Sensory Characteristics and Psychosocial Factors Related With Non-specific Neck Musculoskeletal Pain Chronification

NCT04330573 | Completed

• 1 other identifier: CNSNP-USJ
• Study Type: observational
• Target: 68
• Locations: 1 country
• Sites: 1

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.

Conditions

Neck Pain

Keywords

chronic non-specific neck pain; musculoskeletal pain; psychosocial factors; sensory characteristics; pressure pain thresholds; temporal summation

Outcome Measures

Primary Outcomes (2)

• Neck Disability Index Change

  It is a 10-item questionnaire that measures a patient's self-reported neck pain related disability. Questions include activities of daily living, such as: personal care, lifting, reading, work, driving, sleeping, recreational activities, pain intensity, concentration and headache. The 10 item scores are then summed to yield a global NDI score, which has a range of 0-50 where higher values reflect greater neck disability. 1 and 6-month results were subtracted from baseline. As such, positive change scores for neck disability indicate improvement

  T0 (baseline); T1 (1 month); T2 (6 months).

• Quick-DASH change

  The purpose of the QuickDASH is to use 11 items to measure physical function and symptoms in people with any or multiple musculoskeletal disorders of the upper limb. The QuickDASH is a widely used reference of self reported disability. The 11 item scores are then summed to yield a global QuickDASH score, which has a range of 11-100 where higher values reflect greater shoulder/arm disability. 1 and 6-month results were subtracted from baseline. As such, positive change scores for shoulder/arm disability indicate improvement

  T0 (baseline); T1 (1 month); T2 (6 months).

Secondary Outcomes (11)

• Pressure Pain Threshold change

  T0 (baseline); T1 (1 month); T2 (6 months).

• Temporal Summation change

  T0 (baseline); T1 (1 month); T2 (6 months).

• Area of pain assessed by bodycharts change

  T0 (baseline); T1 (1 month); T2 (6 months).

• Pain Intensity change- Visual Analogic Scale

  T0 (baseline); T1 (1 month); T2 (6 months).

• Pain Duration change

  T0 (baseline); T1 (1 month); T2 (6 months).

Study Arms (2)

Chronic Non-Specific Neck Pain

Patients with chronic non-specific neck pain. No interventions

Other: No intervention. Observational study

Control/Healthy Group

Volunteers without pain. No interventions.

Other: No intervention. Observational study

Interventions

No intervention. Observational study OTHER

Observational study

Chronic Non-Specific Neck Pain; Control/Healthy Group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study was divided into 2 groups: individuals with Chronic Non-Specific Neck Pain and healthy controls.

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Universidad San Jorge: lead
• Hospital General de la Defensa en Zaragoza: collaborator

Study Sites (1)

Hospital General de la Defensa

Zaragoza, 50009, Spain

Location

MeSH Terms

Conditions

Neck Pain; Musculoskeletal Pain

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Muscular Diseases; Musculoskeletal Diseases

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr. Pablo Herrero, PT, PhD

Study Record Dates

• First Submitted: March 25, 2020
• First Posted: April 1, 2020
• Study Start: April 15, 2020
• Primary Completion: December 15, 2020
• Study Completion: January 22, 2021
• Last Updated: January 25, 2021

Record last verified: 2021-01

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)