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Effectiveness of Dry Needling and Physical Therapy Versus Physical Therapy Alone Following Shoulder Stabilization Repair

Primary Purpose

Shoulder Pain

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Rehabilitation and Dry Needling
Rehabilitation
Sponsored by
Keller Army Community Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Shoulder Pain focused on measuring Dry Needling, Shoulder Stabilization

Eligibility Criteria

18 Years - 40 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 18-40 yo DOD Beneficiaries
  • Status Post Shoulder Stabilization Repair Surgery

Exclusion Criteria:

  • Self-Reported Pregnancy
  • History of blood borne pathogens/infectious disease/active infection/metal allergy
  • Bleeding disorders or currently taking anti-coagulant medications
  • Participants who are not fluent in English

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    Rehabilitation and Dry Needling

    Rehabilitation

    Arm Description

    Standard Rehabilitation Protocol following shoulder stabilization surgery and Dry Needling to the Shoulder girdle 1 time a week for 4 weeks between weeks 4 and 8 post operatively

    Standard Rehabilitation Protocol following shoulder stabilization surgery alone

    Outcomes

    Primary Outcome Measures

    Shoulder Flexion and External Rotation Passive Range of Motion as measured with standard Goniometer
    Baseline ROM change from baseline 4 week time point to follow up at 8 week time point

    Secondary Outcome Measures

    Global Rating of Change Score
    Patient Specific Functional Score
    Shoulder Pain and Disability Index
    Shoulder Functional Movement
    Pain
    Numeric Pain Rating Scale
    Shoulder Flexion and External Rotation Passive Range of Motion as measured with standard Goniometer

    Full Information

    First Posted
    March 1, 2016
    Last Updated
    March 5, 2018
    Sponsor
    Keller Army Community Hospital
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02704975
    Brief Title
    Effectiveness of Dry Needling and Physical Therapy Versus Physical Therapy Alone Following Shoulder Stabilization Repair
    Official Title
    Effectiveness of Trigger Point Dry Needling and Physical Therapy Versus Physical Therapy Alone Following Shoulder Stabilization Repair: A Randomized Controlled Trial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    March 2018
    Overall Recruitment Status
    Completed
    Study Start Date
    March 2016 (undefined)
    Primary Completion Date
    December 2017 (Actual)
    Study Completion Date
    December 2017 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Keller Army Community Hospital

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    The purpose of this single-blinded, randomized clinical trial is to determine the effectiveness of dry needling compared to a standard shoulder rehabilitation program on range of motion, functional movement, and pain in patients who have undergone shoulder stabilization surgery. Measurements of the aforementioned dependent variables will be taken at time intervals of four weeks, eight weeks, 12 weeks, and six months post-operatively. It is hypothesized that the inclusion of dry needling will result in an increase in range of motion, increase in functional movement, and decrease in pain at an accelerated rate when compared to rehabilitation alone.
    Detailed Description
    Methodology /Technical Approach 30-50 subjects at least four weeks after shoulder stabilization surgery will be randomized into two groups (one experimental group and one control group). Subjects in the experimental group will receive Trigger Point Dry Needling (TDN) intervention with standard rehabilitation protocol (Appendix A) while subjects in the control group will receive the same standard rehabilitation protocol without TDN. The experimental group will receive trigger point dry needling one time per week for four to six weeks in addition to the standard rehabilitation protocol. The control group will receive only the standard rehabilitation protocol. Baseline measurements will be taken at approximately four weeks post operatively, and subsequent measurements will be recorded at eight weeks, 12 weeks, and six months. All patients who have undergone a shoulder stabilization procedure will be invited to participate. Description of the study and informed consent will take place prior to randomization. Concealed randomization will take place 0-7 days post-operatively. At 4 weeks post-operatively, the following assessment tests will be undertaken: supine shoulder flexion, supine shoulder external rotation, supine shoulder internal rotation, functional movement testing, functional outcome measures, and the numeric pain rating scale. 1,2,3 Those subjects in the 'experimental group' will receive manual palpation of all upper quarter muscles, including the cervical and thoracic spine region, to detect the presence of myofascial trigger points (TPs). Dry needling will be performed to all detected TPs by a provider trained and experienced in TDN. In addition to the TDN intervention, the experimental group subjects will undergo a rehabilitation program in accordance with a shoulder stabilization repair protocol which is the standard of care for this surgical procedure. Per the shoulder stabilization protocol, subjects will be instructed in a home exercise plan (HEP) that will reinforce the clinical treatment, will be provided with a handout of instructions, and will be required to demonstrate all exercises correctly. Subjects in the 'control group' will undergo a rehabilitation program as described above for the 'experimental group', except that they will not receive a TDN intervention. Objectives: To determine if the addition of upper quarter TDN to a rehabilitation protocol is more effective in improving range of motion and functional movement when compared to a rehabilitation protocol alone after shoulder stabilization surgery. To determine if the addition of upper quarter TDN to a rehabilitation protocol is more effective in decreasing pain than a rehabilitation protocol alone after shoulder stabilization surgery.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Shoulder Pain
    Keywords
    Dry Needling, Shoulder Stabilization

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Factorial Assignment
    Masking
    Outcomes Assessor
    Allocation
    Randomized
    Enrollment
    39 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Rehabilitation and Dry Needling
    Arm Type
    Experimental
    Arm Description
    Standard Rehabilitation Protocol following shoulder stabilization surgery and Dry Needling to the Shoulder girdle 1 time a week for 4 weeks between weeks 4 and 8 post operatively
    Arm Title
    Rehabilitation
    Arm Type
    Active Comparator
    Arm Description
    Standard Rehabilitation Protocol following shoulder stabilization surgery alone
    Intervention Type
    Device
    Intervention Name(s)
    Rehabilitation and Dry Needling
    Intervention Description
    Subjects will receive post-operative rehabilitation that is the standard of care for the surgical procedure they underwent. Rehabilitation will begin within one week after surgery and will continue for the duration of their recovery; two to three treatments a week for approximately 6-9 months. Subjects in this group will also receive dry needling as an adjunct intervention. Dry needling treatment will be performed one time a week for four weeks and will begin four weeks post-operative.
    Intervention Type
    Device
    Intervention Name(s)
    Rehabilitation
    Intervention Description
    Subjects will receive post-operative rehabilitation that is the standard of care for the surgical procedure they underwent. Rehabilitation will begin within one week after surgery and will continue for the duration of their recovery; two to three treatments a week for approximately 6-9 months.
    Primary Outcome Measure Information:
    Title
    Shoulder Flexion and External Rotation Passive Range of Motion as measured with standard Goniometer
    Description
    Baseline ROM change from baseline 4 week time point to follow up at 8 week time point
    Time Frame
    Change from Baseline at 4 weeks to 8 weeks
    Secondary Outcome Measure Information:
    Title
    Global Rating of Change Score
    Time Frame
    4 weeks, 8 weeks, 12 weeks, 6 months
    Title
    Patient Specific Functional Score
    Time Frame
    4 weeks, 8 weeks, 12 weeks, 6 months
    Title
    Shoulder Pain and Disability Index
    Time Frame
    4 weeks, 8 weeks, 12 weeks, 6 months
    Title
    Shoulder Functional Movement
    Time Frame
    4 weeks, 8 weeks, 12 weeks, 6 months
    Title
    Pain
    Description
    Numeric Pain Rating Scale
    Time Frame
    4 weeks, 8 weeks, 12 weeks, 6 months
    Title
    Shoulder Flexion and External Rotation Passive Range of Motion as measured with standard Goniometer
    Time Frame
    12 weeks, 6 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    40 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: 18-40 yo DOD Beneficiaries Status Post Shoulder Stabilization Repair Surgery Exclusion Criteria: Self-Reported Pregnancy History of blood borne pathogens/infectious disease/active infection/metal allergy Bleeding disorders or currently taking anti-coagulant medications Participants who are not fluent in English

    12. IPD Sharing Statement

    Plan to Share IPD
    No

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