Chronic Nonspecific Neck PainNCT03562338
Predictive Model of Recovery in Patients With Chronic Nonspecific Neck Pain Undergoing Manual Therapy and Exercise
A study testing Manual Therapy and Exercise (Physiotherapy Intervention) in people with Chronic Nonspecific Neck Pain, run by Universidade Nova de Lisboa.
Trial summary
The aim of this study is to develop a predictive model to identify which patients with chronic nonspecific neck pain are more likely to benefit from manual therapy and exercise program, or usual care. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Chronic Nonspecific Neck Pain
- What is being tested?
- Manual Therapy and Exercise (Physiotherapy Intervention)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- No sites listed yet
- Study dates
- 11 Jun 2018to Feb 2019
- 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
- Chronic nonspecific neck pain at least 3 months, defined as pain in the cervical region without a specific anatomopathological diagnosis;
- Adults between 18 and 65 years of age and literate in Portuguese;
Who cannot join
- History of cervical trauma and/or history of surgery in the prior 6 months;
- Clinical signs of infection, tumor, neurological, inflammatory or systemic diseases;
- Pregnancy
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Modelo Preditivo Para os Resultados de Sucesso Com um Programa Combinado de Terapia Manual e exercício em indivíduos Com Dor Cervical crónica de Origem não-especifica
The aim of this study is to develop a predictive model to identify which patients with chronic nonspecific neck pain are more likely to benefit from manual therapy and exercise program, or usual care.
- Conditions
- Chronic Nonspecific Neck Pain
- Being tested
- Manual Therapy and Exercise (Physiotherapy Intervention), Usual Care (Physiotherapy Intervention)
- Keywords
- chronic nonspecific neck pain, disability, predictive model, rehabilitation, pain intensity
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Manual Therapy and Exercise (Physiotherapy Intervention)Other
Participants in this group will receive a 6-weeks program of mobilization and progressive exercise for the neck flexors, 2 times a week.
Usual Care (Physiotherapy Intervention)Other
Participants in this group will receive usual care in physiotherapy during the 6-weeks period.
| Study group | Role | What they receive |
|---|---|---|
| Manual Therapy and Exercise | Experimental | Not described Receives: Other: Manual Therapy and Exercise (Physiotherapy Intervention) |
| Usual Care | Active comparator | Not described Receives: Other: Usual Care (Physiotherapy Intervention) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in Neck Pain Intensity as measured by the Numeric pain rating scale (NRPS) at 3 weeks.
The change will be defined on the Minimal Clinically Important Difference in treatment response defined as a decrease of ≥2 point in NRPS (range: 0 - 10 points).
Measured: 3 weeks
Change from baseline in Neck Pain Intensity as measured by the Numeric pain rating scale (NRPS) at 6 weeks.
The change will be defined on the Minimal Clinically Important Difference in treatment response defined as a decrease of ≥2 point in NRPS (range: 0 - 10 points).
Measured: 6 weeks
Change from baseline in Neck Pain Intensity as measured by the Numeric pain rating scale (NRPS) at follow-up 3 months.
The change will be defined on the Minimal Clinically Important Difference in treatment response defined as a decrease of ≥2 point in NRPS (range: 0 - 10 points).
Measured: Follow-up 3 months
Change from baseline in Neck Disability as measured by the Neck Disability Index (NDI) at 3 weeks.
The change will be defined on the Minimal Clinically Important Difference in treatment response defined as a decrease of ≥27% in NDI (range: 0-50 and higher scores are indicative of more disability).
Measured: 3 weeks
Change from baseline in Neck Disability as measured by the Neck Disability Index (NDI) at 6 weeks.
The change will be defined on the Minimal Clinically Important Difference in treatment response defined as a decrease of ≥27% in NDI (range: 0-50 and higher scores are indicative of more disability).
Measured: 6 weeks
Change from baseline in Neck Disability as measured by the Neck Disability Index (NDI) at follow-up 3 months.
The change will be defined on the Minimal Clinically Important Difference in treatment response defined as a decrease of ≥27% in NDI (range: 0-50 and higher scores are indicative of more disability).
Measured: Follow-up 3 months
Secondary outcomes (3)
Clinical Important Treatment response in global perceived recovery as measured by Patient's Global Impression of Change Scale at 3 weeks
The clinically Important treatment response in global perceived recovery was defined as a value of ≥5 in Patient's Global Impression of Change Scale (range: 1-7 Likert Scale)
Measured: 3 weeks
Clinical Important Treatment response in global perceived recovery as measured by Patient's Global Impression of Change Scale at 6 weeks
The clinically Important treatment response in global perceived recovery was defined as a value of ≥5 in Patient's Global Impression of Change Scale (range: 1-7 Likert Scale)
Measured: 6 weeks
Clinical Important Treatment response in global perceived recovery as measured by Patient's Global Impression of Change Scale at follow-up 3 months
The clinically Important treatment response in global perceived recovery was defined as a value of ≥5 in Patient's Global Impression of Change Scale (range: 1-7 Likert Scale)
Measured: Follow-up 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jun 2018
- Study start11 Jun 2018 (estimated)
- Primary completionFeb 2019 (estimated)
- Study completionFeb 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Nonspecific Neck PainStudies of the same condition, open and under way.
- 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
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universidade Nova de Lisboa
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Lúcia Domingues, Principal investigator, NOVA Medical School | Faculdade de Ciências Médicas, Universidade Nova de Lisboa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03562338
- Sponsor's protocol ID
- NOVA.MS|FCM-UNL
- Status last verified
- Jun 2018
- First submitted
- 24 May 2018
- Last updated
- 19 Jun 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Modelo Preditivo Para os Resultados de Sucesso Com um Programa Combinado de Terapia Manual e exercício em indivíduos Com Dor Cervical crónica de Origem não-especifica
- ClinicalTrials.gov ID
- NCT03562338
- Acronym / sponsor ID
- NOVA.MS|FCM-UNL
- Conditions
- Chronic Nonspecific Neck Pain
- Keywords
- chronic nonspecific neck pain, disability, predictive model, rehabilitation, pain intensity
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Universidade Nova de LisboaUniversity, hospital or other
- Study start
- 11 Jun 2018 (estimated)
- Primary completion
- Feb 2019 (estimated)
- Study completion
- Feb 2019 (estimated)
- First posted
- 19 Jun 2018 (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 aim of this study is to develop a predictive model to identify which patients with chronic nonspecific neck pain are more likely to benefit from manual therapy and exercise program, or usual care.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Manual Therapy and Exercise | Experimental | Other: Manual Therapy and Exercise (Physiotherapy Intervention) |
| Usual Care | Active comparator | Other: Usual Care (Physiotherapy Intervention) |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Chronic nonspecific neck pain at least 3 months, defined as pain in the cervical region without a specific anatomopathological diagnosis;
- Adults between 18 and 65 years of age and literate in Portuguese;
Key exclusion criteria (3 listed)
- History of cervical trauma and/or history of surgery in the prior 6 months;
- Clinical signs of infection, tumor, neurological, inflammatory or systemic diseases;
- Pregnancy
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 |
|---|---|---|
| Manual Therapy and Exercise (Physiotherapy Intervention)Participants in this group will receive a 6-weeks program of mobilization and progressive exercise for the neck flexors, 2 times a week. | Other | Manual Therapy and Exercise |
| Usual Care (Physiotherapy Intervention)Participants in this group will receive usual care in physiotherapy during the 6-weeks period. | Other | Usual Care |
Primary outcome
Change from baseline in Neck Pain Intensity as measured by the Numeric pain rating scale (NRPS) at 3 weeks.
Time frame: 3 weeks
The change will be defined on the Minimal Clinically Important Difference in treatment response defined as a decrease of ≥2 point in NRPS (range: 0 - 10 points).
Change from baseline in Neck Pain Intensity as measured by the Numeric pain rating scale (NRPS) at 6 weeks.
Time frame: 6 weeks
The change will be defined on the Minimal Clinically Important Difference in treatment response defined as a decrease of ≥2 point in NRPS (range: 0 - 10 points).
Change from baseline in Neck Pain Intensity as measured by the Numeric pain rating scale (NRPS) at follow-up 3 months.
Time frame: Follow-up 3 months
The change will be defined on the Minimal Clinically Important Difference in treatment response defined as a decrease of ≥2 point in NRPS (range: 0 - 10 points).
Change from baseline in Neck Disability as measured by the Neck Disability Index (NDI) at 3 weeks.
Time frame: 3 weeks
The change will be defined on the Minimal Clinically Important Difference in treatment response defined as a decrease of ≥27% in NDI (range: 0-50 and higher scores are indicative of more disability).
Change from baseline in Neck Disability as measured by the Neck Disability Index (NDI) at 6 weeks.
Time frame: 6 weeks
The change will be defined on the Minimal Clinically Important Difference in treatment response defined as a decrease of ≥27% in NDI (range: 0-50 and higher scores are indicative of more disability).
Change from baseline in Neck Disability as measured by the Neck Disability Index (NDI) at follow-up 3 months.
Time frame: Follow-up 3 months
The change will be defined on the Minimal Clinically Important Difference in treatment response defined as a decrease of ≥27% in NDI (range: 0-50 and higher scores are indicative of more disability).
3 secondary outcomes
Clinical Important Treatment response in global perceived recovery as measured by Patient's Global Impression of Change Scale at 3 weeks
Time frame: 3 weeks
Clinical Important Treatment response in global perceived recovery as measured by Patient's Global Impression of Change Scale at 6 weeks
Time frame: 6 weeks
Clinical Important Treatment response in global perceived recovery as measured by Patient's Global Impression of Change Scale at follow-up 3 months
Time frame: Follow-up 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jun 2018.
Related trials for Chronic Nonspecific Neck Pain
Not yet recruiting
Comparison of the Effectiveness of Motor Imagery Exercises and Suboccipital Myofascial Release Techniques in Nonspecific Chronic Neck Pain
Non-specific Chronic Neck Pain
Not yet recruiting
Digital Use, 24-Hour Movement Behaviors, and Myofascial Release in University Students With Neck Pain
Forward Head Posture, Chronic Nonspecific Neck Pain
Not yet recruiting
Comparative Effectiveness Randomised Controlled Trial of Hybrid Muscle Conditioning
Chronic Nonspecific Neck Pain
RecruitingObservational study
Physical Profile of Cervicogenic Headache: Comparison With Neck Pain and Healthy Controls
Cervicogenic Headache, Chronic Neck Pain
Enrolling by invitation
Workplace Exercise Therapy With or Without Manual Therapy in Chronic Spinal Pain
Back Pain, Neck Pain
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.
Lúcia Domingues principal investigator
NOVA Medical School | Faculdade de Ciências Médicas, Universidade Nova de Lisboa
Questions about this trial
What is this clinical trial studying?
A study testing Manual Therapy and Exercise (Physiotherapy Intervention) in people with Chronic Nonspecific Neck Pain, run by Universidade Nova de Lisboa.
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 2 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 19 Jun 2018. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Lúcia Domingues (00351967648456, lucia.domingues@nms.unl.pt), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline in Neck Pain Intensity as measured by the Numeric pain rating scale (NRPS) at 3 weeks. (time frame: 3 weeks). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 19 Jun 2018.