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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04856813
Other study ID # CEIM/HU/2020/5/055
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date August 1, 2021
Est. completion date July 9, 2022

Study information

Verified date November 2022
Source University of Jaén
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

It is an interventional study that proves the eficacy of the manual therapy with active manual therapy and combined with exercise in cervical pain.


Description:

The study will be divided in two different groups: - A control group (group A) : they will receive a treatment with manual therapy and physical exercise. - An experimental group (group B) : they will receive the previous treatment, but also the pacient's do active muscle active contraction. The exercise is compound by a home program of several exercises with diferent difficulties. The contraction will consist on a combination of concentric and isometric work. being the patient's pain threshold the one that will guide us to the choice of the predominance of concentric or isometric contraction . Both groups will be joined by a five-minute work on pain education.


Recruitment information / eligibility

Status Completed
Enrollment 42
Est. completion date July 9, 2022
Est. primary completion date December 9, 2021
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 60 Years
Eligibility Inclusion Criteria: - accept to participate in the study, through informed consent - subjects with chronic nonspecific neck pain lasting equal to or more than 3 months Exclusion Criteria: - Present neck pain caused by serious pathology such as: inflammatory, congenital, infectious, metabolic and neoplastic diseases. - Cervical pathology of traumatic origin with less than 6 months of evolution. - Rheumatic diseases. - Neck pain with neurological signs such as: radiculopathy and myelopathy. - Previous surgery of the cervical spine. - Pregnancy. - Have received physiotherapeutic treatment in the cervical region during the month prior to the inclusion of the study. - Have the intention of receiving other physiotherapeutic treatments different from the one proposed during the study period. - Present serious mental disorders.

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Manual therapy active
massage or ischemic compression with active contraction, tha will be isometric or concentric.
Manual therapy
massage or isquemic compression without contraction

Locations

Country Name City State
Spain Alexander achalandabaso Alcalá De Henares Madrid

Sponsors (1)

Lead Sponsor Collaborator
Alexander Achalandabaso

Country where clinical trial is conducted

Spain, 

Outcome

Type Measure Description Time frame Safety issue
Primary Change in Neck disability Using the Neck Disability Index (NDI). It is made up of 10 items and each item is scored on a 6-point Likert scale (0 to 5), leading to a total score ranging from 0 to 50 (0 to 4 = no disability; 5 to 14 = mild disability; 15 to 24 = moderate disability; 25 to 34 = severe disability; and 35 to 50 = complete disability). Baseline, 1 month (primary timepoint) , 2 months and 5 months after intervention commencement.
Secondary Change in pain perception Using the Visual Analog Scale (VAS) from 0 to 10 Baseline, 1 month (primary timepoint), 2 months and 5 months after intervention commencement.
Secondary Change in Range of motion (ROM) Using a inclinometer Baseline, 1 month (primary timepoint) and 2 months after intervention commencement.
Secondary Change in craniocervical flexion Using the craniocervical flexion test (CCFT) we make a evaluation of the strength of the deep cervical flexor muscles. From 22 to 30 mmHg of preasure. Baseline, 1 month (primary timepoint) and 2 months after intervention commencement.
Secondary Change in kinesophobia Using the Tampa Scale for Kinesiophobia-11 (TSK-11), self-report of 17 items that address fear of movement and injury relapse. Four of the items are negatively written and scored inverse (4, 8, 12 and 16). The scores are added together to obtain a total score, with higher values reflecting greater kinesiophobia. Baseline, 1 month (primary timepoint) , 2 months and 5 months after intervention commencement.
Secondary Change in Catastrophism Using the Pain catastrophizing scale from 0 to 56 Baseline, 1 month (primary timepoint), 2 months and 5 months after intervention commencement.
Secondary Change in Sleep Quality Using the Pittsburgh Sleep Quality Index Baseline, 1 month (primary timepoint) , 2 months and 5 months after intervention commencement.
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