Neck PainNCT03187808
Effects of Single Thoracic Manipulation and Special Massage Technique (RT Technique) on Chronic Mechanical Neck Pain
A study testing Single thoracic manipulation and Special massage technique (RT technique) in people with Neck Pain, run by Khon Kaen University.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 59 years
- Conditions the study is for
- Neck Pain
- What is being tested?
- Single thoracic manipulation and Special massage technique (RT technique)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- Jul 2016to Apr 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 59 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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).
Who cannot join
- 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
Show all 10Show fewer
- 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
About this study
Official title: The Effect of Single Thoracic Manipulation Combined With Special Massage Technique on Mechanical Neck Pain: A Randomized Controlled Trial
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.
Read the 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"
- Conditions
- Neck Pain
- Being tested
- Single thoracic manipulation, Special massage technique (RT technique)
- Keywords
- Neck pain, Thoracic manipulation, special massage
- Medical subject headings
- Neck Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Single thoracic manipulationOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Group A | Experimental | Group A is a group of performing single thoracic manipulation at zygapophyseal joint of T6-T7. Receives: Other: Single thoracic manipulation |
| Group B | Experimental | Group B is a group of performing single thoracic manipulation combined with special massage technique (RT technique). Receives: Other: Single thoracic manipulation; Other: Special massage technique (RT technique) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain level at rest
A Visual Analog Scale (VAS) will be used for recording level of pain at rest.
Measured: Change from baseline at 3 weeks
Secondary outcomes (4)
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.
Measured: Change from baseline at 3 weeks
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.
Measured: Change from baseline at 3 weeks
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.
Measured: Change from baseline at 3 weeks
Adverse effects
After the intervention is complete, the subjects will be asked about any symptoms that are the side effect occurring from treatment.
Measured: Change from baseline at 3 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2017
- Study startJul 2016
- Primary completionFeb 2017
- Study completionApr 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neck PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Khon Kaen University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, RAWIPORN PITHAK, Khon Kaen University
- Investigators
- RUNGTHIP PUNTUMETAKUL, Ph.D, Study director, Faculty of Associated Medical Science, Khon Kaen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03187808
- Sponsor's protocol ID
- BNOJPH-KKU-RP-001
- Status last verified
- Jun 2017
- First submitted
- 16 Jan 2017
- Last updated
- 15 Jun 2017
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No: The participants' data and documents in this study will not be shared to other researchers.
Study at a glance
From the registry record, last updated by the sponsor on 15 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Single Thoracic Manipulation Combined With Special Massage Technique on Mechanical Neck Pain: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03187808
- Acronym / sponsor ID
- BNOJPH-KKU-RP-001
- Conditions
- Neck Pain
- Keywords
- Neck pain, Thoracic manipulation, special massage
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Khon Kaen UniversityUniversity, hospital or other
- Study start
- Jul 2016 (actual)
- Primary completion
- Feb 2017 (actual)
- Study completion
- Apr 2017 (actual)
- First posted
- 15 Jun 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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"
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A | Experimental | Other: Single thoracic manipulationGroup A is a group of performing single thoracic manipulation at zygapophyseal joint of T6-T7. |
| Group B | Experimental | Other: Single thoracic manipulation, Other: Special massage technique (RT technique)Group B is a group of performing single thoracic manipulation combined with special massage technique (RT technique). |
Who may qualify
- Ages
- 18 to 59 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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).
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Single thoracic manipulationThe 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. | Other | Group A, Group B |
| Special massage technique (RT technique)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. | Other | Group B |
Primary outcome
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.
4 secondary outcomes
Cervical Range of Motion (CROM)
Time frame: Change from baseline at 3 weeks
Upper limb tension test 1 (ULTT1)
Time frame: Change from baseline at 3 weeks
The Neck Disability Index Thai version (NDI-TH)
Time frame: Change from baseline at 3 weeks
Adverse effects
Time frame: Change from baseline at 3 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jun 2017.
- Individual participant dataSharing planned: No. The participants' data and documents in this study will not be shared to other researchers.
Related trials for Neck Pain
RecruitingPhase 2
Effectiveness of Phenotype-based Pain Management Guidelines for Head and Neck Cancer Related Pain: a Pilot Study
Cancer Pain, Orofacial Pain
RecruitingPhase 2
Phenotype-based Model for Managing Chronic Post-treatment Pain Among Head and Neck Cancer Survivors: a Pilot Study
Chronic Postsurgical Pain, Chronic Post Cancer Surgery Pain
Recruiting
Longitudinal Stripping Massage vs. Percussion Device for Neck Pain: Ultrasound Study.
Chronic Neck Pain
Not yet recruiting
Lumbar Erector Spinae Plane Block Versus PENG Block for Hip Fracture Surgery
Femur Neck Fracture, Hip Fractures
Not yet recruitingObservational study
Relationship of Forward Head Posture With Burnout and Quality of Life
Forward Head Posture
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
RUNGTHIP PUNTUMETAKUL, Ph.D study director
Faculty of Associated Medical Science, Khon Kaen University
Questions about this trial
What is this clinical trial studying?
A study testing Single thoracic manipulation and Special massage technique (RT technique) in people with Neck Pain, run by Khon Kaen University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Jun 2017. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain level at rest (time frame: Change from baseline at 3 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jun 2017.