Clinical trial NCT04749823: The NEXERCISE-trial: Reshaping Exercise Programs for Patients With Non-specific Neck Pain
Official title: The NEXERCISE-trial: When Pain Neuroscience and Clinical Exercise Physiology Meet: Reshaping Exercise Programs for Patients With Non-specific Neck Pain
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Neck Pain
Chronic Pain
Keywords: local neck exercises
general aerobic exercises
pain intensity
cost effectiveness
Lead sponsor: University Ghent
Sponsor class: OTHER
First posted: 2021-02-11
Enrollment: 48
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: Chronic non-specific neck pain is a common musculoskeletal complaint in which several biopsychosocial factors can be involved. This condition is associated with a high socio-economic burden. The standard of care treatment for chronic neck pain in clinical practice is a combination of advice, passive manual treatment techniques and neck exercises. The implementation of exercise for the treatment of chronic neck pain is indeed recommended in several clinical guidelines. Nevertheless, exercise programs show positive though limited effects, which can be explained by its biomechanical and physiological effects on muscles and joints, but a current lack of taking into account important biopsychosocial and neurophysiological factors. For instance, specific local exercises can lead to acute pain flare-ups, hampering patient satisfaction and the adherence to exercise programs. While it is shown that general aerobic exercise leads to decreased generalized pain sensitivity, also in the affected body parts, both immediately and on the longer term, although on the longer term the effects on local pain sensitivity are better for specific local exercises.

It can be hypothesized that a blended treatment program in which local specific neck exercises are combined with general aerobic exercise in counteractive amount will avoid pain flare-ups and maladaptive exercise perceptions, positively influencing treatment adherence and generating the most optimal clinical outcome due to the local and general effects.

Therefore the aim of this project is to investigate the effect of a blended treatment program (I) to a specific exercise program alone (C1) and to a general aerobic exercise program alone (C2) on pain intensity and cost effectiveness (primary outcome measures), and also on Global Perceived Effect, other pain-related outcomes, quality of life and functionality, lifestyle factors, and health-economic measures (secondary outcome measures) (O) in chronic non-specific neck pain patients (P).

Eligibility criteria: 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

Primary outcomes:
measure: Pain intensity
timeFrame: After treatment (12weeks)
Secondary outcomes:
measure: Pain sensitivity
timeFrame: Baseline and after 12 weeks treatment
measure: Central sensitivity
timeFrame: Baseline and after 12 weeks treatment
measure: Pain intensity
timeFrame: baseline, after 6 weeks of treatment and 3 months after treatment
measure: Neck pain-related disability
timeFrame: Baseline, after 6 weeks treatment, after 12 weeks treatment, after 3 months
measure: Health-related quality of life
timeFrame: Baseline, after 6 weeks treatment, after 12 weeks treatment, after 3 months
measure: Physical activity
timeFrame: Baseline and after 12 weeks of treatment
measure: Insomnia
timeFrame: Baseline and after 12 weeks treatment
measure: Sleep quality
timeFrame: Baseline and after 12 weeks treatment
measure: Stress
timeFrame: Baseline and after 12 weeks treatment
measure: Productivity losses
timeFrame: Baseline, after 6 weeks treatment, after 12 weeks treatment, after 3 months
measure: Medical consumption
timeFrame: Baseline, after 6 weeks treatment, after 12 weeks treatment, after 3 months
measure: Treatment adherence
timeFrame: Baseline, after 6 weeks treatment, after 12 weeks treatment, after 3 months
measure: Global Perceived effect
timeFrame: Baseline, after 6 weeks treatment, after 12 weeks treatment, after 3 months
measure: Cost effectiveness
timeFrame: Baseline, after 6 weeks treatment, after 12 weeks treatment, after 3 months
Other outcomes:
Locations:
city: Ghent
country: Belgium
facility: Department of rehabilitation sciences (Ghent University)
state: Gente
Study officials:
affiliation: University Ghent
name: Mira Meeus, Prof.Dr.
role: PRINCIPAL_INVESTIGATOR
References: