Neck PainNEXERCISENCT04749823
The NEXERCISE-trial: Reshaping Exercise Programs for Patients With Non-specific Neck Pain
A study testing Blended treatment program, Specific strength exercise program and General aerobic exercise program in people with Neck Pain and Chronic Pain, run by University Ghent at 1 site in Belgium.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Neck Pain, Chronic Pain
- What is being tested?
- Blended treatment program, Specific strength exercise program and General aerobic exercise program
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteBelgium
- Study dates
- 1 Mar 2021to 1 Sep 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Neck pain > 3 months
- Mean pain intensity > 3/10 during the preceding month
- Native Dutch speaker
- Being able to walk normally
Who cannot join
- 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 locations and contacts
1 site in 1 country.
Belgium1 site
Department of rehabilitation sciences (Ghent University)
Ghent, Gente, 9000
About this study
Official title: The NEXERCISE-trial: When Pain Neuroscience and Clinical Exercise Physiology Meet: 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.
Read the 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).
- Conditions
- Neck Pain, Chronic Pain
- Being tested
- Blended treatment program, Specific strength exercise program, General aerobic exercise program
- Keywords
- local neck exercises, general aerobic exercises, pain intensity, cost effectiveness
- Medical subject headings
- Neck Pain, Chronic Pain, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blended treatment programOther
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 programOther
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 programOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Blended treatment program | Experimental | 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. Receives: Other: Blended treatment program |
| Specific strength exercise program | Active comparator | 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.. Receives: Other: Specific strength exercise program |
| General aerobic exercise program | Active comparator | 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. Receives: Other: General aerobic exercise program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain intensity
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.
Measured: After treatment (12weeks)
Secondary outcomes (14)
Pain sensitivity
Pain sensitivity assessed by determine pressure pain thresholds (PPT) with an algometer at local and distal locations. Lower thresholds mean higher mechanical hypersensitivity.
Measured: Baseline and after 12 weeks treatment
Central sensitivity
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
Measured: Baseline and after 12 weeks treatment
Pain intensity
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.
Measured: baseline, after 6 weeks of treatment and 3 months after treatment
Neck pain-related disability
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.
Measured: Baseline, after 6 weeks treatment, after 12 weeks treatment, after 3 months
Health-related quality of life
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.
Measured: Baseline, after 6 weeks treatment, after 12 weeks treatment, after 3 months
Physical activity
Physical activity monitored by activity trackers.
Measured: Baseline and after 12 weeks of treatment
Insomnia
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.
Measured: Baseline and after 12 weeks treatment
Sleep quality
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.
Measured: Baseline and after 12 weeks treatment
Stress
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.
Measured: Baseline and after 12 weeks treatment
Productivity losses
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.
Measured: Baseline, after 6 weeks treatment, after 12 weeks treatment, after 3 months
Medical consumption
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.
Measured: Baseline, after 6 weeks treatment, after 12 weeks treatment, after 3 months
Treatment adherence
The patient's ability to fully and accurately observe and perform the advice and instructions, will be evaluated by a online diary.
Measured: Baseline, after 6 weeks treatment, after 12 weeks treatment, after 3 months
Global Perceived effect
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.
Measured: Baseline, after 6 weeks treatment, after 12 weeks treatment, after 3 months
Cost effectiveness
Euro Quality of life 5D questionnaire (score = 0-100, higher scores = better outcome)
Measured: Baseline, after 6 weeks treatment, after 12 weeks treatment, after 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Feb 2021
- Study start1 Mar 2021
- Primary completion1 Sep 2022
- Study completion1 Sep 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Neck PainStudies of the same condition, open and under way.
- More trials run by University GhentThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Ghent
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mira Meeus, Prof.Dr., Principal investigator, University Ghent
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04749823
- Sponsor's protocol ID
- BC-5419
- Acronym
- NEXERCISE
- Status last verified
- Jan 2024
- First submitted
- 26 Oct 2020
- Last updated
- 11 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Bontinck J, Meeus M, Voogt L, Chys M, Coppieters I, Cagnie B, De Meulemeester K. Online Exercise Programs for Chronic Nonspecific Neck Pain: A Randomized Controlled Trial Reveals Comparable Effects of Global, Local, and Combined Approaches. Phys Ther. 2024 Jun 4;104(6):pzae040. doi: 10.1093/ptj/pzae040.
PubMed 38498321
Study at a glance
From the registry record, last updated by the sponsor on 11 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The NEXERCISE-trial: When Pain Neuroscience and Clinical Exercise Physiology Meet: Reshaping Exercise Programs for Patients With Non-specific Neck Pain
- ClinicalTrials.gov ID
- NCT04749823
- Acronym / sponsor ID
- NEXERCISE / BC-5419
- Conditions
- Neck Pain, Chronic Pain
- Keywords
- local neck exercises, general aerobic exercises, pain intensity, cost effectiveness
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- University GhentUniversity, hospital or other
- Study start
- 1 Mar 2021 (actual)
- Primary completion
- 1 Sep 2022 (actual)
- Study completion
- 1 Sep 2022 (actual)
- First posted
- 11 Feb 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Blended treatment program | Experimental | Other: Blended treatment programThe 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. |
| Specific strength exercise program | Active comparator | Other: Specific strength exercise programThis 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.. |
| General aerobic exercise program | Active comparator | Other: General aerobic exercise programThis 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Neck pain > 3 months
- Mean pain intensity > 3/10 during the preceding month
- Native Dutch speaker
- Being able to walk normally
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Blended treatment programA 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. | Other | Blended treatment program |
| Specific strength exercise programThis 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. | Other | Specific strength exercise program |
| General aerobic exercise programThis 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. | Other | General aerobic exercise program |
Primary outcome
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.
14 secondary outcomes
Pain sensitivity
Time frame: Baseline and after 12 weeks treatment
Central sensitivity
Time frame: Baseline and after 12 weeks treatment
Pain intensity
Time frame: baseline, after 6 weeks of treatment and 3 months after treatment
Neck pain-related disability
Time frame: Baseline, after 6 weeks treatment, after 12 weeks treatment, after 3 months
Health-related quality of life
Time frame: Baseline, after 6 weeks treatment, after 12 weeks treatment, after 3 months
Physical activity
Time frame: Baseline and after 12 weeks of treatment
Insomnia
Time frame: Baseline and after 12 weeks treatment
Sleep quality
Time frame: Baseline and after 12 weeks treatment
Stress
Time frame: Baseline and after 12 weeks treatment
Productivity losses
Time frame: Baseline, after 6 weeks treatment, after 12 weeks treatment, after 3 months
Medical consumption
Time frame: Baseline, after 6 weeks treatment, after 12 weeks treatment, after 3 months
Treatment adherence
Time frame: Baseline, after 6 weeks treatment, after 12 weeks treatment, after 3 months
Global Perceived effect
Time frame: Baseline, after 6 weeks treatment, after 12 weeks treatment, after 3 months
Cost effectiveness
Time frame: Baseline, after 6 weeks treatment, after 12 weeks treatment, after 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jan 2024.
- Derived from this study: PubMed 38498321Bontinck J, Meeus M, Voogt L, Chys M, Coppieters I, Cagnie B, De Meulemeester K. Online Exercise Programs for Chronic Nonspecific Neck Pain: A Randomized Controlled Trial Reveals Comparable Effects of Global, Local, and Combined Approaches. Phys Ther. 2024 Jun 4;104(6):pzae040. doi: 10.1093/ptj/pzae040.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mira Meeus, Prof.Dr. principal investigator
University Ghent
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Blended treatment program, Specific strength exercise program and General aerobic exercise program in people with Neck Pain and Chronic Pain, run by University Ghent at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain intensity (time frame: After treatment (12weeks)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04749823, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jan 2024.