registered