search
Back to results

Exercise and Post-dry Needling Soreness

Primary Purpose

Shoulder Pain

Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Eccentric Exercise
Detuned Ultrasound
Placebo
Sponsored by
Universidad Rey Juan Carlos
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Shoulder Pain focused on measuring trigger points, disability, post-dry needling soreness, eccentric exercise

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Sites / Locations

  • Universidad Rey Juan Carlos

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Sham Comparator

Placebo Comparator

Arm Label

Eccentric Exercise

Detuned Ultrasound

Placebo

Arm Description

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

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

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Changes in spontaneous shoulder pain before and after the intervention
A Numerical Pain Rate Scale (NPRS, 0-10) will be used to assess spontaneous shoulder pain
Changes in disability before and after the intervention
The Disabilities of the Arm, Shoulder and Hand (DASH) questionnaire will be used to assess disability induced by shoulder pain.
Changes in functionality before and after the intervention
The Shoulder Pain and Disability Index (SPADI) questionnaire will be used to assess function of the uppr extremity related to shoulder pain

Full Information

First Posted
September 21, 2015
Last Updated
January 20, 2016
Sponsor
Universidad Rey Juan Carlos
search

1. Study Identification

Unique Protocol Identification Number
NCT02558686
Brief Title
Exercise and Post-dry Needling Soreness
Official Title
Effects of Eccentric Exercise, Sham or Placebo on Post-Needling Soreness by Dry Needling on Active Trigger Points
Study Type
Interventional

2. Study Status

Record Verification Date
January 2016
Overall Recruitment Status
Completed
Study Start Date
October 2015 (undefined)
Primary Completion Date
January 2016 (Actual)
Study Completion Date
January 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universidad Rey Juan Carlos

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Shoulder Pain
Keywords
trigger points, disability, post-dry needling soreness, eccentric exercise

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
90 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Eccentric Exercise
Arm Type
Experimental
Arm Description
Individuals will perform 3 sets of 10 repetitions of eccentric exercise of the infraspinatus muscle after the application of trigger point dry needling
Arm Title
Detuned Ultrasound
Arm Type
Sham Comparator
Arm Description
Individuals will received 10 minutes of detuned ultrasound on the infraspinatus muscle after the application of trigger point dry needling
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Individuals will not perform any action after the application of trigger point dry needling
Intervention Type
Other
Intervention Name(s)
Eccentric Exercise
Intervention Description
Individuals will perform 3 sets of 10 repetitions of eccentric exercise of the infraspinatus muscle after the application of trigger point dry needling
Intervention Type
Other
Intervention Name(s)
Detuned Ultrasound
Intervention Description
Individuals will received 10 minutes of detuned ultrasound on the infraspinatus muscle after the application of trigger point dry needling
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
Individuals will not perform any action after the application of trigger point dry needling
Primary Outcome Measure Information:
Title
Changes in post-dry needling pain intensity before and after the intervention
Description
A Numerical Pain Rate Scale (NPRS, 0-10) will be used to record post-dry needling soreness and pain
Time Frame
Baseline, 24 hours after, 48 hours after and 72 hours after treatment
Secondary Outcome Measure Information:
Title
Changes in spontaneous shoulder pain before and after the intervention
Description
A Numerical Pain Rate Scale (NPRS, 0-10) will be used to assess spontaneous shoulder pain
Time Frame
Baseline and 72 hours after treatment
Title
Changes in disability before and after the intervention
Description
The Disabilities of the Arm, Shoulder and Hand (DASH) questionnaire will be used to assess disability induced by shoulder pain.
Time Frame
Baseline and 72 hours after treatment
Title
Changes in functionality before and after the intervention
Description
The Shoulder Pain and Disability Index (SPADI) questionnaire will be used to assess function of the uppr extremity related to shoulder pain
Time Frame
Baseline and 72 hours after treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Cesar Fernández-de-las-Peñas, PhD
Organizational Affiliation
Universidad Rey Juan Carlos
Official's Role
Principal Investigator
Facility Information:
Facility Name
Universidad Rey Juan Carlos
City
Alcorcon
State/Province
Madrid
ZIP/Postal Code
28922
Country
Spain

12. IPD Sharing Statement

Learn more about this trial

Exercise and Post-dry Needling Soreness

We'll reach out to this number within 24 hrs