Neck PainNCT05321537
Comparison of Somatosensory Versus Endurance-strength Exercise in Patients With Chronic Neck Pain
A study testing Therapeutic exercises in people with Neck Pain, run by Alexander Achalandabaso at 1 site in Spain.
Trial summary
Aim: To compare the effects of somatosensory exercise vs endurance-strength exercise on the deep cervical flexor muscles on pain and perceived disability in patients with chronic neck pain. Study design: Protocol of a clinical trial, controlled, parallel and a blinded assessor. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Neck Pain
- What is being tested?
- Therapeutic exercises
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteSpain
- Study dates
- 19 Mar 2022to 8 May 2023
- 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
- Subjects of age between 18 and 65 years
- Neck pain of 3 or more months of evolution
Who cannot join
- Cervical Disability Index less than 15/50
- Infection
- Oncological processes
- Neck or arm surgery
- Neck or arm trauma
- Positive neurological signs
- Rheumatic diseases
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of Somatosensory Exercise Versus Endurance-strength Exercise in Patients With Chronic Neck Pain: a Randomized Clinical Trial
Aim: To compare the effects of somatosensory exercise vs endurance-strength exercise on the deep cervical flexor muscles on pain and perceived disability in patients with chronic neck pain.
Study design: Protocol of a clinical trial, controlled, parallel and a blinded assessor.
Population: Subjects aged 18 to 65 years with neck pain of 3 or more months of evolution.
Read the detailed description
The study will be carried out at the Faculty of Nursing and Physiotherapy of the University of Alcalá. A total of 60 subjects with nonspecific chronic neck pain will be selected and randomly assigned into two intervention groups. The first group will perform a somatosensory exercise program and a second group will perform activation and endurance-strength exercises of the deep cervical flexors. The duration of the intervention will be 8 weeks, with 6 sessions of physical therapy and daily home exercise. The variables pain, pressure pain threshold, disability, endurance-strength, proprioception, quality of life, kinesiophobia, quality of sleep and depression will be analyzed. Measurements will be taken pre-treatment, post-treatment and a follow-up at 3 months.
- Conditions
- Neck Pain
- Being tested
- Therapeutic exercises
- Keywords
- neck pain, chronic pain, therapeutic exercise, proprioception, motor control
- Medical subject headings
- Neck Pain, Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Therapeutic exercisesOther
A somatosensory training and an endurance-strength training protocol
| Study group | Role | What they receive |
|---|---|---|
| Somatosensory training | Experimental | It consists of head relocation exercises, eye tracking, gaze stability and eye-head coordination. It requires the use of special material, the pupillary glasses allow the gaze to be fixed by restricting peripheral vision and the laser pointer provides visual feedback on the positioning of the head. Receives: Other: Therapeutic exercises |
| Endurance-strength training | Experimental | It consists of low-load training of the craniocervical flexor muscles. This exercise is specific for the deep cervical flexor muscles, while seeking minimal activation of the superficial flexor muscles. This training consists of 5 phases, starting with a pressure of 20 mmHg, progressively increasing 2 mmHg in each phase. Receives: Other: Therapeutic exercises |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain change
To assess pain, the Visual Analogue Scale will be used, which consists of a 10-centimeter horizontal line, at whose ends is the maximum expression of a symptom.
Measured: Pre-intervention, post-intervention (2 months) and follow-up of 3 months after the end.
Disability change
Disability will be assessed using the validated Spanish version of the Cervical Disability Index. Its range score is 0-50, higher values mean greater disability.
Measured: Pre-intervention, post-intervention (2 months) and follow-up of 3 months after the end.
Secondary outcomes (7)
Pressure Pain Threshold change
To assess the Pressure Pain Threshold, a analog pressure algometer will be used. The pressure will be performed bilaterally on the levator scapulae, upper trapezius, splenius capitis and sternocleidomastoid.
Measured: Pre-intervention, post-intervention (2 months) and follow-up of 3 months after the end.
Endurance of craniocervical flexion change
The isometric endurance of the deep flexor muscles of the neck will be measured with the Craniocervical Flexion Test, using a pressure biofeedback.
Measured: Pre-intervention, post-intervention (2 months) and follow-up of 3 months after the end.
Proprioception change
The proprioception of the head and neck in space will be evaluated using the Cervical Joint Positioning Error Test.
Measured: Pre-intervention, post-intervention (2 months) and follow-up of 3 months after the end.
Kinesiophobia change
The patients' level of fear of movement will be evaluated using the Tampa Scale for Kinesiophobia. Range score is 11-44, higher values mean greater fear of injury.
Measured: Pre-intervention, post-intervention (2 months) and follow-up of 3 months after the end.
Sleep quality change
To assess sleep quality we will use the Pittsburgh Sleep Quality Index, using the Spanish version. Range score is 0-21, higher values mean worse outcome.
Measured: Pre-intervention, post-intervention (2 months) and follow-up of 3 months after the end.
Quality of life change
Quality of life will be assessed with the 12-Item Short Form Survey, second version (SF-12v2), using its Spanish version. This questionnaire is made up of 12 items which measure both physical and mental items. Range score is PCS 24-56,6 and MCS 19-60,8, higher values mean higher quality of life.
Measured: Pre-intervention, post-intervention (2 months) and follow-up of 3 months after the end.
Depression change
To assess depression, the Beck Depression Inventory in its second edition (BDI-II), in its Spanish version, will be used. Range score is 0-63, higher values mean worse outcome.
Measured: Pre-intervention, post-intervention (2 months) and follow-up of 3 months after the end.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Apr 2022
- Study start19 Mar 2022
- Primary completion14 Dec 2022
- Study completion8 May 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- A single center, parallel, randomized, blinded rater, controlled clinical trial will be conducted. The 25 requirements proposed by the CONSORT declaration will be followed.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alexander Achalandabaso
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Alexander Achalandabaso, University of Jaén
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05321537
- Sponsor's protocol ID
- CEIM/2022/1/001
- Status last verified
- May 2023
- First submitted
- 23 Mar 2022
- Last updated
- 9 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Somatosensory Exercise Versus Endurance-strength Exercise in Patients With Chronic Neck Pain: a Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT05321537
- Acronym / sponsor ID
- CEIM/2022/1/001
- Conditions
- Neck Pain
- Keywords
- neck pain, chronic pain, therapeutic exercise, proprioception, motor control
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Alexander AchalandabasoUniversity, hospital or other
- Study start
- 19 Mar 2022 (actual)
- Primary completion
- 14 Dec 2022 (actual)
- Study completion
- 8 May 2023 (actual)
- First posted
- 11 Apr 2022 (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.
Aim: To compare the effects of somatosensory exercise vs endurance-strength exercise on the deep cervical flexor muscles on pain and perceived disability in patients with chronic neck pain.
Study design: Protocol of a clinical trial, controlled, parallel and a blinded assessor.
Population: Subjects aged 18 to 65 years with neck pain of 3 or more months of evolution.
Detailed description
The study will be carried out at the Faculty of Nursing and Physiotherapy of the University of Alcalá. A total of 60 subjects with nonspecific chronic neck pain will be selected and randomly assigned into two intervention groups. The first group will perform a somatosensory exercise program and a second group will perform activation and endurance-strength exercises of the deep cervical flexors. The duration of the intervention will be 8 weeks, with 6 sessions of physical therapy and daily home exercise. The variables pain, pressure pain threshold, disability, endurance-strength, proprioception, quality of life, kinesiophobia, quality of sleep and depression will be analyzed. Measurements will be taken pre-treatment, post-treatment and a follow-up at 3 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- A single center, parallel, randomized, blinded rater, controlled clinical trial will be conducted. The 25 requirements proposed by the CONSORT declaration will be followed.
| Arm | Type | Receives |
|---|---|---|
| Somatosensory training | Experimental | Other: Therapeutic exercisesIt consists of head relocation exercises, eye tracking, gaze stability and eye-head coordination. It requires the use of special material, the pupillary glasses allow the gaze to be fixed by restricting peripheral vision and the laser pointer provides visual feedback on the positioning of the head. |
| Endurance-strength training | Experimental | Other: Therapeutic exercisesIt consists of low-load training of the craniocervical flexor muscles. This exercise is specific for the deep cervical flexor muscles, while seeking minimal activation of the superficial flexor muscles. This training consists of 5 phases, starting with a pressure of 20 mmHg, progressively increasing 2 mmHg in each phase. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Subjects of age between 18 and 65 years
- Neck pain of 3 or more months of evolution
Key exclusion criteria (7 listed)
- Cervical Disability Index less than 15/50
- Infection
- Oncological processes
- Neck or arm surgery
- Neck or arm trauma
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 |
|---|---|---|
| Therapeutic exercisesA somatosensory training and an endurance-strength training protocol | Other | Endurance-strength training, Somatosensory training |
Primary outcome
Pain change
Time frame: Pre-intervention, post-intervention (2 months) and follow-up of 3 months after the end.
To assess pain, the Visual Analogue Scale will be used, which consists of a 10-centimeter horizontal line, at whose ends is the maximum expression of a symptom.
Disability change
Time frame: Pre-intervention, post-intervention (2 months) and follow-up of 3 months after the end.
Disability will be assessed using the validated Spanish version of the Cervical Disability Index. Its range score is 0-50, higher values mean greater disability.
7 secondary outcomes
Pressure Pain Threshold change
Time frame: Pre-intervention, post-intervention (2 months) and follow-up of 3 months after the end.
Endurance of craniocervical flexion change
Time frame: Pre-intervention, post-intervention (2 months) and follow-up of 3 months after the end.
Proprioception change
Time frame: Pre-intervention, post-intervention (2 months) and follow-up of 3 months after the end.
Kinesiophobia change
Time frame: Pre-intervention, post-intervention (2 months) and follow-up of 3 months after the end.
Sleep quality change
Time frame: Pre-intervention, post-intervention (2 months) and follow-up of 3 months after the end.
Quality of life change
Time frame: Pre-intervention, post-intervention (2 months) and follow-up of 3 months after the end.
Depression change
Time frame: Pre-intervention, post-intervention (2 months) and follow-up of 3 months after the end.
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 9 May 2023.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Therapeutic exercises in people with Neck Pain, run by Alexander Achalandabaso 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 2 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 9 May 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 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?
Pain change (time frame: Pre-intervention, post-intervention (2 months) and follow-up of 3 months after the end.). The study lists 2 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 9 May 2023.