Ischemic Compression on Post-needling Soreness

Neck Pain Clinical Trial

Official title:

Ischemic Compression After Dry Needling of a Latent Myofascial Trigger Point Reduces Post-needling Soreness Intensity and Duration.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02169700
• Other study ID #: 10/2014
• Status: Completed
• Phase: N/A
• First received: June 17, 2014
• Last updated: September 28, 2015
• Start date: December 2013
• Est. completion date: May 2014

Study information

• Verified date: September 2015
• Source: Universidad Rey Juan Carlos
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Comité Ético de Investigación Clínica
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 90
• Est. completion date: May 2014
• Est. primary completion date: February 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 39 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Neck Pain

Intervention

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).

Locations

Country	Name	City	State
Spain	Universidad Rey Juan Carlos	Alcorcón	Madrid

Sponsors (1)

Lead Sponsor	Collaborator
Universidad Rey Juan Carlos

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Psychological variables	Catastrophizing, kinesiophobia, pain anxiety and fear of pain	Before dry needling intervention	Yes
Primary	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	From Baseline in pain intensity at during needling and at 72 hours	Yes
Secondary	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.	CROM measurements were taken before needling, after the intervention, and at 24 and 72 hours post-treatment.	Yes