Specific Neurodynamic Exercises on Disability and Neck Pain in Old Women (USNP)

May 8, 2023 updated by: Roberto Méndez Sánchez, University of Salamanca

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

Study Type

Interventional

Enrollment (Actual)

56

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Salamanca, Spain, 37007
        • University of Salamanca

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

65 years and older (Older Adult)

Accepts Healthy Volunteers

Yes

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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:

  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.
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

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Roberto Méndez-Sánchez, PhD, University of Salamanca

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 16, 2022

Primary Completion (Actual)

December 23, 2022

Study Completion (Actual)

January 20, 2023

Study Registration Dates

First Submitted

October 19, 2022

First Submitted That Met QC Criteria

October 22, 2022

First Posted (Actual)

October 27, 2022

Study Record Updates

Last Update Posted (Actual)

May 10, 2023

Last Update Submitted That Met QC Criteria

May 8, 2023

Last Verified

May 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • USalamancaNeckPain

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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.

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