Ischemic Compression on Post-needling Soreness
Primary Purpose
Neck Pain
Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Ischemic compression. Dry Needling
Sponsored by
About this trial
This is an interventional treatment trial for Neck Pain focused on measuring Ischemic compression, Myofascial trigger points, Post-needling soreness
Eligibility Criteria
Inclusion Criteria:
- Subjects were included if they presented at least one latent MTrP in the upper trapezius muscle
Exclusion Criteria:
- Presence of coagulation disorders
- Neck or facial pain
- Previous application of a dry needling technique
- MTrP therapy in head or neck within the previous 3 months
- Fibromyalgia
- An insurmountable fear of needles as a reason of refusing the treatment
- History of surgery in the head or neck area
Sites / Locations
- Universidad Rey Juan Carlos
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Sham Comparator
No Intervention
Arm Label
Ischemic compression. Dry Needling
Sham Ischemic compression. Dry Needling
Control group
Arm Description
Ischemic compression was carried out after dry needling.
Sham Ischemic compression was carried out after dry needling.
No intervention. Control group
Outcomes
Primary Outcome Measures
Visual analog scale (VAS)
VAS. Despite being a subjective evaluation, it has been documented in previous studies its reliability and validity and its sensitivity to the clinical changes. For this reason, this scale has been used in numerous clinical trials. The patient places a vertical mark on a flat horizontal line of 10 cm. One extreme is 0 (no pain) and the other extreme is 10 (maximum pain) and it must be a difference of 2 points in the evaluation range to produce minimal improvement which is clinically significant
Secondary Outcome Measures
Cervical Range of Motion (CROM)
The subjects sat in a chair and a CROM goniometerc was placed over his or her head. They were asked to perform active neck movements to the fullest extent of their mobility. Each movement was recorded three times and the average value was calculated. The CROM measurement device has proven to be a reliable measure33 of movement, with an intra-rater reliability ranging from 0.7 to 0.9 and an inter-rater reliability ranging from 0.8 to 0.87.
Full Information
NCT ID
NCT02169700
First Posted
June 17, 2014
Last Updated
September 28, 2015
Sponsor
Universidad Rey Juan Carlos
1. Study Identification
Unique Protocol Identification Number
NCT02169700
Brief Title
Ischemic Compression on Post-needling Soreness
Official Title
Ischemic Compression After Dry Needling of a Latent Myofascial Trigger Point Reduces Post-needling Soreness Intensity and Duration.
Study Type
Interventional
2. Study Status
Record Verification Date
September 2015
Overall Recruitment Status
Completed
Study Start Date
December 2013 (undefined)
Primary Completion Date
February 2014 (Actual)
Study Completion Date
May 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universidad Rey Juan Carlos
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Myofascial trigger points (MTrPs) are identified through physical examination as hypersensitive spots within taut bands of skeletal muscle, painful on compression, triggering characteristic referred pain and generating motor dysfunction as well as autonomic phenomena. Different dry needling procedures have been described in the treatment of MTrPs. Needling therapies which consist in partially inserting and withdrawing the needle from the trigger point site in order to elicit local twitch responses are associated with higher effectiveness in releasing MTrPs. Deep dry needling has obtained a grade A recommendation compared to sham, for immediate reduction of pain in patients with upper-quadrant myofascial pain syndrome. Nevertheless, trigger point dry needling are frequently associated to a post-needling soreness. The application of ischemic compression (IC) after trigger point injection in the upper trapezius muscle has shown higher reduction of pain and disability in myofascial pain patients, compared with trigger point injection alone. To the authors' knowledge, no previous studies have evaluated the effectiveness of IC or any manual therapy methods for the treatment of post-needling soreness. The aims of this study were: (a) to evaluate the effectiveness of IC on reducing post-needling soreness after dry needling of one latent MTrP in the upper trapezius muscle, and (b) to investigate the effect dry needling combined with IC, compared to dry needling alone and dry needling combined with placebo IC will have on cervical range of motion (c) to determine whether psychological factors are predictive of postneedling pain and (d) to analyze if the relationships between psychological variables and postneedling pain varied as a function of postneedling soreness treatment
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neck Pain
Keywords
Ischemic compression, Myofascial trigger points, Post-needling soreness
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
90 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Ischemic compression. Dry Needling
Arm Type
Experimental
Arm Description
Ischemic compression was carried out after dry needling.
Arm Title
Sham Ischemic compression. Dry Needling
Arm Type
Sham Comparator
Arm Description
Sham Ischemic compression was carried out after dry needling.
Arm Title
Control group
Arm Type
No Intervention
Arm Description
No intervention. Control group
Intervention Type
Procedure
Intervention Name(s)
Ischemic compression. Dry Needling
Intervention Description
Ischemic compression was carried out after dry needling. Dry needling was performed with a solid filament needle. Subjects were asked to lie in a prone position. The MTrP was held firmly in a pincer grasp. Before inserting the needle, the patient was advised about the possible sharp pain and muscle twitching. The needle was inserted perpendicular to the skin. Then, the muscle fibers were repeatedly perforated by rapidly inserting and partially withdrawing the needles from the MTrP until two local twitch responses were elicited from the muscle. On removal of the needle, the area was compressed firmly with a cotton bud for two minutes. Immediately after the needling, subjects were randomly assigned to one of three groups (IC, sham and control).
Primary Outcome Measure Information:
Title
Visual analog scale (VAS)
Description
VAS. Despite being a subjective evaluation, it has been documented in previous studies its reliability and validity and its sensitivity to the clinical changes. For this reason, this scale has been used in numerous clinical trials. The patient places a vertical mark on a flat horizontal line of 10 cm. One extreme is 0 (no pain) and the other extreme is 10 (maximum pain) and it must be a difference of 2 points in the evaluation range to produce minimal improvement which is clinically significant
Time Frame
From Baseline in pain intensity at during needling and at 72 hours
Secondary Outcome Measure Information:
Title
Cervical Range of Motion (CROM)
Description
The subjects sat in a chair and a CROM goniometerc was placed over his or her head. They were asked to perform active neck movements to the fullest extent of their mobility. Each movement was recorded three times and the average value was calculated. The CROM measurement device has proven to be a reliable measure33 of movement, with an intra-rater reliability ranging from 0.7 to 0.9 and an inter-rater reliability ranging from 0.8 to 0.87.
Time Frame
CROM measurements were taken before needling, after the intervention, and at 24 and 72 hours post-treatment.
Other Pre-specified Outcome Measures:
Title
Psychological variables
Description
Catastrophizing, kinesiophobia, pain anxiety and fear of pain
Time Frame
Before dry needling intervention
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
39 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Subjects were included if they presented at least one latent MTrP in the upper trapezius muscle
Exclusion Criteria:
Presence of coagulation disorders
Neck or facial pain
Previous application of a dry needling technique
MTrP therapy in head or neck within the previous 3 months
Fibromyalgia
An insurmountable fear of needles as a reason of refusing the treatment
History of surgery in the head or neck area
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Josué Fernández Carnero, PhD
Organizational Affiliation
Universidad 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
Citations:
PubMed Identifier
25836591
Citation
Martin-Pintado-Zugasti A, Pecos-Martin D, Rodriguez-Fernandez AL, Alguacil-Diego IM, Portillo-Aceituno A, Gallego-Izquierdo T, Fernandez-Carnero J. Ischemic Compression After Dry Needling of a Latent Myofascial Trigger Point Reduces Postneedling Soreness Intensity and Duration. PM R. 2015 Oct;7(10):1026-1034. doi: 10.1016/j.pmrj.2015.03.021. Epub 2015 Mar 31.
Results Reference
derived
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Ischemic Compression on Post-needling Soreness
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