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Efficacy of Neuromuscular Bandage Technique Against Jones Technique After the Supraespinatus Muscle Tendon Suture

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02812381
Recruitment Status : Completed
First Posted : June 24, 2016
Last Update Posted : August 31, 2016
Sponsor:
Information provided by (Responsible Party):
Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal

Tracking Information
First Submitted Date  ICMJE March 29, 2016
First Posted Date  ICMJE June 24, 2016
Last Update Posted Date August 31, 2016
Study Start Date  ICMJE July 2016
Actual Primary Completion Date July 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 21, 2016)
Change in the DASH between sixth and eighth week , in patients with supraespinatus muscle tendon suture. [ Time Frame: From first day of the sixth week after surgery to twelve days after of the first medition. ]
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,
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 21, 2016)
Change in the VAS between sixth and eighth week , in patients with supraespinatus muscle tendon suture. [ Time Frame: From first day of the sixth week after surgery to twelve days after of the first medition. ]
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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: June 21, 2016)
Change in the ROM between sixth and eighth week , in patients with supraespinatus muscle tendon suture. [ Time Frame: From first day of the sixth week after surgery to twelve days after of the first medition. ]
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
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE Efficacy of Neuromuscular Bandage Technique Against Jones Technique After the Supraespinatus Muscle Tendon Suture
Official Title  ICMJE Efficacy of Neuromuscular Bandage Technique Against Jones Technique After the Supraespinatus Muscle Tendon Suture: a Prospective Randomized Clinical Trial
Brief 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.

Detailed 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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Condition  ICMJE Pain
Intervention  ICMJE
  • Procedure: KT
    to aplicate neuromuscular bandage technique(KT)
  • Procedure: SCS
    To aplicate strain-counterstrain above trigger point
Study Arms  ICMJE
  • Active Comparator: SCS (Jones tecnique)
    18 patients were treatment with straincounterstrain
    Intervention: Procedure: SCS
  • Sham Comparator: KT Kinesiotaping
    18 patients were treatment with neuromuscular bandage
    Intervention: Procedure: KT
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: June 21, 2016)
36
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE August 2016
Actual Primary Completion Date July 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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 .
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02812381
Other Study ID Numbers  ICMJE BC-2013
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Plan Description: The investigators would like to share in the magazine "Manual Therapy"
Responsible Party Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal
Study Sponsor  ICMJE Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: ANA ROMOJARO, THERAPIST UNIVERSIDAD DE ALCALA
PRS Account Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal
Verification Date March 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP