Neck Pain ChronicNCT02676141
Responsiveness of the German Version of the Neck Disability Index (NDI-G)
An observational study of Neck Pain Chronic, run by Balgrist University Hospital at 1 site in Switzerland.
Trial summary
This study evaluates if the German Version of the NDI is sensitive to change over time. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Neck Pain Chronic
- What is being tested?
- Manual Therapy
- How many people
- 50 participants
- Where
- 1 siteSwitzerland
- Study dates
- Jan 2016to 10 Feb 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with chronic neck pain.
Who may be able to join
- Chronic neck pain
- over 18 years old
- informed consent
- able to speak, write and read German.
Who cannot join
- Any problems that may exclude Manual Therapy treatment of the cervical spine e.g fractures
Trial locations and contacts
1 site in 1 country.
About this study
This study evaluates if the German Version of the NDI is sensitive to change over time.
Read the detailed description
Chronic neck pain patients will be asked to participate in the study.
The participants are asked to fill out the NDI at the beginning of the study and after seven weeks. Additionally the participants will fill out the PGIC.
- Conditions
- Neck Pain Chronic
- Being tested
- Manual Therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of the German Version of the Neck Disability Index (NDI-G)
Questionnaire to evaluate the subjective restriction of the participants
Measured: Change from Baseline to seven weeks
Secondary outcomes (1)
Patient's Global Impression of Change Scale (PGIC)
Questionnaire measuring the change of the patient.
Measured: Seven weeks after the baseline measurement
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2016 (estimated)
- Study startJan 2016
- Primary completion1 Dec 2018
- Study completion10 Feb 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Neck Pain ChronicStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Balgrist University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Maastricht University
- Responsible party
- Principal investigator, Swanenburg, Balgrist University Hospital
- Investigators
- Jaap Swanenburg, PhD, Principal investigator, Balgrist University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02676141
- Sponsor's protocol ID
- 2015-00068
- Other IDs
- 2015
- Status last verified
- Feb 2019
- First submitted
- 29 Jan 2016
- Last updated
- 21 Feb 2019
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
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.
PubMed 36244985
Study at a glance
From the registry record, last updated by the sponsor on 21 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Responsiveness of the German Version of the Neck Disability Index (NDI-G)
- ClinicalTrials.gov ID
- NCT02676141
- Acronym / sponsor ID
- 2015-00068
- Conditions
- Neck Pain Chronic
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Balgrist University HospitalUniversity, hospital or other
- Collaborators
- Maastricht University
- Study start
- Jan 2016 (actual)
- Primary completion
- 1 Dec 2018 (actual)
- Study completion
- 10 Feb 2019 (actual)
- First posted
- 8 Feb 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study evaluates if the German Version of the NDI is sensitive to change over time.
Detailed description
Chronic neck pain patients will be asked to participate in the study.
The participants are asked to fill out the NDI at the beginning of the study and after seven weeks. Additionally the participants will fill out the PGIC.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with chronic neck pain.
Key inclusion criteria (4 listed)
- Chronic neck pain
- over 18 years old
- informed consent
- able to speak, write and read German.
Key exclusion criteria (1 listed)
- Any problems that may exclude Manual Therapy treatment of the cervical spine e.g fractures
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Manual TherapyThe 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. | Other | – |
Primary outcome
Change of the German Version of the Neck Disability Index (NDI-G)
Time frame: Change from Baseline to seven weeks
Questionnaire to evaluate the subjective restriction of the participants
1 secondary outcome
Patient's Global Impression of Change Scale (PGIC)
Time frame: Seven weeks after the baseline measurement
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Feb 2019.
- Derived from this study: PubMed 36244985Langenfeld 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.
- Individual participant dataSharing planned: No
Related trials for Neck Pain Chronic
Recruiting
Longitudinal Stripping Massage vs. Percussion Device for Neck Pain: Ultrasound Study.
Chronic Neck Pain
RecruitingPhase 2
Phenotype-based Model for Managing Chronic Post-treatment Pain Among Head and Neck Cancer Survivors: a Pilot Study
Chronic Postsurgical Pain, Chronic Post Cancer Surgery Pain
Active, not recruiting
Multimodal Manual Therapy vs. Maitland Mobilization for Chronic Non-Specific Neck Pain
Chronic Neck Pain
Not yet recruiting
Comparison of the Effectiveness of Motor Imagery Exercises and Suboccipital Myofascial Release Techniques in Nonspecific Chronic Neck Pain
Non-specific Chronic Neck Pain
Not yet recruiting
Digital Use, 24-Hour Movement Behaviors, and Myofascial Release in University Students With Neck Pain
Forward Head Posture, Chronic Nonspecific Neck Pain
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jaap Swanenburg, PhD principal investigator
Balgrist University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Neck Pain Chronic, run by Balgrist University Hospital at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of the German Version of the Neck Disability Index (NDI-G) (time frame: Change from Baseline to seven weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02676141, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Feb 2019.