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CompletedNCT02646579Updated Jul 18, 2019

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

An interventional study of Spinal and Peripheral Dry Needling and Peripheral Dry Needling in Plantar Fasciitis, Achilles Tendinitis and Patellofemoral Pain Syndrome, sponsored by Emory University. Completed at 1 site in United States. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2019-07-18.

Sponsored by Emory University · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
34
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Plantar Fasciitis
  • Achilles Tendinitis
  • Patellofemoral Pain Syndrome

Keywords

  • Orthopedics
03

In context

Fasciitis

235 studies on the registry are indexed under Fasciitis; 37 are open to participants now.

This study's enrollment of 34 is below the median of 54 across 192 interventional studies indexed under Fasciitis.

Browse Fasciitis studies →

Lead sponsor

Emory University is the lead sponsor of 1,386 studies on the registry; 236 are open to participants now.

Of its 229 completed or terminated interventional studies of FDA-regulated products, 174 (76%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
34 participants (actual)

Study arms

  • 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

  • Active comparator
    Peripheral Dry Needling

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

    Procedure: Peripheral Dry Needling

Interventions

  • ProcedureSpinal 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.

  • ProcedurePeripheral 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.

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: Baseline, Visit 2 (Up to 7 days)

Secondary outcomes

  1. 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.

    Time frame: Baseline, Visit 2 (Up to 7 days)

  2. 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.

    Time frame: Baseline, Visit 2 (Up to 7 days)

  3. 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.

    Time frame: Baseline, Visit 2 (Up to 7 days)

  4. 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.

    Time frame: Baseline, Visit 2 (Up to 7 days)

  5. 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.

    Time frame: Baseline, Visit 2 (Up to 7 days)

07

Study locations

1 site
  • The Emory Clinic
    Atlanta, Georgia 30322, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 18, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02646579
Lead sponsor
Emory University
Responsible party
Marie Johanson (Associate Professor, Emory University) — Principal investigator
First posted
Jan 5, 2016
Start date
Oct 27, 2017
Primary completion
May 1, 2019
Completion
May 1, 2019
Last update
Jul 18, 2019

Study contacts

Marie Johanson, PhD
principal investigator · Emory University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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