Diaphragmatic Breathing Training in Chronic Spinal Pain
NCT07539116, Not applicable, Completed, Democritus University of Thrace
Trial 10
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
| Field | Value | Source |
|---|---|---|
| Title | Diaphragmatic Breathing Training in Chronic Spinal Pain | ClinicalTrials.gov |
| NCT number | NCT07539116 | ClinicalTrials.gov |
| Status | Completed | ClinicalTrials.gov |
| Phases | Not applicable | ClinicalTrials.gov |
| Enrollment | 183 participants, actual | ClinicalTrials.gov |
| Lead sponsor | Democritus University of Thrace | ClinicalTrials.gov |
| Conditions | Chronic Non-specific Low-Back Pain, Chronic Non-specific Neck Pain | ClinicalTrials.gov |
| Interventions | Structured Exercise program, Diaphragmatic Breathing Training | ClinicalTrials.gov |
| First posted | 2026-04-20 | ClinicalTrials.gov |
| Last updated | 2026-04-20 | ClinicalTrials.gov |
Registered outcomes 9
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description | Source |
|---|---|---|---|---|
| Primary | Pain intensity and pain-related interference | Baseline, post-intervention (12 weeks), and 4-week follow-up | Pain intensity and interference were assessed using the Brief Pain Inventory - Short Form (BPI-SF). Pain severity and interference scores range from 0 to 10, with higher scores indicating greater pain and functional impact. | ClinicalTrials.gov |
| Primary | Emotional status (anxiety and depression) | Baseline, post-intervention (12 weeks), and 4-week follow-up | Emotional status was assessed using the Hospital Anxiety and Depression Scale (HADS), a 14-item instrument with two subscales (anxiety and depression), each item scored from 0 to 3, with higher scores indicating greater symptom severity. | ClinicalTrials.gov |
| Primary | Cognitive flexibility | Baseline, post-intervention (12 weeks), and 4-week follow-up | Cognitive flexibility was assessed using the Trail Making Test (Part A and Part B) and the Stroop Color-Word Test. Performance was evaluated based on completion time and interference indices, with higher completion times and greater interference indicating lower cognitive flexibility. | ClinicalTrials.gov |
| Secondary | Adherence to the intervention | Throughout the 12-week intervention period | Adherence was defined as the total time (in minutes) of home-based (unsupervised) practice, recorded prospectively by participants throughout the intervention period using standardized weekly logs. Participants documented the frequency, type, and duration of exercise and, where applicable, diaphragmatic breathing practice. | ClinicalTrials.gov |
| Secondary | Quality of life (WHOQOL-BREF total and domain scores) | Baseline, post-intervention (12 weeks), and 4-week follow-up | Quality of life was assessed using the World Health Organization Quality of Life - BREF (WHOQOL-BREF), a 26-item instrument measuring physical, psychological, social, and environmental domains. Items are rated on a 5-point Likert scale, with higher scores indicating better perceived quality of life. | ClinicalTrials.gov |
| Other | Semantic and Phonemic Verbal Fluency Performance | Baseline, post-intervention (12 weeks), and 4-week follow-up | Verbal fluency was assessed using semantic and phonemic fluency tasks. Performance was measured as the number of correct words generated within a fixed time interval, with higher scores indicating better verbal fluency and cognitive flexibility. | ClinicalTrials.gov |
| Other | Nonverbal Reasoning Performance (WAIS-IV Matrix Reasoning) | Baseline, post-intervention (12 weeks), and 4-week follow-up | Nonverbal reasoning ability was assessed using the Matrix Reasoning subtest of the Wechsler Adult Intelligence Scale-IV (WAIS-IV). Scores reflect abstract reasoning and problem-solving ability, with higher scores indicating better performance. | ClinicalTrials.gov |
| Other | Illness Perceptions (Illness Perception Questionnaire) | Baseline, post-intervention (12 weeks), and 4-week follow-up | Illness perceptions were assessed using the Illness Perception Questionnaire (IPQ), which evaluates cognitive and emotional representations of illness. Higher scores reflect stronger or more negative illness-related beliefs, depending on the subscale. | ClinicalTrials.gov |
| Other | Coping Strategies (Brief COPE) | Baseline, post-intervention (12 weeks), and 4-week follow-up | Coping strategies were assessed using the Brief COPE questionnaire. The instrument evaluates different coping responses to stress, with higher scores indicating greater use of specific coping strategies. | 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 1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as | Source |
|---|---|---|
| 42737000 | DERIVED | PubMed |
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 3
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 |
|---|---|---|
| Stroop Color-Word Test | Primary outcome | ConductCognition |
| Matrix Reasoning | Other outcome | ConductCognition |
| Verbal Fluency | Other 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)