NCT05596019

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
56

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jul 2022

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 16, 2022

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

October 19, 2022

Completed
8 days until next milestone

First Posted

Study publicly available on registry

October 27, 2022

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 23, 2022

Completed
28 days until next milestone

Study Completion

Last participant's last visit for all outcomes

January 20, 2023

Completed
Last Updated

May 10, 2023

Status Verified

May 1, 2023

Enrollment Period

5 months

First QC Date

October 19, 2022

Last Update Submit

May 8, 2023

Conditions

Keywords

exerciseneck painneurodynamicelderly

Outcome Measures

Primary Outcomes (2)

  • 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."

    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.

    four weeks

Secondary Outcomes (6)

  • Cervical range of motion

    four weeks

  • Hand grip strength

    four weeks

  • upper limb strength

    four weeks

  • Pressure pain threshold

    four weeks

  • Kinesiophobia

    four weeks

  • +1 more secondary outcomes

Study Arms (2)

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.

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.

Procedure: multimodal exercise

Interventions

Specific neurodynamic exercises in women older than 65 years with neck pain

neurodynamics specific exercise group

Multimodal and nonspecific exercises in women older than 65 years with neck pain

The nonspecific exercise group

Eligibility Criteria

Age65 Years+
Sexfemale
Healthy VolunteersYes
Age GroupsOlder Adult (65+)

You may qualify if:

  • Women older than 65 years.
  • Neck pain

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Salamanca

Salamanca, 37007, Spain

Location

MeSH Terms

Conditions

Neck PainMotor Activity

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsBehavior

Study Officials

  • Roberto Méndez-Sánchez, PhD

    University of Salamanca

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Masking Details
Single blind masking with blinded assessor.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Longitudinal prospective, controlled, single-blind study
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

October 19, 2022

First Posted

October 27, 2022

Study Start

July 16, 2022

Primary Completion

December 23, 2022

Study Completion

January 20, 2023

Last Updated

May 10, 2023

Record last verified: 2023-05

Locations