Clinical trial NCT03187808: 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
Overall status: COMPLETED
Phase: NA
Conditions: Neck Pain
Keywords: Neck pain, Thoracic manipulation, special massage
Lead sponsor: Khon Kaen University
Sponsor class: OTHER
First posted: 2017-06-15
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 59
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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"

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:

1. Cervical radiculopathy or myelopathy
2. History of whiplash injury within 6 weeks of examination
3. History of cervical surgery or thoracic surgery
4. History of cervical or thoracic injuries including fracture or dislocation
5. Fibromyalgia syndrome
6. The serious spinal conditions including spinal osteoporosis, spinal tuberculosis, and tumors
7. History of treated by spinal manipulation within 2 months before participating in the study
8. The diseases that are contra-indication to receive a spinal manipulation, such as hypertension, heart disease and meningitis
9. Pregnancy

Primary outcomes:
measure: Pain level at rest
timeFrame: Change from baseline at 3 weeks
Secondary outcomes:
measure: Cervical Range of Motion (CROM)
timeFrame: Change from baseline at 3 weeks
measure: Upper limb tension test 1 (ULTT1)
timeFrame: Change from baseline at 3 weeks
measure: The Neck Disability Index Thai version (NDI-TH)
timeFrame: Change from baseline at 3 weeks
measure: Adverse effects
timeFrame: Change from baseline at 3 weeks
Other outcomes:
Locations:
Study officials:
affiliation: Faculty of Associated Medical Science, Khon Kaen University
name: RUNGTHIP PUNTUMETAKUL, Ph.D
role: STUDY_DIRECTOR
References: