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
About this trial
This is an interventional treatment trial for Shoulder Pain focused on measuring Dry Needling, Shoulder Stabilization
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
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
NCT ID
NCT02704975
First Posted
March 1, 2016
Last Updated
March 5, 2018
Sponsor
Keller Army Community Hospital
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
Learn more about this trial
Effectiveness of Dry Needling and Physical Therapy Versus Physical Therapy Alone Following Shoulder Stabilization Repair
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