Plantar FasciitisNCT02646579
Effects of Dry Needling Using Spinal and Peripheral Sites Versus Peripheral Sites Only
A study testing Spinal and Peripheral Dry Needling and Peripheral Dry Needling in people with Plantar Fasciitis and Achilles Tendinitis, run by Emory University at 1 site in United States.
Trial 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 more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Plantar Fasciitis, Achilles Tendinitis, Patellofemoral Pain Syndrome
- What is being tested?
- Spinal and Peripheral Dry Needling and Peripheral Dry Needling
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 1 siteUnited States
- Study dates
- 27 Oct 2017to 1 May 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Unilateral chronic lower extremity musculoskeletal condition
- Ability to perform a unilateral one-quarter squat on involved side without pain
- Asymptomatic during walking
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
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.
- Being tested
- Spinal and Peripheral Dry Needling, Peripheral Dry Needling
- Keywords
- Orthopedics
- Medical subject headings
- Fasciitis, Plantar, Patellofemoral Pain Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Spinal and Peripheral Dry NeedlingProcedure or surgery
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 NeedlingProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Spinal and Peripheral Dry Needling | Experimental | Participants will receive dry needling to the low back and painful areas in the leg. Receives: Procedure: Spinal and Peripheral Dry Needling |
| Peripheral Dry Needling | Active comparator | Participants will receive dry needling to painful areas in the leg. Receives: Procedure: Peripheral Dry Needling |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline, Visit 2 (Up to 7 days)
Secondary outcomes (5)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline, Visit 2 (Up to 7 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jan 2016 (estimated)
- Study start27 Oct 2017
- Primary completion1 May 2019
- Study completion1 May 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Plantar FasciitisStudies of the same condition, open and under way.
- More trials run by Emory UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- Emory University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marie Johanson, Emory University
- Investigators
- Marie Johanson, PhD, Principal investigator, Emory University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02646579
- Sponsor's protocol ID
- IRB00084277
- Status last verified
- Jul 2019
- First submitted
- 4 Jan 2016
- Last updated
- 18 Jul 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Dry Needling Using Spinal and Peripheral Sites Versus Peripheral Sites Only Among Individuals With Chronic Lower Extremity Conditions
- ClinicalTrials.gov ID
- NCT02646579
- Acronym / sponsor ID
- IRB00084277
- Keywords
- Orthopedics
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- Emory UniversityUniversity, hospital or other
- Study start
- 27 Oct 2017 (actual)
- Primary completion
- 1 May 2019 (actual)
- Study completion
- 1 May 2019 (actual)
- First posted
- 5 Jan 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Spinal and Peripheral Dry Needling | Experimental | Procedure: Spinal and Peripheral Dry NeedlingParticipants will receive dry needling to the low back and painful areas in the leg. |
| Peripheral Dry Needling | Active comparator | Procedure: Peripheral Dry NeedlingParticipants will receive dry needling to painful areas in the leg. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Unilateral chronic lower extremity musculoskeletal condition
- Ability to perform a unilateral one-quarter squat on involved side without pain
- Asymptomatic during walking
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Spinal and Peripheral Dry NeedlingParticipants 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. | Procedure or surgery | Spinal and Peripheral Dry Needling |
| Peripheral Dry NeedlingParticipants 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. | Procedure or surgery | Peripheral Dry Needling |
Primary outcome
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.
5 secondary outcomes
Change in Muscle Strength of Hip Abductors assessed using a dynamometer
Time frame: Baseline, Visit 2 (Up to 7 days)
Change in Muscle Strength of Knee Extensors/Flexors assessed using a dynamometer
Time frame: Baseline, Visit 2 (Up to 7 days)
Change in Muscle Strength of Ankle Dorsiflexors/Platarflexors assessed using a dynamometer
Time frame: Baseline, Visit 2 (Up to 7 days)
Change in Unilateral Hop Distance
Time frame: Baseline, Visit 2 (Up to 7 days)
Change in Single-limb Standing Balance Test Time
Time frame: Baseline, Visit 2 (Up to 7 days)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jul 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marie Johanson, PhD principal investigator
Emory University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Spinal and Peripheral Dry Needling and Peripheral Dry Needling in people with Plantar Fasciitis and Achilles Tendinitis, run by Emory University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Pain Level assessed using the Visual Analogue Scale (VAS) (time frame: Baseline, Visit 2 (Up to 7 days)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jul 2019.