NCT04540614

Brief Summary

The purpose of this study is to determine which treatment is more effective for chronic neck pain associated with Upper Cross Syndrome.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started May 2020

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

May 21, 2020

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

May 22, 2020

Completed
4 months until next milestone

First Posted

Study publicly available on registry

September 7, 2020

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 3, 2021

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

June 4, 2021

Completed
Last Updated

September 14, 2021

Status Verified

February 1, 2021

Enrollment Period

12 months

First QC Date

May 22, 2020

Last Update Submit

September 11, 2021

Conditions

Keywords

chronic neck painupper crossed syndromerounded shoulder posture

Outcome Measures

Primary Outcomes (9)

  • Craniovertebral angle

    tha angle formed by the horizontal line through C7 and the line formed between C7 and the tragus of the ear

    0 week

  • Craniovertebral angle

    tha angle formed by the horizontal line through C7 and the line formed between C7 and the tragus of the ear

    4 week

  • Craniovertebral angle

    tha angle formed by the horizontal line through C7 and the line formed between C7 and the tragus of the ear

    8 week

  • Shoulder angle

    the angle formed by the horizontal line through C7 and the line formed between C7 and the acromion

    0 week

  • Shoulder angle

    the angle formed by the horizontal line through C7 and the line formed between C7 and the acromion

    4 week

  • Shoulder angle

    the angle formed by the horizontal line through C7 and the line formed between C7 and the acromion

    8 week

  • VAS

    The Visual Analogue Scale 0 no pain 10 worst pain

    0 week

  • VAS

    The Visual Analogue Scale 0 no pain 10 worst pain

    4 week

  • VAS

    The Visual Analogue Scale 0 no pain 10 worst pain

    8 week

Secondary Outcomes (6)

  • Muscle Strenght

    0 week

  • Muscle Strenght

    4 week

  • Muscle Strenght

    8 week

  • Muscle Activity

    0 week

  • Muscle Activity

    4 week

  • +1 more secondary outcomes

Study Arms (2)

Intervention

EXPERIMENTAL

70 participants receiving active comparator treatment plus experimental

Other: Strengthening exercises programme

Control

ACTIVE COMPARATOR

70 participants receiving active comparator treatment

Other: Strengthening exercises programme

Interventions

Strengthening exercises for Deep Cervical Flexors, Shoulder external rotators, scapular adductors and thoracic erector muscles

ControlIntervention

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Chronic neck pain for at least 3 months
  • º or less in the craniovertebral angle
  • º or less in the shoulder angle

You may not qualify if:

  • herniated disk, radiculopathy, diseases of the spine

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fisiosesto

Madrid, 28009, Spain

Location

MeSH Terms

Conditions

Neck PainOculocerebral hypopigmentation syndrome type Preus

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Carlos García

    Fisiosesto

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 22, 2020

First Posted

September 7, 2020

Study Start

May 21, 2020

Primary Completion

May 3, 2021

Study Completion

June 4, 2021

Last Updated

September 14, 2021

Record last verified: 2021-02

Data Sharing

IPD Sharing
Will not share

Locations