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Ischemic Compression on Post-needling Soreness

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ClinicalTrials.gov Identifier: NCT02169700
Recruitment Status : Completed
First Posted : June 23, 2014
Last Update Posted : September 29, 2015
Sponsor:
Information provided by (Responsible Party):
Josue Fernandez Carnero, Universidad Rey Juan Carlos

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

Condition or disease Intervention/treatment Phase
Neck Pain Procedure: Ischemic compression. Dry Needling Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 90 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Ischemic Compression After Dry Needling of a Latent Myofascial Trigger Point Reduces Post-needling Soreness Intensity and Duration.
Study Start Date : December 2013
Actual Primary Completion Date : February 2014
Actual Study Completion Date : May 2014

Arm Intervention/treatment
Experimental: Ischemic compression. Dry Needling
Ischemic compression was carried out after dry needling.
Procedure: Ischemic compression. 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.
Procedure: Ischemic compression. 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



Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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.


Other Outcome Measures:
  1. Psychological variables [ Time Frame: Before dry needling intervention ]
    Catastrophizing, kinesiophobia, pain anxiety and fear of pain



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 39 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02169700


Locations
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Spain
Universidad Rey Juan Carlos
Alcorcón, Madrid, Spain, 28922
Sponsors and Collaborators
Universidad Rey Juan Carlos
Investigators
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Principal Investigator: Josué Fernández Carnero, PhD Universidad Rey Juan Carlos
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Josue Fernandez Carnero, PhD, Universidad Rey Juan Carlos
ClinicalTrials.gov Identifier: NCT02169700    
Other Study ID Numbers: 10/2014
First Posted: June 23, 2014    Key Record Dates
Last Update Posted: September 29, 2015
Last Verified: September 2015
Keywords provided by Josue Fernandez Carnero, Universidad Rey Juan Carlos:
Ischemic compression
Myofascial trigger points
Post-needling soreness
Additional relevant MeSH terms:
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Neck Pain
Pain
Neurologic Manifestations