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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02704975

Enrollment

Registered

2016-03-10

Start date

2016-03-31

Completion date

2017-12-31

Last updated

2025-11-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Shoulder Pain

Keywords

Dry Needling, Shoulder Stabilization

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: 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.

Interventions

DEVICERehabilitation 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.

DEVICERehabilitation

Study design

Allocation

RANDOMIZED

Intervention model

FACTORIAL

Primary purpose

TREATMENT

Masking

SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 40 Years

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

Design outcomes

Primary

Measure	Time frame	Description
Shoulder Flexion Passive Range of Movement (PROM)	at 8 weeks post-op, 12 weeks post-op, 6 months post-op	Subject is supine with hips and knees flexed for stabilization. Elbow will be extended, forearm relaxed, and wrist in neutral position. Subjects' arm will be raised into forward flexion by the practitioner. The stationary arm of the goniometer will be placed parallel to the spine but at the lateral aspect of the body. The moving arm of the goniometer will be placed along the midline of the humerus.
Shoulder External Rotation PROM at 8 Weeks	at 8 weeks post-op, 12 weeks post-op, 6 months post-op	Subject is supine on the plinth with hips and knees flexed for stabilization. Tested arm abducted to 90 degrees. Elbow flexed to 90 degrees. Forearm in the midposition between supination and pronation and perpendicular to the plinth. Subject arm rotated by the practitioner. The stationary arm of the goniometer will be horizontal to the plinth with the pivot of the protractor on the olecranon process. The moving arm of the goniometer is in line with the styloid process of the ulna.
Shoulder Internal Rotation (IR) PROM	at 8 weeks post-op, 12 weeks post-op, 6 months post-op	Subject is supine on the plinth with hips and knees flexed for stabilization. Tested arm abducted to 90 degrees, elbow flexed to 90 degrees, forearm in the midposition between supination and pronation and perpendicular to the plinth,. Subject arm internally rotated by practitioner. Stationary arm of goniometer horizontal to the plinth with the pivot of the protractor on the olecranon process. Moving arm of the goniometer in line with the styloid process of the ulna.
Numeric Pain Rating Scale (NPRS)	at 8 weeks post-op, 12 weeks post-op, 6 months post-op	Numeric Pain Rating Scale. Numerical Scale from 1-10. Subjects are asked self-report pain on a scale from 1 - 10, 1 being the least amount of pain and 10 being the most. The Minimum Important Difference for the NPRS (on a scale from 0-10) range from -1.5 (small change) to -3.0 (medium change) to -3.5 (large change)

Secondary

Measure	Time frame	Description
Patient Specific Functional Scale	at 8 weeks post-op, 12 weeks post-op, 6 months post-op	The PSFS is a self-report questionnaire assessing pain, instability and activities of daily living (ADLs). The Minimum Important Difference for the PSFS (on a scale from 0-10) range from 1.3 (small change) to 2.3 (medium change) to 2.7 (large change). The total score is reported.
Shoulder Pain and Disability Index Functional Outcome Measure	at 8 weeks post-op, 12 weeks post-op, 6 months post-op	The SPADI is a self-report questionnaire assessing pain and disability. The Minimum Important Difference for the SPADI (on a 100- point scale) is 13.2. The total score is reported. Minimum score is 0.
Global Rating of Change	at 8 weeks post-op, 12 weeks post-op, 6 months post-op	Score is rated from -7 (very great deal worse) to +7 (very great deal better) where subjects check an answer that best describes their current perceived status since injury onset to time of follow up. Meaningful patient improvement/deterioration (on a 15 point scale) is considered to be \>5 or \<-5.

Participant flow

Participants by arm

Arm	Count
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 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.	19
Rehabilitation Standard Rehabilitation Protocol following shoulder stabilization surgery alone 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.	20
Total	39

Baseline characteristics

Characteristic	Total	Rehabilitation and Dry Needling	Rehabilitation
Age, Continuous	20.78 years STANDARD_DEVIATION 3.33	19.9 years STANDARD_DEVIATION 1.1	21.6 years STANDARD_DEVIATION 4.5
Global Rating of Change (GROC)	4.6 units on a scale STANDARD_DEVIATION 2	4.5 units on a scale STANDARD_DEVIATION 2	4.8 units on a scale STANDARD_DEVIATION 2
Numeric Pain Rating Scale (NPRS)	2.38 units on a scale STANDARD_DEVIATION 1.8	2.21 units on a scale STANDARD_DEVIATION 1.8	2.55 units on a scale STANDARD_DEVIATION 1.8
Patient Specific Functional Scale (PSFS)	3.2 units on a scale STANDARD_DEVIATION 2.2	2.9 units on a scale STANDARD_DEVIATION 2.2	3.5 units on a scale STANDARD_DEVIATION 2.1
Race and Ethnicity Not Collected	0 Participants	—	—
Region of Enrollment United States	39 Participants	19 Participants	20 Participants
Sex: Female, Male Female	6 Participants	3 Participants	3 Participants
Sex: Female, Male Male	33 Participants	16 Participants	17 Participants
Shoulder External Rotation (ER) PROM	29.34 degrees STANDARD_DEVIATION 18.7	30 degrees STANDARD_DEVIATION 15.9	28.67 degrees STANDARD_DEVIATION 21.4
Shoulder Flexion Passive Range of Motion (PROM)	131.1 degrees STANDARD_DEVIATION 14.7	134.2 degrees STANDARD_DEVIATION 15.1	128 degrees STANDARD_DEVIATION 14.5
Shoulder Internal Rotation (IR) PROM	40.1 degrees STANDARD_DEVIATION 15.6	44.5 degrees STANDARD_DEVIATION 12.6	36.8 degrees STANDARD_DEVIATION 17.9
Shoulder Pain and Disability Index (SPADI)	42 units on a scale STANDARD_DEVIATION 18.4	42.8 units on a scale STANDARD_DEVIATION 21.9	41.4 units on a scale STANDARD_DEVIATION 17

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk
deaths Total, all-cause mortality	0 / 19	0 / 20
other Total, other adverse events	0 / 19	0 / 20
serious Total, serious adverse events	0 / 19	0 / 20

Outcome results

Primary

Numeric Pain Rating Scale (NPRS)

Numeric Pain Rating Scale. Numerical Scale from 1-10. Subjects are asked self-report pain on a scale from 1 - 10, 1 being the least amount of pain and 10 being the most. The Minimum Important Difference for the NPRS (on a scale from 0-10) range from -1.5 (small change) to -3.0 (medium change) to -3.5 (large change)