Thoracic Paraspinal Soft Tissue Mobilizations in Treatmen... | NCT03111225

Studies
Thoracic Paraspinal Soft Tissue Mobilizations in Treatment of Patients With Upper Limb Complex Regional Pain Syndrome

NCT03111225

Sponsor

Reuth Rehabilitation Hospital

Status

Completed

Last Update Posted

Sep 6, 2019Actual

Enrollment

49Actual

Phase

Not Applicable

Conditions

Complex Regional Pain Syndromes

Interventions

massage

Countries

Israel

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2019

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 6, 2016Actual

Primary Completion Date

Sep 17, 2017Actual

Completion Date

Sep 17, 2017Actual

First Submitted Date

Apr 7, 2017

First Submission Date that Met QC Criteria

Apr 7, 2017

First Posted Date

Apr 12, 2017Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 5, 2019

Last Update Posted Date

Sep 6, 2019Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

This study examines the prevalence of trigger points in muscles in the thorax in upper limb Complex Regional Pain Syndrome (CRPS) patients, compared to healthy subjects. In addition, we will examine if adding treatment to muscles in the thoracic area (to the regular physical therapy treatment) will alleviate some of the sensitivity in the upper limb in CRPS patients.

Detailed Description

This study examines the prevalence of trigger points in muscles in the thorax in upper limb Complex Regional Pain Syndrome (CRPS) patients, compared to healthy subjects. The muscles that will be examined are: Subclavius, Pectoralis minor, Rhomboids, Infraspinatus and Serratus superior posterior.

In addition, we will examine if adding treatment to muscles in the thoracic area (to the regular physical therapy treatment) will alleviate some of the sensitivity in the upper limb in CRPS patients.This will be examined in an A-B-A design: at first the patients will be examined. Then they will recieve conventional physiotherapy treatment for a month. After a month, they will be examined again, and then they will recieve soft tissue massage to the thoracic area for 15 minutes in addition to the conventional physiotherapy treatment. After a month of the combined treatment, the patients will be examined a third and final time.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

49Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
CRPS patients	Experimental	CRPS patients that will be examined for trigger points in the thoracic muscles. 10 out of the 23 will also be included in the intervention stage and will recieve a month of conventional physiotherapy, and a month of conventional physiotherapy with addition of massage to the thoracic area.	Diagnostic Test: massage
healthy controls	No Intervention	healthy controls that will be examined for trigger points in the thoracic muscles (and will be compared to the CRPS patients)

Interventions

Name	Type	Description	Arm Group Labels	Other Names
massage	Diagnostic Test	a 15 minutes thoracic massage will be added to the regular physical therapy treatment	CRPS patients

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Disabilities of the Arm, Shoulder and Hand (DASH) questionnaire	Questionnaire that examines upper limb function	10 minutes

Secondary Outcomes

Measure	Description	Time Frame
Goniometer	shoulder flexion range of motion	1 minute
CRPS severity score (CSS)	form filled by an MD after an interview and examination of a patient

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusions Criteria for "cases" in stage 1 and all subjects of stage 2:

Age between 18-70
CRPS diagnosed by board certified specialist in rehabilitation or pain medicine
Constant chronic pain for ≥six months preceding the trial;
Spontaneous pain in a day of first evaluation (numeric pain rating scale (NPRS) ≥4/10)
Stimulated pain is not attributable to other causes, such as peripheral inflammation.

Inclusions Criteria for "controls" in stage 1:

Age between 18-70
Do not suffer from any medical issues or chronic pain

Exclusion criteria for all subjects in stages 1 and 2:

Tumors
Participation in another interventional clinical trial.
History of major psychiatric or neurological illness (like stroke).
Rheumatoid arthritis or other major rheumatologic disorders.
Fibromyalgia or any other systemic illness.
Pregnancy.

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

70 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Jean-Jeaques Vatine, Prof	Reuth Rehabilitation Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Reuth Rehabilitation Hospital		Tel Aviv			Israel

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D020918	Complex Regional Pain Syndromes

Ancestor Terms

ID	Term
D001342	Autonomic Nervous System Diseases
D009422	Nervous System Diseases
D010523	Peripheral Nervous System Diseases
D009468	Neuromuscular Diseases

Browse Leaves

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Browse Branches

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