- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02558686
Exercise and Post-dry Needling Soreness
January 20, 2016 updated by: César Fernández-de-las-Peñas, Universidad Rey Juan Carlos
Effects of Eccentric Exercise, Sham or Placebo on Post-Needling Soreness by Dry Needling on Active Trigger Points
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
90
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Madrid
-
Alcorcon, Madrid, Spain, 28922
- Universidad Rey Juan Carlos
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Eccentric Exercise
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 perform 3 sets of 10 repetitions of eccentric exercise of the infraspinatus muscle after the application of trigger point dry needling
|
Sham Comparator: Detuned Ultrasound
Individuals will received 10 minutes of detuned ultrasound on 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
|
Placebo Comparator: Placebo
Individuals will not perform any action after the application of trigger point dry needling
|
Individuals will not perform any action after the application of trigger point dry needling
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Changes in post-dry needling pain intensity before and after the intervention
Time Frame: Baseline, 24 hours after, 48 hours after and 72 hours after treatment
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Changes in spontaneous shoulder pain before and after the intervention
Time Frame: Baseline and 72 hours after treatment
|
A Numerical Pain Rate Scale (NPRS, 0-10) will be used to assess spontaneous shoulder pain
|
Baseline and 72 hours after treatment
|
Changes in disability before and after the intervention
Time Frame: Baseline and 72 hours after treatment
|
The Disabilities of the Arm, Shoulder and Hand (DASH) questionnaire will be used to assess disability induced by shoulder pain.
|
Baseline and 72 hours after treatment
|
Changes in functionality before and after the intervention
Time Frame: Baseline and 72 hours after treatment
|
The Shoulder Pain and Disability Index (SPADI) questionnaire will be used to assess function of the uppr extremity related to shoulder pain
|
Baseline and 72 hours after treatment
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: César Fernández-de-las-Peñas, PhD, Universidad Rey Juan Carlos
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
October 1, 2015
Primary Completion (Actual)
January 1, 2016
Study Completion (Actual)
January 1, 2016
Study Registration Dates
First Submitted
September 21, 2015
First Submitted That Met QC Criteria
September 22, 2015
First Posted (Estimate)
September 24, 2015
Study Record Updates
Last Update Posted (Estimate)
January 21, 2016
Last Update Submitted That Met QC Criteria
January 20, 2016
Last Verified
January 1, 2016
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- URJC 2015-12
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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