NCT02646579

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
34

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2017

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 4, 2016

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 5, 2016

Completed
1.8 years until next milestone

Study Start

First participant enrolled

October 27, 2017

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2019

Completed
Last Updated

July 18, 2019

Status Verified

July 1, 2019

Enrollment Period

1.5 years

First QC Date

January 4, 2016

Last Update Submit

July 16, 2019

Conditions

Plantar FasciitisAchilles TendinitisPatellofemoral Pain Syndrome

Keywords

Orthopedics

Outcome Measures

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.

    Baseline, Visit 2 (Up to 7 days)

Secondary Outcomes (5)

  • Change in Muscle Strength of Hip Abductors assessed using a dynamometer

    Baseline, Visit 2 (Up to 7 days)

  • Change in Muscle Strength of Knee Extensors/Flexors assessed using a dynamometer

    Baseline, Visit 2 (Up to 7 days)

  • Change in Muscle Strength of Ankle Dorsiflexors/Platarflexors assessed using a dynamometer

    Baseline, Visit 2 (Up to 7 days)

  • Change in Unilateral Hop Distance

    Baseline, Visit 2 (Up to 7 days)

  • Change in Single-limb Standing Balance Test Time

    Baseline, Visit 2 (Up to 7 days)

Study Arms (2)

Spinal and Peripheral Dry Needling

EXPERIMENTAL

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

Procedure: Spinal and Peripheral Dry Needling

Peripheral Dry Needling

ACTIVE COMPARATOR

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

Procedure: Peripheral Dry Needling

Interventions

Spinal and Peripheral Dry NeedlingPROCEDURE

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.

Spinal and Peripheral Dry Needling
Peripheral Dry NeedlingPROCEDURE

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.

Peripheral Dry Needling

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Emory Clinic

Atlanta, Georgia, 30322, United States

Location

MeSH Terms

Conditions

Fasciitis, PlantarPatellofemoral Pain Syndrome

Condition Hierarchy (Ancestors)

FasciitisMusculoskeletal DiseasesFoot DiseasesJoint Diseases

Study Officials

  • Marie Johanson, PhD

    Emory University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

January 4, 2016

First Posted

January 5, 2016

Study Start

October 27, 2017

Primary Completion

May 1, 2019

Study Completion

May 1, 2019

Last Updated

July 18, 2019

Record last verified: 2019-07

Locations

US(1)