Chronic Non-specific Neck PainNCT04841642
Feasibility and Impact of a Tele-rehabilitation Program in Patients With Chronic and Non-specific Neck Pain
A study testing MANUAL THERAPY and THERAPEUTIC EXERCISE in people with Chronic Non-specific Neck Pain, run by University of Jaén at 1 site in Spain.
Trial summary
Chronic neck pain has a high prevalence in developed countries, being one of the main causes of years lived with disability and deterioration of the quality of life. Telerehabilitation is presented as a resource capable of favoring, with its development and implementation, the transition to a universal and quality… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Chronic Non-specific Neck Pain
- What is being tested?
- MANUAL THERAPY and THERAPEUTIC EXERCISE
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 46 participants
- Where
- 1 siteSpain
- Study dates
- 1 Nov 2021to 31 Aug 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
- People between 18 and 65 years of age
- Neck pain of more than 3 months of evolution
- Access and knowledge in the use of the internet
- Complete the informed consent
Who cannot join
- Previous trauma to the cervical region (such as whiplash)
- Neck surgery
- Osteoporosis
- Arthritis
- Cervical radiculopathy associated with externalized cervical hernia
- Vertigo or vertebrobasilar insufficiency
Show all 11Show fewer
- Cancer
- Vertebral fracture
- Fibromyalgia
- Cognitive impairment
- Psychiatric disorders.
Trial locations and contacts
1 site in 1 country.
About this study
Chronic neck pain has a high prevalence in developed countries, being one of the main causes of years lived with disability and deterioration of the quality of life. Telerehabilitation is presented as a resource capable of favoring, with its development and implementation, the transition to a universal and quality health service. The main objective of the study is to assess the change in disability produced by a telerehabilitation program (applied in the intervention group) in patients with chronic and nonspecific neck pain compared to the recommendation of home exercises (control group).
The study that will be carried out will be a controlled and randomized clinical trial (ECCA), single-blind, longitudinal and prospective with two groups (intervention group and control group). The main study variables that are intended to be analyzed pre and post intervention are disability, quality of life, pain, adherence, and depression and anxiety.
The study will take place between June 2020 and May 2021 in specialized physiotherapy clinics.
- Conditions
- Chronic Non-specific Neck Pain
- Being tested
- MANUAL THERAPY, THERAPEUTIC EXERCISE
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MANUAL THERAPYOther
The investigators will apply manual therapy for ten minutes a week, for 8 weeks, based on cervical mobilizations and suboccipital inhibitions.
THERAPEUTIC EXERCISEOther
The exercises recommendations will be based on a simulation of the exercises in the same session of the manual therapy of each week, helped by the physiotherapist.
The access to telerehabilitation will be through a web page, through which patients could see explanatory videos of the exercises as many times as they need.
| Study group | Role | What they receive |
|---|---|---|
| Manual therapy and a telerehabilitation program | Experimental | In the experimental group, an intervention based on manual therapy and a telerehabilitation program based on exercises will be carried out.
The investigators will apply manual therapy for ten minutes a week based on cervical mobilizations and suboccipital inhibitions.
The access to telerehabilitation will be through a web page, through which patients could see explanatory videos of the exercises as many times as they need. Receives: Other: MANUAL THERAPY; Other: THERAPEUTIC EXERCISE |
| Manual therapy and recommendations for home exercises | Active comparator | In the control group, the same manual therapy intervention and recommendations for home exercises will be applied.
This exercises recommendations will be based on a simulation of the exercise in the same session of the manual therapy of each week. Receives: Other: MANUAL THERAPY; Other: THERAPEUTIC EXERCISE |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in disability
Using the Neck Disability Index (NDI). It is made up of 10 items and each item is scored on a 6-point Likert scale (0 to 5), leading to a total score ranging from 0 to 50 (0 to 4 = no disability; 5 to 14 = mild disability; 15 to 24 = moderate disability; 25 to 34 = severe disability; and 35 to 50 = complete disability).
Measured: Baseline, 8 weeks and 2 month after intervention.
Secondary outcomes (6)
Changes in the health-related quality of life
Using the Short Form 12 Health Survey (SF-12). It is made up of a subset of 12 items from the SF-36 (physical function, social function, physical role, emotional role, mental health, vitality, bodily pain and general health), including 1-2 items from each of the 8 scales of the SF-36.
Measured: Baseline, 8 weeks and 2 month after intervention.
Changes in depression and anxiety
Using the Hospital Anxiety and Depression Scale (HADS). It consists of two series of seven questions (a total of 14 items), one represents the anxiety subscale and the other the depression. Each item is valued according to a four-point frequency scale that ranges from 0 to 3 (0 = I always do it; 1 = not so much; 2 = definitely not that much; 3 = not at all).
Measured: Baseline, 8 weeks and 2 month after intervention.
Changes in Kinesiophobia
Using the Tampa Scale for Kinesiophobia-11 (TSK-11), self-report of 17 items that address fear of movement and injury relapse. Four of the items are negatively written and scored inverse (4, 8, 12 and 16). The scores are added together to obtain a total score, with higher values reflecting greater kinesiophobia.
Measured: Baseline, 8 weeks and 2 month after intervention.
Changes in the pain: Visual Analog Scale (VAS)
Using the Visual Analog Scale (VAS). Each item is scored 0-10 (0= no pain; 10= the major pain that the patient can imagine) yielding a total between 0 and 10.
Measured: Baseline, 8 weeks and 2 month after intervention.
Adherence to treatment
Using a record book of the completion of the treatment program, where the activity carried out will be reflected.
Measured: At 4 and 8 weeks of treatment
Pressure pain threshold
Using a digital pressure algometer at a speed of 1 kg / cm2 / s perpendicular to the skin surface.
The patient will be required to immediately indicate when the sensation of pressure (kg / cm2) becomes a sensation of pain, and thus terminate the compression.
Measured: Baseline, 8 weeks and 2 month after intervention.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Apr 2021
- Study start1 Nov 2021
- Primary completion28 Feb 2022
- Study completion31 Aug 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Non-specific 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
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Jaén
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alexander Achalandabaso, University of Jaén
- Investigators
- Alexander Achalandabaso, PhD, Study director, University of Jaen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04841642
- Sponsor's protocol ID
- CEIM/HU/2020/50
- Status last verified
- Nov 2022
- First submitted
- 7 Apr 2021
- Last updated
- 2 Nov 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility and Impact of a Tele-rehabilitation Program in Patients With Chronic and Non-specific Neck Pain
- ClinicalTrials.gov ID
- NCT04841642
- Acronym / sponsor ID
- CEIM/HU/2020/50
- Conditions
- Chronic Non-specific Neck Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 46 participants (actual)
- Lead sponsor
- University of JaénUniversity, hospital or other
- Study start
- 1 Nov 2021 (actual)
- Primary completion
- 28 Feb 2022 (actual)
- Study completion
- 31 Aug 2022 (actual)
- First posted
- 12 Apr 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.
Chronic neck pain has a high prevalence in developed countries, being one of the main causes of years lived with disability and deterioration of the quality of life. Telerehabilitation is presented as a resource capable of favoring, with its development and implementation, the transition to a universal and quality health service. The main objective of the study is to assess the change in disability produced by a telerehabilitation program (applied in the intervention group) in patients with chronic and nonspecific neck pain compared to the recommendation of home exercises (control group).
The study that will be carried out will be a controlled and randomized clinical trial (ECCA), single-blind, longitudinal and prospective with two groups (intervention group and control group). The main study variables that are intended to be analyzed pre and post intervention are disability, quality of life, pain, adherence, and depression and anxiety.
The study will take place between June 2020 and May 2021 in specialized physiotherapy clinics.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Manual therapy and a telerehabilitation program | Experimental | Other: MANUAL THERAPY, Other: THERAPEUTIC EXERCISEIn the experimental group, an intervention based on manual therapy and a telerehabilitation program based on exercises will be carried out. The investigators will apply manual therapy for ten minutes a week based on cervical mobilizations and suboccipital inhibitions. The access to telerehabilitation will be through a web page, through which patients could see explanatory videos of the exercises as many times as they need. |
| Manual therapy and recommendations for home exercises | Active comparator | Other: MANUAL THERAPY, Other: THERAPEUTIC EXERCISEIn the control group, the same manual therapy intervention and recommendations for home exercises will be applied. This exercises recommendations will be based on a simulation of the exercise in the same session of the manual therapy of each 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)
- People between 18 and 65 years of age
- Neck pain of more than 3 months of evolution
- Access and knowledge in the use of the internet
- Complete the informed consent
Key exclusion criteria (11 listed)
- Previous trauma to the cervical region (such as whiplash)
- Neck surgery
- Osteoporosis
- Arthritis
- Cervical radiculopathy associated with externalized cervical hernia
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 THERAPYThe investigators will apply manual therapy for ten minutes a week, for 8 weeks, based on cervical mobilizations and suboccipital inhibitions. | Other | Manual therapy and a telerehabilitation program, Manual therapy and recommendations for home exercises |
| THERAPEUTIC EXERCISEThe exercises recommendations will be based on a simulation of the exercises in the same session of the manual therapy of each week, helped by the physiotherapist. The access to telerehabilitation will be through a web page, through which patients could see explanatory videos of the exercises as many times as they need. | Other | Manual therapy and a telerehabilitation program, Manual therapy and recommendations for home exercises |
Primary outcome
Changes in disability
Time frame: Baseline, 8 weeks and 2 month after intervention.
Using the Neck Disability Index (NDI). It is made up of 10 items and each item is scored on a 6-point Likert scale (0 to 5), leading to a total score ranging from 0 to 50 (0 to 4 = no disability; 5 to 14 = mild disability; 15 to 24 = moderate disability; 25 to 34 = severe disability; and 35 to 50 = complete disability).
6 secondary outcomes
Changes in the health-related quality of life
Time frame: Baseline, 8 weeks and 2 month after intervention.
Changes in depression and anxiety
Time frame: Baseline, 8 weeks and 2 month after intervention.
Changes in Kinesiophobia
Time frame: Baseline, 8 weeks and 2 month after intervention.
Changes in the pain: Visual Analog Scale (VAS)
Time frame: Baseline, 8 weeks and 2 month after intervention.
Adherence to treatment
Time frame: At 4 and 8 weeks of treatment
Pressure pain threshold
Time frame: Baseline, 8 weeks and 2 month after intervention.
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 2 Nov 2022.
Related trials for Chronic Non-specific Neck Pain
Active, not recruiting
Multimodal Manual Therapy vs. Maitland Mobilization for Chronic Non-Specific Neck Pain
Chronic 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
Active, not recruiting
Cervical Stabilization vs Scapular Clock Exercises for Chronic Non-Specific Neck Pain
Chronic Non-Specific Neck Pain
RecruitingObservational study
Upper Extremity Exercise Capacity in Chronic Non-specific Neck Pain
Neck Pain
Recruiting
Telerehabilitation, Face-to-Face Exercises, and a Mixed Model in Chronic Non-Specific Neck Pain
Chronic Non-specific 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.
Alexander Achalandabaso, PhD study director
University of Jaen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MANUAL THERAPY and THERAPEUTIC EXERCISE in people with Chronic Non-specific Neck Pain, run by University of Jaén at 1 site in Spain.
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 11 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 2 Nov 2022. 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 Spain. 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?
Changes in disability (time frame: Baseline, 8 weeks and 2 month after intervention.). 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 2 Nov 2022.