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Completed

NCT Number: NCT03187808

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

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.

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Key information

Conditions

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

Age range

18 year–59 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

  • 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"

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Single thoracic manipulation

Other

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.

Special massage technique (RT technique)

Other

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 outcomes

  1. Pain level at rest

    Time frame: Change from baseline at 3 weeks

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

Secondary outcomes

  1. Cervical Range of Motion (CROM)

    Time frame: Change from baseline at 3 weeks

    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.

  2. Upper limb tension test 1 (ULTT1)

    Time frame: Change from baseline at 3 weeks

    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.

  3. The Neck Disability Index Thai version (NDI-TH)

    Time frame: Change from baseline at 3 weeks

    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.

  4. Adverse effects

    Time frame: Change from baseline at 3 weeks

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

Sponsors and collaborators

Lead sponsor

Khon Kaen University

Other

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Jun 15, 2017
Registry last updated
Jun 15, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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