Neck PainNCT04768790
Effects of Multimodal Exercises Integrated With Cognitive-behavioral Therapy in Subjects With Chronic Neck Pain
A study testing multidisciplinary program and General program in people with Neck Pain, run by University of Cagliari at 1 site in Italy.
Trial summary
The etiology of cervical pain is multifactorial and studies based on the bio-psychosocial model also link chronic neck pain to psychological factors. Among them, kinesiophobia has been reported as an important determinant. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Neck Pain
- What is being tested?
- multidisciplinary program and General program
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 170 participants
- Where
- 1 siteItaly
- Study dates
- 1 Nov 2020to 31 Dec 2024
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- diagnosis of chronic non-specific neck pain
- documented history of pain lasting more than 3 months
- good knowledge of the Italian language
- age over 18.
Who cannot join
- acute and subacute neck pain
- cognitive impairment
- presence of specific causes of neck pain (history of spinal surgery, spinal deformity, herniated disc, infection, fracture, myelopathy or malignancy, whiplash injury, systemic or neuromuscular disease, cognitive impairment) evaluated by medical history and diagnostics for images
- have previously undergone cognitive-behavioral therapy.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Multimodal Exercises Integrated With Cognitive-behavioral Therapy in Subjects With Chronic Neck Pain: a Randomized Controlled Study With One Year Follow-up
The etiology of cervical pain is multifactorial and studies based on the bio-psychosocial model also link chronic neck pain to psychological factors. Among them, kinesiophobia has been reported as an important determinant. Over time, the use of multidisciplinary interventions for chronic vertebral pain (instead of segmental treatments) has grown in order to improve disability, pain and proactive behaviors towards the problem manifested. To date, the evidence relating to the effects of multidisciplinary approaches is inconclusive and lacking. In light of these premises, it appears necessary to deepen the conduct of studies aimed at evaluating the efficacy of a multidisciplinary rehabilitation program that integrates cognitive-behavioral therapy based on kinesiophobia with specific exercises, in the treatment of chronic neck pain of working subjects.
Read the detailed description
Background The etiology of cervical pain is multifactorial and includes age, gender, incongruous postures, repeated efforts. Studies based on the bio-psychosocial model also link chronic neck pain to psychological factors. Among them, kinesiophobia has been reported as an important determinant. It is debatable whether interventions targeting cognitive processes and pain-associated behaviors can lead to clinically significant changes in terms of disability, pain and quality of life of these individuals.
Furthermore, there is uncertainty about the effectiveness of the types of exercises to be proposed. This makes it difficult to choose between general exercises (aimed at improving cervical muscle and joint skills) and motor-oriented (or task-oriented) exercises (aimed at cervical functional recovery in an ecological context). Over time, the use of multidisciplinary interventions for chronic vertebral pain (instead of segmental treatments) has grown in order to improve disability, pain and proactive behaviors towards the problem manifested. To date, the evidence relating to the effects of multidisciplinary approaches is inconclusive and lacking. In light of these premises, it appears necessary to deepen the conduct of studies aimed at evaluating the efficacy of a multidisciplinary rehabilitation program that integrates cognitive-behavioral therapy based on kinesiophobia with specific exercises, in the treatment of chronic neck pain of working subjects.
Hypothesis The hypothesis is that a multidisciplinary rehabilitation program induces clinically significant and long-term improvements in the disability, pain and quality of life of working subjects with chronic neck pain.
Objectives of the study Verify the effectiveness of a multidisciplinary program in inducing clinically significant and long-term improvements in the disability, pain and quality of life of working subjects suffering from chronic neck pain. Evaluate the work discomfort linked to the condition of chronic neck pain.
Study procedure The subjects eligible for the study will be assigned to one of two treatment programs (multidisciplinary or general) using a permuted block randomization procedure.
The interventions will be offered by a psychologist and two physiotherapists of equal experience, responsible separately for the multidisciplinary and general groups. Each participant will be assessed individually by postural observation, cervical and muscle mobility examination. Based on this evaluation, the exercises will be planned and performed on a single patient. Patients assigned to the multidisciplinary team will meet with a psychologist once a week.
Description of the interventions of the multidisciplinary program: multimodal exercises to improve, through gradual exposure, cervical mobility, postural control and strengthening of the cervical muscles; stabilization techniques for the deep neck muscles; task-oriented exercises maintaining the activation of the deep spinal muscle. Under the supervision of a psychologist, the subjects will also be involved in cognitive-behavioral therapy aimed at modifying the fear of movement (kinesiophobia) and the maladaptive behavior of the disease.
Description of the interventions of the general program: exercises for muscle strengthening, regional stretching and spinal mobilization.
Description of the interventions that will be carried out on both groups: ergonomic consultancy. At the end of the treatment, patients will be asked to continue with the exercises at home. At the end of each session a control of the program performed will be conducted based on a manual that includes the complete list of exercises to be performed. Patients' GPs will be asked to avoid referrals for other visits / other treatments while the programs are running.
Type of data collected:
- Personal and anthropometric data; lifestyle habits; work, pharmacological and pathological history; levels of neck disability, kinesiophobia, catastrophism, intensity of pain, quality of life, work discomfort.
Questionnaires will be administered before treatment, ten weeks after (post-treatment) and 12 months after the end of treatment (follow-up).
At the end of the treatment, subjects will be asked to rate the effectiveness of the treatment using a Likert Global Perceived Effect scale. Using a specific form, patients will be asked to report any symptoms they experience during the study that may require further treatment.
The end date of the follow up will be considered that of December 31, 2021.
The effects of the treatment between the two groups over time will be analyzed through the use of linear models with mixed effects for repeated measurements. The differences between the two groups relating to measures with non-normal distribution will be analyzed by Mann-Whitney U test. The null hypothesis will be rejected for p values> 0.05 (two-tailed test).
- Conditions
- Neck Pain
- Being tested
- multidisciplinary program, General program
- Medical subject headings
- Neck Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
multidisciplinary programOther
multimodal exercises to improve, through gradual exposure, cervical mobility, postural control and strengthening of the cervical muscles; stabilization techniques for the deep neck muscles; task-oriented exercises maintaining the activation of the deep spinal muscle. Under the supervision of a psychologist, the subjects will also be involved in cognitive-behavioral therapy aimed at modifying the fear of movement (kinesiophobia) and the maladaptive behavior of the disease. Ergonomic consultancy.
General programOther
exercises for muscle strengthening, regional stretching and spinal mobilization. Ergonomic consultancy.
| Study group | Role | What they receive |
|---|---|---|
| Multidisciplinary Group | Experimental | Description of the interventions of the multidisciplinary program: multimodal exercises to improve, through gradual exposure, cervical mobility, postural control and strengthening of the cervical muscles; stabilization techniques for the deep neck muscles; task-oriented exercises maintaining the activation of the deep spinal muscle. Under the supervision of a psychologist, the subjects will also be involved in cognitive-behavioral therapy aimed at modifying the fear of movement (kinesiophobia) and the maladaptive behavior of the disease. Ergonomic consultancy. Receives: Other: multidisciplinary program |
| General Group | Active comparator | Description of the interventions of the general program: exercises for muscle strengthening, regional stretching and spinal mobilization. Ergonomic consultancy. Receives: Other: General program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline Neck Disability Index at 10 weeks and 12 months
Neck Disability Index, a self-administered 10-item questionnaire concerning neck pain disability, rates the intensity of pain and its disabling effects on typical daily activities. The score, expressed as a percentage, ranges from 0 (no disability) to 100 (maximum disability). Investigators used the Italian version which proved to be reliable and valid
Measured: Questionnaires will be administered before treatment, ten weeks after (post-treatment) and 12 months after the end of treatment (follow-up).
Change from Baseline Tampa Scale of Kinesiophobia at 10 weeks and 12 months
Tampa Scale of Kinesiophobia is a self-report questionnaire that assesses pain beliefs and pain-related fear of movement/reinjury in subjects with musculoskeletal complaints. the 13-item Italian version ranges from 13 (best health status) to 52 (worst health status).
Measured: Questionnaires will be administered before treatment, ten weeks after (post-treatment) and 12 months after the end of treatment (follow-up).
Change from Baseline Pain Catastrophizing Scale at 10 weeks and 12 months
Pain Catastrophizing Scale assesses catastrophizing in subjects with musculoskeletal complaints, and consists of a 13-item self-report questionnaire. The total score ranges from 0 to 52 with 52 indicating the worst health status.
Investigators used the Italian version which proved to be reliable and valid.
Measured: Questionnaires will be administered before treatment, ten weeks after (post-treatment) and 12 months after the end of treatment (follow-up).
Change from Baseline Numerical Rating Scale at 10 weeks and 12 months
Numerical Rating Scale assesses pain intensity using an 11-pointnumerical rating scale ranging from 0 (no pain) to10 (the worst imaginable pain).
Measured: Questionnaires will be administered before treatment, ten weeks after (post-treatment) and 12 months after the end of treatment (follow-up).
Change from Baseline Short-Form Health Survey Questionnaire at 10 weeks and 12 months
Quality of life is assessed using the Italian version of the self-report Short-Form Health Survey with its eight domain scores ranging from 0 (the worst perceived quality of life) to 100 (the best perceived quality of life).
Measured: Questionnaires will be administered before treatment, ten weeks after (post-treatment) and 12 months after the end of treatment (follow-up).
Change from Baseline Global Perceived Effect at 10 weeks and 12 months
Global Perceived Effect is a self-administered measure of treatment satisfaction consisting of a five-level Likert scale (1=helped a lot, 2=helped, 3=helped only a little, 4=did not help, 5=made things worse).
Measured: Questionnaires will be administered before treatment, ten weeks after (post-treatment) and 12 months after the end of treatment (follow-up).
Secondary outcomes (2)
Change from Baseline Work Ability Index at 10 weeks and 12 months
The Work Ability Index is an instrument used in occupational health care and research to assess work ability of workers exploring different dimensions; WAI is scored by summing the points received for each item: the best possible rating on the index is 49 points and the worst is 7 points.
Measured: Questionnaires will be administered before treatment, ten weeks after (post-treatment) and 12 months after the end of treatment (follow-up).
Change from Baseline of Anamnestic survey of the upper limbs and spine's pathologies at 10 weeks and 12 months
Anamnestic and clinical evaluation of the pathologies affecting the upper limbs and spine, over the last 12 months.
Measured: Questionnaires will be administered before treatment, ten weeks after (post-treatment) and 12 months after the end of treatment (follow-up).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Feb 2021
- Study start1 Nov 2020
- Primary completion31 Dec 2024 (estimated)
- Study completion31 Dec 2024 (estimated)
Why it stopped: Lack of resources
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.
- 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
- Model description
- Randomized Controlled Trial
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 170 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Cagliari
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marco Monticone, University of Cagliari
- Investigators
- Marco Monticone, MD, PhD, Principal investigator, Dept. Medical Sciences and Public Health, University of Cagliari, Cagliari, Italy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04768790
- Sponsor's protocol ID
- PG/2020/16818
- Status last verified
- Nov 2023
- First submitted
- 13 Dec 2020
- Last updated
- 4 Dec 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Monticone M, Simone Vullo S, Lecca LI, Meloni F, Portoghese I, Campagna M. Effectiveness of multimodal exercises integrated with cognitive-behavioral therapy in working patients with chronic neck pain: protocol of a randomized controlled trial with 1-year follow-up. Trials. 2022 May 21;23(1):425. doi: 10.1186/s13063-022-06340-7.
PubMed 35597965
Study at a glance
From the registry record, last updated by the sponsor on 4 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Multimodal Exercises Integrated With Cognitive-behavioral Therapy in Subjects With Chronic Neck Pain: a Randomized Controlled Study With One Year Follow-up
- ClinicalTrials.gov ID
- NCT04768790
- Acronym / sponsor ID
- PG/2020/16818
- Conditions
- Neck Pain
- Study type
- Interventional
- Recruitment status
- SuspendedReason stopped: Lack of resources
- Enrolment
- 170 participants (estimated)
- Lead sponsor
- University of CagliariUniversity, hospital or other
- Study start
- 1 Nov 2020 (actual)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 24 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 etiology of cervical pain is multifactorial and studies based on the bio-psychosocial model also link chronic neck pain to psychological factors. Among them, kinesiophobia has been reported as an important determinant. Over time, the use of multidisciplinary interventions for chronic vertebral pain (instead of segmental treatments) has grown in order to improve disability, pain and proactive behaviors towards the problem manifested. To date, the evidence relating to the effects of multidisciplinary approaches is inconclusive and lacking. In light of these premises, it appears necessary to deepen the conduct of studies aimed at evaluating the efficacy of a multidisciplinary rehabilitation program that integrates cognitive-behavioral therapy based on kinesiophobia with specific exercises, in the treatment of chronic neck pain of working subjects.
Detailed description
Background The etiology of cervical pain is multifactorial and includes age, gender, incongruous postures, repeated efforts. Studies based on the bio-psychosocial model also link chronic neck pain to psychological factors. Among them, kinesiophobia has been reported as an important determinant. It is debatable whether interventions targeting cognitive processes and pain-associated behaviors can lead to clinically significant changes in terms of disability, pain and quality of life of these individuals.
Furthermore, there is uncertainty about the effectiveness of the types of exercises to be proposed. This makes it difficult to choose between general exercises (aimed at improving cervical muscle and joint skills) and motor-oriented (or task-oriented) exercises (aimed at cervical functional recovery in an ecological context). Over time, the use of multidisciplinary interventions for chronic vertebral pain (instead of segmental treatments) has grown in order to improve disability, pain and proactive behaviors towards the problem manifested. To date, the evidence relating to the effects of multidisciplinary approaches is inconclusive and lacking. In light of these premises, it appears necessary to deepen the conduct of studies aimed at evaluating the efficacy of a multidisciplinary rehabilitation program that integrates cognitive-behavioral therapy based on kinesiophobia with specific exercises, in the treatment of chronic neck pain of working subjects.
Hypothesis The hypothesis is that a multidisciplinary rehabilitation program induces clinically significant and long-term improvements in the disability, pain and quality of life of working subjects with chronic neck pain.
Objectives of the study Verify the effectiveness of a multidisciplinary program in inducing clinically significant and long-term improvements in the disability, pain and quality of life of working subjects suffering from chronic neck pain. Evaluate the work discomfort linked to the condition of chronic neck pain.
Study procedure The subjects eligible for the study will be assigned to one of two treatment programs (multidisciplinary or general) using a permuted block randomization procedure.
The interventions will be offered by a psychologist and two physiotherapists of equal experience, responsible separately for the multidisciplinary and general groups. Each participant will be assessed individually by postural observation, cervical and muscle mobility examination. Based on this evaluation, the exercises will be planned and performed on a single patient. Patients assigned to the multidisciplinary team will meet with a psychologist once a week.
Description of the interventions of the multidisciplinary program: multimodal exercises to improve, through gradual exposure, cervical mobility, postural control and strengthening of the cervical muscles; stabilization techniques for the deep neck muscles; task-oriented exercises maintaining the activation of the deep spinal muscle. Under the supervision of a psychologist, the subjects will also be involved in cognitive-behavioral therapy aimed at modifying the fear of movement (kinesiophobia) and the maladaptive behavior of the disease.
Description of the interventions of the general program: exercises for muscle strengthening, regional stretching and spinal mobilization.
Description of the interventions that will be carried out on both groups: ergonomic consultancy. At the end of the treatment, patients will be asked to continue with the exercises at home. At the end of each session a control of the program performed will be conducted based on a manual that includes the complete list of exercises to be performed. Patients' GPs will be asked to avoid referrals for other visits / other treatments while the programs are running.
Type of data collected:
- Personal and anthropometric data; lifestyle habits; work, pharmacological and pathological history; levels of neck disability, kinesiophobia, catastrophism, intensity of pain, quality of life, work discomfort.
Questionnaires will be administered before treatment, ten weeks after (post-treatment) and 12 months after the end of treatment (follow-up).
At the end of the treatment, subjects will be asked to rate the effectiveness of the treatment using a Likert Global Perceived Effect scale. Using a specific form, patients will be asked to report any symptoms they experience during the study that may require further treatment.
The end date of the follow up will be considered that of December 31, 2021.
The effects of the treatment between the two groups over time will be analyzed through the use of linear models with mixed effects for repeated measurements. The differences between the two groups relating to measures with non-normal distribution will be analyzed by Mann-Whitney U test. The null hypothesis will be rejected for p values> 0.05 (two-tailed test).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized Controlled Trial
| Arm | Type | Receives |
|---|---|---|
| Multidisciplinary Group | Experimental | Other: multidisciplinary programDescription of the interventions of the multidisciplinary program: multimodal exercises to improve, through gradual exposure, cervical mobility, postural control and strengthening of the cervical muscles; stabilization techniques for the deep neck muscles; task-oriented exercises maintaining the activation of the deep spinal muscle. Under the supervision of a psychologist, the subjects will also be involved in cognitive-behavioral therapy aimed at modifying the fear of movement (kinesiophobia) and the maladaptive behavior of the disease. Ergonomic consultancy. |
| General Group | Active comparator | Other: General programDescription of the interventions of the general program: exercises for muscle strengthening, regional stretching and spinal mobilization. Ergonomic consultancy. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- diagnosis of chronic non-specific neck pain
- documented history of pain lasting more than 3 months
- good knowledge of the Italian language
- age over 18.
Key exclusion criteria (4 listed)
- acute and subacute neck pain
- cognitive impairment
- presence of specific causes of neck pain (history of spinal surgery, spinal deformity, herniated disc, infection, fracture, myelopathy or malignancy, whiplash injury, systemic or neuromuscular disease, cognitive impairment) evaluated by medical history and diagnostics for images
- have previously undergone cognitive-behavioral therapy.
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 |
|---|---|---|
| multidisciplinary programmultimodal exercises to improve, through gradual exposure, cervical mobility, postural control and strengthening of the cervical muscles; stabilization techniques for the deep neck muscles; task-oriented exercises maintaining the activation of the deep spinal muscle. Under the supervision of a psychologist, the subjects will also be involved in cognitive-behavioral therapy aimed at modifying the fear of movement (kinesiophobia) and the maladaptive behavior of the disease. Ergonomic consultancy. | Other | Multidisciplinary Group |
| General programexercises for muscle strengthening, regional stretching and spinal mobilization. Ergonomic consultancy. | Other | General Group |
Primary outcome
Change from Baseline Neck Disability Index at 10 weeks and 12 months
Time frame: Questionnaires will be administered before treatment, ten weeks after (post-treatment) and 12 months after the end of treatment (follow-up).
Neck Disability Index, a self-administered 10-item questionnaire concerning neck pain disability, rates the intensity of pain and its disabling effects on typical daily activities. The score, expressed as a percentage, ranges from 0 (no disability) to 100 (maximum disability). Investigators used the Italian version which proved to be reliable and valid
Change from Baseline Tampa Scale of Kinesiophobia at 10 weeks and 12 months
Time frame: Questionnaires will be administered before treatment, ten weeks after (post-treatment) and 12 months after the end of treatment (follow-up).
Tampa Scale of Kinesiophobia is a self-report questionnaire that assesses pain beliefs and pain-related fear of movement/reinjury in subjects with musculoskeletal complaints. the 13-item Italian version ranges from 13 (best health status) to 52 (worst health status).
Change from Baseline Pain Catastrophizing Scale at 10 weeks and 12 months
Time frame: Questionnaires will be administered before treatment, ten weeks after (post-treatment) and 12 months after the end of treatment (follow-up).
Pain Catastrophizing Scale assesses catastrophizing in subjects with musculoskeletal complaints, and consists of a 13-item self-report questionnaire. The total score ranges from 0 to 52 with 52 indicating the worst health status. Investigators used the Italian version which proved to be reliable and valid.
Change from Baseline Numerical Rating Scale at 10 weeks and 12 months
Time frame: Questionnaires will be administered before treatment, ten weeks after (post-treatment) and 12 months after the end of treatment (follow-up).
Numerical Rating Scale assesses pain intensity using an 11-pointnumerical rating scale ranging from 0 (no pain) to10 (the worst imaginable pain).
Change from Baseline Short-Form Health Survey Questionnaire at 10 weeks and 12 months
Time frame: Questionnaires will be administered before treatment, ten weeks after (post-treatment) and 12 months after the end of treatment (follow-up).
Quality of life is assessed using the Italian version of the self-report Short-Form Health Survey with its eight domain scores ranging from 0 (the worst perceived quality of life) to 100 (the best perceived quality of life).
Change from Baseline Global Perceived Effect at 10 weeks and 12 months
Time frame: Questionnaires will be administered before treatment, ten weeks after (post-treatment) and 12 months after the end of treatment (follow-up).
Global Perceived Effect is a self-administered measure of treatment satisfaction consisting of a five-level Likert scale (1=helped a lot, 2=helped, 3=helped only a little, 4=did not help, 5=made things worse).
2 secondary outcomes
Change from Baseline Work Ability Index at 10 weeks and 12 months
Time frame: Questionnaires will be administered before treatment, ten weeks after (post-treatment) and 12 months after the end of treatment (follow-up).
Change from Baseline of Anamnestic survey of the upper limbs and spine's pathologies at 10 weeks and 12 months
Time frame: Questionnaires will be administered before treatment, ten weeks after (post-treatment) and 12 months after the end of treatment (follow-up).
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Dec 2023.
- Derived from this study: PubMed 35597965Monticone M, Simone Vullo S, Lecca LI, Meloni F, Portoghese I, Campagna M. Effectiveness of multimodal exercises integrated with cognitive-behavioral therapy in working patients with chronic neck pain: protocol of a randomized controlled trial with 1-year follow-up. Trials. 2022 May 21;23(1):425. doi: 10.1186/s13063-022-06340-7.
- Individual participant dataSharing planned: No
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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.
Marco Monticone, MD, PhD principal investigator
Dept. Medical Sciences and Public Health, University of Cagliari, Cagliari, Italy
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing multidisciplinary program and General program in people with Neck Pain, run by University of Cagliari at 1 site in Italy.
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 4 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: paused, as of the sponsor's last update on 4 Dec 2023. 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 Italy. 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?
Results are not available in the source record.
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?
Change from Baseline Neck Disability Index at 10 weeks and 12 months (time frame: Questionnaires will be administered before treatment, ten weeks after (post-treatment) and 12 months after the end of treatment (follow-up).). 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?
On the ClinicalTrials.gov record for NCT04768790, 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 4 Dec 2023.