Skip to main content
OpenTrials
Completed

NCT Number: NCT04749823

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Neck Pain Chronic Pain Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of rehabilitation sciences (Ghent University)

Ghent, Gente, 9000, Belgium

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Blended treatment program

Other

A combined treatment program with specific active neck exercises and general aerobic training in counteractive amount will be executed during 12 weeks. Nine supervised sessions will be supplemented with 1 to 3 weekly unsupervised home exercise sessions.

Specific strength exercise program

Other

This program includes an individual, patient-tailored exercise program with the aim of retraining the neck musculature. A detailed exercise programme will be constructed in which all exercises are listed with the amount of repetitions and series of each exercise. Strength exercises will be performed by means of dumbbells with different weights and elastic bands with different degrees of resistance. The amount of weight or resistance, and the amount of series and repetitions will be evaluated during the first session. This exercise programme will be re-evaluated repeatedly during the course of the program. Specific strength neck exercises will be performed for 30 minutes. Nine supervised sessions will be supplemented with 1 to 3 weekly unsupervised home exercise sessions.

General aerobic exercise program

Other

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

Primary outcomes

  1. Pain intensity

    Time frame: After treatment (12weeks)

    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.

Secondary outcomes

  1. Pain sensitivity

    Time frame: Baseline and after 12 weeks treatment

    Pain sensitivity assessed by determine pressure pain thresholds (PPT) with an algometer at local and distal locations. Lower thresholds mean higher mechanical hypersensitivity.

  2. Central sensitivity

    Time frame: Baseline and after 12 weeks treatment

    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

  3. Pain intensity

    Time frame: baseline, after 6 weeks of treatment and 3 months after treatment

    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.

  4. Neck pain-related disability

    Time frame: Baseline, after 6 weeks treatment, after 12 weeks treatment, after 3 months

    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.

  5. Health-related quality of life

    Time frame: Baseline, after 6 weeks treatment, after 12 weeks treatment, after 3 months

    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.

  6. Physical activity

    Time frame: Baseline and after 12 weeks of treatment

    Physical activity monitored by activity trackers.

  7. Insomnia

    Time frame: Baseline and after 12 weeks treatment

    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.

  8. Sleep quality

    Time frame: Baseline and after 12 weeks treatment

    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.

  9. Stress

    Time frame: Baseline and after 12 weeks treatment

    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.

  10. Productivity losses

    Time frame: Baseline, after 6 weeks treatment, after 12 weeks treatment, after 3 months

    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.

  11. Medical consumption

    Time frame: Baseline, after 6 weeks treatment, after 12 weeks treatment, after 3 months

    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.

  12. Treatment adherence

    Time frame: Baseline, after 6 weeks treatment, after 12 weeks treatment, after 3 months

    The patient's ability to fully and accurately observe and perform the advice and instructions, will be evaluated by a online diary.

  13. Global Perceived effect

    Time frame: Baseline, after 6 weeks treatment, after 12 weeks treatment, after 3 months

    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.

  14. Cost effectiveness

    Time frame: Baseline, after 6 weeks treatment, after 12 weeks treatment, after 3 months

    Euro Quality of life 5D questionnaire (score = 0-100, higher scores = better outcome)

Sponsors and collaborators

Lead sponsor

University Ghent

Other

Registry information

Official study title

The NEXERCISE-trial: When Pain Neuroscience and Clinical Exercise Physiology Meet: Reshaping Exercise Programs for Patients With Non-specific Neck Pain

Acronym: NEXERCISE

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Feb 11, 2021
Registry last updated
Jan 11, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.