Mobility Clinical Trial
NCT number | NCT02833779 |
Other study ID # | SSD |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | July 5, 2016 |
Last updated | July 14, 2016 |
Start date | April 2010 |
Verified date | July 2016 |
Source | Basque Health Service |
Contact | n/a |
Is FDA regulated | No |
Health authority | Spain: Basuqe Health Service |
Study type | Interventional |
Pathology of the rotator cuff and subacromial bursa is considered to be the principal cause
of pain and symptoms arising from the shoulder. Physiotherapy specialists often disagree
about which type of exercise is most appropriate. Manual Physiotherapy combined with guided
exercise is a commonly applied clinical treatment, but no proof of its effectiveness has
been shown. Clinical trials comparing results of treating subacromial syndrome of the
shoulder with guided self-treatment and conventional physiotherapy yielded a slightly higher
improvement, basically because patients suffered from chronic tendinitis and the treatment
period lasted only two weeks. That is the reason why the investigators propose a long-term
follow-up study and a more complete assessment of effectiveness of the exercise prescribed
to improved this pathology.
Objectives:
- Assessment of effectiveness of two different types of treatment of subacromial syndrome
of the shoulder.
- Comparison of effectiveness of both treatments in order to select that one yielding
better results as the one to be applied as a routine practice.
Patients will be assigned one of the following treatments:
- Group 1: patients will be taught exercises in groups of six people, on a daily basis
for twelve sessions.
- Group 2: patients will be taught the same exercise as Group 1, individually, and will
receive manual therapy consisting of muscular and joint re-centering.
A modified version of the Constant scale will be used to assess mobility and pain shoulder.
Status | Completed |
Enrollment | 89 |
Est. completion date | |
Est. primary completion date | October 2013 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | N/A and older |
Eligibility |
Inclusion Criteria: - History of shoulder pain defined as at least 2 positive results in subacromial impingement tests. - Self-perceived pain reported by the patient under clinical examination of the shoulder. - A minimum of 90ยบ mobility in flexion. Exclusion Criteria: - Luxation, a history of surgery, or evidence the current shoulder pain or other symptoms under cervical examination or other shoulder bone disease, except for acromioclavicular joint arthrosis. - Patients were receiving other physiotherapy or rehabilitation treatments. - Patients had been treated for SIS (subacromial impingement syndrome) with injection of anti-inflammatory or analgesic drugs in the last month. |
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Basque Health Service |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | The assessment of pain with a visual analogue scale. | Six Months | Yes | |
Primary | The mobility (joint range of motion) with a goniometer. | Six Months | Yes |
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