Neck PainUSNPNCT05596019
Specific Neurodynamic Exercises on Disability and Neck Pain in Old Women
A study testing specific neurodynamic exercises and multimodal exercise in people with Neck Pain, run by University of Salamanca at 1 site in Spain.
Trial summary
This is a randomized, parallel, double-blind clinical trial. The main objective is to compare the efficacy of multimodal exercise with specific neurodynamic exercises and multimodal exercise with non-specific exercises in disability and neck pain in women older than 65 years. Read more about this study
- Who is it for?
- Ages 65 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Neck Pain
- What is being tested?
- specific neurodynamic exercises and multimodal exercise
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 56 participants
- Where
- 1 siteSpain
- Study dates
- 16 Jul 2022to 20 Jan 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 65 years and older
- Women only
- Healthy volunteers accepted
- Older adult
Who may be able to join
- Women older than 65 years.
- Neck pain
Who cannot join
- Tumors
- Pacemakers
- Fibrillations
- Cardiac pathology or uncontrolled hypertension
- History of severe trauma/recent cervical surgery
- Uncontrolled systemic and inflammatory pathologies
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- Congenital collagen compromise
- Presence of difficulties in performing the Initial Evaluation tests
- Language barriers
- Pending litigation or legal claim
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effectiveness of Specific Neurodynamic Exercises Compared With Non-specific Exercises on Disability and Neck Pain in Women Older Than 65 Years
This is a randomized, parallel, double-blind clinical trial. The main objective is to compare the efficacy of multimodal exercise with specific neurodynamic exercises and multimodal exercise with non-specific exercises in disability and neck pain in women older than 65 years.
The intervention in both groups will be carried out for 4 weeks, with three weekly sessions. Two evaluations will be carried out, a pre-intervention evaluation and a post-intervention evaluation. We will assess neck pain, disability, upper limb strength, cervical mobility, cervical pressure pain thresholds, kinesiophobia and catastrophism.
- Conditions
- Neck Pain
- Being tested
- specific neurodynamic exercises, multimodal exercise
- Keywords
- exercise, neck pain, neurodynamic, elderly
- Medical subject headings
- Neck Pain, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
specific neurodynamic exercisesProcedure or surgery
Specific neurodynamic exercises in women older than 65 years with neck pain
multimodal exerciseProcedure or surgery
Multimodal and nonspecific exercises in women older than 65 years with neck pain
| Study group | Role | What they receive |
|---|---|---|
| neurodynamics specific exercise group | Experimental | The experimental group will perform a multimodal therapeutic physical exercise program. The components of balance, walking, cardiovascular endurance, strength and flexibility will be worked globally, in addition to including respiratory exercises.
Specific neurodynamic exercises oriented to the treatment of the main nerves of the brachial plexus will be included as part of the exercise sessions. The specific neurodynamic program will consist of the following exercises:
1. Opening of the cervical conjunction holes with cranio-cervical and cervical flexion movements, cervical lateroflexions and lateral vertebral sliding self-mobilizations.
2. Opening of the thoracic passages of the brachial plexus with stretching of the scalene muscles, opening of the costoclavicular space and stretching of the pectoralis minor muscles.
3. Specific exercises of neurodynamic sliding of the nerves of the upper limb: median, radial and ulnar nerves. Receives: Procedure: specific neurodynamic exercises |
| The nonspecific exercise group | Active comparator | The nonspecific exercise group performed balance, cardiovascular endurance, stability, upper and lower limb strength, flexibility, and breathing exercises. Receives: Procedure: multimodal exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain intensity
Numerical Pain Rating Scale (NPRS) will be used. It is a scale used to quantify the patient's pain level on an 11-point numerical scale 0-10 with 0 being "no pain" and 10 being the "worst possible pain."
Measured: four weeks.
Neck disability
The Neck Disability Index (NDI) will be used. It is a modification of the Oswestry Low Back Pain Disability Index. It is a scale used to measure disability associated with cervical pain due to acute or chronic conditions. He has 10 items: 7 related to activities of daily living, 2 related to pain and 1 related to concentration. The test can be interpreted with a maximum score of 50.
Measured: four weeks
Secondary outcomes (6)
Cervical range of motion
The Cervical Range of Motion (CROM) device (Performance Attainment Associates, USA) will be used to measure the cervical range of motion, including flexion, extension, lateral flexion and rotation.
Measured: four weeks
Hand grip strength
The strength will be recorded with Jamar Plus: Digital dynamometer to assess grip strength.
Measured: four weeks
upper limb strength
The strength in upper limb movements will be recorded with the device "wireless MicroFET 2": Hand-held dynamometer for force assessment.
Measured: four weeks
Pressure pain threshold
Pressure algometry measurements will be performed with a digital algometer to assess pressure pain thresholds. (Algometer model: Pain Test™ FPIX 10).
Measured: four weeks
Kinesiophobia
The Tampa Scale for kinesiophobia (TSK-13) will be used. It is a patient-reported outcome measure designed to help identify kinesiophobia. This version is a 13-item questionnaire aimed at the assessment of fear of movement/re-injury. Each item is provided with a 4-points Likert scale with scoring alternatives ranging from "strongly disagree" [0] to "strongly agree" [4] . This gives a possible total raw score range from 0 to 52.
Measured: four weeks
Catastrophism
Pain Catastrophizing Scale (PCS) will be used. People are asked to indicate the degree to which they have the above thoughts and feelings when they are experiencing pain using the 0 (not at all) to 4 (all the time) scale. A total score is yielded (ranging from 0-52).
Measured: four weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Oct 2022
- Study start16 Jul 2022
- Primary completion23 Dec 2022
- Study completion20 Jan 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
- Longitudinal prospective, controlled, single-blind study
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 56 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Salamanca
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Roberto Méndez Sánchez, University of Salamanca
- Investigators
- Roberto Méndez-Sánchez, PhD, Principal investigator, University of Salamanca
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05596019
- Sponsor's protocol ID
- USalamancaNeckPain
- Acronym
- USNP
- Status last verified
- May 2023
- First submitted
- 19 Oct 2022
- Last updated
- 10 May 2023
- 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 10 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Specific Neurodynamic Exercises Compared With Non-specific Exercises on Disability and Neck Pain in Women Older Than 65 Years
- ClinicalTrials.gov ID
- NCT05596019
- Acronym / sponsor ID
- USNP / USalamancaNeckPain
- Conditions
- Neck Pain
- Keywords
- exercise, neck pain, neurodynamic, elderly
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 56 participants (actual)
- Lead sponsor
- University of SalamancaUniversity, hospital or other
- Study start
- 16 Jul 2022 (actual)
- Primary completion
- 23 Dec 2022 (actual)
- Study completion
- 20 Jan 2023 (actual)
- First posted
- 27 Oct 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.
This is a randomized, parallel, double-blind clinical trial. The main objective is to compare the efficacy of multimodal exercise with specific neurodynamic exercises and multimodal exercise with non-specific exercises in disability and neck pain in women older than 65 years.
The intervention in both groups will be carried out for 4 weeks, with three weekly sessions. Two evaluations will be carried out, a pre-intervention evaluation and a post-intervention evaluation. We will assess neck pain, disability, upper limb strength, cervical mobility, cervical pressure pain thresholds, kinesiophobia and catastrophism.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- Longitudinal prospective, controlled, single-blind study
| Arm | Type | Receives |
|---|---|---|
| neurodynamics specific exercise group | Experimental | Procedure: specific neurodynamic exercisesThe experimental group will perform a multimodal therapeutic physical exercise program. The components of balance, walking, cardiovascular endurance, strength and flexibility will be worked globally, in addition to including respiratory exercises. Specific neurodynamic exercises oriented to the treatment of the main nerves of the brachial plexus will be included as part of the exercise sessions. The specific neurodynamic program will consist of the following exercises: 1. Opening of the cervical conjunction holes with cranio-cervical and cervical flexion movements, cervical lateroflexions and lateral vertebral sliding self-mobilizations. 2. Opening of the thoracic passages of the brachial plexus with stretching of the scalene muscles, opening of the costoclavicular space and stretching of the pectoralis minor muscles. 3. Specific exercises of neurodynamic sliding of the nerves of the upper limb: median, radial and ulnar nerves. |
| The nonspecific exercise group | Active comparator | Procedure: multimodal exerciseThe nonspecific exercise group performed balance, cardiovascular endurance, stability, upper and lower limb strength, flexibility, and breathing exercises. |
Who may qualify
- Ages
- 65 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (2 listed)
- Women older than 65 years.
- Neck pain
Key exclusion criteria (10 listed)
- Tumors
- Pacemakers
- Fibrillations
- Cardiac pathology or uncontrolled hypertension
- History of severe trauma/recent cervical 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 |
|---|---|---|
| specific neurodynamic exercisesSpecific neurodynamic exercises in women older than 65 years with neck pain | Procedure or surgery | neurodynamics specific exercise group |
| multimodal exerciseMultimodal and nonspecific exercises in women older than 65 years with neck pain | Procedure or surgery | The nonspecific exercise group |
Primary outcome
Pain intensity
Time frame: four weeks.
Numerical Pain Rating Scale (NPRS) will be used. It is a scale used to quantify the patient's pain level on an 11-point numerical scale 0-10 with 0 being "no pain" and 10 being the "worst possible pain."
Neck disability
Time frame: four weeks
The Neck Disability Index (NDI) will be used. It is a modification of the Oswestry Low Back Pain Disability Index. It is a scale used to measure disability associated with cervical pain due to acute or chronic conditions. He has 10 items: 7 related to activities of daily living, 2 related to pain and 1 related to concentration. The test can be interpreted with a maximum score of 50.
6 secondary outcomes
Cervical range of motion
Time frame: four weeks
Hand grip strength
Time frame: four weeks
upper limb strength
Time frame: four weeks
Pressure pain threshold
Time frame: four weeks
Kinesiophobia
Time frame: four weeks
Catastrophism
Time frame: four weeks
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 10 May 2023.
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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.
Roberto Méndez-Sánchez, PhD principal investigator
University of Salamanca
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing specific neurodynamic exercises and multimodal exercise in people with Neck Pain, run by University of Salamanca 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 10 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 10 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 intensity (time frame: four weeks.). 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 10 May 2023.