Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT05846022 |
| Other study ID # |
B2022:098 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
May 9, 2023 |
| Est. completion date |
June 30, 2023 |
Study information
| Verified date |
September 2023 |
| Source |
University of Manitoba |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
The goal of this clinical trial is to compare the immediate effects of stimulating shoulder
muscles with an acupuncture needle (dry needling) on people from thirty to fifty years old
with recurrent neck pain. The main questions this trial aims to answer are does dry needling
tight shoulder muscles have an effect on:
1. the ability to turn your head with speed and accuracy,
2. your neck mobility,
3. pain,
4. the tenderness in the muscles,
5. change in your everyday function.
Participants will be asked to undergo a dry needling intervention, then participants will be
asked to complete measurements before and after the including a pain scale, neck mobility, a
functional questionnaire, pressure sensitivity and movement time for a repetitive head
turning task. Researchers will compare the dry needling to the sham needling to see if there
is a change in the measurements pre- and post-intervention.
Description:
Study Design:
This is a prospective, single blind, randomized control trial with two groups. This
intervention effectiveness study will utilize a pre-post clinical trial design to measure the
immediate effects of the treatment of dry needling on motor performance. Specifically, dry
needling bilateral upper trapezius myofascial trigger points with the primary outcome of
motor performance measured by a discrete aiming head movement task called the Fitts' head
turning task. Empirical evidence supports Fitts' head turning task to quantitatively measure
neuromuscular functional impairments related to restricted cervical range of movement.
Approval from the University of Manitoba (HS25717) ethics committee has been attained.
Purpose:
The aim of this randomized clinical trial is to measure the immediate effects of dry needling
on motor function. Specifically, the effect of a single session of dry needling to
shoulder/neck muscles on the performance of a repetitive head turning task.
Objectives:
1. To determine whether dry needling upper trapezius results in improved motor performance
measured by the Fitts Head turning task when compared to sham needling.
2. To determine whether dry needling upper trapezius results in improved neck range of
motion measured by Cervical Range of Motion instrument when compared to sham needling.
3. To determine whether dry needling upper trapezius results in a change in pain scores
measured by a visual analogue scale when compared to sham needling.
4. To determine whether dry needling upper trapezius results in a change in functional
ability measured by the Neck Disability Index when compared to sham needling.
5. To determine whether dry needling upper trapezius results in a reduction of pain
pressure thresholds measured by pressure algometry when compared to sham needling.
Sampling:
The demographic pool will sample ages from thirty to fifty and both genders to represent a
natural clinical population. A sample size calculation was completed using G*power software
based on parameters from a doctoral thesis examining the effects of cervical spinal
manipulation on movement time (Geoff Gelly, Applied Health Sciences Post Doctoral Candidate,
University of Manitoba). Thirty-six to forty participants, including controls, will be
enrolled in this study.
Participant recruitment:
Participants will be recruited from the local community of Winnipeg. Advertising will be
posted in outpatient clinics, exercise gyms and studios. Outpatient practitioners (including
doctors, physiotherapists, chiropractors, massage therapists) will be asked to provide the
study's information to clients who meet the inclusion criteria. The practitioner involved
with providing health care but not with the research will disclose the contact information to
the researcher with the client's verbal consent or alternately provide the study staff's
contact information. The researchers will use the personal health information/contact
information for contact purposes alone. Email lists provided by clinics, gyms, studios will
be sent to disseminate posters digitally. Potential participants will be sent a recruitment
email with a written description of the project and the eligibility criteria. Potential
participants will be asked to contact the outcome assessor via telephone or email if they are
interested in participating. One reminder email will be sent to potential participants two
weeks after the initial email. Another strategy will be a snowball approach, requesting
potential participants to forward the invitation to any friends or colleagues that may fit
the eligibility criteria. Finally, invitations to participate will be posted on social media
pages as well as through researcher social media accounts (for example, Facebook, Instagram).
Data Collection Procedures:
Dry needling intervention:
Dry needling involves the insertion of solid monofilament needles into tender points in tight
muscle bands for therapeutic purposes. Needles inserted into taut muscle fibres create an
electrical discharge that results in twitches or muscle spasm in the targeted muscle. Dry
needling is a technique that falls within the "standard of care" of physiotherapy practice,
though requires training beyond basic physiotherapy education requirements. This technique
may only be implemented by fully licensed physiotherapists registered on the College of
Physiotherapists of Manitoba Acupuncture Roster. This intervention of dry needling involves
the insertion of a fine sterile needle into upper trapezius muscle fibres bilaterally using a
clean needling technique. Before the needle insertion, the muscle is pulled up and away from
the thorax where it is held for the intervention. The location of the needle insertion is the
taut fibres in the middle one third of the upper trapezius muscle belly. The insertion
involves placing the needle's guide tube with needle tip slightly withdrawn on the patient's
skin, then the index finger provides a quick tap to bypass free nerve endings below the skin,
the tube is removed, then the needle is advanced into the muscle in an anterior-superior
direction. The needle is plunged in the trigger point region until a local muscle twitch or
sustained contraction response is achieved. An attempt to achieve four to six local muscle
twitch responses will be made for therapeutic purposes. Needles and any material with body
fluids are disposed of in a biohazard container.
Sham needling intervention:
There are many challenges of creating a convincing sham for an invasive technique like dry
needling. The goal is to test the effectiveness of dry needling beyond the puncture's effect,
thus including the puncture with the sham intervention allows the effects of needling the
muscle to be isolated. Thus, the procedures for the sham needling intervention will follow
the same set up as the dry needling intervention, however penetration will be shallow into
the skin alone and the "in and out" plunging movement will be simulated with the needle's
guide tube.
Data Collection and Analysis:
Descriptive statistical analysis will be conducted on participant demographics including
gender, whether myofascial trigger points are unilateral or bilateral, age, height, weight,
body mass index. The muscle's response to the needling intervention will be documented with
the number of local muscle twitch response(s) observed.
Data management:
The outcome assessor will collect participant demographics and outcome measures on paper on
the day of data collection, which will be stored in a locked filing cabinet within the locked
laboratory space. A list of names and email addresses of participants will be kept in a
secure electronic file so we can contact, send reminders to complete the survey and a summary
of the results of the study. Participants' data will be collected and stored using a
participant identification number. A participant contact information form will link the
unique identification number to the participants' name, email address and telephone number.
The participant contact information will be kept in a separate password protected computer
and a password protected device. Indirect identifiers are being collected to enhance
transferability of the study. Demographics of the participants will allow the research
audience to consider the results with the context of the sample of the population studied.
Health Insurance Portability and Accountability Act compliant software system called Jane
will be used for setting up appointment dates and appointment reminders. The participant's
name and email are required for this process. Data base information including the
demographics, Fitts' task data, visual analogue scales, neck disability index, range of
movement data, pressure algometry data and the effectiveness of blinding questionnaire will
be stored initially on a password protected computer with password protected files and then
will be uploaded to the College of Rehabilitation Sciences R: drive at the University of
Manitoba. Consent forms and all other electronic data such as participant contact information
will be uploaded to password protected files and stored on the College of Rehabilitation
Sciences R: drive at University of Manitoba and will only be accessible to investigators
listed in ethics submission. Once data is uploaded, the original sources will be deleted.
Upon completion of the study, de-identified data will be transferred to co-investigator's R:
drive for long-term storage and will be kept for five years for publication purposes.
Reporting for adverse events:
The primary investigator will report unexpected events to the academic supervisor, who will
review unanticipated problems and report them to the Research Ethics board, as necessary.
While there is no guaranteed direct benefit to the participant from participation in this
study, researchers are hopeful that the result of this study will support a dry needling as a
clinical intervention for improving motor performance with the potential to decrease
recurrent neck pain.
Change in management:
This randomized control trial is intended to meet the requirements of a master's thesis, thus
there will be no change in the principal investigator. A test-retest study only requires
follow-up one week post intervention, thus if recruitment goes smoothly, retaining the
outcome assessor will be necessary for a short-term.
Plan for missing data:
This is a test-retest experiment that takes place within ninety minutes (about one and a half
hours), so provided participants can attend the session there is not a considerable risk for
missing data. Two questionnaires that will be used in the follow up to this study are The
Neck Disability Index and a questionnaire to assess the success of the blinding, which will
be administered by email one week after data collection and will require a nominal amount of
time to complete (about five minutes). The Neck Disability Index is scored on the number of
questions answered, which accommodates for missing answers. If participants neglect to answer
either of the email questionnaires attempts will be made to follow up on the telephone or
email. If investigators are unable to collect missing data, the questionnaires will be
omitted.
Statistical analysis:
Assessment of normal distribution and assumptions of linearity, interdependence, normality,
and equal variance will be undertaken for the total sample and both groups. A mixed model
Analysis of Variance will be used for the primary outcome, the Fitts' Task, to assess the
between group effect (dry needling versus sham needling) and the within group effect (pre
versus post intervention). Post hoc tests (Tukey's honestly significant difference) will be
used to perform specific comparisons. The same approach will be used to analyze secondary
outcomes. For all statistical analysis, p values of 0.05 will be considered significant.
Statistical software will be utilized to analyze the data.
