Immediate Effect of a Single Cervical Spinal Manipulation

NCT04059692 | Completed

• 1 other identifier: ID0025
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Neck Pain

Keywords

neck pain; manual therapy; movement

Outcome Measures

Primary Outcomes (2)

• Range of motion

  Angular excursion of the cervical motion.

  1 day

• Harmonicity

  Is the absolute value of the correlation coefficient between: Ӫ and Ө. Thus Harmonicity quantifies the fit between the actual movement and the simple harmonic motion.

  1 day

Secondary Outcomes (2)

• Disability of the neck

  1 day

• Impression of Change

  1 day

Study Arms (2)

Cervical manipulation intervention

EXPERIMENTAL

To perform the evaluation and detect the cervical vertebral level with mobility restriction, with the patient in supine position, a cervical examination is carried out to determine the mobility restriction, both in flexo-extension, as in inclination and rotation. To check the level of restriction, the post-anterior sliding test is performed. The manipulation is performed following the criteria of thrust manipulations. A maximum of 3 manipulations are applied in total per subject, one for each level (high level C1-C2, medium level C3-C6, and low level C7), if necessary.

Other: Placebo intervention

Placebo intervention

PLACEBO COMPARATOR

This group will receive 15 minutes of sham techniques in a supine position over the stretcher. First, a series of short-time and no pressure contact with physiotherapist´s hands is performed in several points of head and shoulders for 10 minutes. Subsequently, light touch is applied on standardized anatomic areas, for 2 minutes each time.

Other: Cervical manipulation intervention

Interventions

Cervical manipulation intervention OTHER

Cervical manipulative technique

Placebo intervention

Placebo intervention OTHER

Sham intervention

Cervical manipulation intervention

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Valencia: lead

Study Sites (1)

Gemma Victoria Espí-López

Valencia, 46010, Spain

Location

Related Publications (3)

• Rey-Eiriz G, Alburquerque-Sendin F, Barrera-Mellado I, Martin-Vallejo FJ, Fernandez-de-las-Penas C. Validity of the posterior-anterior middle cervical spine gliding test for the examination of intervertebral joint hypomobility in mechanical neck pain. J Manipulative Physiol Ther. 2010 May;33(4):279-85. doi: 10.1016/j.jmpt.2010.03.005.

  PMID: 20534314 RESULT

• Puentedura EJ, Landers MR, Cleland JA, Mintken PE, Huijbregts P, Fernandez-de-Las-Penas C. Thoracic spine thrust manipulation versus cervical spine thrust manipulation in patients with acute neck pain: a randomized clinical trial. J Orthop Sports Phys Ther. 2011 Apr;41(4):208-20. doi: 10.2519/jospt.2011.3640. Epub 2011 Feb 18.

  PMID: 21335931 RESULT

• Serra-Ano P, Venegas W, Page A, Ingles de la Torre M, Aguilar-Rodriguez M, Espi-Lopez G. Immediate Effects of a Single Session of Cervical Spine Manipulation on Cervical Movement Patterns in People With Nonspecific Neck Pain: A Randomized Controlled Trial. J Manipulative Physiol Ther. 2023 Jan;46(1):17-26. doi: 10.1016/j.jmpt.2023.05.006. Epub 2023 Jul 7.

  PMID: 37422751 DERIVED

MeSH Terms

Conditions

Neck Pain

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Gemma V Espí-López

  Faculty of Physiotherapy. University of Valencia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: The subjects do not know the group to which they belong. The evaluator does not know the treatment applied.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: The study design is experimental

Study Record Dates

• First Submitted: August 14, 2019
• First Posted: August 16, 2019
• Study Start: September 1, 2019
• Primary Completion: December 15, 2019
• Study Completion: December 30, 2019
• Last Updated: April 20, 2020

Record last verified: 2020-04

Locations

ES (1)