- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02169700
Ischemic Compression on Post-needling Soreness
September 28, 2015 updated by: Josue Fernandez Carnero, Universidad Rey Juan Carlos
Ischemic Compression After Dry Needling of a Latent Myofascial Trigger Point Reduces Post-needling Soreness Intensity and Duration.
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
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
90
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
-
-
Madrid
-
Alcorcón, Madrid, Spain, 28922
- Universidad Rey Juan Carlos
-
-
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
18 years to 39 years (Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
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
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: Ischemic compression. Dry Needling
Ischemic compression was carried out after dry needling.
|
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).
|
|
Sham Comparator: Sham Ischemic compression. Dry Needling
Sham Ischemic compression was carried out after dry needling.
|
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).
|
|
No Intervention: Control group
No intervention. Control group
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Visual analog scale (VAS)
Time Frame: From Baseline in pain intensity at during needling and at 72 hours
|
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
|
From Baseline in pain intensity at during needling and at 72 hours
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Cervical Range of Motion (CROM)
Time Frame: CROM measurements were taken before needling, after the intervention, and at 24 and 72 hours post-treatment.
|
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.
|
CROM measurements were taken before needling, after the intervention, and at 24 and 72 hours post-treatment.
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Psychological variables
Time Frame: Before dry needling intervention
|
Catastrophizing, kinesiophobia, pain anxiety and fear of pain
|
Before dry needling intervention
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the 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
December 1, 2013
Primary Completion (Actual)
February 1, 2014
Study Completion (Actual)
May 1, 2014
Study Registration Dates
First Submitted
June 17, 2014
First Submitted That Met QC Criteria
June 18, 2014
First Posted (Estimate)
June 23, 2014
Study Record Updates
Last Update Posted (Estimate)
September 29, 2015
Last Update Submitted That Met QC Criteria
September 28, 2015
Last Verified
September 1, 2015
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 10/2014
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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