Neck Pain Clinical Trial
— SMCervicalOfficial title:
Immediate Effect of a Single Cervical Spinal Manipulation on Cervical Movement Pattern
Verified date | April 2020 |
Source | University of Valencia |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Objective: The aim of the present study is to analyze the immediate effect of a single
cervical spinal manipulation on cervical movement pattern. Further, To perform the sample
size calculation, the investigators took into consideration that the investigators pretend to
achieve a medium effect size (d=0.5) of the differences with two groups (EG and CG) and two
aimed to explore the impact on pain, disability and patient's improvement-perceived
sensation, comparing with a placebo.
Methods: The study design is experimental and purposive sampling was used to select the study
participants. The grouping allocation was randomized. The people volunteer to participate in
the study, are assigned to the experimental group (EG) that will receive a single
manipulation, to the control group (CG) that will receive a single placebo treatment.
The participants will be assessed twice, one before the treatment and the other, after the
end. Head movement is recorded by means of a video-photogrammetry system from the coordinates
of a set of eight reflective markers located on a helmet. The movements will be record at 200
fps.
In each evaluation, the perceived pain and the neck disability index are also recorded. And
the impression of change is evaluated only in the second evaluation.
Outcomes. Pain, Disability of the neck, Impression of Change, Range of motion (RoM), Maximum
angular velocity (MAV), Maximum angular acceleration (MAA) and Harmonicity (HARM).
Intervention: The intervention, in both groups, it includes only one session that lasted 15
minutes approximately: a) Cervical manipulation intervention and b)Placebo intervention.
Status | Completed |
Enrollment | 50 |
Est. completion date | December 30, 2019 |
Est. primary completion date | December 15, 2019 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 55 Years |
Eligibility |
Inclusion Criteria: - Perceived pain scored 3 or above, in a visual analogue scale - Neck functional status revealing a mild disability - Minimun duration of the symptoms being one month. Exclusion Criteria: - inflammatory rheumatic disease or an inner ear disorder. - the use of antidepressant opioid or sedative drugs. - current vertigo or dizziness. - visual loss. - neurological disorder, - trunk or shoulder surgery within the past year. |
Country | Name | City | State |
---|---|---|---|
Spain | Gemma Victoria Espí-López | Valencia |
Lead Sponsor | Collaborator |
---|---|
University of Valencia |
Spain,
Puentedura EJ, Landers MR, Cleland JA, Mintken PE, Huijbregts P, Fernández-de-Las-Peñas C. Thoracic spine thrust manipulation versus cervical spine thrust manipulation in patients with acute neck pain: a randomized clinical trial. J Orthop Sports Phys The — View Citation
Rey-Eiriz G, Alburquerque-Sendín F, Barrera-Mellado I, Martín-Vallejo FJ, Fernández-de-las-Peñas C. Validity of the posterior-anterior middle cervical spine gliding test for the examination of intervertebral joint hypomobility in mechanical neck pain. J M — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Range of motion | Angular excursion of the cervical motion. | 1 day | |
Primary | Harmonicity | Is the absolute value of the correlation coefficient between: ? and ?. Thus Harmonicity quantifies the fit between the actual movement and the simple harmonic motion. | 1 day | |
Secondary | Disability of the neck | To determine how neck pain affects a patient's daily life. Scoring is reported on a 0-50 scale, 0 being the best possible score. | 1 day | |
Secondary | Impression of Change | The self-reported measure 'Patient Global Impression of Change' that reflects a patient's belief about the efficacy of treatment. This is a one-item questionnaire in which patients rank their change following an intervention on a scale from 1 to 7 (1, very much improved; 2, much improved; 3, minimally improved; 4, no change; 5, minimally worse; 6, much worse; 7, very much worse). | 1 day |
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