NCT02776865

Brief Summary

This study was conducted to compare the efficacy of hydrodilatation with hyaluronic acid under ultrasonographic guidance plus physical therapy (PT) with that of PT alone for treating adhesive capsulitis

Trial Health

55
Monitor

Trial Health Score

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

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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

October 1, 2015

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

May 16, 2016

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 18, 2016

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2016

Completed
Last Updated

May 18, 2016

Status Verified

March 1, 2016

Enrollment Period

1 year

First QC Date

May 16, 2016

Last Update Submit

May 17, 2016

Conditions

Keywords

suprascapular nerve block

Outcome Measures

Primary Outcomes (1)

  • change in constant shoulder score

    the total constant score ranges from 0 to 100 points, with higher scores indicative of better function. The score is divided into four sections: pain, activity of daily living, ROM and strength

    at 4, 12 wk

Secondary Outcomes (3)

  • change in pain intensity

    at 4, 12 wk

  • change in Shoulder Pain And disability index

    at 6, 12 wk

  • change in glenohumeral joint range of motion

    at 4, 12 wk

Study Arms (2)

physical therapy and suprascapular nerve block

EXPERIMENTAL

patient received ultrasound-guided suprascapular nerve block as well as physical therapy.

Drug: suprascapular nerve blockOther: physical therapy

physical therapy only

ACTIVE COMPARATOR

patient received physical therapy only.

Other: physical therapy

Interventions

4ml 2% xylocaine

Also known as: 4cc 2% xylocaine
physical therapy and suprascapular nerve block

patient received traditional physical therapy, including therapeutic exercise and stretch exercise

Also known as: rehabilitation
physical therapy and suprascapular nerve blockphysical therapy only

Eligibility Criteria

Age40 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • chronic shoulder pain with duration of complaints more than 3 months
  • diagnosis of frozen shoulder or rotator cuff disorder

You may not qualify if:

  • other conditions involving the shoulder ( rheumatoid arthritis, Hill-Sachs lesions,osteoporosis, or malignancies in the shoulder region);
  • neurologic deficits affecting shoulder function in normal daily activities;
  • shoulder pain caused by cervical radiculopathy
  • a history of drug allergy to xylocaine
  • pregnancy or lactation;
  • received injection into the affected shoulder during the preceding 3 months

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Taipei veteran general hospital

Taipei, Taiwan

RECRUITING

MeSH Terms

Interventions

LidocainePhysical Therapy ModalitiesRehabilitation

Intervention Hierarchy (Ancestors)

AcetanilidesAnilidesAmidesOrganic ChemicalsAniline CompoundsAminesTherapeuticsAftercareContinuity of Patient CarePatient CareHealth ServicesHealth Care Facilities Workforce and Services

Central Study Contacts

Jia chi Wang, MD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 16, 2016

First Posted

May 18, 2016

Study Start

October 1, 2015

Primary Completion

October 1, 2016

Last Updated

May 18, 2016

Record last verified: 2016-03

Locations