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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05596019
Other study ID # USalamancaNeckPain
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date July 16, 2022
Est. completion date January 20, 2023

Study information

Verified date May 2023
Source University of Salamanca
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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. 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.


Recruitment information / eligibility

Status Completed
Enrollment 56
Est. completion date January 20, 2023
Est. primary completion date December 23, 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 65 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Procedure:
specific neurodynamic exercises
Specific neurodynamic exercises in women older than 65 years with neck pain
multimodal exercise
Multimodal and nonspecific exercises in women older than 65 years with neck pain

Locations

Country Name City State
Spain University of Salamanca Salamanca

Sponsors (1)

Lead Sponsor Collaborator
University of Salamanca

Country where clinical trial is conducted

Spain, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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.
Primary 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 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. four weeks
Secondary Hand grip strength The strength will be recorded with Jamar Plus: Digital dynamometer to assess grip strength. four weeks
Secondary upper limb strength The strength in upper limb movements will be recorded with the device "wireless MicroFET 2": Hand-held dynamometer for force assessment. four weeks
Secondary Pressure pain threshold Pressure algometry measurements will be performed with a digital algometer to assess pressure pain thresholds. (Algometer model: Pain Testâ„¢ FPIX 10). four weeks
Secondary 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. four weeks
Secondary 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). four weeks
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