NCT02735967

Brief Summary

The aim of this study will be to evaluate the effects of the use of manual therapy and diadynamic in muscle trigger points in the upper trapezius muscle in individuals diagnosed with shoulder impingement syndrome, unilateral shoulder as functional capacity, pain intensity and pain threshold the pressure.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2016

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2016

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2016

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

April 2, 2016

Completed
11 days until next milestone

First Posted

Study publicly available on registry

April 13, 2016

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2016

Completed
Last Updated

July 20, 2016

Status Verified

July 1, 2016

Enrollment Period

1 month

First QC Date

April 2, 2016

Last Update Submit

July 18, 2016

Conditions

Outcome Measures

Primary Outcomes (1)

  • shoulder disability

    questionnaire of quality of life developed to assess pain and associated with specific inability to shoulder disorders.

    Change from Baseline in the Shoulder Pain and Disability Index at 4 weeks

Secondary Outcomes (2)

  • intensity of pain

    Change from Baseline in The Numerical rating pain scale at 4 weeks

  • level of pressure pain

    change from Baseline in ThePressure Pain Threshold at 4 weeks

Study Arms (3)

Group manual therapy + diadynamic

EXPERIMENTAL

Initially, the positional release techniques will be performed while maintaining this position for 90 seconds procedure is repeated 3 times. Then, the therapist performs the ischemic compression technique on the myofascial trigger point, the compression is maintained for 90 seconds by 3 replications. Through an electrotherapy device were applied diadynamic in that myofascial trigger point previously marked. 4 minutes from the fixed two-phase mode will be applied (DF), 4 minutes long periods (LP) and 4 minutes short periods (CP), the first and second intensely in the sensitive line and the third motor threshold, both supportable according to each patient.

Other: manual therapyDevice: diadynamic current

Group manual therapy

ACTIVE COMPARATOR

Initially, the positional release techniques will be performed while maintaining this position for 90 seconds procedure is repeated 3 times. Then, the therapist performs the ischemic compression technique on the myofascial trigger point, the compression is maintained for 90 seconds by 3 replications.

Other: manual therapy

Group diadynamic

ACTIVE COMPARATOR

An electrotherapy device were applied diadynamic in that myofascial trigger point previously marked. 4 minutes from the fixed two-phase mode will be applied (DF),4 minutes long periods (LP) and 4 minutes short periods (CP), the first and second intensely in the sensitive line and the third motor threshold, both supportable according to each patient.

Device: diadynamic current

Interventions

the positional release techniques will be performed while maintaining this position for 90 seconds procedure is repeated 3 times. Then, the therapist performs the ischemic compression technique on the myofascial trigger point, the compression is maintained for 90 seconds by 3 replications.

Group manual therapyGroup manual therapy + diadynamic

Through an electrotherapy device were applied diadynamic in that myofascial trigger point previously marked. 4 minutes from the fixed two-phase mode will be applied (DF), 4 minutes long periods (LP) and 4 minute short periods (CP), the first and second intensely in the sensitive line and the third motor threshold, both supportable according to each patient.

Group diadynamicGroup manual therapy + diadynamic

Eligibility Criteria

Age18 Years - 59 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • history of anterior lateral and unilateral shoulder pain
  • with more than 3 months duration
  • intensity of at least 4 points on the Numerical Rating Pain Scale
  • positivity in at least 2 of 3 orthopedic tests for impingement syndrome: Neer, Hawkins or Jobe
  • Associated with these characteristics volunteers should submit myofascial trigger points unilateral and active, centrally located in the trapezius muscle descending fibers associated with painful shoulder

You may not qualify if:

  • diagnosis of bilateral impingement syndrome shoulder
  • fibromyalgia
  • muscle injury
  • history of trauma on the shoulder
  • ruptured tendons
  • ligamentous laxity
  • symptoms of numbness and / or tingling in the upper limbs
  • corticosteroid injection use shoulder
  • making use of anti-inflammatory
  • they performed surgery or physical therapy treatment in the last 6 months in the affected shoulder.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cid André Fidelis de Paula Gomes

São Paulo, São Paulo, 01415000, Brazil

Location

Related Links

MeSH Terms

Conditions

Shoulder Impingement Syndrome

Interventions

Musculoskeletal Manipulations

Condition Hierarchy (Ancestors)

Joint DiseasesMusculoskeletal DiseasesShoulder InjuriesWounds and Injuries

Intervention Hierarchy (Ancestors)

Complementary TherapiesTherapeuticsPhysical Therapy ModalitiesRehabilitation

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Phd

Study Record Dates

First Submitted

April 2, 2016

First Posted

April 13, 2016

Study Start

March 1, 2016

Primary Completion

April 1, 2016

Study Completion

June 1, 2016

Last Updated

July 20, 2016

Record last verified: 2016-07

Data Sharing

IPD Sharing
Will share

Locations