NCT02558686

Brief Summary

Application of trigger point dry needling can induce post-dry needling soreness. This is not a negative experience, but sometimes some patients want to reduce it as much as possible. Manual therapies and exercise strategies targeting to decrease post-dry needling soreness need to be investigated.

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 Oct 2015

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

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 21, 2015

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 24, 2015

Completed
7 days until next milestone

Study Start

First participant enrolled

October 1, 2015

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2016

Completed
Last Updated

January 21, 2016

Status Verified

January 1, 2016

Enrollment Period

3 months

First QC Date

September 21, 2015

Last Update Submit

January 20, 2016

Conditions

Keywords

trigger pointsdisabilitypost-dry needling sorenesseccentric exercise

Outcome Measures

Primary Outcomes (1)

  • Changes in post-dry needling pain intensity before and after the intervention

    A Numerical Pain Rate Scale (NPRS, 0-10) will be used to record post-dry needling soreness and pain

    Baseline, 24 hours after, 48 hours after and 72 hours after treatment

Secondary Outcomes (3)

  • Changes in spontaneous shoulder pain before and after the intervention

    Baseline and 72 hours after treatment

  • Changes in disability before and after the intervention

    Baseline and 72 hours after treatment

  • Changes in functionality before and after the intervention

    Baseline and 72 hours after treatment

Study Arms (3)

Eccentric Exercise

EXPERIMENTAL

Individuals will perform 3 sets of 10 repetitions of eccentric exercise of the infraspinatus muscle after the application of trigger point dry needling

Other: Eccentric Exercise

Detuned Ultrasound

SHAM COMPARATOR

Individuals will received 10 minutes of detuned ultrasound on the infraspinatus muscle after the application of trigger point dry needling

Other: Detuned Ultrasound

Placebo

PLACEBO COMPARATOR

Individuals will not perform any action after the application of trigger point dry needling

Other: Placebo

Interventions

Individuals will perform 3 sets of 10 repetitions of eccentric exercise of the infraspinatus muscle after the application of trigger point dry needling

Eccentric Exercise

Individuals will received 10 minutes of detuned ultrasound on the infraspinatus muscle after the application of trigger point dry needling

Detuned Ultrasound
PlaceboOTHER

Individuals will not perform any action after the application of trigger point dry needling

Placebo

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Unilateral non-traumatic shoulder pain
  • Shoulder pain from at least 6 months
  • Shoulder pain of more than 3 points on a NPRS
  • Presence of active trigger point in the infraspinatus muscle

You may not qualify if:

  • bilateral shoulder pain
  • younger than 18 or older than 65 years
  • shoulder injury
  • upper extremity surgery
  • fibromyalgia syndrome
  • neck or shoulder surgery
  • cervical radiculopathy
  • whiplash
  • any type of intervention for the neck-shoulder the previous year

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Universidad Rey Juan Carlos

Alcorcón, Madrid, 28922, Spain

Location

MeSH Terms

Conditions

Shoulder Pain

Condition Hierarchy (Ancestors)

ArthralgiaJoint DiseasesMusculoskeletal DiseasesPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Cesar Fernández-de-las-Peñas, PhD

    Universidad Rey Juan Carlos

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

September 21, 2015

First Posted

September 24, 2015

Study Start

October 1, 2015

Primary Completion

January 1, 2016

Study Completion

January 1, 2016

Last Updated

January 21, 2016

Record last verified: 2016-01

Locations