The NEXERCISE-trial: Reshaping Exercise Programs for Patients With Non-specific Neck Pain

University Ghent

Status: Completed

Conditions: Chronic Pain; Neck Pain

Treatments: Other: Blended treatment program; Other: Specific strength exercise program; Other: General aerobic exercise program

Study type: Interventional

Funder types: Other

Identifiers

NCT04749823

BC-5419

Details and patient eligibility

About

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.

Full 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).

Enrollment: 48 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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48 participants in 3 patient groups

Blended treatment program

Experimental group

Description:

The blended treatment program will consist of a combination of specific active exercises of the neck and general aerobic exercises. This contains a program of 12 weeks, including 9 supervised online sessions supplemented with 1 to 3 individual home exercises sessions without supervision per week, with a total of 3 sessions/week.

Treatment:

Other: Blended treatment program

Specific strength exercise program

Active Comparator group

Description:

This group will receive an exercise program with specific strength exercises of the neck muscles. Within a 12-week period, patients will receive 9 online treatment sessions under supervision and 1 to 3 additional home exercise sessions without supervision, with a total of 3 sessions/week..

Treatment:

Other: Specific strength exercise program

General aerobic exercise program

Active Comparator group

Description:

This control group will perform general aerobic exercises. Within a 12-week period, patients will be instructed to perform a general aerobic exercise session 3 times a week.

Treatment:

Other: General aerobic exercise program