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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02812381
Other study ID # BC-2013
Secondary ID
Status Completed
Phase N/A
First received March 29, 2016
Last updated August 30, 2016
Start date July 2016
Est. completion date August 2016

Study information

Verified date March 2016
Source Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal
Contact n/a
Is FDA regulated No
Health authority Spain: Comité Ético de Investigación Clínica
Study type Interventional

Clinical Trial Summary

The suture of the supraspinatus tendon is a common surgery that requires physical therapy for back pain and functional impairment to such surgery. Kinesiotaping technique (KT) is being used to treat myofascial trigger points that appear after surgery and for the treatment of physiotherapy in the supraspinatus muscle and deltoid.

To evaluate the effectiveness of KT technique over the technique of Jones (Straincounterstrain or SCS) in patients undergoing suture the tendon of the supraspinatus muscle.


Description:

Objective: To evaluate the effectiveness of the KT technique against Jones (Strain-Counterstrain or SCS) technique in patients with the suture of the tendon of the supraspinatus muscle.

Design: Test clinically controlled, randomized, masking of intervention by double placebo and blind to the subject of the essay and the Studio analyst.

METHOD: Patients with supraspinatus tendon suture are randomly divided into two groups: a group treated with KT (n = 18) and other treated with SCS (n = 18). The treatment was applied the 1st, 4th and 8th day of physical therapy session. All patients were evaluated the 1st and the 12th day of the session with the visual analog scale of pain (VAS), with the scale of Disabilities of the arm, shoulder and hand (DASH) to assess the functionality and active direction-finding (ROM) to assess travel articulate.


Recruitment information / eligibility

Status Completed
Enrollment 36
Est. completion date August 2016
Est. primary completion date July 2016
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Among patients attending the 1st and 5th week after Intervention.

- Patients with age above 18 years.

- Patients of both sexes.

- Patients with a detectable with algometer trigger point in the supraspinatus and / or deltoid .

Exclusion Criteria:

- Patient with Impaired Communication .

- Patients with signs of infection .

- Patients with previous surgery on the shoulder or shoulder capsulitis submit .

- Patient scammers cervical herniated discs or brachial neuropathy .

- Patients with tumor pathology.

- Patients with fibromyalgia,

- Pregnant patients.

- Patients with central pain .

- Patients conducted simultaneously treatments .

Study Design

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


Related Conditions & MeSH terms


Intervention

Procedure:
KT
to aplicate neuromuscular bandage technique(KT)
SCS
To aplicate strain-counterstrain above trigger point

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal

Outcome

Type Measure Description Time frame Safety issue
Other Change in the ROM between sixth and eighth week , in patients with supraespinatus muscle tendon suture. All participants (36) has been mesured:
First day of the sixth week after surgery with ROM
Four days later of the first medition , it repeated the technique asigned but it hasn´t been mesured.
Eight days later or the first meditión, it repeated the technique asigned but it hasn´t been mesured.
Twelve days later of the first medition , it repeated the mesured with ROM
From first day of the sixth week after surgery to twelve days after of the first medition. Yes
Primary Change in the DASH between sixth and eighth week , in patients with supraespinatus muscle tendon suture. All participants (36) has been mesured:
First day of the sixth week after surgery with DASH,
Four days later of the first medition , it repeated the technique asigned but it hasn´t been mesured.
Eight days later or the first meditión, it repeated the technique asigned but it hasn´t been mesured.
Twelve days later of the first medition , it repeated the mesured with DASH,
From first day of the sixth week after surgery to twelve days after of the first medition. Yes
Secondary Change in the VAS between sixth and eighth week , in patients with supraespinatus muscle tendon suture. All participants (36) has been mesured:
First day of the sixth week after surgery with VAS scale.
Four days later of the first medition , it repeated the technique asigned but it hasn´t been mesured.
Eight days later or the first meditión, it repeated the technique asigned but it hasn´t been mesured.
Twelve days later of the first medition , it repeated the mesured with VAS
From first day of the sixth week after surgery to twelve days after of the first medition. Yes
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