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Completed

NCT Number: NCT02646579

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

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.

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Key information

Conditions

Plantar Fasciitis Achilles Tendinitis Fasciitis Fasciitis, Plantar Foot Diseases Joint Diseases Musculoskeletal Diseases Patellofemoral Pain Syndrome

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The Emory Clinic

Atlanta, Georgia, 30322, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Spinal and Peripheral Dry Needling

Procedure

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.

Peripheral Dry Needling

Procedure

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 outcomes

  1. Change in Pain Level assessed using the Visual Analogue Scale (VAS)

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

    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 outcomes

  1. Change in Muscle Strength of Hip Abductors assessed using a dynamometer

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

    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.

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

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

    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.

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

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

    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.

  4. Change in Unilateral Hop Distance

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

    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.

  5. Change in Single-limb Standing Balance Test Time

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

    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.

Sponsors and collaborators

Lead sponsor

Emory University

Other

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
Jan 5, 2016
Registry last updated
Jul 18, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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