- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05596019
Specific Neurodynamic Exercises on Disability and Neck Pain in Old Women (USNP)
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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Salamanca, Spain, 37007
- University of Salamanca
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Women older than 65 years.
- Neck pain
Exclusion Criteria:
- Tumors
- Pacemakers
- Fibrillations
- Cardiac pathology or uncontrolled hypertension
- History of severe trauma/recent cervical surgery
- Uncontrolled systemic and inflammatory pathologies
- Congenital collagen compromise
- Presence of difficulties in performing the Initial Evaluation tests
- Language barriers
- Pending litigation or legal claim
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: neurodynamics specific exercise group
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:
|
Specific neurodynamic exercises in women older than 65 years with neck pain
|
|
Active Comparator: The nonspecific exercise group
The nonspecific exercise group performed balance, cardiovascular endurance, stability, upper and lower limb strength, flexibility, and breathing exercises.
|
Multimodal and nonspecific exercises in women older than 65 years with neck pain
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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."
|
four weeks.
|
|
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.
|
four weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Cervical range of motion
Time Frame: four weeks
|
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.
|
four weeks
|
|
Hand grip strength
Time Frame: four weeks
|
The strength will be recorded with Jamar Plus: Digital dynamometer to assess grip strength.
|
four weeks
|
|
upper limb strength
Time Frame: four weeks
|
The strength in upper limb movements will be recorded with the device "wireless MicroFET 2": Hand-held dynamometer for force assessment.
|
four weeks
|
|
Pressure pain threshold
Time Frame: four weeks
|
Pressure algometry measurements will be performed with a digital algometer to assess pressure pain thresholds.
(Algometer model: Pain Test™ FPIX 10).
|
four weeks
|
|
Kinesiophobia
Time Frame: four weeks
|
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.
|
four weeks
|
|
Catastrophism
Time Frame: four weeks
|
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).
|
four weeks
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Roberto Méndez-Sánchez, PhD, University of Salamanca
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- USalamancaNeckPain
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Neck Pain
-
Hochschule OsnabruckNot yet recruitingNeck Pain | Chronic Neck Pain | Neck Disability | Neck Pain Musculoskeletal | Neck Disease
-
Istanbul University - CerrahpasaRecruitingNonspecific Neck Pain | Neck Pain MusculoskeletalTurkey (Türkiye)
-
Universitat Internacional de CatalunyaNot yet recruitingChronic Neck Pain | Non-specific Neck PainSpain
-
The Hong Kong Polytechnic UniversityNot yet recruitingChronic Neck Pain | Neck Pain Treatment | Neck Pain ChronicHong Kong
-
Benha UniversityCompletedNeck Pain | Mechanical Neck Pain | Pain Threshold | Cervical Pain, Posterior | Neck Pain Musculoskeletal | Extracorporeal Shock Wave TherapyEgypt
-
University of LahoreCompletedNeck Pain | Mechanical Neck Pain | Mobilization | Neck Pain Musculoskeletal | Proprioceptive Neuromuscular FacilitationPakistan
-
Hacettepe UniversityRecruitingNeck Pain | Cervical Pain | Neck Pain, Posterior | Neck Muscle Issue | Cervical Pain, PosteriorTurkey
-
Fatih TekinPamukkale UniversityCompletedChronic Neck Pain | Persistent Neck Pain | Neuroscience ApproachTurkey
-
Hacettepe UniversityNot yet recruitingChronic Neck PainTurkey (Türkiye)
-
Riphah International UniversityCompletedChronic Neck PainPakistan
Clinical Trials on specific neurodynamic exercises
-
Kahramanmaras Sutcu Imam UniversityCompleted
-
Istanbul UniversityCompletedCarpal Tunnel Syndrome | Peripheral Neuropathy | Median Nerve EntrapmentTurkey
-
Universidad Rey Juan CarlosCompleted
-
University of DeustoUniversity of the Basque Country (UPV/EHU); Osakidetza; Matia FoundationRecruitingCervical Pain | Cervical Radiculopathy | Cervical Radicular PainSpain
-
Cairo UniversityBatterjee Medical CollegeCompleted
-
Linkoeping UniversityCompletedWhiplash Associated DisorderSweden
-
University of BergenNorwegian Fund for Postgraduate Training in PhysiotherapyNot yet recruitingPregnancy Related | Diastasis Recti AbdominisNorway
-
Istanbul University - Cerrahpasa (IUC)RecruitingScoliosis | Adolescent ScoliosisTurkey
-
Xinhua Hospital, Shanghai Jiao Tong University...Xinhua Hospital Chongming Branch; Shanghai First Rehabilitation Hospital; Shanghai... and other collaboratorsUnknownScoliosis Idiopathic AdolescentChina
-
Linkoeping UniversityCompleted