Chronic Pain Clinical Trial
— NEXERCISEOfficial title:
The NEXERCISE-trial: When Pain Neuroscience and Clinical Exercise Physiology Meet: Reshaping Exercise Programs for Patients With Non-specific Neck Pain
NCT number | NCT04749823 |
Other study ID # | BC-5419 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | March 1, 2021 |
Est. completion date | September 1, 2022 |
Verified date | January 2024 |
Source | University Ghent |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The Nexercise-trial is a blended treatment program for patients with chronic non-specific neck pain. We will investigate whether a blended treatment approach, combining specific neck exercises and general aerobic exercises, has better outcome (on medical impact for the patient and socio-economic impact) than a specific neck exercise program alone or a general aerobic exercise program alone.
Status | Completed |
Enrollment | 48 |
Est. completion date | September 1, 2022 |
Est. primary completion date | September 1, 2022 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 65 Years |
Eligibility | Inclusion Criteria: - Neck pain > 3 months - Mean pain intensity > 3/10 during the preceding month - Native Dutch speaker - Being able to walk normally Exclusion Criteria: - People with specific causes of neck pain (such as cervical disc herniation with nerve root impingement, severe osteoarthritis, fractures) - Major depression or psychiatric illness - Life threatening, metabolic, cardiovascular, neurologic, systemic diseases, diagnosed sleeping disorder - Pregnancy or given birth in the preceding year - History of head, neck or shoulder surgery - Fibromyalgia and chronic fatigue syndrome - Body mass index > 30 kg/m2 |
Country | Name | City | State |
---|---|---|---|
Belgium | Department of rehabilitation sciences (Ghent University) | Ghent | Gente |
Lead Sponsor | Collaborator |
---|---|
University Ghent |
Belgium,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Pain intensity | Pain intensity by the Brief Pain Inventory (BPI). The BPI includes four ratings of pain intensity (items 3-7), and seven other ratings on the impact of pain. Intensity is recorded on numerical scales from zero (no pain) to ten (pain as bad as you can imagine). Also, intensity is rated at the time of completing the questionnaires (pain now) as well as its worst, least, and average over the past day or week. The BPI also records the location of the pain on a diagram of a human figure. Patients are also asked to select words that best describe their pain and to indicate the extent and duration of pain relief obtained from analgesics. | After treatment (12weeks) | |
Secondary | Pain sensitivity | Pain sensitivity assessed by determine pressure pain thresholds (PPT) with an algometer at local and distal locations. Lower thresholds mean higher mechanical hypersensitivity. | Baseline and after 12 weeks treatment | |
Secondary | Central sensitivity | Central sensitivity by the Central Sensitization Inventory (CSI) questionnaire. The CSI is a two-part questionnaire that contains a 25-item survey that assesses the frequency of health-related symptoms associated with central sensitivity syndromes. Each question may be answered as follows: Never (0 points), Rarely (1 point), Sometimes (2 points), Often (3 points), or Always (4 points). The higher the total score, the more likely central sensitisation is present. Subclinical: 0 to 29 Mild: 30 to 39 Moderate: 40 to 49 Severe: 50 to 59 Extreme: 60 to 100 |
Baseline and after 12 weeks treatment | |
Secondary | Pain intensity | Pain intensity by the Brief Pain Inventory (BPI). The BPI includes four ratings of pain intensity (items 3-7), and seven other ratings on the impact of pain. Intensity is recorded on numerical scales from zero (no pain) to ten (pain as bad as you can imagine). Also, intensity is rated at the time of completing the questionnaires (pain now) as well as its worst, least, and average over the past day or week. The BPI also records the location of the pain on a diagram of a human figure. Patients are also asked to select words that best describe their pain and to indicate the extent and duration of pain relief obtained from analgesics. | baseline, after 6 weeks of treatment and 3 months after treatment | |
Secondary | Neck pain-related disability | Neck pain-related disability assessed by the Neck Disability Index (NDI). The test has a maximum score of 50. 0 points means : no activity limitations , 50 points means complete activity limitation. A higher score indicates more patient-rated disability. | Baseline, after 6 weeks treatment, after 12 weeks treatment, after 3 months | |
Secondary | Health-related quality of life | Health-related quality of life assessed by the Short Form Health Survey- 36 items (SF-36). The questionnaire contains scales for physical and social function, mental health, energy, pain and general health perception. A higher score represents a better health. |
Baseline, after 6 weeks treatment, after 12 weeks treatment, after 3 months | |
Secondary | Physical activity | Physical activity monitored by activity trackers. | Baseline and after 12 weeks of treatment | |
Secondary | Insomnia | Self-reported sleep by the Insomnia Severity Index (ISI). The questionnaire assesses the severity of both nighttime and daytime components of insomnia. Scores are ranging from 0 to 28. The higher the score the worse the insomnia. | Baseline and after 12 weeks treatment | |
Secondary | Sleep quality | Sleep quality by the Pittsburgh Sleep Quality Index (PSQI). The PSQI-scores vary from 0 to 21. A score higher than 5 indicates bad sleep quality. | Baseline and after 12 weeks treatment | |
Secondary | Stress | Self-reported by the Depression Anxiety and Stress Scale (DASS). Participants indicate on a 4-point scale the extent to which each of 42 statements applied over the past week. Higher scores on each subscale indicate increasing severity of depression, anxiety, or stress. | Baseline and after 12 weeks treatment | |
Secondary | Productivity losses | Productivity losses by iMTA Productivity Cost Questionnaire. The iMTA Productivity Cost Questionnaire (iPCQ) includes three modules measuring productivity losses of paid work due to 1) absenteeism and 2) presenteeism and productivity losses related to 3) unpaid work. | Baseline, after 6 weeks treatment, after 12 weeks treatment, after 3 months | |
Secondary | Medical consumption | iMTA Medical Consumption Questionnaire (iMCQ), a generic instrument for measuring medical costs. The iMCQ includes questions related to frequently occurring contacts with health care providers. | Baseline, after 6 weeks treatment, after 12 weeks treatment, after 3 months | |
Secondary | Treatment adherence | The patient's ability to fully and accurately observe and perform the advice and instructions, will be evaluated by a online diary. | Baseline, after 6 weeks treatment, after 12 weeks treatment, after 3 months | |
Secondary | Global Perceived effect | The Global Perceived Effect (GPE) scale is a self-report tool for the patient to rate on a numeric scale, how much their pain condition has improved (+5) or worsened (-5) since a predefined time point. | Baseline, after 6 weeks treatment, after 12 weeks treatment, after 3 months | |
Secondary | Cost effectiveness | Euro Quality of life 5D questionnaire (score = 0-100, higher scores = better outcome) | Baseline, after 6 weeks treatment, after 12 weeks treatment, after 3 months |
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