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

Primary Purpose

Neck Pain

Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
specific neurodynamic exercises
multimodal exercise
Sponsored by
University of Salamanca
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Neck Pain focused on measuring exercise, neck pain, neurodynamic, elderly

Eligibility Criteria

65 Years - undefined (Older Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

  • University of Salamanca

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

neurodynamics specific exercise group

The nonspecific exercise group

Arm Description

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: Opening of the cervical conjunction holes with cranio-cervical and cervical flexion movements, cervical lateroflexions and lateral vertebral sliding self-mobilizations. 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. Specific exercises of neurodynamic sliding of the nerves of the upper limb: median, radial and ulnar nerves.

The nonspecific exercise group performed balance, cardiovascular endurance, stability, upper and lower limb strength, flexibility, and breathing exercises.

Outcomes

Primary Outcome Measures

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."
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.

Secondary Outcome Measures

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.
Hand grip strength
The strength will be recorded with Jamar Plus: Digital dynamometer to assess grip strength.
upper limb strength
The strength in upper limb movements will be recorded with the device "wireless MicroFET 2": Hand-held dynamometer for force assessment.
Pressure pain threshold
Pressure algometry measurements will be performed with a digital algometer to assess pressure pain thresholds. (Algometer model: Pain Test™ FPIX 10).
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.
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).

Full Information

First Posted
October 19, 2022
Last Updated
May 8, 2023
Sponsor
University of Salamanca
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1. Study Identification

Unique Protocol Identification Number
NCT05596019
Brief Title
Specific Neurodynamic Exercises on Disability and Neck Pain in Old Women
Acronym
USNP
Official Title
Effectiveness of Specific Neurodynamic Exercises Compared With Non-specific Exercises on Disability and Neck Pain in Women Older Than 65 Years
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Completed
Study Start Date
July 16, 2022 (Actual)
Primary Completion Date
December 23, 2022 (Actual)
Study Completion Date
January 20, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Salamanca

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neck Pain
Keywords
exercise, neck pain, neurodynamic, elderly

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Longitudinal prospective, controlled, single-blind study
Masking
ParticipantOutcomes Assessor
Masking Description
Single blind masking with blinded assessor.
Allocation
Randomized
Enrollment
56 (Actual)

8. Arms, Groups, and Interventions

Arm Title
neurodynamics specific exercise group
Arm Type
Experimental
Arm Description
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: Opening of the cervical conjunction holes with cranio-cervical and cervical flexion movements, cervical lateroflexions and lateral vertebral sliding self-mobilizations. 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. Specific exercises of neurodynamic sliding of the nerves of the upper limb: median, radial and ulnar nerves.
Arm Title
The nonspecific exercise group
Arm Type
Active Comparator
Arm Description
The nonspecific exercise group performed balance, cardiovascular endurance, stability, upper and lower limb strength, flexibility, and breathing exercises.
Intervention Type
Procedure
Intervention Name(s)
specific neurodynamic exercises
Intervention Description
Specific neurodynamic exercises in women older than 65 years with neck pain
Intervention Type
Procedure
Intervention Name(s)
multimodal exercise
Intervention Description
Multimodal and nonspecific exercises in women older than 65 years with neck pain
Primary Outcome Measure Information:
Title
Pain intensity
Description
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."
Time Frame
four weeks.
Title
Neck disability
Description
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.
Time Frame
four weeks
Secondary Outcome Measure Information:
Title
Cervical range of motion
Description
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.
Time Frame
four weeks
Title
Hand grip strength
Description
The strength will be recorded with Jamar Plus: Digital dynamometer to assess grip strength.
Time Frame
four weeks
Title
upper limb strength
Description
The strength in upper limb movements will be recorded with the device "wireless MicroFET 2": Hand-held dynamometer for force assessment.
Time Frame
four weeks
Title
Pressure pain threshold
Description
Pressure algometry measurements will be performed with a digital algometer to assess pressure pain thresholds. (Algometer model: Pain Test™ FPIX 10).
Time Frame
four weeks
Title
Kinesiophobia
Description
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.
Time Frame
four weeks
Title
Catastrophism
Description
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).
Time Frame
four weeks

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Roberto Méndez-Sánchez, PhD
Organizational Affiliation
University of Salamanca
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Salamanca
City
Salamanca
ZIP/Postal Code
37007
Country
Spain

12. IPD Sharing Statement

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Specific Neurodynamic Exercises on Disability and Neck Pain in Old Women

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