Nonspecific Neck PainPhase 1/2NCT01984021
Evaluation of the Immediate Effect of Acupuncture on the Upper Trapezius Muscle in Patients With Nonspecific Neck Pain.
A Phase 1/2 study testing Acupuncture in people with Nonspecific Neck Pain, run by University of Nove de Julho at 1 site in Brazil.
Trial summary
The aim of the proposed study is to evaluate the immediate effect of acupuncture on pain, cervical range of motion and electromyographic activity of the upper trapezius muscle in patients with nonspecific neck pain.Twelve patients with nonspecific neck pain and 12 healthy subjects will be enrolled in a randomized… Read more about this study
- Who is it for?
- Ages 18 to 40 years
- Conditions the study is for
- Nonspecific Neck Pain
- What is being tested?
- Acupuncture
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 24 participants
- Where
- 1 siteBrazil
- Study dates
- Dec 2013to May 2015
- Phase
- Phase 1/2
- 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 40 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 18 to 40 years
- male and female volunteers
Who cannot join
- history of neurological disorders
- neck surgery
- chronic neck pain resulting from a traumatic incident
- chronic musculoskeletal condition
- medical diagnosis of fibromyalgia; systemic disease
- connective tissue disorder
- non-tolerance of needles; current pregnancy
- having undergone physical therapy use of analgesic, muscle relaxant.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of the Immediate Effect of Acupuncture on Pain, Cervical Range of Motion and Electromyographic Activity of the Upper Trapezius Muscle in Patients With Nonspecific Neck Pain: Randomized, Single-blinded, Sham-controlled Study.
The aim of the proposed study is to evaluate the immediate effect of acupuncture on pain, cervical range of motion and electromyographic activity of the upper trapezius muscle in patients with nonspecific neck pain.Twelve patients with nonspecific neck pain and 12 healthy subjects will be enrolled in a randomized, single-blind, crossover study. Each patient will receive two forms of treatment in random order: a single session of traditional acupuncture and sham acupuncture. To eliminate carry-over treatment effects, a one-week wash-out period will be respected between sessions. Surface electromyography will be used to determine motor control in the upper trapezius muscle before and after treatment. The outcome measures in the group with neck pain will be a numerical pain rating scale (range: 0 [no pain] to 10 [maximum pain]), documentation of the pain area on a body chart and cervical range of motion. Linear regression analysis will be applied for each individual to investigate associations between the sEMG variables and force (excluding the sixth step). The slopes of the regression lines will be used to measure the sensitivity of the sEMG variables regarding changes in force. The Shapiro-Wilk test will be used to test the normality of the data distribution regarding RMS and MDF values in the third and sixth step of the step contraction. Paired samples (Student's t-test or Wilcoxon test) will be used to test differences between third and sixth contraction step. A mixed linear model will be used to analyze and compare the sEMG data during sustained contraction (five steps) between pre-acupuncture (EMG-1) and post-acupuncture (EMG-2) evaluations. These comparisons will demonstrate whether acupoints TE-5 and LI-11 affect the activity of the upper trapezius muscle, as hypothesized. The pain (NRS, PPT and area) and cervical ROM data collected during the four evaluations will also be compared using a mixed linear model. The Statistical Package for Social Sciences (SPSS, version 19.0 for Windows) will be employed for the statistical analysis, with the level of significance set to 5% (p < 0.05).
- Conditions
- Nonspecific Neck Pain
- Being tested
- Acupuncture, Sham acupuncture
- Keywords
- Physical Therapy Modalities, Neck pain, Acupuncture
- Medical subject headings
- Neck Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AcupunctureDevice
Sham acupunctureDevice
| Study group | Role | What they receive |
|---|---|---|
| traditional acupuncture (tACP) | Experimental | In the upper trapezius muscle with the greatest area pain and lowest PPT score will be chosen for acupuncture. Sterile acupuncture needles measuring 0.25 x 13 mm (Suzhou Huanqiu Acupuncture Medical Appliance Co. Ltd.®) will be inserted in TE-5 (located on the dorsal face of the forearm between the radius and ulna 3 cm above the joint line of the wrist) and LI-11 (located at the outermost point of the skinfold of elbow flexion in the direction of the lateral epicondyle of the elbow). Receives: Device: Acupuncture |
| sham acupuncture (sACP) | Placebo comparator | The needles will be inserted 1 cm to the side of TE-5 (located on the dorsal face of the forearm between the radius and ulna 3 cm above the joint line of the wrist) and 1 cm to the side of LI-11 (in the direction of the styloid process of the radius).The acupuncture needles are positioned at different acupoints. Receives: Device: Sham acupuncture |
What is being measured
The primary outcome is the main question the study is designed to answer.
electromyographic activity
The EMG signal will be recorded in the dominant upper trapezius muscle in patients with nonspecific neck pain, will be evaluated before and after treatment.
Measured: 1 Year
Secondary outcomes (1)
cervical range of motion
A cervical range of motion instrument will be used to determine cervical spine movements. This instrument is composed of two gravity goniometers and a compass goniometer and has demonstrated to be a reliable tool with adequate validity. The device will be placed on the top of the head and the patient will be instructed to move the head as far as possible without pain in a standard fashion: right rotation, left rotation, flexion, extension, right lateral flexion and left lateral flexion. Three trials will be conducted in randomized order for each direction of movement and mean values will be recorded for analysis.
Measured: 1 Year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Nov 2013 (estimated)
- Study startDec 2013
- Primary completionMay 2015
- Study completionMay 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Nonspecific 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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Nove de Julho
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Cid André Fidelis de Paula Gomes, University of Nove de Julho
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01984021
- Sponsor's protocol ID
- 483712
- Status last verified
- May 2015
- First submitted
- 7 Nov 2013
- Last updated
- 2 Jun 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Calamita SA, Biasotto-Gonzalez DA, De Melo NC, dos Santos DM, de Lassa R, de Mendonca FS, Oliveira CS, Amorim CF, Gonzalez TO, Fumagalli MA, de Gomes CA, Politti F. Evaluation of the immediate effect of acupuncture on pain, cervical range of motion and electromyographic activity of the upper trapezius muscle in patients with nonspecific neck pain: study protocol for a randomized controlled trial. Trials. 2015 Mar 19;16:100. doi: 10.1186/s13063-015-0623-3.
PubMed 25872667
Study at a glance
From the registry record, last updated by the sponsor on 2 Jun 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Immediate Effect of Acupuncture on Pain, Cervical Range of Motion and Electromyographic Activity of the Upper Trapezius Muscle in Patients With Nonspecific Neck Pain: Randomized, Single-blinded, Sham-controlled Study.
- ClinicalTrials.gov ID
- NCT01984021
- Acronym / sponsor ID
- 483712
- Conditions
- Nonspecific Neck Pain
- Keywords
- Physical Therapy Modalities, Neck pain, Acupuncture
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- University of Nove de JulhoUniversity, hospital or other
- Study start
- Dec 2013
- Primary completion
- May 2015 (actual)
- Study completion
- May 2015 (actual)
- First posted
- 14 Nov 2013 (estimated)
- 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.
The aim of the proposed study is to evaluate the immediate effect of acupuncture on pain, cervical range of motion and electromyographic activity of the upper trapezius muscle in patients with nonspecific neck pain.Twelve patients with nonspecific neck pain and 12 healthy subjects will be enrolled in a randomized, single-blind, crossover study. Each patient will receive two forms of treatment in random order: a single session of traditional acupuncture and sham acupuncture. To eliminate carry-over treatment effects, a one-week wash-out period will be respected between sessions. Surface electromyography will be used to determine motor control in the upper trapezius muscle before and after treatment. The outcome measures in the group with neck pain will be a numerical pain rating scale (range: 0 [no pain] to 10 [maximum pain]), documentation of the pain area on a body chart and cervical range of motion. Linear regression analysis will be applied for each individual to investigate associations between the sEMG variables and force (excluding the sixth step). The slopes of the regression lines will be used to measure the sensitivity of the sEMG variables regarding changes in force. The Shapiro-Wilk test will be used to test the normality of the data distribution regarding RMS and MDF values in the third and sixth step of the step contraction. Paired samples (Student's t-test or Wilcoxon test) will be used to test differences between third and sixth contraction step. A mixed linear model will be used to analyze and compare the sEMG data during sustained contraction (five steps) between pre-acupuncture (EMG-1) and post-acupuncture (EMG-2) evaluations. These comparisons will demonstrate whether acupoints TE-5 and LI-11 affect the activity of the upper trapezius muscle, as hypothesized. The pain (NRS, PPT and area) and cervical ROM data collected during the four evaluations will also be compared using a mixed linear model. The Statistical Package for Social Sciences (SPSS, version 19.0 for Windows) will be employed for the statistical analysis, with the level of significance set to 5% (p < 0.05).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| traditional acupuncture (tACP) | Experimental | Device: AcupunctureIn the upper trapezius muscle with the greatest area pain and lowest PPT score will be chosen for acupuncture. Sterile acupuncture needles measuring 0.25 x 13 mm (Suzhou Huanqiu Acupuncture Medical Appliance Co. Ltd.®) will be inserted in TE-5 (located on the dorsal face of the forearm between the radius and ulna 3 cm above the joint line of the wrist) and LI-11 (located at the outermost point of the skinfold of elbow flexion in the direction of the lateral epicondyle of the elbow). |
| sham acupuncture (sACP) | Placebo comparator | Device: Sham acupunctureThe needles will be inserted 1 cm to the side of TE-5 (located on the dorsal face of the forearm between the radius and ulna 3 cm above the joint line of the wrist) and 1 cm to the side of LI-11 (in the direction of the styloid process of the radius).The acupuncture needles are positioned at different acupoints. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- 18 to 40 years
- male and female volunteers
Key exclusion criteria (8 listed)
- history of neurological disorders
- neck surgery
- chronic neck pain resulting from a traumatic incident
- chronic musculoskeletal condition
- medical diagnosis of fibromyalgia; systemic disease
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 |
|---|---|---|
| Acupuncture | Device | traditional acupuncture (tACP) |
| Sham acupuncture | Device | sham acupuncture (sACP) |
Primary outcome
electromyographic activity
Time frame: 1 Year
The EMG signal will be recorded in the dominant upper trapezius muscle in patients with nonspecific neck pain, will be evaluated before and after treatment.
1 secondary outcome
cervical range of motion
Time frame: 1 Year
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 2 Jun 2015.
- Derived from this study: PubMed 25872667Calamita SA, Biasotto-Gonzalez DA, De Melo NC, dos Santos DM, de Lassa R, de Mendonca FS, Oliveira CS, Amorim CF, Gonzalez TO, Fumagalli MA, de Gomes CA, Politti F. Evaluation of the immediate effect of acupuncture on pain, cervical range of motion and electromyographic activity of the upper trapezius muscle in patients with nonspecific neck pain: study protocol for a randomized controlled trial. Trials. 2015 Mar 19;16:100. doi: 10.1186/s13063-015-0623-3.
- Related InfoLink provided by the sponsor.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Acupuncture in people with Nonspecific Neck Pain, run by University of Nove de Julho at 1 site in Brazil.
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 2 inclusion and 8 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 2 Jun 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
electromyographic activity (time frame: 1 Year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01984021, which also lists 1 linked publication.
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 2 Jun 2015.