Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03689283
Other study ID # RegisU
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date October 25, 2018
Est. completion date January 21, 2020

Study information

Verified date January 2020
Source Regis University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This study would be the first study to assess the immediate effects of dry needling of latent trigger points of the gastrocnemius muscle on muscle stiffness, gait, range of motion, and strength. The study has the potential to demonstrate that dry needling may have immediate effects on mechanical properties of muscle and may thus guide future treatment for individuals with changes in muscle tissue secondary to pain and/or injury.


Description:

Participants will complete the following tests: muscle stiffness testing in both a relaxed and contracted position, GAITRite for spatial and temporal gait characteristics, the Ankle Lunge Test (ALT) to assess range of motion, and calf strength using a dynamometer. Subjects will then receive treatment according to which group they are randomized. Muscle stiffness, gait, motion and strength will be reassessed immediately following treatment at the first session. Four to10 days later, participants will complete the same tests and measures prior to treatment being administered a second time. Another 4-10 days after the second session, participants will complete the tests and measures one final time.


Recruitment information / eligibility

Status Completed
Enrollment 102
Est. completion date January 21, 2020
Est. primary completion date December 31, 2019
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 50 Years
Eligibility Inclusion Criteria:

1. Age 18-50 years

2. Able to read and speak sufficient English to complete consent form

3. Symmetrical gait pattern demonstrated through observation

4. Presence of latent trigger point in gastrocnemius muscle

Exclusion Criteria:

1. Any prior foot/ankle surgery, deformity, or injury on the which would affect strength of the gastrocnemius

2. Any prior acupuncture or dry needling within the past month

3. History of systemic disorder in which dry needling would be contraindicated (i.e. bleeding disorders or anticoagulant medication use)

4. Have fractures of the spine, hip, or knee that would likely affect their weight bearing or gait

5. Restrictions in plantar flexion range of motion which would inhibit performing a heel raise

6. No specific calf injury in the past 6 months

7. Participants known or thought to be pregnant

Study Design


Intervention

Other:
Dry Needling
Individuals randomized to the Dry Needling Group will receive dry needling to latent trigger points of the gastrocnemius muscle
Sham Dry Needlling
Individuals randomized to the Control group will receive sham needling to the gastrocnemius muscle

Locations

Country Name City State
United States Regis University Denver Colorado

Sponsors (1)

Lead Sponsor Collaborator
Regis University

Country where clinical trial is conducted

United States, 

References & Publications (4)

Ballyns JJ, Turo D, Otto P, Shah JP, Hammond J, Gebreab T, Gerber LH, Sikdar S. Office-based elastographic technique for quantifying mechanical properties of skeletal muscle. J Ultrasound Med. 2012 Aug;31(8):1209-19. — View Citation

Bandy WD, Nelson R, Beamer L. COMPARISON OF DRY NEEDLING VS. SHAM ON THE PERFORMANCE OF VERTICAL JUMP. Int J Sports Phys Ther. 2017 Oct;12(5):747-751. — View Citation

Chuang LL, Wu CY, Lin KC. Reliability, validity, and responsiveness of myotonometric measurement of muscle tone, elasticity, and stiffness in patients with stroke. Arch Phys Med Rehabil. 2012 Mar;93(3):532-40. doi: 10.1016/j.apmr.2011.09.014. Epub 2012 Jan 4. — View Citation

Furlan AD, van Tulder M, Cherkin D, Tsukayama H, Lao L, Koes B, Berman B. Acupuncture and dry-needling for low back pain: an updated systematic review within the framework of the cochrane collaboration. Spine (Phila Pa 1976). 2005 Apr 15;30(8):944-63. Review. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary MyotonPRO Muscle stiffness will be measured in both a resting and contracted state utilizing this non-invasive device 2 years
Secondary Knee to wall Group by time differences will be assessed for talocrural motion (knee to wall) 2 years
Secondary GAITRite Group by time differences will be assessed for gait variables (utilizing the GAITRite 6-meter mat) 2 years
Secondary Handheld dynamometer Group by time differences will be assessed for strength of the gastrosoleus complex (utilizing a handheld dynamometer) 2 years
See also
  Status Clinical Trial Phase
Completed NCT04157439 - Manual Treatment Regimens in Upper Trapezius Trigger Point N/A
Completed NCT04559906 - Spray Stretch Technique Versus Sustain Pressure for Trapezius Triggers N/A
Completed NCT04157426 - Percutaneous Electrolysis Versus Dry Needling in Levator Scapulae N/A
Enrolling by invitation NCT06029413 - Myo vs. Myofascial Injection for Myofascial Trigger Points N/A
Recruiting NCT06051799 - Effects of Pressure Release of Myofascial Trigger Points on Mechanical Neck Pain. N/A
Completed NCT04285216 - Effects of Dry Needling and Strain Counter Strain Technique in Myofascial Trigger Points of Upper Trapezius N/A
Completed NCT03273985 - Effectiveness of Dry Needling in Shortened Triceps Surae Muscle N/A
Not yet recruiting NCT05995639 - Dry Needling Versus Ozone in Myofascial Pain Syndrome N/A
Active, not recruiting NCT04108390 - Gluteus Medius Dry Needling and Ankle Instability N/A
Completed NCT03888586 - Comparison of Dry Needling and Deep Friction Massage in Patients With Subacromial Pain Syndrome N/A
Completed NCT05185050 - Prevalence of Myofascial Pain Syndrome in Adolescent Idiopathic Scoliosis
Completed NCT04823013 - Comparison of High Power Pain Threshold Ultrasound and Ischemic Compression Techniques for Treatment of Trigger Points N/A
Completed NCT04832074 - Immediate Stiffness Changes in Myofascial Trigger Points After Dry Needling N/A
Completed NCT05879016 - Different Taping Methods in Myofascial Pain Syndrome N/A
Recruiting NCT05535010 - The Effect of the Presence of Active Trigger Points in the Muscles Innervated by the Affected Nerve Roots on the Treatment Results of Transforaminal Epidural Steroid Injection in Patients With Lumbar Radiculopathy. N/A
Completed NCT04316793 - Effects of Dry Needling When Applied to the Infraspinatus Muscle in People With Chronic Shoulder Pain N/A
Completed NCT05279794 - Efficacy of Two Types of Non-invasive Erector Spinae Muscle Taut Band Therapy in University Students With Low Back Pain N/A
Not yet recruiting NCT05688800 - Pressure Release Versus Thoracic Manipulation in Rhomboids MPS N/A
Completed NCT05265468 - Noninvasive Treatment of Upper Trapezius Active Trigger Points in College Students With Neck Pain N/A
Completed NCT05258201 - Effect of Muscle Energy Technique Versus Strain-counterstrain on Upper Trapezius Trigger Points N/A