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Research Proposal

Phase II Clinical Trial of Dry Needling


Intervention on II-V MCP joints
Andrew Kozerski and Isaac Weir
Patient Case
• The patient was a 20-year-old male, who was referred to physical therapist (PT) for
evaluation and treatment for pain on 3rd metacarpophalangeal (MCP) joint of the
right hand, with limited range of motion (ROM) and muscle weakness. The patient
reported noticing swelling on right hand during latest hospitalization for
Streptococcal Toxic Shock Syndrome around 6 months prior to the PT referral. He
described progressively increasing pain, stiffness, weakness of MCP joints of the
right hand but worse on 3rd MCP joint even after hospital discharge. The patient
reported that over the counter anti-inflammatory medication provided poor to fair
relief from pain. The patient denied any trauma or accident to cause initial pain
onset on affected area. No diagnostic imaging was performed at that time. The PT
examination revealed: decreased grip strength in the right hand; inability to make a
full fist; and limited ROM at the 3rd right MCP joint. The ROM for the right wrist,
hand, and the rest of fingers was normal. The PT plans to use physical modalities
and exercises: to increase joint flexibility; to increase grip strength; and to improve
hand dexterity and coordination. This plan is congruent with the patient’s goal to
tolerate daily activities using right hand and fingers and return to recreational and
sport activities with minimum to no pain/difficulty.
Clinical Question
• Does dry needling (I) offer an effective increase in ROM and strength (O)
in a 20 year old male with limited ROM and weakness (P) in the 3rd
MCP joint due to inflammation?
Introduction
• Range of motion (ROM) and muscle weakness are two common
musculoskeletal disorders
• Most research on dry needling focuses on myofascial trigger point
release 1
• There is limited research into how dry needling can restore both ROM
and muscle strength 2
• To address the limited research, a dry needling technique specific to the
treatment of decreased range of motion and strength within metacarpal
(MCP) joints II-V was developed
• Purpose of study is to test the efficacy of dry needling in restoring ROM
and strength in MCP joints II-V
Subjects
• Participants will be recruited from within the lower peninsula of
Michigan.
– All subjects who meet the proper criteria will be included up to 50
subjects on a first come first serve basis
• Inclusion criteria:
– Muscular pathologies limiting ROM and/or strength at MCP joints II-
V
– Muscular strength not eclipsing 80% of the uninvolved to involved
side
– Participants with ROM deficits
– Ages 18 to 40
– Ability to tolerate treatment involving needles
Subjects cont.
• Exclusion criteria:
– Severe muscle tone or other neuromuscular pathologies
– Participants with cognitive or communication barriers
– Participants with transmittable diseases
– Lymphedema in the upper extremities
– Participants with trypanophobia
– Recent history of surgical repair within either hand
Methods: Intervention
• Dry needling techniques that attempt to address decreased ROM and
strength in MCP II-V
• A predetermined pattern of dry needle insertions for each MCP
• Treatment sessions last ~20 minutes
• Led by DN-2 certified licensed physical therapist
Methods: Intervention Protocol
• I. Insertion of the dry needles (3 minutes)
– 30 mm, 0.18 gauge diameter needles will be placed in the muscle
bellies of the lumbricals and palmar interossei
• II. Treatment (15 minutes)
– The needles will remain static in the muscle bellies for 5,10 or 15
minutes based on the week of treatment
• III. Post-treatment (2 minutes)
– The needles will be removed by the supervising certified and
licensed clinician, and the insertion points will be evaluated for any
adverse reactions such as bleeding
Methods: Preliminary Protocol
Methods: Study Design
• Phase II clinical trial:
– Primary Goal: To test efficacy of dry needling in increasing ROM and
muscle strength across the MCP joint
– Secondary Goal: Ensure the safety and replicability of dry needling
in the hand in a clinically controlled setting
• Treatment
– 6 treatment sessions
– 3 weeks of treatments
• Participant pool size
– 50 participants
• Goal of α<0.05 and a power of at least 80%
Methods: Data Collection & Analysis
• Primary outcomes
– Upper Extremity QuickDASH scale 3
– Goniometry for MCP joint flexion, and abduction 4
– Pinch dynamometry for MCP flexion 5
• Secondary outcomes
– Jebsen-Taylor Hand Function Test 6
– Upper Extremity Functional Index 7
Methods: Data Analysis
Methods: Statistics
• Dependant t-test (for just pre and post test)
• Effect size
• One way repeated measures ANOVA
Discussion: Anticipated Results
• Effectiveness of the dry needling technique will support increased ROM
and strength within II-V MCP joints of the participants
• Regression of symptoms will not be supported
• Adverse reaction will not be supported within our population
• Safety precautions and proper cleansing techniques will be followed
Discussion: Limitations
• Depth of penetration of the needle will be dependent on the certified
and licensed physical therapist’s skill level
• Goniometric ROM will be dependent on the certified and licensed
physical therapist’s skill level
• Drop out due to intolerance
References
• 1 Lew J, Kim J, Nair P. Comparison of dry needling and trigger point manual therapy in patients
with neck and upper back myofascial pain syndrome: a systematic review and meta-analysis. J
Man Manip Ther. 2021;29(3):136-146. doi:10.1080/10669817.2020.1822618
• 2 Bynum R, Garcia O, Herbst E, et al. Effects of Dry Needling on Spasticity and Range of Motion:
A Systematic Review. Am J Occup Ther. 2021;75(1):7501205030p1-7501205030p13.
doi:10.5014/ajot.2021.041798
• 3 Changulani M, Okonkwo U, Keswani T, Kalairajah Y. Outcome evaluation measures for wrist
and hand: which one to choose?. Int Orthop. 2008;32(1):1-6. doi:10.1007/s00264-007-0368-z
• 4 Gajdosik RL, Bohannon RW. Clinical measurement of range of motion. Review of goniometry
emphasizing reliability and validity. Phys Ther. 1987 Dec;67(12):1867-72. doi:
10.1093/ptj/67.12.1867. PMID: 3685114.
• 5 Shin H, Moon SW, Kim GS, et al. Reliability of the pinch strength with digitalized pinch
dynamometer. Ann Rehabil Med. 2012;36(3):394-399. doi:10.5535/arm.2012.36.3.394
• 6 Sığırtmaç İC, Öksüz Ç. Investigation of reliability, validity, and cutoff value of the Jebsen-Taylor
Hand Function Test. J Hand Ther. 2021;34(3):396-403. doi:10.1016/j.jht.2020.01.004
• 7 Chesworth BM, Hamilton CB, Walton DM, et al. Reliability and validity of two versions of the
upper extremity functional index. Physiother Can. 2014 Summer;66(3):243-53. doi:
10.3138/ptc.2013-45. PMID: 25125777; PMCID: PMC4130402.

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