NCT04351971

Brief Summary

Background: Skeletal muscle-type pain is one of the main reasons for consultations in health centers. In Chile, it is estimated that the prevalence reaches 33% in men and 50% in women, increasing considerably with age, with cervical pain being one of the main conditions, estimating that 80% of the population has experienced cervicalgia at some time. lifetime. The main symptom is neck pain and restriction of movement, mainly affecting the mobility of the upper cervical region. Although there are studies evaluating the effectiveness of manual techniques, there are currently no studies evaluating the effects on cervical muscle activity and pressure threshold. Therefore, the objective of the present investigation is to evaluate the immediate effects of a manual therapy technique on the threshold pressure of muscular trigger points and on the muscular activity of the upper cervical region in patients with chronic pain and restriction of cervical mobility. higher. Methods: Clinical trial, randomized, prospective, double-blind study (patient and evaluator). The participants (21 subjects) were divided into 2 groups. The control group will receive a C0-C0 placebo mobilization technique and the experimental group will receive the C0-C1 mobilization technique. In both groups the technique will be carried out by mobilization cycles of 15 seconds and 3 seconds of rest for a total period of 5 min. Pressure threshold, activation of the superficial deep musculature and articular range of the upper cervical region will be measured.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
22

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Apr 2020

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 10, 2020

Completed
Same day until next milestone

Study Start

First participant enrolled

April 10, 2020

Completed
7 days until next milestone

First Posted

Study publicly available on registry

April 17, 2020

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 20, 2020

Completed
12 days until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2020

Completed
Last Updated

April 17, 2020

Status Verified

April 1, 2020

Enrollment Period

1 month

First QC Date

April 10, 2020

Last Update Submit

April 15, 2020

Conditions

Keywords

manual therapiesChronic PainRange of Motion

Outcome Measures

Primary Outcomes (1)

  • Changes in grade of range of motion of the cervical spine in patients with chronic neck pain

    The procedure consists of evaluating the cervical flexion, extension, inclination and rotation ranges. The final record will correspond to the average of two measurements on one side and on the contralateral side. The range of motion will be measured with a goniometer

    pre-intervention/immediately after the intervention

Secondary Outcomes (1)

  • Changes in muscle pressure threshold, measured in kilograms, in patients with chronic neck pain

    pre-intervention/immediately after the intervention

Study Arms (2)

Intervention Group

EXPERIMENTAL

The dorsal sliding technique C0-C1 will be applied to this group.

Other: Intervention Group

Placebo group

SHAM COMPARATOR

A placebo dorsal mobilization technique will be applied

Other: Placebo group

Interventions

The patient's position is in the supine position. The therapist identifies the arches of the atlas and positions one hand at this level with the fingers extended. The other hand is located in the occipital region. Subsequently, the therapist makes a pressure with his shoulder assessing the movement and applies a pressure to the back. This technique is performed by mobilization cycles of 15 seconds and 3 seconds of rest for a total period of 5 minutes.The patient's position is in the supine position. The therapist identifies the arches of the atlas and positions one hand at this level with the fingers extended. The other hand is located in the occipital region. Subsequently, the therapist makes a pressure with his shoulder assessing the movement and applies a pressure to the back. This technique is performed by mobilization cycles of 15 seconds and 3 seconds of rest for a total period of 5 minutes.

Intervention Group

The technique consists of placing the patient in the supine position, one hand is located in the arches of the atlas, the other hand is located in the occipital. The therapist's shoulder is located in the anterior region. This position is maintained for 5 minutes without exerting pressure.

Placebo group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • years old and over
  • Chronic cervical pain
  • Sign the informed consent form

You may not qualify if:

  • History of cervical trauma (Sprains, fracture and / or dislocation of cervical joints)
  • Subjects with administration of pain relievers, opiates or muscle relaxants
  • Inability to tolerate the supine position
  • Subjects with vertiginous syndrome
  • Subjects with cognitive impairment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Universidad San Sebastián

Concepción, 4081322, Chile

RECRUITING

MeSH Terms

Conditions

Neck PainChronic Pain

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Central Study Contacts

GONZALO ARIAS, M.ed.

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Masking Details
Study participants will be assigned a random number and will be divided into two research groups (control group and intervention group). In this sense, both the patient and the therapist in charge of carrying out the evaluation will not know which group each subject belongs to.
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

April 10, 2020

First Posted

April 17, 2020

Study Start

April 10, 2020

Primary Completion

May 20, 2020

Study Completion

June 1, 2020

Last Updated

April 17, 2020

Record last verified: 2020-04

Locations