Dry Needling for Sub Acromial Pain Syndrome

STUDY PURPOSE:

The purpose of this study is to assess the long-term additive effectiveness of dry needling
(DN) therapy to a standard physical therapy (PT) approach of manual therapy and exercise for
patients with subacromial pain syndrome.

HYPOTHESIS AND PRIMARY AIM:

Primary Aim: Compare 1-year outcomes in patients that receive standard PT treatment versus
standard PT and DN versus standard PT and sham DN, in patients with SAPS (self-reported
outcomes and shoulder-related healthcare utilization). Standard PT will consist of
therapeutic exercise and manual therapy, which is considered standard of care PT treatment
for individuals with SAPS.

The hypothesis for the primary aim: DN in addition to standard PT treatment will be more
effective than standard PT alone. There will be no difference between the Sham DN + standard
PT and the standard PT only groups.

BACKGROUND AND SIGNIFICANCE:

Subacromial pain syndrome (SAPS) is among the most common and self-limiting disorders of the
musculoskeletal system. The point prevalence of shoulder symptoms has been reported to range
from 20-33% and the incidence of shoulder complaints in the general population is increasing.
Furthermore, several authors have reported low rates of perceived recovery (patient reports
of "being cured") for patients with a new episode of shoulder or neck pain. According to Bot
et al, less than 25% of patients with a first episode of shoulder pain reported recovery
after 3 months, and only 32% stated they had recovered (no longer had symptoms) after 1 year.
Other studies have investigated the prognosis of shoulder pain in general practice. Pope et
al reported recovery rates of only 21% after 6 months and 49% after 18 months. Van der Windt
et al and Winters et al reported recovery rates of 51% and 59% after 12 to 18 months,
respectively. Finally, Rekola et al reported that 25% of patients with shoulder or neck pain
experienced at least one episode of recurrence within 12 months. These findings suggest that
shoulder pain can be recurrent and frequently progresses to the chronic stage. This is
clearly a musculoskeletal condition requiring further research to identify effective
management strategies.

RESEARCH DESIGN AND METHODS:

This will be a randomized clinical trial with 3 arms. This is a pragmatic comparative
effectiveness trial utilizing interventions that are all standard of care and already
utilized in clinical care. The experimental nature of the study is the comparative
effectiveness using sham needling, and the assessment of whether an additive combination of
treatments is better than the standard treatment alone.

Self-reported outcome measures will be captured at baseline, 6 weeks, 6 months, and 1 year.
The investigators will observe healthcare-related expenditures and utilization for all groups
for one year following enrollment in order to uncover differences in health-seeking behaviors
and health care cost following the intervention between the treatment groups.

INTERVENTIONS:

Randomization: Subjects will then be randomized into one of three arms (Group I = Standard PT
Treatment PLUS TPDN, Group II = Standard PT Treatment PLUS Sham TPDN, Group III = Standard PT
Treatment only). The method of group assignment will be sequentially numbered opaque sealed
envelopes (SNOSE). To minimize the risk of predicting the treatment assignment of the next
eligible patient, randomization will be performed in permuted blocks of 2 or 4 with random
variation of the blocking number. All self-report measures will be filled out prior to
randomization.

Blinding: Due to the nature of this study, it is not possible to fully blind the patient or
the clinician providing the intervention to the treatment received, although the patient will
not know the details of the other study groups in which they are not a part of. The patient
will be blinded to whether they receive real or sham TPDN, but they will know if they are in
the group does not receive either. The evaluator and physical therapist providing the
intervention will be different individuals. The assessor performing the baseline measurements
and outcome assessments will be blinded to the patient's group assignment. Patients will be
instructed not to discuss the intervention received with the assessor unless medically
necessary. Incidence of unmasking will be recorded.

Treatment Groups Description:

This will be a pragmatic study, where patients will be required to try and attend at least 10
sessions over a 6-week period, but can attend more if the therapist believes there is still
progress to be made. This mimics actual clinical practice. The number of actual sessions will
be recorded.

Standard PT Treatment: All three groups will receive manual therapy and exercise
interventions provided by their physical therapist. The exact dosage and choice of exercise
and manual therapy techniques will not controlled in the study. Documentation of dosage and
utilization rates of each will be captured for each patient session in order to determine if
these variables influence outcomes. A full shoulder exam will be conducted per standard of
care at this time as well. All treating clinicians will receive a basic training session to
review the exercise and manual therapy techniques that will be used.

Dry Needling:

In addition to the standard PT interventions, the Dry Needling (DN) group will receive 6 DN
sessions as part of their rehabilitation visits (they will occur at the same time). In 6 of
the scheduled 10 visits, dry-needling intervention will be performed. They will have one DN
session per week, which is consistent with typical clinical practice. After they complete
their standard PT treatment, and while still in the clinic, the rotator cuff and periscapular
muscles will be evaluated for the presence of MTrPs. Once located, the MTrPs will be treated
with DN technique, as this is consistent with routine clinical practice. Potential muscles to
receive TPDN treatment include the following: suprapsinatus, teres minor, infraspinatus,
deltoid, upper trapezius, middle trapezius, levator scapula, pec major and pec minor.

SEIRIN Acupuncture needles (50mm length; 0.30mm diameter) will be used to perform the dry
needling procedure. The skin will be prepped with an alcohol swab, gloves will be worn and
clean needle technique will be used at all times. The needle will be inserted over the MTrP
with a goal of inserting to the depth of the MTrP in an attempt to elicit a local twitch
response (LTR). After needle insertion the treating clinician will "piston" the needle (in
and out motion). Pistoning will be performed for approximately 5-10 seconds. Each MTrP will
be treated in this fashion with up to 3 muscle groups treated within a single session.
Clinicians will document the location of MTrP's and at which visit they were identified and
treated.

Sham DN: In addition to the standard PT treatment, patients in the sham DN group will receive
what appears to be a DN treatment, but it will not be done with the acupuncture needles and
the skin will not be punctured. The Sham DN procedure will be performed over the site of
identified MTrPs using a guide tube and a toothpick. The clinician preps the skin with an
alcohol wipe and holds the skin taut around the area in contact with the needle, just as is
done in actual dry-needling technique. A guide tube is positioned firmly over the area to be
treated and a toothpick is inserted in the guide tube. The clinician taps the toothpick to
mimic the skin prick from a needle and the guide tube is removed. The clinician maintains
pressure on the end of the toothpick and moves the end furthest from the skin in different
directions to mimic the pistoning and changes in needle angle that occur in actual dry
needling. Care will be taken to treat from 1-3 muscle groups for 5-10 seconds per MrTP
identified. Following completion of the 6-week treatment period, subjects will be asked to
identify which treatment group they were it in order to assess if the sham procedure was
successful in mimicking the DN procedure.

SETTING:

This study will take place in the physical therapy clinics at Wilford Hall Ambulatory
Surgical Center (WHASC), on Lackland Air Force Base in San Antonio, TX and the CPT Jennifer
Moreno PT clinic at Fort Sam Houston, San Antonio TX.

RISK:

As with all clinical research, there is a small risk of inadvertent breach of confidentiality
of PHI/PII. The likelihood of this breach is low given the efforts the research team will
take to protect this information.

Potential risks to subjects in this study are minimal. The procedures used in this study are
standard procedures that are used in everyday clinical practice in the PT clinics that are
participating. The use of manual therapy and exercise treatments for patients with
subacromial pain syndrome is supported by clinical practice guidelines in the United States
and elsewhere. There are no associated study-related risks with the treatment, as it is all
standard of care. Although there are no research-related risks associated with this study,
there are some minor risks from the procedures used in this study, which would be present
regardless of whether the patient decides to participate in the study or not. If they
participate in physical therapy, there is a risk for increased pain or muscle soreness as a
result from exercise and manual therapy procedures used in physical therapy. The majority of
these instances are transient, lasting less than 24 hours.

The risks from the DN needling intervention are also minor and transient. Specifically, there
is a small risk of pain, bruising and bleeding. The likelihood of these occurrences is
approximately 20%. They are characterized as minor because they resolve within 24 hours and
do not require additional medical attention. There is a small risk of more serious medical
events with dry needling. These include haematoma, pneumothorax, and nerve lesion. These
occurrences are very rare, occurring at a rate of < 0.04%.50

Although the risks to patients related directly to the study are extremely low, the
investigators will implement monitoring procedures to ensure the safety and protection of
subjects. Members of the research team are credentialed providers, and familiar with managing
patients with shoulder pain. The research team will always monitor the safety and
appropriateness of each patient in the study. All personnel involved with the research who
will be responsible for collecting and handling the data will have completed the CITI
training and will be trained by one of the investigators. Protection of patient
confidentiality and procedures for reporting adverse events will be included in these
training sessions. Any adverse events occurring as a result of participation in this study
will be reported immediately to the principal investigator and the Institutional Review Board
involved with the study. The Principal Investigator will meet on a weekly basis with the
study staff to review study progress, including any adverse events or breaches of patient
confidentiality.

DATA ANALYSIS All data will be analysed in IBM SPSS 24 (Chicago, IL). Descriptive statistics
will be performed to describe the sociodemographic (age, sex, race, etc.) and health
characteristics (disability, pain intensity, psychosocial factors, etc.) of the entire
sample, and comparisons made between groups. Means and standard deviations will be computed
for continuous data and frequency distributions will be analyzed for categorical data. For
differences in shoulder-related healthcare utilization, RRs (risk ratio) for a healthcare
utilization event between patients in each group will be derived and compared. Point
estimates with 95% Confidence Intervals will be reported.

Comparison of self-report outcomes between groups at baseline, 6 weeks, 6 months and 1 year
will be performed using a linear mixed-effects model, which is flexible in accommodating data
assumed to be missing at random. Significance is set at 0.05 and 95% confidence intervals
will be reported for all relevant data. Sensitivity analysis will be run adjusting for other
demographic and/or prognostic variables (OSPRO-YF, pain intensity, PROMIS-29 sleep or mental
health domains, etc) that may affect the outcome.

Sample Size: In order to generate 80% power for this study, with 3 potential treatment arms,
based an effect size difference in SPADI scores of 12%, the investigaros need a total sample
size of 108 subjects (36 per group). With an estimated 20% loss to follow-up or drop outs at
1 year, the investigators will plan on enrolling 130 subjects into the study in order to have
108 complete their 1-year follow-ups. Calculations derived with G*Power.

FUNDING SUPPORT: None

Inclusion Criteria:

- Age 18 to 65

- Read and speak English well enough to provide informed consent, follow study
instructions, and independently answer the questionnaires/surveys

- Tricare beneficiary

- Primary complaint of new episode of shoulder pain; defined as not having sought care
for shoulder condition in 6 months prior

- Available and willing to come in for treatment (~10 sessions over 6 week period)

- Meets criteria for SAPS from description below, by having 2 of the 4 following
physical exam findings:

- Impingement signs (Neer, Hawkins, or Jobe tests)

- Painful arc

- Pain with isometric resistance (ER/IR/ABD)

- Rotator cuff weakness on the injured side in comparison to the opposite side

Exclusion Criteria:

- History of shoulder dislocation, subluxation, fracture, adhesive capsulitis of the
glenohumeral joint, or cervical/shoulder/upper back surgery

- Presence of cervical radiculopathy, radiculitis, or referral from cervical spine

- Total baseline SPADI score less than 20% (to prevent a ceiling effect with treatment)

- Anyone pending a medical evaluation board, discharge from the military for medical
reasons, or pending or undergoing any litigation for an injury

- Unable to give informed consent to participate in the study.

- Pregnancy