Effects of Dry Needling Using Spinal and Peripheral Sites Versus Peripheral Sites Only

Effects of Dry Needling Using Spinal and Peripheral Sites Versus Peripheral Sites Only Among Individuals With Chronic Lower Extremity Conditions

The purpose of this study is to determine if dry needling both low back and extremity areas is more effective for reducing pain and improving strength, balance and functional performance among patients with chronic musculoskeletal conditions compared to dry needling of extremity areas only.

Study Overview

• Status: Completed
• Conditions: Plantar Fasciitis; Patellofemoral Pain Syndrome; Achilles Tendinitis
• Intervention / Treatment: Procedure: Spinal and Peripheral Dry Needling; Procedure: Peripheral Dry Needling

Detailed Description

This study will determine if spinal and peripheral dry needling sites results in decreased pain, increased muscle strength, increased proprioception and increased functional performance among individuals with chronic musculoskeletal conditions of the lower extremities, such as plantar fasciitis, Achilles tendinopathy, and patellofemoral pain syndrome. Specific aims are to determine if individuals with chronic musculoskeletal conditions of the lower extremities receiving dry needling to both spinal and peripheral sites exhibit differences in pain, muscle strength, proprioception, and unilateral hop test scores compared to individuals with chronic musculoskeletal conditions of the lower extremities receiving dry needling to peripheral sites only.

• Study Type: Interventional
• Enrollment (Actual): 34
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Georgia
    • Atlanta, Georgia, United States, 30322
      • The Emory Clinic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Unilateral chronic lower extremity musculoskeletal condition
• Ability to perform a unilateral one-quarter squat on involved side without pain
• Asymptomatic during walking

Exclusion Criteria:

• History of systemic neurological or arthritic condition
• History of bony or peripheral nerve trauma or surgery lower extremities
• No contraindications to dry needling
• Not currently receiving treatment for the chronic lower extremity musculoskeletal condition

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Spinal and Peripheral Dry Needling; Participants will receive dry needling to the low back and painful areas in the leg.	Procedure: Spinal and Peripheral Dry Needling; Participants will be positioned lying flat and the relevant spinal level will be treated using a Seirin L- type 50 mm needle. The needle will be inserted to a depth no greater than three-quarters length of the needle for 30 seconds using a vertical pistoning technique and then statically up to 10 minutes.
Active Comparator: Peripheral Dry Needling; Participants will receive dry needling to painful areas in the leg.	Procedure: Peripheral Dry Needling; Participants will be positioned lying flat and the relevant peripheral points will be treated using a Seirin L- type 50 mm needle. The peripheral treatment site(s) will be determined by the physical therapist's palpation of active or latent trigger points or tender points. The needle will be inserted to a depth no greater than three-quarters length of the needle for 30 seconds using a vertical pistoning technique and then statically up to 10 minutes.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Pain Level assessed using the Visual Analogue Scale (VAS)	Pain level will be assessed using the Visual Analogue Scale (VAS). The pain VAS is a self-reported, single-item scale that ranks pain level from no pain to worst imaginable pain on a single scale line. Using a ruler, the score is determined by measuring the distance (mm) on the 10-cm line between the "no pain" anchor and the participant's mark, providing a range of scores from 0-100.	Baseline, Visit 2 (Up to 7 days)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Muscle Strength of Hip Abductors assessed using a dynamometer	The strength of the hip abductors will be assessed using a dynamometer. The subjects will be asked to exert maximal force against the dynamometer and the reading is recorded. Scores are based on force production in kilograms or pounds; kilograms (0-90), pounds (0-200). Higher pressure scores indicate better muscle strength of the hip abductor muscles.	Baseline, Visit 2 (Up to 7 days)
Change in Muscle Strength of Knee Extensors/Flexors assessed using a dynamometer	The strength of the knee extensors/flexors will be assessed using a dynamometer. The subjects will be asked to exert maximal force against the dynamometer and the reading is recorded. Scores are based on force production in kilograms or pounds; kilograms (0-90), pounds (0-200). Higher pressure scores indicate better muscle strength of the knee extensor/flexor muscles.	Baseline, Visit 2 (Up to 7 days)
Change in Muscle Strength of Ankle Dorsiflexors/Platarflexors assessed using a dynamometer	The strength of the ankle dorsiflexors/platarflexors will be assessed using a dynamometer. The subjects will be asked to exert maximal force against the dynamometer and the reading is recorded. Scores are based on force production in kilograms or pounds; kilograms (0-90), pounds (0-200). Higher pressure scores indicate better muscle strength of the ankle dorsiflexor/platarflexor muscles.	Baseline, Visit 2 (Up to 7 days)
Change in Unilateral Hop Distance	Participants will perform a single leg hop for distance with each lower extremity. After demonstration, each participant will be allowed 1 trial per leg. Beginning with the toes immediately behind the starting line, participants will perform one hop to complete a trial. The hop will be measured from the starting line to the end of the toes after completion of a trial. Each limb will be tested two times with the maximal distance scored for each limb. Scores will be recorded as absolute distance (in centimeters). An increase in the score (distance covered) from baseline visit to visit 2 indicates better functional performance of the muscles.	Baseline, Visit 2 (Up to 7 days)
Change in Single-limb Standing Balance Test Time	Participants will attempt to balance themselves within a defined area on a single limb. The maximum amount of time will be calculated both with and without their eyes closed. The opposite leg must be out in front of the participant fully extended and will not be allowed to touch any part of the body. The test will be timed, up to two minutes, on each limb with two trials on either side.	Baseline, Visit 2 (Up to 7 days)

Collaborators and Investigators

• Sponsor: Emory University
• Investigators: Principal Investigator: Marie Johanson, PhD, Emory University

Study record dates

Study Major Dates

• Study Start (Actual): October 27, 2017
• Primary Completion (Actual): May 1, 2019
• Study Completion (Actual): May 1, 2019

Study Registration Dates

• First Submitted: January 4, 2016
• First Submitted That Met QC Criteria: January 4, 2016
• First Posted (Estimate): January 5, 2016

Study Record Updates

• Last Update Posted (Actual): July 18, 2019
• Last Update Submitted That Met QC Criteria: July 16, 2019
• Last Verified: July 1, 2019

More Information

Terms related to this study

• Keywords: Orthopedics
• Additional Relevant MeSH Terms: Wounds and Injuries; Foot Diseases; Joint Diseases; Musculoskeletal Diseases; Muscular Diseases; Tendon Injuries; Tendinopathy; Fasciitis; Fasciitis, Plantar; Patellofemoral Pain Syndrome
• Other Study ID Numbers: IRB00084277

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No