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

Effectiveness of Trigger Point Dry Needling and Physical Therapy Versus Physical Therapy Alone Following Shoulder Stabilization Repair: A Randomized Controlled Trial

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.

Study Overview

• Status: Completed
• Conditions: Shoulder Pain
• Intervention / Treatment: Device: Rehabilitation and Dry Needling; Device: Rehabilitation

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:

1. 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.
2. 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.

• Study Type: Interventional
• Enrollment (Actual): 39
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 40 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Factorial Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Rehabilitation and Dry Needling; 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	Device: Rehabilitation and Dry Needling; 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.
Active Comparator: Rehabilitation; Standard Rehabilitation Protocol following shoulder stabilization surgery alone	Device: Rehabilitation; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	Change from Baseline at 4 weeks to 8 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Global Rating of Change Score		4 weeks, 8 weeks, 12 weeks, 6 months
Patient Specific Functional Score		4 weeks, 8 weeks, 12 weeks, 6 months
Shoulder Pain and Disability Index		4 weeks, 8 weeks, 12 weeks, 6 months
Shoulder Functional Movement		4 weeks, 8 weeks, 12 weeks, 6 months
Pain	Numeric Pain Rating Scale	4 weeks, 8 weeks, 12 weeks, 6 months
Shoulder Flexion and External Rotation Passive Range of Motion as measured with standard Goniometer		12 weeks, 6 months

Collaborators and Investigators

• Sponsor: Keller Army Community Hospital

Study record dates

Study Major Dates

• Study Start: March 1, 2016
• Primary Completion (Actual): December 1, 2017
• Study Completion (Actual): December 1, 2017

Study Registration Dates

• First Submitted: March 1, 2016
• First Submitted That Met QC Criteria: March 4, 2016
• First Posted (Estimate): March 10, 2016

Study Record Updates

• Last Update Posted (Actual): March 6, 2018
• Last Update Submitted That Met QC Criteria: March 5, 2018
• Last Verified: March 1, 2018

More Information

Terms related to this study

• Keywords: Dry Needling, Shoulder Stabilization
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Joint Diseases; Musculoskeletal Diseases; Arthralgia; Shoulder Pain
• Other Study ID Numbers: 16-007

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO