NCT04059692: SMCervical

Immediate Effect of a Single Cervical Spinal Manipulation

Completed NA Last updated 20 April 2020

What this trial tests

NA trial testing Cervical manipulation intervention in Neck Pain in 50 participants. Completed in 30 December 2019.

Timeline

1 September 2019

Primary endpoint
15 December 2019

30 December 2019

Quick facts

Lead sponsor	University of Valencia
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	treatment
Enrollment	50
Start date	1 September 2019
Primary completion	15 December 2019
Estimated completion	30 December 2019
Sites	1 location across Spain

Drugs / interventions tested

• Cervical manipulation intervention
• Placebo intervention

Conditions studied

• Neck Pain — all drugs for Neck Pain →

Sponsor

University of Valencia

Who can join

Adults 18 to 55, any sex, with Neck Pain. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Application of functional regression in biomechanical assessment of neck disability: Selection of clinically relevant variables.
   Aragón-Basanta E, Ayala G, Serra-Añó P, Page Á. · · 2026 · PMID 41712652 · DOI 10.1371/journal.pone.0340428