NCT02169700

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
90

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Dec 2013

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2013

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2014

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2014

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

June 17, 2014

Completed
6 days until next milestone

First Posted

Study publicly available on registry

June 23, 2014

Completed
Last Updated

September 29, 2015

Status Verified

September 1, 2015

Enrollment Period

2 months

First QC Date

June 17, 2014

Last Update Submit

September 28, 2015

Conditions

Keywords

Ischemic compressionMyofascial trigger pointsPost-needling soreness

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (1)

  • Cervical Range of Motion (CROM)

    CROM measurements were taken before needling, after the intervention, and at 24 and 72 hours post-treatment.

Other Outcomes (1)

  • Psychological variables

    Before dry needling intervention

Study Arms (3)

Ischemic compression. Dry Needling

EXPERIMENTAL

Ischemic compression was carried out after dry needling.

Procedure: Ischemic compression. Dry Needling

Sham Ischemic compression. Dry Needling

SHAM COMPARATOR

Sham Ischemic compression was carried out after dry needling.

Procedure: Ischemic compression. Dry Needling

Control group

NO INTERVENTION

No intervention. Control group

Interventions

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).

Ischemic compression. Dry NeedlingSham Ischemic compression. Dry Needling

Eligibility Criteria

Age18 Years - 39 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Subjects were included if they presented at least one latent MTrP in the upper trapezius muscle

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Universidad Rey Juan Carlos

Alcorcón, Madrid, 28922, Spain

Location

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Neck Pain

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Josué Fernández Carnero, PhD

    Universidad Rey Juan Carlos

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD

Study Record Dates

First Submitted

June 17, 2014

First Posted

June 23, 2014

Study Start

December 1, 2013

Primary Completion

February 1, 2014

Study Completion

May 1, 2014

Last Updated

September 29, 2015

Record last verified: 2015-09

Locations