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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02338908
Other study ID # URJC 31/2140
Secondary ID
Status Completed
Phase N/A
First received January 11, 2015
Last updated March 14, 2016
Start date January 2015
Est. completion date March 2016

Study information

Verified date March 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

Shoulder pain is highly prevalent in the society. The role of muscle tissues in this pathology has received increasing interest. Some studies have proposed the role of myofascial trigger points in this population. The purpose of the current clinical trial is to compare the effects of physiotherapy treatment consisting of an eccentric exercise protocol versus the same physical therapy program plus the addition of trigger point dry needling (TrP-DN) on pain and function in patients suffering from unspecific shoulder pain.


Recruitment information / eligibility

Status Completed
Enrollment 50
Est. completion date March 2016
Est. primary completion date March 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 3 months

- Shoulder pain of more than 4 points on a NPRS

Exclusion Criteria:

- bilateral shoulder symptoms

- younger than 18 or older than 65 years

- history of shoulder fractures or dislocation

- cervical radiculopathy

- previous interventions with steroid injections

- fibromyalgia syndrome

- previous history of shoulder or neck surgery

- any type of intervention for the neck-shoulder area during 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:
exercise program
Patients will be asked to perform an eccentric loading exercise program for the shoulder musculature, particularly the supraspinatus and infraspinatus muscles, to be performed on an individual basis twice every day. The therapeutic protocol will be applied for 5 weeks.
TrP-DN
In addition, within the second and fourth sessions, they will receive TrP-DN over active TrPs in the shoulder muscles

Locations

Country Name City State
Spain César Fernández-de-las-Peñas Alcorcon Madrid

Sponsors (2)

Lead Sponsor Collaborator
Universidad Rey Juan Carlos Hospital General Universitario Gregorio Marañon

Country where clinical trial is conducted

Spain, 

Outcome

Type Measure Description Time frame Safety issue
Primary Changes in disability between baseline and follow-up periods The Disabilities of the Arm, Shoulder and Hand (DASH) will be used to determine the disability induced by shoulder pain Baseline, one week after the last intervention and 3, 6 and 12 months after the intervention Yes
Secondary Changes in shoulder pain between baseline and follow-up periods A 10-point Numerical Pain Rating Scale (NPRS; 0: no pain, 10: maximum pain) will be used to assess the patients' current level of shoulder pain and the worst level of pain experienced in the preceding week in the shoulder area. Baseline, one week after the last intervention and 3, 6 and 12 months after the intervention Yes
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