- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02826590
The Effects of Spinal Mobilizations on Symptoms, Neck 3D Movement, Neck Muscle Electromyography and Sympathetic Nervous System Activity in People With Neck Pain
October 2, 2017 updated by: King's College London
This study investigates the effects of spinal mobilizations on symptoms, 3D movement of the neck, neck muscle electromyography and sympathetic nervous system activity in people with neck pain.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
40
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Gipuzkoa
-
Donostia, Gipuzkoa, Spain
- Atlas Fisioterapia
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Intermittent neck pain
- That worsens or improves with certain neck movements or positions
- Has not been caused by a blow, fall or accident
Exclusion Criteria:
- Cervicobrachialgia
- Has been treated with or is awaiting neck surgery
- Diagnosed with a particular inflammatory disease or spinal condition
- Where treatment with cervical mobilizations is contraindicated
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Neck passive mobilizations
|
Passive mobilizations performed to the neck of the participant by a Physiotherapist
|
|
Placebo Comparator: Manual contact
|
Manual contact applied to the neck of the participant by a Physiotherapist
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in muscle activity assessed by neck muscle electromyography
Time Frame: Baseline and 2 minutes after intervention
|
Baseline and 2 minutes after intervention
|
|
|
Change in 3D neck movement assessed with a 10 camera Vicon system
Time Frame: Baseline and 2 minutes after intervention
|
Baseline and 2 minutes after intervention
|
|
|
Change in sympathetic nervous system activity assessed by measuring right hand finger temperature
Time Frame: Baseline for 2 minutes immediately before intervention, during intervention (15 minutes) and for 2 minutes immediately after intervention
|
Measurement unit: degrees celsius
|
Baseline for 2 minutes immediately before intervention, during intervention (15 minutes) and for 2 minutes immediately after intervention
|
|
Change in sympathetic nervous system activity assessed by measuring right hand finger galvanic response
Time Frame: Baseline for 2 minutes immediately before intervention, during intervention (15 minutes) and for 2 minutes immediately after intervention
|
Measurement unit: microsiemens
|
Baseline for 2 minutes immediately before intervention, during intervention (15 minutes) and for 2 minutes immediately after intervention
|
|
Global rating of change scale
Time Frame: Baseline and 10 minutes after intervention
|
Baseline and 10 minutes after intervention
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
June 1, 2016
Primary Completion (Actual)
July 31, 2017
Study Completion (Actual)
July 31, 2017
Study Registration Dates
First Submitted
June 14, 2016
First Submitted That Met QC Criteria
July 7, 2016
First Posted (Estimate)
July 11, 2016
Study Record Updates
Last Update Posted (Actual)
October 3, 2017
Last Update Submitted That Met QC Criteria
October 2, 2017
Last Verified
September 1, 2017
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2016/066
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.