NCT04695665

Brief Summary

The goal of this study is to determine the applicability of McGill ́s method to patients with diagnoses, collectively referred to as Vertebrogenic Algic syndrome, by comparing the measured data of proband with different diagnosis locations Vertebrogenic Algic syndrome in the Czech Republic.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2020

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 15, 2020

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 15, 2020

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 30, 2020

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

January 3, 2021

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 5, 2021

Completed
Last Updated

January 6, 2021

Status Verified

January 1, 2021

Enrollment Period

Same day

First QC Date

January 3, 2021

Last Update Submit

January 5, 2021

Conditions

Vertebrogenic Pain Syndrome

Keywords

pain syndromeefficiencystabilizationMcGill method

Outcome Measures

Primary Outcomes (2)

  • Pain relief

    change in pain perception measured on a visual analog scale - from 0 (without pain) to 10 (maximum pain)

    4 weeks, 2 times a week exercising for 60 minutes

  • multi-segmental efficiency

    comparison of the effectiveness of therapy of the three evaluated groups against each other by Short Form (SF36) Healthy survey questionnaire, the scale from 100 to 900, lower value indicate a higher effect

    4 weeks

Study Arms (3)

Cervical pain

ACTIVE COMPARATOR

Only patients with positive Cervical pain syndrome.

Other: Cervical pain

Thoracic pain

ACTIVE COMPARATOR

Only patients with positive Thoracic pain syndrome.

Other: Thoracic pain

Lumbar pain

ACTIVE COMPARATOR

Only patients with positive Lumbar pain syndrome.

Other: Lumbar pain

Interventions

Cervical painOTHER

Exercise program for cervical spine according to McGill's approach.

Cervical pain
Thoracic painOTHER

Exercise program for thoracic spine according to McGill's approach.

Thoracic pain
Lumbar painOTHER

Exercise program for lumbar spine according to McGill's approach.

Lumbar pain

Eligibility Criteria

Age20 Years - 55 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • cervical pain syndrome
  • thoracic pain syndrome
  • lumbar pain syndrome

You may not qualify if:

  • red falgs

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Charles University, Faculty of physical education and sport

Prague, Czechia

Location

MeSH Terms

Conditions

Back PainSomatoform Disorders

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsMental Disorders

Study Officials

  • Jitka Malá, Ph.D.

    Charles University, Faculty of physical education and sport

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
assistant professor

Study Record Dates

First Submitted

January 3, 2021

First Posted

January 5, 2021

Study Start

March 15, 2020

Primary Completion

March 15, 2020

Study Completion

May 30, 2020

Last Updated

January 6, 2021

Record last verified: 2021-01

Data Sharing

IPD Sharing
Will not share

Locations

CZ(1)