Clinical trial NCT04330573: Sensory Characteristics and Psychosocial Factors Related With Non-specific Neck Musculoskeletal Pain Chronification
Official title: Sensory Characteristics and Psychosocial Factors Related With Non-specific Neck Musculoskeletal Pain Chronification
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Neck Pain
Keywords: chronic non-specific neck pain
musculoskeletal pain
psychosocial factors
sensory characteristics
pressure pain thresholds
temporal summation
Lead sponsor: Universidad San Jorge
Sponsor class: OTHER
Collaborators: name: Hospital General de la Defensa en Zaragoza
First posted: 2020-04-01
Enrollment: 68
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study was divided into 2 groups: individuals with Chronic Non-Specific Neck Pain and healthy controls.

Brief summary: Chronic pain is commonly defined as any pain which lasts more than 12 weeks. Chronic non-specific neck pain (CNSNP) has no specific underlying disease causing the pain. There are neurophysiological factors that may modulate pain response and perception in the central nervous system, producing sensory changes such as the presence of temporal summation (TS) and pressure, cold or heat hyperalgesia. TS describes the progressive increase in reported pain intensity as a function of repeated noxious stimulation (e.g. thermal, electrical or mechanical). TS and hyperalgesia are measured through quantitative sensory tests (QST) where pain pressure thresholds (PPT) are measured with an algometer. The current evidence show that PPTs are significantly lower compared to healthy subjects and the association between PPTs, pain intensity and disability are inconsistent. Further, there are psychosocial factors (catastrophizing, kinesiophobia, stress...) that may influence the pain experience. This psychosocial factors associated with chronic pain are not systematically collected in the QST literature complicating the interpretation of data. The objectives of this study are 1) to determine disability, sensory (TS and PPTs) and psychosocial changes (kinesiophobia, catastrophizing, sleep quality, life quality, stress and anxiety) in the natural evolution or in the result of physiotherapy treatment in CNSNP individuals, 2) to study the correlations between disability, psychosocial and sensory factors and 3) to observe if there is a homogeneity between the subjects.


Eligibility criteria: Inclusion criteria for individuals with CNSNP were:

1. age between 18 and 65 years;
2. capable to understand, write, and speak in Spanish;
3. having suffered neck pain during the last 12 weeks at least;
4. pain localized in the neck region with or without pain radiation;
5. Negative Spurling test;
6. Negative Self-Administered Leeds Assessment of Neuropathic Symptoms and Signs (S-LANSS);
7. Negative Upper Limb Tension Test for the median nerve;
8. PainDetect test with non-neuropathic pain result. .

Exclusion Criteria:

1. Presence of red flag as reported in the medical history (i.e. tumor, fracture, metabolic diseases, rheumatoid arthritis, osteoporosis);
2. Neck pain with cervical radiculopathy;
3. fibromyalgia syndrome,
4. previous neck surgery;
5. currently undergoing any type of pain treatment or having received physical therapy in the previous 3 months.

Primary outcomes:
measure: Neck Disability Index Change
timeFrame: T0 (baseline); T1 (1 month); T2 (6 months).
measure: Quick-DASH change
timeFrame: T0 (baseline); T1 (1 month); T2 (6 months).
Secondary outcomes:
measure: Pressure Pain Threshold change
timeFrame: T0 (baseline); T1 (1 month); T2 (6 months).
measure: Temporal Summation change
timeFrame: T0 (baseline); T1 (1 month); T2 (6 months).
measure: Area of pain assessed by bodycharts change
timeFrame: T0 (baseline); T1 (1 month); T2 (6 months).
measure: Pain Intensity change- Visual Analogic Scale
timeFrame: T0 (baseline); T1 (1 month); T2 (6 months).
measure: Pain Duration change
timeFrame: T0 (baseline); T1 (1 month); T2 (6 months).
measure: Catastrophism change. Pain Catastrophizing Scale
timeFrame: T0 (baseline); T1 (1 month); T2 (6 months).
measure: Kinesiophobia change. Tampa Scale for Kinesiophobia
timeFrame: T0 (baseline); T1 (1 month); T2 (6 months).
measure: Quality of Life change. The 5-level EQ-5D version (EQ-5D-5L)
timeFrame: T0 (baseline); T1 (1 month); T2 (6 months).
measure: Stress change. Perceived Stress Scale
timeFrame: T0 (baseline); T1 (1 month); T2 (6 months).
measure: Quality of Sleep change . Pittsburgh Questionnaire
timeFrame: T0 (baseline); T1 (1 month); T2 (6 months).
measure: Anxiety-Depression change. DASS 21.
timeFrame: T0 (baseline); T1 (1 month); T2 (6 months).
Other outcomes:
Locations:
city: Zaragoza
country: Spain
facility: Hospital General de la Defensa
Study officials:
References: