Effectiveness of Astym Treatment For de Quervain's Tenosynovitis
Phase: NA
Conditions: de Quervain's Disease
Sponsor: NYU Langone Health

07/27/15 Version Date 1 
 
 
 
Title of Research Project: Effectiveness of ASTYM treatment when added to   traditional therapy for 
treatment of de Quervain’s tenosynovitis 
 
     Principal Investigator: Stephen Van Lew, MS, OTR/L 
 
     Co-Investigators: April O’Connell, OTR/L, CHT; Monica Seu, OTR/L, CHT, Francoise Cherry,     
     OTR/L,CHT; Daniel Geller, MS, MPH, OTR/L; William Finley, OTR/L, Julie Fernandez, OTR/L,  
     CHT 
 
IRB#  
s14-01059 
NCT#   
NCT02442622  
 
 

07/27/15 Version Date 2 
 
 
Table of Contents 
I. 
Purpose of Study and Background 
 
 
 
2-7 
1) Purpose of Study 
 
 
 
 
2 
2) Background   
 
 
 
 
2-5 
3) Study Design  
 
 
 
 
6 
II. 
Characteristics of Research Population  
 
7 
1) Number of Subjects  
 
 
 
7 
2) Gender of subjects 
 
 
 
 
7 
3) Age of Subjects 
 
 
 
 
 
7 
4) Racial and Ethnic Origin 
 
 
 
 
7 
5) Inclusionary criteria  
 
 
 
7 
6) Exclusionary criteria  
 
 
 
7 
7) Subject withdrawal criteria   
 
 
7 
8) Vulnerable subjects   
 
 
 
7 
III. 
Methods and Procedures  
 
 
 
8-13 
1) Methods and Procedures  
 
 
 
8-11 
2) Schematic Diagram   
 
 
 
12 
3) Data Analysis and Monitoring  
 
 
 
13 
 
 
 
4) Data Storage and confidentiality  
 
 
13 
IV. 
Risk and Benefit analysis   
 
 
 
12-13 
1) Risk 
 
 
 
 
 
 
12 
2) Protection against risk 
 
 
 
 
12-13 
3) Potential benefits to subjects  
 
 
 
13 
V. 
Investigators qualification and experience 
 
 
13 
VI. 
Subject identification, recruitment and Consent/Accent  
13-14 
1) Method of subject identification and recruitment  13 
2) Process of consent  
 
 
 
 
13 
3) Subject capacity  
 
 
 
 
13 
4) Subjects representative comprehension  
 
13 
5) Debriefing procedures 
 
 
 
 
13-14 
6) Consent forms 
 
 
 
 
14 
7) Documentation of consent   
 
 
14 
8) Cost to subjects  
 
 
 
 
14 
9) Payment for participation 
 
 
 
14 
VII. 
References Cited   
 
 
 
 
15-17 
VIII. 
Appendix   
 
 
 
 
 
18 
 
 
 
 
Title of Research Project: Effectiveness of ASTYM treatment when added to   
traditional therapy for treatment of de Quervain’s tenosynovitis 

07/27/15 Version Date 3 
 
 
 
     Principal Investigator: Stephen Van Lew, MS, OTR/L 
     Co-Investigators: April O’Connell, OTR/L, CHT; Monica Seu, OTR/L, CHT, Francoise Cherry,     
     OTR/L,CHT; Daniel Geller, MS, MPH, OTR/L; William Finley, OTR/L, Julie Fernandez, OTR/L,  
     CHT 
 
IRB#-s 14-01059 
 
 
I.Purpose of Study and Background 
• Purpose of study:  
To determine if the addition of Astym treatment to traditional therapy produces a more positive outcome 
than traditional therapy alone for the treatment of de Quervain’s tenosynovitis. 
 
• Background: 
de Quervain's disease is caused by a stenosis of the first dorsal compartment of the wrist1, 2 and 3 that 
contains the tendons and synovial sheaths of the abductor pollicis longus (APL) and the extensor pollicis 
brevis (EPB) muscles.4 The APL acts at the base of the first metacarpal to abduct the thumb while the 
EPB extends the metacarpophalangeal joint and contributes to radial abduction of the thumb.5 The 
narrowing of the compartment is a result of the thickening of its septum2 and 3 with no sign of acute 
inflammation1, 3, 6 and 7 but with signs of chronic degeneration.2, 8 and 9 During menopause age,1, 3, 7 and 9 
women are especially vulnerable to this condition. A higher prevalence is also noted during pregnancy or 
in the postpartum period.10 and 11 Neither ethnicity1 nor hand dominance1 and 7 have an influence on the 
appearance of symptoms. The disease affects 1.3% of working women and 0.5% of working men in 
general.12 
The main presenting symptom is pain on the radial side of the wrist, which can radiate proximally or 
distally and is aggravated by thumb or wrist movements.1, 2, 3, 6 and 9 Other possible symptoms include 
impaired function of the thumb,1, 3 and 6 stiffness,1 paresthesia,1, 6 and 9 sleep disturbance,1 and 6 swelling or 
tenderness over the radial styloid process,1, 2, 3, 6 and 7 and thumb weakness.13 and 14  

07/27/15 Version Date 4 
 
 
To date, there is no recognized, standardized, or consistent therapeutic treatment program that has been 
documented for the management of de Quervain’s. Traditional treatments for de Quervain’s tenosynovitis 
include: (1) injection of corticosteroids into the first dorsal compartment; (2) immobilization of the wrist 
and thumb in a neutral position with a forearm based thumb spica splint; (3) a combination of both. 
Several case series and clinical trials have studied corticosteroid injections alone and in combination with 
other modalities including splinting and NSAIDS. The success rate with injections of various 
corticosteroid formulations ranges from 62-93% 15, 16 and 17. Other conservative treatments include 
adjusting the work environment, non-steroidal anti-inflammatory drugs (NSAIDS), ultrasound, 
manipulation, nerve and tendon gliding, stretching, and strengthening15, 16 and 17. Although NSAIDS, 
splinting, and local corticosteroid injection often show promise in relieving symptoms initially, several 
researchers have found that long-term successful outcomes are poor20
 
In a 3-armed study, Weiss et al. studies use of corticosteroid injections and splinting together and 
separately to determine their clinical effect. They observed a 67% improvement with injection alone, 
57% improvement with both injection and splinting, and 19% improvement with splinting alone.21
Lane et al. separated their study population into minimal, moderate, and severe illness based on clinical 
symptoms. They identified a success rate of 88% with use of NSAIDS and splints in patients with 
“minimal” symptoms but only a 32% success rate with “moderate to severe” symptoms22. There are 
surprisingly few scientific studies that identify the efficacy of treatment for this relatively common 
condition. Systematic reviews that show inconclusive results because of poor quality studies indicates 
that clinicians have yet to discover the ‘‘magic bullet’’ that will resolve the most recalcitrant 
tendinopathies of the elbow, wrist, and hand20. This is especially true if patients are hesitant or unwilling 
to receive a corticosteroid injection. 

07/27/15 Version Date 5 
 
 
 
The Astym treatment technique (Performance Dynamics, Muncie, IN) has been used in the NYU 
Langone Medical Center for 4 years with level 5 evidence as an alternative to corticosteroid injections for 
the treatment of de Quervain’s tenosynovitis. Astym is based on an expansion of soft tissue massage and 
manual therapy concepts. It incorporates the use of specially designed hand-held instruments that enable 
clinicians to deliver a controlled amount of microtrauma into specific areas of connective tissue 
structures.  Astym tools are not FDA approved and meet the definition of a non-significant risk device 
secondary to not meeting the criteria for a significant risk device because: 
1. It is NOT an implant with potential serious risk to subjects’ health, safety or welfare. 
2. It is NOT purported or represented for use supporting or sustaining human life with potential serious 
risk to subjects’ health, safety, welfare. 
3. It is NOT for substantial importance in diagnosing, curing, mitigating, or treating disease or otherwise 
preventing impairment or human health with potential serious risk to subject health, safety, welfare. 
4. It does NOT present a potential for serious risk to subject health, safety, welfare. 
 It is theorized that this treatment process leads to the reabsorption of fibrosis and soft tissue regeneration.  
 
In a study by Davidson et al24 Astym was utilized to introduce a controlled amount of micro- trauma into 
enzyme-induced injured rat Achilles tendons. This controlled injury caused a small amount of 
microvascular trauma and hemorrhage that induced a localized inflammatory response. In Davidson's 
study, a light microscope demonstrated increased fibroblast proliferation in the Astym study group24. 
They concluded that although healing in rats may not translate directly to humans, the findings suggest 
that Astym treatment approach may promote healing via increased fibroblast recruitment. In a follow-up 
study by Gehlsen et al,25 they examined morphological changes in the rat Achilles tendon after enzyme-

07/27/15 Version Date 6 
 
 
induced injury with collagenase and subsequent pressure variations with the Astym process. A pressure 
transducer was embedded into one of the Astym instruments and interfaced to a computer which 
controlled the pressure variations. They concluded that morphological evidence indicated that application 
of heavy pressure promoted the healing process to a greater degree than light or moderate pressure. 
During the Astym treatment process, a lubricant is applied to the patient's skin prior to treatment to 
reduce the coefficient of friction and prevent abrasive trauma to the overlying skin. The angled edge of 
the instruments `catches' on the areas of fibrosis and triggers a localized inflammatory response. The 
instruments are then moved via longitudinal strokes along the affected musculotendinous structures23. As 
the instruments glide over the skin, the clinician and patient can detect changes in the underlying soft 
tissues through the resonant properties of the instruments. The patient is treated in a seated position, 
addressing the extremity (hand, wrist, forearm, and elbow). In addition to the treatment at the wrist, the 
entire upper extremity is evaluated for compensatory strain patterns that may manifest as fibrosis. 
In therapy related research, Fowler et al. 26 examined cumulative trauma disorders in a large 
manufacturing plant and found that 25 out of 29 extremities treated with the Astym system resolved. The 
criteria utilized for resolution were full return to pre-injury activities and functional ability with less than 
or equal to 3/10 pain on a visual analog scale. 
 
In a case report by Baker and Wilson23 examining Astym in the treatment of a bilateral carpal tunnel 
syndrome (CTS) patient, they found that Astym was shown to be an effective treatment approach for 
resolving the patient's symptoms. An article by Ettema et al27 reported on the physiological changes that 
occur in the subsynovial layer of tissue during carpal tunnel. An electron microscope found fibrotic 
changes as a result of a shearing injury. The anatomy of the flexor tendons are similar to that of the 
tendons involved in de Quervain’s. If Astym has been shown to be an effective treatment approach for 

07/27/15 Version Date 7 
 
 
CTS, then it is reasonable to hypothesize that Astym would be an effective treatment for de Quervain’s 
tenosynovitis. But does the Astym treatment along with stretching and exercise work better than the gold 
standard of care of splinting and exercise alone.
 
• Study design:  
 
The research question for this study is: 
 
Does adding an Astym treatment protocol to existing standard of care treatment of de Quervain’s  
tenosynovitis increase outcomes of individuals with this condition?  
 
 
       
       The Alternative Hypothesis for this study is: 
 
              Participants receiving the Astym treatment protocol will have greater improvements in pain  
              reduction and function as compared to those subjects in the control group receiving the 
              standard of care therapy treatment  
 
             This is a randomized controlled study using repeated measure design with 2 groups:             
                            
A. Control group who will receive standard of care rehabilitation intervention for the 
treatment of de Quervain’s tenosynovitis.  
 
B. Experimental group will receive standard of care rehabilitation interventions plus 
Astym treatment protocol.  
 
             Three outcomes measures will be used for the study: 
 
1. Numeric Rating Scale for Pain- This scale is a single point scale from 0-10. The 
participant picks one number to represent their pain, where 0 represents no pain and 10 
represents worst pain imaginable. 
 
2. Quick Dash-This is an 11 item questionnaire in which participants self-score themselves 
using a 1-5 point scale.  One represents no difficulty in performing task whereas 5 
represents unable to perform task. 
 
 
3. Sequential Occupational Dexterity Assessment-This is a test to measure dexterity and 
bimanual abilities in activities of daily living. It includes 12 tasks with participants being 
scored on their ability, difficulty and pain during the task. 
 

07/27/15 Version Date 8 
 
 
II. Characteristics of research population 
• Number of subjects: N=32 (16 in each group) 
 
• Gender of subjects: Both male and female participants will be included in the study. 
Demographic data will be included in the analysis of results. 
 
• Age of subjects: 18-65yrs old 
 
• Racial and ethnic origin: There will be no racial or ethnic restrictions to this study. Data on 
racial/ethnic origin will not be gathered by the researchers. It is assumed based on current 
client population that the sample will be diverse.   
 
• Inclusion criteria: 
i. Positive Finkelstein’s test: The client will report pain over the first compartment of the 
extensor retinaculum when the thumb is tucked in the hand and deviated ulnarly.  
ii. Persistent symptoms for >3 wks which have not resolved after an additional 3 weeks of 
splinting 
iii. A diagnosis by a physician of “de Quervain’s”, “fist compartment tenosynovitis”,  or 
“radial styloid tenosynovitis” 
iv. Patients must agree and comply to a predetermined splinting regimen  
 
• Exclusion criteria: 
i. History of cortical steroid injection to affected wrist and/or thumb 
ii. Comorbidity such as osteoarthritis, rheumatoid arthritis, auto-immune disease or 
inflammatory conditions. 
iii. Clotting deficits 
iv. Positive Cozen’s sign which would indicate intersection syndrome38 
v. Post-partum mothers <6 months and pregnant women10-11 
vi. Cleared c-spine via Spurling’s Test34-35 performed by combining cervical extension, side-
bending, and axial compression to the cervical spine.  
 
• Vunerable subjects: 
No vulnerable subjects will be included in this study 
 
 
III. Methods and Procedures: 
• Methods and procedures:  
i. 
Randomized selection of 2 groups both seen for one evaluation and 12 therapy 
sessions scheduled 2x/week for 6 weeks (total of 12 sessions) for either traditional 
therapy including splinting and exercises or traditional therapy with Astym  protocol. 
At least 2 days in between therapy sessions to allow sufficient healing. 
ii. 
Randomization using computer-generated random numbers. The 3 Outcome 
measurements will be taken during evaluation and re-evaluation will be collected by 
two designated hand therapists other than the treating therapist. The data collectors 
will be blinded. 
 
 
 

07/27/15 Version Date 9 
 
 
iii. 
Data collection are taken at baseline, and after 12 sessions of therapy at discharge. . 
Quick DASH and VAS scale scores and questionnaire regarding patient compliance 
will be completed by phone interview at 3 month follow up.  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Research design: 
Patients with the diagnosis of de Quervain’s from referring physician will be provided with a pre-
fabricated Ossur thumb spica splint for use as indicated in splinting program13,15-17 ,instructed on a home 
exercise program as part of  standard of care along with being  educated about the research study.  If 
interested, they will be consented, and scheduled for a follow-up visit 3 weeks later.  If not interested, 
they will be scheduled for a 3 week follow-up session and treated if needed. Upon their return, the 
patients will be screened by the researcher OT for inclusion and exclusion criteria. If subject meets the 
criteria, they will be randomized into either (1) control or (2) Astym group  and then evaluated by a  
blinded Certified Hand Therapist or hand therapist Fine motor coordination will be tested by using the 
Sequential Occupational Dexterity Assessment (SODA) 39.  Pain and functional loss will be measured via 
the Visual Analog Scale (VAS)40 and Quick Dash41-45. They are then seen for formal therapy 2/x for  6 
weeks for a total of 12 therapy session.  If the subject does not meet criteria or decide not to participate in 
 
 

07/27/15 Version Date 10 
 
 
the study, they are deemed a screen failure, dismissed from study, and will continue with treatment if 
needed.  
The subjects will be seen twice a week for 6 weeks for 30 minute sessions by a separate treating therapist 
from the evaluating therapist. The patient will start at phase I; however, will not progress to the next 
phase of treatment if symptoms and pain are provoked.. When he/she tolerates exercises without pain or 
exacerbation of symptoms, the patient is progressed to Phase II and then phase III .Prior to discharge, if 
the subject has not achieved phase III, the therapist will incorporate Phase III exercises, for strengthening 
and functional movements of the hand, forearm, elbow and shoulder to be completed at home. . All 
subjects, either in control or Astym group, will receive only 12 sessions of therapy regardless if they 
progress through the all 3 phases. Astym group will receive traditional therapy with Astym every session, 
while the control group will only receive traditional therapy. See protocol below.  
Control group: Traditional therapy for de Quervain’s Tenosynovitis17-19, 21-22, 30-33:  
 
Phase I: Reduction of splint use andstrengthening initiated once patient can perform pain free AROM 
(monitor symptoms to not exacerbate condition) 
o Goals include: teaching self-management techniques for long-term control, 
ergonomics education, regaining flexibility and tolerance to light functional 
tasks without pain, initiation of splint wean off program  
o Moist heat pack for 10 minutes28 at beginning of treatment session 
o Stretching 4x/day for 30-45 seconds, including stretching prior to and after 
exercise: 
▪ UD of wrist with thumb tucked under fingers and wrist in neutral 
▪  Wrist flexion with elbow extended forearm pronated 
▪ Wrist extension with elbow extended forearm supinated 
o Isometric grip/pinch strengthening  
▪ Submaximal contractions to avoid increased microtrauma to 
musculotendinous unit 
▪ Strengthening started at 1 set of 5 reps with 2 second hold per repetition 
and working up to 6 seconds (as pain allows) 3x/day 
Phase II: Progress to strengthening of wrist and hand with emphasis on eccentric loading  
o Goals include: increasing patient tolerance to heavier demands of tasks without 
exacerbation of symptoms, return to normalcy of function without use of splint 
o Moist hot pack for 10 minutes28 at beginning of treatment 
o Advance patient once they can perform AROM, passive stretching of wrist, 
thumb and composite wrist/thumb, and isometrics pain free 
o Using light theraband, 2 second count concentric motion followed by 4 second 
count eccentric motion for wrist strengthening in flexion, extension, radial and 
ulnar deviation with elbow flexed at 30-45 degrees and forearm supported 
o Gentle grip, chuck pinch, lateral pinch and thumb opposition strengthening into 
soft- medium putty starting at 15 repetitions building to 30 repetitions each 
without exacerbation of symptoms 
o Thumb abduction and extension with yellow power web or light resistance 
rubber bands 3 sets of 10 reps 
o Continue stretching 4x/day for 30-45 seconds, with stretching prior to and after 
exercises: 
▪ UD of wrist with thumb tucked under fingers and wrist in neutral 
▪  Wrist flexion with elbow extended forearm pronated 
▪ Wrist extension with elbow extended forearm supinated 

07/27/15 Version Date 11 
 
 
 
Phase III: Continue therapy, incorporate strengthening and functional movements for forearm, elbow 
and shoulder and prepare patient for discharge to home exercise program 
o Goals include: Pain free functional use of affected extremity during all tasks 
without use of splint 
o Replace moist heat pack with Upper Body Ergometer for 10 min  
o Continue stretching 4x/day for 30-45 seconds, with stretching prior to and after 
exercises: 
▪ UD of wrist with thumb tucked under fingers and wrist in neutral 
▪  Wrist flexion with elbow extended forearm pronated 
▪ Wrist extension with elbow extended forearm supinated 
o Adding multi joint strengthening exercises to match job demands using 
dumbbells 
Patient discharged to home exercise program after 12 sessions of therapy with review of ergonomics, 
stretches, and exercises at last session.Astym group: Traditionaltherapy WITH Astym protocol for 
De Quervain’s Tenosynovitis17:  
Phase II:  Reduction of splint use and strengthening once patient can perform AROM pain free (monitor 
symptoms to not exacerbate condition) 
o Goals include: teaching self-management techniques for long-term control, 
ergonomics education, regaining flexibility and tolerance to light functional 
tasks without pain, initiation of splint wean off program  
o Moist  heat pack for 10 minutes28 at beginning of treatment 
o Astym treatment to affected extremity per de Quervain’s protocol, 
including de Quervain’s strokes (See Appendix I) 
o Stretching 4x/day for 30-45 seconds: 
▪ UD of wrist with thumb tucked under fingers and wrist in neutral 
▪  Wrist flexion with elbow extended forearm pronated 
▪ Wrist extension with elbow extended forearm supinated 
o Isometric grip/pinch strengthening  
▪ Submaximal contractions to avoid increased microtrauma to 
musculotendinous unit 
▪ Strengthening started at 1 set of 5 reps, 2 seconds per rep working up to 
6 seconds (as pain allows) 3x/day 
 
Phase II: Progress to strengthening of wrist and hand with emphasis on eccentric loading  
o Goals include: increasing tolerance to heavier demands of tasks without 
exacerbation of symptoms, return to normalcy of function without use of splint 
o Moist heat pack for 10 minutes28 at beginning of treatment 
o Continue Astym to affected extremity per de Quervain’s protocol, 
including de Quervain’s strokes  
o Advance patient once they can perform AROM, passive stretching of wrist, 
thumb and composite wrist/thumb, and isometrics pain free 
o Using light theraband, 2 second count concentric motion followed by 4 second 
count eccentric motion for wrist strengthening in flexion, extension, radial and 
ulnar deviation with elbow flexed at 30-45* and forearm supported 
o Gentle grip, chuck pinch, lateral pinch and thumb opposition strengthening into 
soft- medium putty starting at 15 repetitions building to 30 repetitions each 
without exacerbation of symptoms 

07/27/15 Version Date 12 
 
 
o Thumb abduction and extension with yellow power web or light resistance 
rubber bands 3 sets of 10 reps 
o Continue stretching 4x/day for 30-45 seconds, with stretching prior to and after 
exercises: 
▪ UD of wrist with thumb tucked under fingers and wrist in neutral 
▪  Wrist flexion with elbow extended forearm pronated 
▪ Wrist extension with elbow extended forearm supinated 
 
Phase III: Continue therapy, incorporate strengthening and functional movements for forearm, elbow 
and shoulder and prepare patient for discharge to home exercise program 
o Goals include: Pain free functional use of affected extremity during all tasks 
without use of splint 
o Replace moist heat pack with Upper Body Ergometer for 10 min  
o Continue Astym to affected extremity per de Quervain’s protocol, 
including de Quervain’s strokes for a max of 12 sessions 
o Continue stretching 4x/day for 30-45 seconds, with stretching prior to and after 
exercises: 
▪ UD of wrist with thumb tucked under fingers and wrist in neutral 
▪  Wrist flexion with elbow extended forearm pronated 
▪ Wrist extension with elbow extended forearm supinated 
o Adding multi joint strengthening exercises to match job demands using 
dumbbells 
o Patient discharged to HEP after 12 sessions of therapy with review of 
ergonomics, stretches, and exercises at last session. 
 
 
Three months after discharge from CMC, Quick DASH and VAS scale scores and questionnaire 
regarding patient compliance will be completed by phone interview.  
 
Data Analysis and Monitoring 
 
            Descriptive statistics will be used along with inferential statistics. The alternative  
              hypothesis will be addressed using a mixed design analysis of variance to test for  
              differences between-groups and within-groups.  In addition we will also analyze the  
              interaction effect between study group and time. All analyses will have an alpha of 0.05.  
              Malchy’s test for sphericity will be performed along with a Bonferroni comparison.  If  
              Malchy’s test for sphericity is significant then a Greenhouse-Geisser or Huynh-Feldt  
              correction will be used.   In addition a repeated measure MANOVA may be used to test the 
              dependent variables in a multivariate method if in fact the dependent variables  
              demonstrate a relationship of linearity.  
     
             Based upon the planned analyses for the primary hypothesis, a mixed repeated measure       
             design with 1 between factor (group membership) and 1 within factor (repeated measures)    
             has 2 groups with 16 subjects each for a total of 32 subjects. This design achieves a 80%  
             power to test the between factor using the above mentioned mixed methods ANOVA using a    
             5% significance level with an actual Cohen’s F effect size of .398            
 
Data Storage and Confidentiality 

07/27/15 Version Date 13 
 
 
           All written data will be stored in a locked draw of a locked office. For data analysis purposes   
            all data will also be stored using Microsoft Excel/ReCap Software.  To ensure confidentiality      
            all participants will be categorized alphanumerically.  
 
IV. Risk/Benefit Assessment 
• 
Risk 
 Potential side effects of Astym treatment include:  
1) Ecchymosis to the treatment area, typically where fibrotic tissue and healing is indicated. 
2) Increased pain or soreness for 24-48 hrs after treatment.  
3) Increased inflammation of affected extremity after treatment. 
4) Vagal response during treatment due to neural effect on tissue from the Astym treatment that include 
but are not limited to light headedness, feeling faint and nausea. 
 
• 
Protection against risks 
Patient education of these risks will help the patient understand some of the temporary side effects that 
they may experience. Icing 3-4 hrs after treatment can limit some of the side effects and help with pain 
and inflammation. Eating 1 hour prior to treatment will also limit vagal response during the Astym 
treatment. Prior to therapy, the patients will be encouraged to tell their therapist to stop treatment if they 
do not wish to continue if they are experiencing any of these symptoms and/or do not wish to continue in 
the study. 
 
• 
Potential benefits to subjects: 
Patients will receive Astym treatment to the affected extremity in addition to traditional therapy they 
would normally receive when being treated for de Quervain’s tenosynovitis. Astym treatment will be 
delivered by a qualified, specially trained occupational therapist where instruments will be applied 
topically to the skin with moderate pressure to stimulate a healing and regenerative response. . We 
believe the additional Astym protocol will increase functional levels for patients along with a greater 
social benefit of the knowledge gained from this experimental study.  
 
• Subject Compensation: 
There will be no compensation to patients for this study.  
 
 
V. Investigators Qualifications & Experience 
• 
Curriculum Vita for each investigator in study related documents 
 
VI. Subject Identification, Recuitment and Consent/Assent 
 
 
Method of subject identification and recruitment 
Clients referred to NYU Langone Center for Musculoskeletal Care with a diagnosis of de Quervain’s, 
radial styloid tenosynovitis, or first compartment tendonitis will be screened by investigators. After initial 
evaluation by a non-treating, blinded therapist, the patient will be provided with consent form and 
information on study (Appendix VIII). The client will be given the opportunity to ask questions to 
clinician and/or any member of the research team at this time or throughout the course of their treatment. 
 
Process of Consent 
                    Clients will be provided with consent form and information on study following the  

07/27/15 Version Date 14 
 
 
                    clinician’s inspection and determination of appropriateness to participate.  
 
                    Subject Capacity  
All clients who are unable to provide informed consent will not be included in this research study. 
 
Subjects Representation Comprehension 
 
                    Clients who are unable to understand the informed consent sheet and/or the educational  
                    hand outs and home exercise plan will not be considered for this study. The participants  
                    will be able to ask questions and request further information upon consent. 
 
 
                 Debriefing  Procedures 
                   Clinicians will provide participants with measurements and results at any time  
                   throughout this study upon participant request. As is standard procedure at NYU   
                   Langone Medical Center clients have the right to access their medical records at any time    
                   which will include all measurements.  
 
                   Consent forms-See study related documents 
                   Documentation of Consent 
                  All signed consent forms will be stored in a locked draw of a locked office. Consent forms  
                  along with all patient documentation will also be scanned into Epic and be available  
                  within the clients chart as is standard protocol here at NYU Center for Musculoskeletal  
                  Care.  Participants will also be provided with a copy of signed consent form.  
                   
                  Costs to Subjects 
                  There will be no additional cost to subjects for participation in this study. The use of   
                  the ASTYM therapy technique is combined with other therapeutic techniques and  
                  modalities and is billed accordingly at NYU Center for Musculoskeletal Care.  
 
                  
 
 
 
 
 
 
 
 
 
 
References Cited: 
1. J.S. Moore, De Quervain's tenosynovitis. Stenosing tenosynovitis of the first dorsal 
compartment. J Occup Environ Med, 39 (1997), pp. 990–1002 
2. de Quervain, On a form of chronic tendovaginitis by Dr. Fritz de Quervain in la Chaux-de-
Fonds. 1895. Am J Orthop, 26 (1997), pp. 641–644 

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3. F. de Quervain, On the nature and treatment of stenosing tendovaginitis on the styloid 
process of the radius. (Translated article: Muenchener Medizinische Wochenschrift 1912, 59, 
56) J Hand Surg, 30B (2005), pp. 392–394 
4. F.H. Netter, Atlas of Human Anatomy. (2nd ed.)ICON Learning Systems, New Jersey (1997). 
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(4th ed.)Mosby, St. Louis (1995) 
6. H. Finkelstein, Stenosing tendovaginitis at the radial styloid process. J Bone Joint Surg, 12A 
(1930), pp. 509–540 
7. N.R. Kay, de Quervain's disease. Changing pathology or changing perception? J Hand Surg, 
25B (2000), pp. 65–69 
8. M.T. Clarke, H.A. Lyall, J.W. Grant, M.H. Matthewson, The histopathology of de Quervain's 
disease. J Hand Surg, 23B (1998), pp. 732–734 
9. R.D. Muckart, Stenosing tendovaginitis of abductor pollicis longus and extensor pollicis 
brevis at the radial styloid (de Quervain's disease). Clin Orthop Relat Res, 33 (1964), pp. 201–
208 
10. S.E. Anderson, L.S. Steinbach, D. De Monaco, H.M. Bonel, Y. Hurtienne, E. Voegelin. “Baby 
wrist”: MRI of an overuse syndrome in mothers. AJR Am J Roentgenol, 182 (2004), pp. 719–
724 
11. J.R. Ritchie, Orthopedic considerations during pregnancy. Clin Obstet Gynecol, 46 (2003), pp. 
456–466 
12. K. Walker-Bone, K.T. Palmer, I. Reading, D. Coggon, C. Cooper, Prevalence and impact of 
musculoskeletal disorders of the upper limb in the general population. Arthritis Rheum, 51 
(2004), pp. 642–651 
13. V.H. Coates, C.M. Turkelson, R. Chapell, W. Bruening, M.D. Mitchell, J.T. Reston, J.R. 
Treadwell, Diagnosis and treatment of worker-related musculoskeletal disorders of the 
upper extremity. Evid Rep Technol Assess (Summ), 62 (2002), pp. 1–12 
14. K. Fournier, D. Bourbonnais, G. Bravo, J. Arsenault, P. Harris, D. Gravel, Reliability and validity of pinch and 
thumb strength measurements in de Quervain's disease. J Hand Ther, 19 (2006), pp. 2–10 
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Appendix I 
Astym Protocol for de Quervain’s Tenosynovitis 
Patient sitting, forearm pronated 
Forearm and arm from wrist to deltoid tuberosity (E,L) 2 strokes in each direction 
Thumb muscles (EPB, APL) (L) (only distal to proximal) 4 strokes 
Lateral epicondyle (L,I) 2 strokes both directions; straight into upper arm, fan into forearm 
Wrist retinaculum (I) 2 strokes both directions 
Patient sitting, forearm supinated 
Forearm and arm from wrist crease through biceps (E, L) 2 strokes both directions 
FCU from wrist to just below medial epicondyle (L on tip) 2 strokes both directions 
Medial epicondyle (L,I) 4 strokes away from epicondyle only; straight proximal, fan distal 

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Wrist retinaculum and around pisiform (I), 2 strokes both directions 
Flexor retinaculum in palm (E) with 90* pivots 2 strokes in each direction 
Flexor retinaculum (L,I) distal to proximal only, “walk” instruments if necessary, 2 strokes per 
instrument 
Thenar eminence (I) 2 strokes in each direction 
Hypothenar eminence (I) 2 strokes in each direction 
Thumb flexors (I) 2 strokes in both directions 
Patient sitting, radial surface facing up 
EPB and APL tendons and muscle bellies (I) 2 strokes in each direction 
Anatomical Snuff Box (I) 2 strokes in each direction 
Web space (I) 2 strokes in each direction 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

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