NCT04627636

Brief Summary

Background: shoulder-hand syndrome is considered a significant reason for the reduction of upper limb functions after stroke. Purpose: To investigate the influence of Myofascial Trigger Points (MTrPs) release and shockwave therapy on pain and functions of the upper extremity in stroke patients with diabetic neuropathy.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at P25-P50 for not_applicable stroke

Timeline
Completed

Started Oct 2019

Shorter than P25 for not_applicable stroke

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

October 1, 2019

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2019

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 30, 2020

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

November 8, 2020

Completed
5 days until next milestone

First Posted

Study publicly available on registry

November 13, 2020

Completed
Last Updated

November 13, 2020

Status Verified

November 1, 2020

Enrollment Period

3 months

First QC Date

November 8, 2020

Last Update Submit

November 8, 2020

Conditions

Keywords

StrokeDiabetic NeuropathyShoulder hand syndrome

Outcome Measures

Primary Outcomes (3)

  • - Complex Regional Pain Syndrome (CRPS) severity score

    It is a quantitative index and valid instrument to score and monitor the severity of CRPS and SHS.

    4 weeks

  • - Figure-of-Eight Method of Measuring Hand Size for hand swelling

    The figure-of-eight technique utilizing tape measurement for hand size

    4 weeks

  • - Visual analogue scale for pain (VAS-P) for pain assessment

    The VAS for pain is a valid and reliable assessment of pain intensity, as a straight horizontal line of fixed length (10 cm) considered the simplest VAS.

    4 weeks

Study Arms (2)

study group

EXPERIMENTAL

which treated with MTrPs release combined with shockwave therapy and conventional program

Other: Myofascial trigger points pressure (MTrP) releaseOther: Shockwave therapy applicationOther: conventional therapy

control group

EXPERIMENTAL

which treated with conventional physical therapy program

Other: conventional therapy

Interventions

Myofascial trigger points pressure (MTrP) release technique, the initial step was to recognize and find the trigger points (TP) , and The second step after TP palpation was the MTrP release technique, as follow, by one or both hands, the thumbs or four fingers of the therapist applied a maintained pressure, pushing internal toward the middle

study group

The JEST-2000 (JOEUN Medical, Dae-Jeon, South Korea) was used for the ESWT. The application of pressure pulses of ESWT was centered around the flexor muscles with hypertonia

study group

Passive ROM exercises performed by the therapist and Bobath Neurodevelopmental Approach (prolonged stretch): The Intervention methods for Bobath involved the activation of key points of control for the reduction of tone

control groupstudy group

Eligibility Criteria

Age45 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • stroke from 4:8 months
  • age ranging from 45:60 years
  • All the patients were identified with SHS as diagnosed by the Diagnostic criteria for SHS post-stroke 18 and were in stage I of syndrome evolution

You may not qualify if:

  • any other causes of shoulder pain in the hemiplegic side of the body
  • a cognitive impairment
  • structured joint deformity in the painful shoulder or hand
  • other musculoskeletal disorders of UE.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Lama S Mahmoud

Al Jīzah, Select State, Egypt

Location

MeSH Terms

Conditions

StrokeDiabetic NeuropathiesReflex Sympathetic Dystrophy

Interventions

Drainage

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular DiseasesPeripheral Nervous System DiseasesNeuromuscular DiseasesDiabetes ComplicationsDiabetes MellitusEndocrine System DiseasesComplex Regional Pain SyndromesAutonomic Nervous System Diseases

Intervention Hierarchy (Ancestors)

TherapeuticsSurgical Procedures, Operative

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: study group: which treated with MTrPs release combined with shockwave therapy and conventional program, while control group: treated with a conventional selected exercise program
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer of physical therapy, Department of Neuromuscular disorders and its surgery, faculty of physical therapy, october 6 univerisity

Study Record Dates

First Submitted

November 8, 2020

First Posted

November 13, 2020

Study Start

October 1, 2019

Primary Completion

December 30, 2019

Study Completion

January 30, 2020

Last Updated

November 13, 2020

Record last verified: 2020-11

Locations