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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06256016
Other study ID # CEI15/002
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date April 4, 2024
Est. completion date December 15, 2024

Study information

Verified date April 2024
Source University of Alcala
Contact Patricia Martinez-Merinero, PhD
Phone +34 8855142
Email gifyd@uah.es
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Neck pain is a common disorder in industrialized countries. Manual therapy techniques have been commonly used in the treatment of this problem. Actually, there is no research work that has evaluated the work well of treatment with soft tissue techniques (massage) applied to the dorsal paravertebral muscle in the management of neck pain. The goal of this study (clinical trial) is to compare the efficacy of a massage protocol performed on the dorsal region in subjects with mechanical neck pain. The researchers will compare: A group that will be treated with a local protocol of cervical manual therapy and therapeutic exercise along with the treatment(massage) of the thoracic region. Another group that will be treated only with a local protocol of cervical manual therapy and therapeutic exercise. It is to see if the inclusion of treatment of the thoracic region improves the local intervention in cervical region.


Recruitment information / eligibility

Status Recruiting
Enrollment 60
Est. completion date December 15, 2024
Est. primary completion date August 15, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years to 70 Years
Eligibility Inclusion Criteria: - Subjects with neck pain. - Pain between 4 and 7 points according to a visual anological scale. - Neck pain lasting more than three months Exclusion Criteria: - Subjects who have suffered a whiplash injury. - Subjects with neck pain and upper extremity pain. - Subjects with a diagnosis of herniated disc. - Subjects with fibromyalgia. - Subjects with any cancer process.

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Neck pain massage
Subjects in this group will be treated with a neck muscle massage protocol. First, pressure inhibition techniques will be applied to the affected muscles. Then deep stroke technique will be performed on each muscle. In addition, effleurages technique will be applied along the thoracic paravertebral muscle. Subjects will also perform an exercise protocol for neck pain.
Neck and thoracic massage
Subjects in this group will be treated with a neck muscle massage protocol. First, pressure inhibition techniques will be applied to the affected muscles. Then deep stroke technique will be performed on each muscle. In addition, deep stroke technique will be applied along the thoracic paravertebral muscle. Subjects will also perform an exercise protocol for neck pain.

Locations

Country Name City State
Spain Physioterapy and Pain center research Alcalá de Henares Madrid

Sponsors (1)

Lead Sponsor Collaborator
University of Alcala

Country where clinical trial is conducted

Spain, 

Outcome

Type Measure Description Time frame Safety issue
Primary Neck pain A Visual Analogue Scale (VAS) is one of the pain rating scales used for measure the intensity pain. The VAS is a straight horizontal line of fixed length, usually 100 mm.The ends are defined as the extreme limits of the parameter to be measured orientated from the left or "10" (worst pain) to the right (best pain) or "0". Change from Baseline pain at 3 month
Secondary Neck disability index This questionnaire has been designed to give us information as to how the neck pain are affecting the subject´s ability to manage in everyday life. The questionnaire has 10 items including pain, personal care, lifting, reading, headaches, concentration, work, driving, sleeping and recreation. It´s interpreted as a raw score, with a maximum score of 50 where "0" is not disability and 50 is the worst disability Change from Baseline pain at 3 month
Secondary Pain catastrophizing Pain Catastrophizing Scale (PCS). The PCS is a 13-item instrumen that task participants to reflect on past painful experiences, and to indicate the degree to which they experienced each of 13 thoughts or feelings when experiencing pain, on 5-point scales with the end points (0) not at all and (4) all the time. The PCS total scores range from 0 - 52. 0 is the best result and 52 is the worst result. Change from Baseline pain at 3 month
Secondary kinesiophobia The Tampa Scale of Kinesiophobia (TSK) describe patient circumstances characterised by an "excessive, irrational, and debilitating fear of physical movement and activity resulting from a feeling of vulnerability to painful injury or reinjury. The TSK is a 17 item assessment checklist.The 17 item TSK total scores range from 17 to 68 where the lowest 17 means no or negligible kinesiophobia, and the higher scores indicate an increasing degree of kinesiophobia. Change from Baseline pain at 3 month
Secondary The Global Rating of Change (GRoC) It's a scale that assesses whether the patient condition has gotten worse, better, or stayed the same and to quantify the magnitude of that change, typically following treatment.Subjects will make global ratings of changes regarding their level of well-being from their neck pain since the initial examination on a 15-point self-report scale (from -7 to 7), where -7 is the worst possible value and 7 is the best possible value. Change from Baseline pain at 3 month
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