- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06256016
Effectiveness of Massage of the Thoracic Region in Neck Pain
Application of Massage to the Dorsal Paravertebral Muscles and Its Efficacy in the Treatment of Neck Pain
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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Madrid
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Alcalá de Henares, Madrid, Spain, 28805
- Physioterapy and Pain center research
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Neck pain massage
Subjects in this group will be treated with a neck muscle massage protocol.
|
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. |
|
Experimental: Neck and thoracic massage
Subjects in this group will be treated with a massage protocol of the neck muscles and the posterior thoracic region.
|
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. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Neck pain
Time Frame: Change from Baseline pain at 3 month
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Neck disability index
Time Frame: Change from Baseline pain at 3 month
|
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
|
|
Pain catastrophizing
Time Frame: Change from Baseline pain at 3 month
|
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
|
|
kinesiophobia
Time Frame: Change from Baseline pain at 3 month
|
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.
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Change from Baseline pain at 3 month
|
|
The Global Rating of Change (GRoC)
Time Frame: Change from Baseline pain at 3 month
|
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
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Daniel Pecos-Martin, PhD, Alcala University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CEI15/002
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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