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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02558686
Other study ID # URJC 2015-12
Secondary ID
Status Completed
Phase N/A
First received September 21, 2015
Last updated January 20, 2016
Start date October 2015
Est. completion date January 2016

Study information

Verified date January 2016
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

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.


Recruitment information / eligibility

Status Completed
Enrollment 90
Est. completion date January 2016
Est. primary completion date January 2016
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 65 Years
Eligibility 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 Design

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


Related Conditions & MeSH terms


Intervention

Other:
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
Detuned Ultrasound
Individuals will received 10 minutes of detuned ultrasound on the infraspinatus muscle after the application of trigger point dry needling
Placebo
Individuals will not perform any action after the application of trigger point dry needling

Locations

Country Name City State
Spain Universidad Rey Juan Carlos Alcorcon 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
Primary 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 Yes
Secondary 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 Baseline and 72 hours after treatment Yes
Secondary 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. Baseline and 72 hours after treatment Yes
Secondary 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 Baseline and 72 hours after treatment Yes
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