- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05265468
Noninvasive Treatment of Upper Trapezius Active Trigger Points in College Students With Neck Pain
May 19, 2022 updated by: Juan Martínez Fuentes, Universidad Católica San Antonio de Murcia
Noninvasive Treatment of Upper Trapezius Active Trigger Points in College Students With Neck Pain. A Randomized Clinical Trial
Hyperexcitable myofascial trigger points located within a taut band of skeletal muscle or fascia cause referred pain, local tenderness, and autonomic changes.
The scientific data refer to an immediate improvement in the symptoms of these active points treated with manual therapy.
Based on these factors, the objective of the study is to determine the effect of the combined therapy of the Jones, Chaitow, Lewit technique and pain-free positioning in participants with the presence of an active upper trapezius trigger point.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
The treatment will last a total of 15 minutes accompanied by a baseline assessment and after 10 minutes of the intervention in 3 experimental groups and a placebo group, of no-pain positioning.
In addition to basic indices and scales of cervical pain and functionality, it is intended to measure flexibility, range of motion, proprioception and cognition through software with sensors of the latest technology when it comes to representing reliable results in differences between techniques.
Study Type
Interventional
Enrollment (Actual)
80
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Murcia, Spain, 30107
- Universidad Católica de Murcia
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
19 years to 40 years (Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- persistent neck pain or headache for more than 3 days
- presence of active trigger point in upper trapezius
Exclusion Criteria:
- Participants who present dizziness, vertigo and/or symptoms aggravated by the movement and/or positioning of the neck;
- who present infection or febrile state at the time of performing the test;
- with anxiety and/or extreme emotional tension;
- who are undergoing pharmacological treatment (analgesics, muscle relaxants, anxiolytics, antidepressants)
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Jones Group (Strain Counterstrain)
Jones Group consist in 90 seconds in a ralease positioning of no pain in muscle acortation
|
No pain positioning technique with diaphragmatic breathing
|
|
Placebo Comparator: Placebo Group
Placebo Group only have to mantain no pain positioning for 3 minutes
|
No pain positioning of participants
|
|
Active Comparator: Lewit Group
Lewit Group consist in a maximum of four minutes of muscular contraction acompaind by stretching techniques
|
Isometric muscular exercise acompained with stretching technique
|
|
Active Comparator: Chaitow Group
Chaitow Group consist in a maximum of four minutes of muscular contraction acompaind by stretching techniques and deep diaphragmatic respiration
|
Isometric muscular exercise acompained with stretching technique and diaphragmatic breathing
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Neck Disability Index
Time Frame: 10 minutes
|
Self-completed neck questionnaire wich consists in 10 sections.
Each one of them (cervical pain intensity, personal care, lifting weights, reading, headache, ability to concentrate, ability to work, driving, sleep and leisure activities) offers 6 possible answers that represent 6 progressive levels of functional capacity, and is scored from 0 to 5. The total score is expressed in percentage terms with respect to the maximum possible
|
10 minutes
|
|
Pain intensity
Time Frame: 10 minutes
|
Measured with Numeric Rating Scale wich consist in measure pain intensity with a score of 0-10
|
10 minutes
|
|
Pression algometer
Time Frame: 10 minutes
|
Measures pressure pain thresholds
|
10 minutes
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Cervical Test
Time Frame: 10 minutes
|
Measured with Baiobit Software.
The range of movement will be measured in grades as per: flexion/extension; right/left rotation; and right/left inclination
|
10 minutes
|
|
Proprioceptive Test
Time Frame: 10 minutes
|
Measured with Baiobit Software o'clock test in a high/medium/low levels wich consist in a velocity and accuracy evaluation of combined cervical movements in the o'clock game test.
|
10 minutes
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
March 14, 2022
Primary Completion (Actual)
March 14, 2022
Study Completion (Actual)
May 19, 2022
Study Registration Dates
First Submitted
January 20, 2022
First Submitted That Met QC Criteria
February 22, 2022
First Posted (Actual)
March 3, 2022
Study Record Updates
Last Update Posted (Actual)
May 20, 2022
Last Update Submitted That Met QC Criteria
May 19, 2022
Last Verified
May 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CE112103
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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.
Clinical Trials on Neck Pain
-
Hochschule OsnabruckNot yet recruitingNeck Pain | Chronic Neck Pain | Neck Disability | Neck Pain Musculoskeletal | Neck Disease
-
Istanbul University - CerrahpasaRecruitingNonspecific Neck Pain | Neck Pain MusculoskeletalTurkey (Türkiye)
-
Universitat Internacional de CatalunyaNot yet recruitingChronic Neck Pain | Non-specific Neck PainSpain
-
The Hong Kong Polytechnic UniversityNot yet recruitingChronic Neck Pain | Neck Pain Treatment | Neck Pain ChronicHong Kong
-
Benha UniversityCompletedNeck Pain | Mechanical Neck Pain | Pain Threshold | Cervical Pain, Posterior | Neck Pain Musculoskeletal | Extracorporeal Shock Wave TherapyEgypt
-
Fatih TekinPamukkale UniversityCompletedChronic Neck Pain | Persistent Neck Pain | Neuroscience ApproachTurkey
-
University of LahoreCompletedNeck Pain | Mechanical Neck Pain | Mobilization | Neck Pain Musculoskeletal | Proprioceptive Neuromuscular FacilitationPakistan
-
Hacettepe UniversityRecruitingNeck Pain | Cervical Pain | Neck Pain, Posterior | Neck Muscle Issue | Cervical Pain, PosteriorTurkey
-
Hacettepe UniversityNot yet recruitingChronic Neck PainTurkey (Türkiye)
-
Qatif Central HospitalEnrolling by invitationNeck Pain | Neck Pain MusculoskeletalSaudi Arabia
Clinical Trials on Jones Group (Strain Counterstrain)
-
Universidad Católica San Antonio de MurciaCompletedLow Back Pain | Trigger Point Pain, MyofascialSpain
-
Long Island UniversityTerminatedOther Instability, Ankle and FootUnited States
-
University Hospitals Cleveland Medical CenterWithdrawnChronic Migraine
-
Riphah International UniversityRecruitingTrigger Point Pain, MyofascialPakistan
-
Kyungnam UniversityCompletedLatent Myofascial Trigger Points | Upper Trapezius MuscleSouth Korea
-
Riphah International UniversityRecruiting
-
Loma Linda UniversityRecruitingLow Back Pain, Mechanical | Piriformis Syndrome | Somatic Dysfunction of Sacral Region (Finding)United States
-
Hasan Kalyoncu UniversityCompletedPain | Fibromyalgia | Physiotherapy | Strain Counterstrain TechniqueTurkey (Türkiye)
-
University of FaisalabadNot yet recruiting
-
Cairo UniversityCompletedSacroiliac Joint Somatic DysfunctionEgypt