NCT03187808

Brief Summary

This study aims to compare the immediate effects of using a single thoracic manipulation combined with special massage technique (RT technique) and single thoracic manipulation alone on pain level at rest, cervical range of motion, upper limb neurodynamic test, neck disability, and adverse effects in chronic mechanical neck pain patients.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jul 2016

Shorter than P25 for not_applicable

Status
completed

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

Study Start

First participant enrolled

July 1, 2016

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

January 16, 2017

Completed
16 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2017

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2017

Completed
3 months until next milestone

First Posted

Study publicly available on registry

June 15, 2017

Completed
Last Updated

June 15, 2017

Status Verified

June 1, 2017

Enrollment Period

7 months

First QC Date

January 16, 2017

Last Update Submit

June 13, 2017

Conditions

Keywords

Neck pain, Thoracic manipulation, special massage

Outcome Measures

Primary Outcomes (1)

  • Pain level at rest

    A Visual Analog Scale (VAS) will be used for recording level of pain at rest.

    Change from baseline at 3 weeks

Secondary Outcomes (4)

  • Cervical Range of Motion (CROM)

    Change from baseline at 3 weeks

  • Upper limb tension test 1 (ULTT1)

    Change from baseline at 3 weeks

  • The Neck Disability Index Thai version (NDI-TH)

    Change from baseline at 3 weeks

  • Adverse effects

    Change from baseline at 3 weeks

Study Arms (2)

Group A

EXPERIMENTAL

Group A is a group of performing single thoracic manipulation at zygapophyseal joint of T6-T7.

Other: Single thoracic manipulation

Group B

EXPERIMENTAL

Group B is a group of performing single thoracic manipulation combined with special massage technique (RT technique).

Other: Single thoracic manipulationOther: Special massage technique (RT technique)

Interventions

The subjects, who were randomly allocated to single thoracic manipulation group, will receive the single thoracic manipulation interventions directly to both sides of zygapophyseal joints of T6-T7. Each subject will be asked to lie on prone position on an experimental table. After that, the researcher will mark on both sides of zygapophyseal joints of T6-T7. Then, the subject will be instructed to take a deep inhalation and exhalation. During the exhalation, the therapist will perform the single thoracic manipulation (screw thrust technique) at zygapophyseal joints of T6-T7. If the audio pop is not heard during the first attempt, the therapist will ask the subject to reposition and repeat the technique. The procedure will be performed for maximum of 2 attempts and within 2 minutes.

Group AGroup B

The special massage technique or RT technique is a treatment that was developed by Puntumetakul and colleagues in 2013 (copyright registration number 314783). The subjects in this group will be asked to lie on side lying position with 90 degrees of hip flexion and 90 degrees of knee flexion. The researcher will perform the RT technique by press their thumb on the treatment lines beside the posterior vertebral line from level of inferior angle of scapula to the lowest rib for 5 seconds per point and 3 sets per treatment line (Figure 8). Total time of this procedure is approximately 2 minutes.

Group B

Eligibility Criteria

Age18 Years - 59 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • They have neck pain on posterior neck or shoulder, which is the area from superior nuchal line to spinous process of 1st thoracic vertebrae, with mechanical characteristics consisting of the symptoms provoked by sustained prolonged neck posture, neck movement or palpation of cervical musculature (Martı´nez-Segura et al., 2006).
  • They have symptoms for at least 3 months in duration.
  • They have pain level at rest at least mild level (from 3 score or greater) measured by Visual Analog Scale (Jensen et al., 2003).
  • They have a baseline Neck Disability Index (NDI) Thai version score of 10% or greater (Suvarnnato et al., 2013).

You may not qualify if:

  • The subjects will be excluded from current study if they have the following conditions including:
  • Cervical radiculopathy or myelopathy
  • History of whiplash injury within 6 weeks of examination
  • History of cervical surgery or thoracic surgery
  • History of cervical or thoracic injuries including fracture or dislocation
  • Fibromyalgia syndrome
  • The serious spinal conditions including spinal osteoporosis, spinal tuberculosis, and tumors
  • History of treated by spinal manipulation within 2 months before participating in the study
  • The diseases that are contra-indication to receive a spinal manipulation, such as hypertension, heart disease and meningitis
  • Pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Neck Pain

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • RUNGTHIP PUNTUMETAKUL, Ph.D

    Faculty of Associated Medical Science, Khon Kaen University

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principle Investigator

Study Record Dates

First Submitted

January 16, 2017

First Posted

June 15, 2017

Study Start

July 1, 2016

Primary Completion

February 1, 2017

Study Completion

April 1, 2017

Last Updated

June 15, 2017

Record last verified: 2017-06

Data Sharing

IPD Sharing
Will not share

The participants' data and documents in this study will not be shared to other researchers.