Disorder of Shoulder Clinical Trial
Official title:
Mulligan Concept Mobilisation With Movement for Shoulder Dysfunction in Older Adults- A Pilot Randomised Clinical Trial
NCT number | NCT02217540 |
Other study ID # | Lirio-001-UAH |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | January 2012 |
Est. completion date | March 2013 |
Verified date | August 2014 |
Source | University of Alcala |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Objective: To pilot the methods proposed for conducting a full randomised clinical trial to evaluate the effect of Mulligan concept mobilization with movement on shoulder functionality in older adults with shoulder dysfunction. Design: Pilot randomised, single-blinded clinical trial. Setting: Three nursing homes, Toledo, Spain. Participants: 44 older adults with shoulder dysfunction. Interventions: Participants will be randomly allocated into control group (n=22) treated with a physiotherapy standard protocol proposed by the Spanish Rheumatology Society; and experimental group (n=22) treated with the same physical therapy standard protocol and Mulligan concept mobilisation with movement. Both interventions will take place three times a week for 2 consecutive weeks. Main outcomes: Primary outcome is shoulder functionality measured with Shoulder Disability Questionnaire (S-SDQ) Spanish version, and secondary outcomes are active glenohumeral range of motion and pain intensity. Data will be collected at baseline, after each group intervention, and 1 and 3 months after finishing interventions.
Status | Completed |
Enrollment | 44 |
Est. completion date | March 2013 |
Est. primary completion date | January 2013 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 65 Years to 100 Years |
Eligibility | Inclusion Criteria: - to be over 65 years old - diagnosed with shoulder dysfunction (shoulder pain and/or limited AROM in the last 4 weeks) by their physician - dependent on at least 1 ADL - with a limited glenohumeral AROM of 25% - 75% - resident in the nursing homes where the study took place. Exclusion Criteria: - subjects with moderate or severe cognitive impairment - specific rheumatic diseases, osteoarthritis, neoplasms - shoulder joint instability - circulatory disorders (hemophilia, clotting problems) - skin problems aggravated by contact with the skin - traumas in the past month - bilateral shoulder disorders |
Country | Name | City | State |
---|---|---|---|
Spain | Mensajeros de la Paz | Villarrubia de Santiago | Toledo |
Lead Sponsor | Collaborator |
---|---|
University of Alcala |
Spain,
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* Note: There are 18 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Spanish-Shoulder Disability Questionnaire | SDQ is mostly used in research and clinical practice in several countries and its score can range from minimum [0=no functional limitation] to maximum [100= affirmative to all items], so higher scores mean higher disability | baseline and 3 times after interventions | |
Secondary | Range of motion and pain | glenohumeral range of motion (flexion, abduction, and external and internal rotations) measured with a universal goniometer (E Nonius-F®) and pain intensity measured with 11-point Verbal Numeric Rating Scale (VNS) for its good reliability and validity and usefulness in older adults | baseline and 3 times after intervention |
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