Back to resultsDry Needling Effectiveness and Post-punction Pain
Primary Purpose
Neck Pain
Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Dry needling
Transcutaneous Nerve Stimulation.
Placebo needling
Sponsored by
About this trial
This is an interventional treatment trial for Neck Pain focused on measuring Miofascial pain syndrom., Trigger point., Dry needling., Transcotaneous Nerve Stimuilation., Hipoalgesia
Eligibility Criteria
Inclusion Criteria:
- Mechanical Neck pain of at least 6 months.
- VAS 2 or greather.
- Existance of miofascial trigger point in trapezius muscle assesed by an expert PT.
Exclusion Criteria:
- Neck pain due secondary to ostheoporosis, metastasis, neoplasias, fractures, infections, cervical stenosis or infexious procces.
- Headache secondary to medular compression presenting one o the following signs: abnormal sensitivity, hiperreflexia, clonus, spread weakness, cervical hernia.
- Neck pain with radiculopathy.
- Whiplash.
- Vertebrobasilar syndrome.
- Dizzyness.
- Pregnancy.
- Having received dry needling treatment before.
Sites / Locations
- Universidad Rey Juan Carlos
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Placebo Comparator
Experimental
Arm Label
dry needling and TENS
Placebo
dry needling
Arm Description
A dry needling treatment was performed on trapezius trigger point number 2, and just after thar, a TENS curretn was applied. Patients will be reassed on fourth day after treatment.
A placebo dry needling was performed on trapezius trigger point number 2. Patients will be reassed on fourth day after treatment.
A dry needling treatment was performed on trapezius trigger point number 2. Patients will be reassed on fourth day after treatment.
Outcomes
Primary Outcome Measures
Visual Analogue Scale
Visual Analogue Scale (VAS) is a subjective evaluation. There are previous studies that demonstrate its reliability and its sensitivity, wich give validity to VAS messures. The messure is made using a two sides 10 centimeters scale. The patient´s face shows an increasing slope that allows the patient to mark his pain level. That mark has his equivalent number on the scale, so 0 is no pain and 10 is maximum pain. A differece of 2 points on the scale means the minimum clinically significant change.
Secondary Outcome Measures
Active Cervical Range of Movement
To messure the cervical range of movement, a CROM will be used. The CROM is a special goniometer that allows therapists to messure cervical movements. It conists on trhee pairs of inclinometers that allow reserchers to messure range of flexion-extension, lateral flexion and rotation. The CROM has a porved reliability, providing a inter-meter reliability from 0,7 to 0,9 and an intra-meter reliability from 0,8 to 0,87. The patient will be seated on a cheir, and he´ll perform cervical movements actively, just untill he starts to feel his pain. Each movement will be messure three times, and the average will be taken.
Pressure Pain Threshold
Pressure Pain Threshold (PPT) is the minimun pressure needed to araise pain. To messure PPT, an digital algometer will be used. An algometer consists on a 1 square centimeter rubber piece inserted on a pressure gauge. Previous studies have shown the reliability of this method (ICC=0,91) and also inter meter (ICC from 0,82 to 0,97) and intra meter (ICC=0,78). The minimun detectable change on the cervical area goes from 0,44 Kg/cm2 to 1,11 Kg/cm2. We will apply the algometer over trapezius trigger point number 2, and the patient will tell the therapist when he start to feel hgis pain. We´ll do the messure 3 times and the average will be taken.
Full Information
NCT ID
NCT04148469
First Posted
October 30, 2019
Last Updated
October 30, 2019
Sponsor
Universidad Rey Juan Carlos
1. Study Identification
Unique Protocol Identification Number
NCT04148469
Brief Title
Dry Needling Effectiveness and Post-punction Pain
Official Title
Benefits and Harms of Dry Needling vs Transcutaneous Nerve Stimulation and Dry Needling in Patients With Chronic Myofascial Neck Pain and Relationship With Psychological Influences
Study Type
Interventional
2. Study Status
Record Verification Date
October 2019
Overall Recruitment Status
Completed
Study Start Date
November 2012 (Actual)
Primary Completion Date
June 12, 2013 (Actual)
Study Completion Date
December 10, 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universidad Rey Juan Carlos
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this estudy was to dertermine if the application of Transcutaneous Nerve Stimiulation (TENS) current have an hypoalgesic effect on pattientes suffering from miofascial neck pain, compared with a only dry needling treatment. Psicological varaibles were also mesured in order to determine how they change after each treatment.
Detailed Description
All patients suffered from mechanical neck pain and were randomized into three groups of treatment. A doible blinded control was carryed out. The main outcome messures were Visual Analogue Scale (VAS). The scondary outcome messures were Pressure Pain hreshold (PPT) and Active Range of Movement (ROM). Also psicologicla messures were taken, like Neck Dissability Index, Level of stress and ansiety, Fear Pain and Pain Avoidance Strategies.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neck Pain
Keywords
Miofascial pain syndrom., Trigger point., Dry needling., Transcotaneous Nerve Stimuilation., Hipoalgesia
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
68 (Actual)
8. Arms, Groups, and Interventions
Arm Title
dry needling and TENS
Arm Type
Experimental
Arm Description
A dry needling treatment was performed on trapezius trigger point number 2, and just after thar, a TENS curretn was applied. Patients will be reassed on fourth day after treatment.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
A placebo dry needling was performed on trapezius trigger point number 2. Patients will be reassed on fourth day after treatment.
Arm Title
dry needling
Arm Type
Experimental
Arm Description
A dry needling treatment was performed on trapezius trigger point number 2. Patients will be reassed on fourth day after treatment.
Intervention Type
Procedure
Intervention Name(s)
Dry needling
Intervention Description
Dry needlin is a manual therapy technique used for miofascuial pain syndrom treatment. The patient will be supine, in a confortable position. The therapist localizes the trapezius trigger point number 2 and then performes the needling until 2 REL are obtenined. The patient will remain supine during 15 minutes.
Intervention Type
Procedure
Intervention Name(s)
Transcutaneous Nerve Stimulation.
Intervention Description
Transcutaneous Nerve Stimulation (TENS) is a current used for pain treatment. The needle will be used as the negative pole and a adhesive patch 2 centimeters lateral will be the positive pole. The frecuency selected will have 2 Hz with pulses of 120 microseconds. The currente will be applied for 15 minutes.
Intervention Type
Procedure
Intervention Name(s)
Placebo needling
Intervention Description
No active technique is performed with the placebo needling. Patient will be supine and a placebo needle willb be performed. The patient will remain supine for 15 minutes.
Primary Outcome Measure Information:
Title
Visual Analogue Scale
Description
Visual Analogue Scale (VAS) is a subjective evaluation. There are previous studies that demonstrate its reliability and its sensitivity, wich give validity to VAS messures. The messure is made using a two sides 10 centimeters scale. The patient´s face shows an increasing slope that allows the patient to mark his pain level. That mark has his equivalent number on the scale, so 0 is no pain and 10 is maximum pain. A differece of 2 points on the scale means the minimum clinically significant change.
Time Frame
Patients will be reassed in four days.
Secondary Outcome Measure Information:
Title
Active Cervical Range of Movement
Description
To messure the cervical range of movement, a CROM will be used. The CROM is a special goniometer that allows therapists to messure cervical movements. It conists on trhee pairs of inclinometers that allow reserchers to messure range of flexion-extension, lateral flexion and rotation. The CROM has a porved reliability, providing a inter-meter reliability from 0,7 to 0,9 and an intra-meter reliability from 0,8 to 0,87. The patient will be seated on a cheir, and he´ll perform cervical movements actively, just untill he starts to feel his pain. Each movement will be messure three times, and the average will be taken.
Time Frame
Patient will be reassed in four days.
Title
Pressure Pain Threshold
Description
Pressure Pain Threshold (PPT) is the minimun pressure needed to araise pain. To messure PPT, an digital algometer will be used. An algometer consists on a 1 square centimeter rubber piece inserted on a pressure gauge. Previous studies have shown the reliability of this method (ICC=0,91) and also inter meter (ICC from 0,82 to 0,97) and intra meter (ICC=0,78). The minimun detectable change on the cervical area goes from 0,44 Kg/cm2 to 1,11 Kg/cm2. We will apply the algometer over trapezius trigger point number 2, and the patient will tell the therapist when he start to feel hgis pain. We´ll do the messure 3 times and the average will be taken.
Time Frame
Patients will be reassed in four days.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Mechanical Neck pain of at least 6 months.
VAS 2 or greather.
Existance of miofascial trigger point in trapezius muscle assesed by an expert PT.
Exclusion Criteria:
Neck pain due secondary to ostheoporosis, metastasis, neoplasias, fractures, infections, cervical stenosis or infexious procces.
Headache secondary to medular compression presenting one o the following signs: abnormal sensitivity, hiperreflexia, clonus, spread weakness, cervical hernia.
Neck pain with radiculopathy.
Whiplash.
Vertebrobasilar syndrome.
Dizzyness.
Pregnancy.
Having received dry needling treatment before.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jose Vicente León Hernández, PT
Organizational Affiliation
Universitdad Rey Juan Carlos
Official's Role
Principal Investigator
Facility Information:
Facility Name
Universidad Rey Juan Carlos
City
Alcorcón
State/Province
Madrid
ZIP/Postal Code
28922
Country
Spain
12. IPD Sharing Statement
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Dry Needling Effectiveness and Post-punction Pain
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