NCT05212870

Brief Summary

There are a limited number of studies examining the difficulty of reaching treatment related to the pandemic process and the general effects of the process in patients with chronic low back and neck pain. However, no study has been found that compares the effects of individuals actively carrying and not carrying the Covid-19 virus. For this reason, the aim of the study is to examine the effects of the pandemic process on the cognitive level, pain catastrophization, physical activity level and quality of life in individuals with chronic low back and neck pain.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
84

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Nov 2021

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

First Submitted

Initial submission to the registry

October 8, 2021

Completed
2 months until next milestone

Study Start

First participant enrolled

November 22, 2021

Completed
2 months until next milestone

First Posted

Study publicly available on registry

January 28, 2022

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 15, 2022

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 15, 2022

Completed
Last Updated

November 21, 2023

Status Verified

August 1, 2022

Enrollment Period

11 months

First QC Date

October 8, 2021

Last Update Submit

November 20, 2023

Conditions

Outcome Measures

Primary Outcomes (1)

  • Pain Severity Assessment- Visual Analog Sacle

    VAS indicates the level of pain that the person is currently experiencing with a vertical line on a plane. The pain felt by the person is marked as "0: I do not feel any pain", "10: I feel very severe pain". Scoring is based on measuring the vertical marking of the participant for pain marked on the plane with a ruler. The validity and reliability study of the scale was done by Price et al. made by

    through study completion, an average of 1 year

Secondary Outcomes (4)

  • Assessment of Cognitive Level: Montreal Cognitive Assessment Scale (MOCA)

    5 minutes, through study completion, an average of 1 year

  • Evaluation of Pain Catastrophization Level: Pain Catastrophization Scale

    5 minutes, through study completion, an average of 1 year

  • Assessment of Physical Activity Level: International Physical Activity Questionnaire (UFAA)-Short Form

    5 minutes, through study completion, an average of 1 year

  • Quality of Life Assessment: SF-36

    5 minutes, through study completion, an average of 1 year

Study Arms (2)

Low back and neck pain group with experience of Covid-19

Other: assessment of cognitive level, pain catastrophe, physical activity level and quality of life

Low back and neck pain group without experience of Covid-19

Other: assessment of cognitive level, pain catastrophe, physical activity level and quality of life

Interventions

assessment of cognitive level, pain catastrophe, physical activity level and quality of life

Low back and neck pain group with experience of Covid-19Low back and neck pain group without experience of Covid-19

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Patients with chronic low back and neck pain

You may qualify if:

  • Those between the ages of 18-60,
  • Having low back or neck pain lasting longer than 3 months,
  • Having a history of Covid-19 (At least 6 weeks-post acute),
  • Individuals with chronic low back and neck pain without a history of Covid-19 will be included.

You may not qualify if:

  • Those with an active diagnosis of Covid-19
  • Having a rheumatological disease,
  • Broken etc. severe deformity that may lead to nerve injury,
  • Having a history of spinal surgery,
  • Having neurological disease in addition to spinal pathology,
  • Having problems such as cancer, diabetes, dementia, organic brain dysfunction,
  • Illiterate individuals will not be included.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hacettepe University

Ankara, 06200, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Neck PainLow Back PainCOVID-19

Interventions

Quality of Life

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsBack PainPneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Health StatusDemographyEpidemiologic MeasurementsPublic HealthEnvironment and Public Health

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor, Physiotherapist

Study Record Dates

First Submitted

October 8, 2021

First Posted

January 28, 2022

Study Start

November 22, 2021

Primary Completion

October 15, 2022

Study Completion

December 15, 2022

Last Updated

November 21, 2023

Record last verified: 2022-08

Locations