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Effects of Single Thoracic Manipulation and Special Massage Technique (RT Technique) on Chronic Mechanical Neck Pain

Primary Purpose

Neck Pain

Status

Completed

Phase

Not Applicable

Locations

Study Type

Interventional

Intervention

Single thoracic manipulation

Special massage technique (RT technique)

About this trial

This is an interventional treatment trial for Neck Pain focused on measuring Neck pain, Thoracic manipulation, special massage

Eligibility Criteria

18 Years - 59 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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).

Exclusion Criteria:

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

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

Group A

Group B

Arm Description

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

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

Outcomes

Primary Outcome Measures

Pain level at rest

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

Secondary Outcome Measures

Cervical Range of Motion (CROM)

The Cervical Range of Motion (CROM) device (Performance Attainment Associates, USA) will be used to measure the cervical range of motion, including flexion, extension, lateral flexion and rotation.

Upper limb tension test 1 (ULTT1)

The details of performing ULTT1 can be described as follow: the examiner will stand at side of tested limb with turn facing towards patient's head, and hold patient's one hand to control his or her thumb and fingers. Next, the examiner will use other hand to keep patient's shoulder in depression position to prevent the movement of shoulder girdle elevation during shoulder abduction. Then, the examiner will perform shoulder abduction with 110 degrees, forearm supination with the wrist and fingers extend, laterally rotation of shoulder, and elbow extension respectively. The last component of the test is the examiner asked patient turning their head to opposite side of tested arm. In current study, the researcher will measure the changing response of first sequence, that patient have a symptoms, to investigate that the intervention may affect the neural tension or not.

The Neck Disability Index Thai version (NDI-TH)

The Neck Disability Index Thai version (NDI-TH) questionnaire (Appendix C), which is a reliable instrument to assess functional disability in neck pain patients with high internal consistency (ICC = 0.85) (Uthaikhup et al., 2011), will be used to assess the subjects' perceived disability level which can be show the impact of their neck pain to the daily living.

Adverse effects

After the intervention is complete, the subjects will be asked about any symptoms that are the side effect occurring from treatment.

Full Information

NCT ID

NCT03187808

First Posted

January 16, 2017

Last Updated

June 13, 2017

Sponsor

Khon Kaen University

1. Study Identification

Unique Protocol Identification Number

NCT03187808

Brief Title

Effects of Single Thoracic Manipulation and Special Massage Technique (RT Technique) on Chronic Mechanical Neck Pain

Official Title

The Effect of Single Thoracic Manipulation Combined With Special Massage Technique on Mechanical Neck Pain: A Randomized Controlled Trial

Study Type

Interventional

2. Study Status

Record Verification Date

June 2017

Overall Recruitment Status

Completed

Study Start Date

July 2016 (Actual)

Primary Completion Date

February 2017 (Actual)

Study Completion Date

April 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Khon Kaen University

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

Detailed Description

- The subjects will be recruited through posted advertisements, and announcements, to find the patients who meet the criteria of mechanical neck pain that is the pain provoked by sustained prolonged neck posture, neck movement or palpation of cervical musculature. The subjects will be screened by screening questionnaire, and then will be examined by a physiotherapist. All subjects will be required to sign an inform consent before participating to the study - The sample size was calculated by using the averaged of pain level at rest after treatment from the single thoracic manipulation combined with special massage group and single thoracic manipulation group, after the preliminary procedure that will be conducted with ten subjects per each group. After that, the variance was calculated by using the equation σ2 = (n1-1)s12 + (n2-1)s22/(n1+n2)-2 and the result will be used for calculate the sample size. A drop out rate will be set as 20%. The effect size (∆), the significant level of lower than 0.05 (Zα(0.05) = 1.96) and a power of test at 90 percent (Zβ(0.2)=1.28) was used to calculate in the equation as follow: n/group = "2(Zα + Zβ)2σ2" /"∆2"

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Neck Pain

Keywords

Neck pain, Thoracic manipulation, special massage

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Outcomes Assessor

Allocation

Randomized

Enrollment

30 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Group A

Arm Type

Experimental

Arm Description

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

Arm Title

Group B

Arm Type

Experimental

Arm Description

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

Intervention Type

Other

Intervention Name(s)

Single thoracic manipulation

Intervention Description

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.

Intervention Type

Other

Intervention Name(s)

Special massage technique (RT technique)

Intervention Description

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.

Primary Outcome Measure Information:

Title

Pain level at rest

Description

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

Time Frame

Change from baseline at 3 weeks

Secondary Outcome Measure Information:

Title

Cervical Range of Motion (CROM)

Description

The Cervical Range of Motion (CROM) device (Performance Attainment Associates, USA) will be used to measure the cervical range of motion, including flexion, extension, lateral flexion and rotation.

Time Frame

Change from baseline at 3 weeks

Title

Upper limb tension test 1 (ULTT1)

Description

Time Frame

Change from baseline at 3 weeks

Title

The Neck Disability Index Thai version (NDI-TH)

Description

Time Frame

Change from baseline at 3 weeks

Title

Adverse effects

Description

After the intervention is complete, the subjects will be asked about any symptoms that are the side effect occurring from treatment.

Time Frame

Change from baseline at 3 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

59 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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). Exclusion Criteria: 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

RUNGTHIP PUNTUMETAKUL, Ph.D

Organizational Affiliation

Faculty of Associated Medical Science, Khon Kaen University

Official's Role

Study Director

12. IPD Sharing Statement

Plan to Share IPD

IPD Sharing Plan Description

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

Learn more about this trial

Effects of Single Thoracic Manipulation and Special Massage Technique (RT Technique) on Chronic Mechanical Neck Pain

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