NCT02676141

Brief Summary

This study evaluates if the German Version of the NDI is sensitive to change over time.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jan 2016

Typical duration for all trials

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

January 1, 2016

Completed
28 days until next milestone

First Submitted

Initial submission to the registry

January 29, 2016

Completed
10 days until next milestone

First Posted

Study publicly available on registry

February 8, 2016

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2018

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 10, 2019

Completed
Last Updated

February 21, 2019

Status Verified

February 1, 2019

Enrollment Period

2.9 years

First QC Date

January 29, 2016

Last Update Submit

February 20, 2019

Conditions

Neck Pain Chronic

Outcome Measures

Primary Outcomes (1)

  • Change of the German Version of the Neck Disability Index (NDI-G)

    Questionnaire to evaluate the subjective restriction of the participants

    Change from Baseline to seven weeks

Secondary Outcomes (1)

  • Patient's Global Impression of Change Scale (PGIC)

    Seven weeks after the baseline measurement

Interventions

Manual TherapyOTHER

The treatment the patients receive is not specifically set up for the study. Participants will already be seeing a practitioner before the participants are included in the study.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients with chronic neck pain.

You may qualify if:

  • Chronic neck pain
  • over 18 years old
  • informed consent
  • able to speak, write and read German.

You may not qualify if:

  • Any problems that may exclude Manual Therapy treatment of the cervical spine e.g fractures

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Balgrist University Hospital

Zurich, 8008, Switzerland

Location

Related Publications (1)

  • Langenfeld A, Gassner AP, Wirth B, Muhlemann MB, Nyiro L, Bastiaenen C, Swanenburg J. Responsiveness of the German version of the Neck Disability Index in chronic neck pain patients: a prospective cohort study with a seven-week follow-up. Arch Physiother. 2022 Oct 17;12(1):23. doi: 10.1186/s40945-022-00149-y.

    PMID: 36244985DERIVED

MeSH Terms

Interventions

Musculoskeletal Manipulations

Intervention Hierarchy (Ancestors)

Complementary TherapiesTherapeuticsPhysical Therapy ModalitiesRehabilitation

Study Officials

  • Jaap Swanenburg, PhD

    Balgrist University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Head of PT Research

Study Record Dates

First Submitted

January 29, 2016

First Posted

February 8, 2016

Study Start

January 1, 2016

Primary Completion

December 1, 2018

Study Completion

February 10, 2019

Last Updated

February 21, 2019

Record last verified: 2019-02

Data Sharing

IPD Sharing
Will not share

Locations

CH(1)