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

Primary Purpose

Plantar Fasciitis, Achilles Tendinitis, Patellofemoral Pain Syndrome

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Spinal and Peripheral Dry Needling
Peripheral Dry Needling
Sponsored by
Emory University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Plantar Fasciitis focused on measuring Orthopedics

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • The Emory Clinic

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Spinal and Peripheral Dry Needling

Peripheral Dry Needling

Arm Description

Participants will receive dry needling to the low back and painful areas in the leg.

Participants will receive dry needling to painful areas in the leg.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.
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.
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.
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.

Full Information

First Posted
January 4, 2016
Last Updated
July 16, 2019
Sponsor
Emory University
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1. Study Identification

Unique Protocol Identification Number
NCT02646579
Brief Title
Effects of Dry Needling Using Spinal and Peripheral Sites Versus Peripheral Sites Only
Official Title
Effects of Dry Needling Using Spinal and Peripheral Sites Versus Peripheral Sites Only Among Individuals With Chronic Lower Extremity Conditions
Study Type
Interventional

2. Study Status

Record Verification Date
July 2019
Overall Recruitment Status
Completed
Study Start Date
October 27, 2017 (Actual)
Primary Completion Date
May 1, 2019 (Actual)
Study Completion Date
May 1, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Emory University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Plantar Fasciitis, Achilles Tendinitis, Patellofemoral Pain Syndrome
Keywords
Orthopedics

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
34 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Spinal and Peripheral Dry Needling
Arm Type
Experimental
Arm Description
Participants will receive dry needling to the low back and painful areas in the leg.
Arm Title
Peripheral Dry Needling
Arm Type
Active Comparator
Arm Description
Participants will receive dry needling to painful areas in the leg.
Intervention Type
Procedure
Intervention Name(s)
Spinal and Peripheral Dry Needling
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
Peripheral Dry Needling
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in Pain Level assessed using the Visual Analogue Scale (VAS)
Description
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.
Time Frame
Baseline, Visit 2 (Up to 7 days)
Secondary Outcome Measure Information:
Title
Change in Muscle Strength of Hip Abductors assessed using a dynamometer
Description
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.
Time Frame
Baseline, Visit 2 (Up to 7 days)
Title
Change in Muscle Strength of Knee Extensors/Flexors assessed using a dynamometer
Description
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.
Time Frame
Baseline, Visit 2 (Up to 7 days)
Title
Change in Muscle Strength of Ankle Dorsiflexors/Platarflexors assessed using a dynamometer
Description
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.
Time Frame
Baseline, Visit 2 (Up to 7 days)
Title
Change in Unilateral Hop Distance
Description
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.
Time Frame
Baseline, Visit 2 (Up to 7 days)
Title
Change in Single-limb Standing Balance Test Time
Description
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.
Time Frame
Baseline, Visit 2 (Up to 7 days)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marie Johanson, PhD
Organizational Affiliation
Emory University
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Emory Clinic
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30322
Country
United States

12. IPD Sharing Statement

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

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