Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

Dry Needling for Sub Acromial Pain Syndrome (DITTO SAPS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03442894
Recruitment Status : Recruiting
First Posted : February 22, 2018
Last Update Posted : October 3, 2018
Sponsor:
Information provided by (Responsible Party):
Benjamin Hando, Wilford Hall Medical Center

Brief Summary:

This trial will investigate the benefit of trigger point dry needling (DN) for individuals with a common cause of shoulder pain - sub-acromial pain syndrome. Sub-acromial pain syndrome, also knowns as SAPS, is one of the most common causes of shoulder pain. Physical therapy treatments are routinely used for treating SAPS. One treatment approach that has been shown to be beneficial is a combination of exercises and manual or manipulative therapy. This approach has been shown to reduce pain and improve overall shoulder function in individuals with SAPS.

Recently, a novel treatment approach for SAPS has emerged that involves trigger point DN to muscles of the shoulder and ribcage. Some studies have shown promising results for this approach while others have not found it to be helpful. Overall there is currently little research available on the benefit of trigger point DN for individuals with SAPS.

This study will investigate whether adding trigger point DN to a treatment program of exercise and manual therapy provides any benefit to individuals with SAPS. To answer this question, this study will divide subjects into three groups. One group will receive just exercise and manual therapy; one group will receive manual therapy and exercise plus trigger point DN and one group will receive manual therapy and exercise plus a sham trigger point DN treatment.

All patients receiving treatment in the study will attend 10 visits to a physical therapy clinic over a 6-week period. Subjects in the dry needling and sham dry needling groups will receive 6 sessions of this treatment in addition to their 10 sessions of exercise and manual therapy.

The investigators will assess the effectiveness of the three treatment protocols by measuring patients pain, shoulder function and disability levels. These outcomes will be assessed at baseline, six weeks, 6 months and one year from enrolling in the study.

In addition to assessing clinical outcomes following treatment, the investigators will assess the amount of health care utilized by each participant in the year following enrollment in the study. The 3 groups will be analyzed to determine if there is a difference in the amount or type of additional healthcare utilized in the year following study enrollment. Examples of healthcare utilization include x-rays, medication and/or surgical procedures.

The investigators hypothesis is that individuals that receive actual trigger point DN in addition to manual therapy and exercise interventions will demonstrate greater improvements in pain, shoulder function and disability when compared to individuals receiving exercise and manual therapy alone or exercise and manual therapy with sham needling. The investigators think these differences in clinical outcomes will be present at each of the follow-up points. Additionally, the investigators hypothesize that individuals receiving actual DN will use less healthcare than those in the other two groups.


Condition or disease Intervention/treatment Phase
Subacromial Impingement Syndrome Procedure: Standard Physical Therapy Treatment Procedure: Dry Needling Procedure: Sham Dry Needling Not Applicable

  Show Detailed Description

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 130 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: 3 groups: Standard physical therapy treatment (SPT), SPT plus dry needling and SPT plus sham dry needling
Masking: Single (Participant)
Masking Description: Subjects in the dry needling and sham dry needling groups will be masked (blinded) to whether or not they are receiving the sham or actual dry needling.
Primary Purpose: Treatment
Official Title: Dry Needling in Addition to Standard Physical Therapy Treatment for Sub-Acromial Pain Syndrome: A Randomized Controlled Trial
Actual Study Start Date : March 6, 2018
Estimated Primary Completion Date : March 2020
Estimated Study Completion Date : March 2021

Arm Intervention/treatment
Active Comparator: Standard PT Treatment

This group will receive manual therapy and exercise interventions provided by their physical therapist. The treatment will occur for 10 sessions over 6 weeks.

Interventions: Manual therapy interventions including mobilization and manipulation of the shoulder girdle spine and ribcage. Exercise interventions will include strengthening and flexibility exercises for rotator cuff and shoulder girdle musculature.

Procedure: Standard Physical Therapy 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. Manual therapy and exercise interventions will be selected to address impairments uncovered in the shoulder exam.

Experimental: Standard PT Treatment plus DN
In addition to the standard PT interventions, the Dry Needling (DN) group will receive 6 DN sessions as part of their rehabilitation visits.
Procedure: Standard Physical Therapy 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. Manual therapy and exercise interventions will be selected to address impairments uncovered in the shoulder exam.

Procedure: 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.

Sham Comparator: Standard PT Treatment plus Sham DN
In addition to the standard PT treatment, patients in the sham DN group will receive 6 sessions of sham DN intervention.
Procedure: Standard Physical Therapy 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. Manual therapy and exercise interventions will be selected to address impairments uncovered in the shoulder exam.

Procedure: Sham Dry Needling
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. 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.




Primary Outcome Measures :
  1. Change in Shoulder Pain and Disability Index (SPADI) scores [ Time Frame: Baseline, 6-weeks, 6 months, 12 months ]
    The SPADI is a 100-point, 13 item self-administered questionnaire. It is divided into two subscales: a five item pain subscale and an eight-item disability subscale. Williams et al have shown that the SPADI is responsive to change and accurately discriminates between patients who are improving or worsening. Michener and Leggin also reported a high test-retest reliability and internal consistency for this instrument. When compared to the Sickness Impact Profile (SIP), Heald et al found that the construct validity of the SPADI is moderately strong and it is more responsive to change than the SIP. A recent systematic review identified a minimal detectable change (MDC) of 18 and a minimally clinically important difference (MCID) of between 8-13 points. The validity and responsiveness to change of SPADI have been described in physical therapy, as well as primary and secondary care settings.


Secondary Outcome Measures :
  1. Patient Reported Outcomes Measurement Information Systems (Promis-29) [ Time Frame: Baseline, 6 weeks, 6 months, 12 months ]
    The Patient-Reported Outcomes Measurement Information Systems (PROMIS) 29-item short form (version 2). The PROMIS 29-item short form efficiently assesses several outcomes important to patients; including, pain intensity and interference, sleep disturbance, anxiety, depression, fatigue, and social role participation using items developed with rigorous methodology and patient input.

  2. Patient Acceptable Symptom Scale (PASS) [ Time Frame: Baseline, 6 weeks, 6 months, 12 months ]
    Often defined as "the highest level of symptoms beyond which patients consider themselves well." This outcome measure has been used in previous studies looking at the effects of cervico-thoracic thrust manipulation on shoulder pain. The question that will be asked to assess this level is, "Taking into account all the activities you have during your daily life, your level of pain, and also your functional impairment, do you consider that your current state is satisfactory?" Individuals who responded "yes" were categorized as a success." Between group differences at four time points will be assessed as percentage of subjects who find their current state acceptable, or answering "yes."

  3. Optimal Screening for Prediction of Referral and Outcome Yellow Flags assessment tool (OSPRO-YF) [ Time Frame: Baseline, 6 weeks, 6 months, 12 months ]
    The OSPRO-YF measures psychosocial risk factors. It may be administered early after injury and sequentially over time.

  4. Healthcare Utilization [ Time Frame: 12 months following enrollment ]
    Healthcare utilization data will be collected from the Military Health System (MHS) Data Repository (MDR) database. Healthcare utilization data will be used to determine any subsequent medical utilization related to shoulder pain. The goal of the MDR database will be to determine which of these subjects sought health care related to shoulder pain in the 12-month period after treatment in this study. This data (type, location, number of clinic visits, types of specialty clinic visits, imaging, and associated medication) will allow us to determine the extent of healthcare utilizations incidence.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03442894


Contacts
Layout table for location contacts
Contact: Ben R Hando, DScPT (361) 857 4599 shoulderpainresearch@gmail.com

Locations
Layout table for location information
United States, Texas
Wilford Hall Ambulatory Surgical Center Recruiting
San Antonio, Texas, United States, 78236
Contact: Ben R Hando, DScPT         
Principal Investigator: Ben R Hando, DScPT         
Sponsors and Collaborators
Wilford Hall Medical Center
Investigators
Layout table for investigator information
Principal Investigator: Ben Hando, DScPT US Air Force

Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Benjamin Hando, Orthopedic and Rehabilitation Flight Commander, Wilford Hall Medical Center
ClinicalTrials.gov Identifier: NCT03442894     History of Changes
Other Study ID Numbers: FWH20170083H
First Posted: February 22, 2018    Key Record Dates
Last Update Posted: October 3, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: There is currently no plan to share the data with other researchers. Our team has not coordinated with other researchers to share our data.

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Benjamin Hando, Wilford Hall Medical Center:
Shoulder pain
Subacromial
bursitis
rotator cuff
tendinopathy
dry needling
myofascial trigger point

Additional relevant MeSH terms:
Layout table for MeSH terms
Syndrome
Shoulder Impingement Syndrome
Disease
Pathologic Processes
Joint Diseases
Musculoskeletal Diseases
Shoulder Injuries
Wounds and Injuries