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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02172079
Other study ID # USAL201000048540
Secondary ID
Status Completed
Phase N/A
First received June 22, 2014
Last updated June 23, 2014
Start date January 2013
Est. completion date January 2014

Study information

Verified date June 2014
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

Controversy exists regarding the effectiveness of manual therapy techniques for the management of impingement syndrome. However, no adequately powered clinical trials have examined the effects of mobilization-with-movement. The purpose of the current study was to perform a randomized controlled trial comparing the effects of real MWM to a group receiving a sham intervention on shoulder pain at different moments and active shoulder range of motion in an adequately powered sample of patients with shoulder impingement syndrome.


Recruitment information / eligibility

Status Completed
Enrollment 42
Est. completion date January 2014
Est. primary completion date January 2014
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 65 Years
Eligibility Inclusion Criteria:

- history of shoulder pain of > 3months duration

- pain localized at the proximal anterolateral shoulder region

- medical diagnosis of shoulder impingement syndrome

- at least 2 positive impingement tests including Neer, Hawking, or Jobe test

Exclusion Criteria:

- diagnosis of fibromyalgia

- pregnancy

- a history of traumatic onset of shoulder pain

- other histories of shoulder injury

- ligamentous laxity based on a positive Sulcus test and apprehension test

- numbness or tingling in the upper extremity

- previous shoulder or cervical spine surgery

- corticosteroid injection on the shoulder within 1 year of the study

- physical therapy 6 months prior to the study

Study Design

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


Related Conditions & MeSH terms


Intervention

Other:
Real mobilization-with-movement (MWM)

Sham mobilization-with-movement (MWM)


Locations

Country Name City State
Spain Francisco Alburquerque Sendín Salamanca

Sponsors (2)

Lead Sponsor Collaborator
César Fernández-de-las-Peñas University of Salamanca

Country where clinical trial is conducted

Spain, 

Outcome

Type Measure Description Time frame Safety issue
Primary Changes in the intensity of shoulder pain before and after the treatment Participants were asked to rate the intensity of their pain using an 11-point numerical pain rating scale (NPRS; 0: no pain; 10: maximum pain) for 3 scores of perceived pain: 1, the intensity of shoulder pain experienced in the last 24h; 2, the intensity of shoulder pain at night; 3, the intensity of shoulder pain during shoulder flexion. Baseline and one week after intervention Yes
Secondary Changes in shoulder range of motion before and after the treatment A universal goniometer was used to assess the participant's shoulder range of motion in the following motions:
Pain-free and maximum (painful) range of motion in shoulder flexion
Pain-free range of motion in shoulder extension
Pain-free range of motion in shoulder abduction
Pain-free range of motion in shoulder external rotation
Pain-free range of motion in shoulder medial (internal) rotation
Baseline and one week after the intervention Yes
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