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| ID | Type | Description | Link |
|---|---|---|---|
| 5P20GM109040 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of General Medical Sciences (NIGMS) | NIH |
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The study team is recruiting 20 adults with spasticity due to chronic stroke for a 7 day study over 2 weeks. In people with chronic stroke, one of the most common and disabling problems is spasticity (increased muscle tone or muscle stiffness). The purpose of this research study is to examine effects of dry needling on the nervous system (pathways between the muscle, spinal cord, and brain) in people with spasticity due to chronic stroke. Dry needling is a procedure in which a thin, stainless steel needle is inserted into the skin to produce a muscle twitch response. It is intended to release a knot in the muscle and relieve pain.
The total study duration is 7 visits over 2 weeks. There will be 4 visits the first week, and 3 visits the second week. The first visit will take about 1.5 hours, during which study staff will determine the best placement of electrodes and create a cast of the participant's leg to aid them in quickly placing the electrodes on the remainder of the visits. The second and fifth visits will last about 3.5 hours, and all other visits will last about 1.5 hours. Dry needling will take place on the fifth visit only. During each visit the participant will be asked to participate in examinations of reflexes (muscle responses to non-invasive nerve stimulation) and leg function.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Single Arm | Experimental | All participants completed 2 weeks of the study. Baseline reflex measurements will be collected during the first week of the study (Visits 1-4). No dry needling will occur during this week, with the aim of tracking any natural variability in nervous system excitability at the same time points as reflex measurements during the intervention week. All participants who participated in baseline reflex measurements during week 1 will continue to the second week of the study (Visits 5-7). Participants will receive dry needling to relieve spasticity in the target calf muscle (middle gastrocnemius) during Visit 5. The study team will examine the effects of this treatment on the nervous system by performing assessments just prior to DDN, immediately after DDN, 90 minutes after DDN, 24 hours after DDN, and 72 hours after DDN. These assessments will examine how you move your leg and how your nervous system responds to non-invasive nerve stimulation. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dry Needling | Behavioral | Dry needling is a procedure in which a thin, stainless steel needle is inserted into the skin to produce a muscle twitch response. It is intended to release a knot in a muscle and relieve pain. |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in the H-reflex Amplitude in Response to Nerve Stimulation | H-reflex amplitude (mV) reflects the excitability of its reflex pathway. Changes in the H-reflex amplitude indicate that DDN influences the spinal excitability. This will be measured in the tibialis anterior and the triceps surae. | 7 days prior (2 time points), 6 days prior, 4 days prior, baseline, immediately after DDN, 90 minutes after DDN, 24 hours after DDN, and 72 hours after DDN |
| Changes in Cutaneous Reflexes Elicited by Non-noxious Stimulation of Cutaneous or Mix Nerves | Changes in the cutaneous reflex amplitudes would indicate that DDN can influence the spinal processing of cutaneous information. | 7 days prior (2 time points), 6 days prior, 4 days prior, baseline, immediately after DDN, 90 minutes after DDN, 24 hours after DDN, and 72 hours after DDN |
| Changes in Perception of Cutaneous Stimuli as Measured by Perception and Radiating Threshold of Cutaneous Nerve Stimulation | Changes in the cutaneous reflex amplitudes would indicate that DDN can influence the spinal processing of cutaneous information. | 7 days prior (2 time points), 6 days prior, 4 days prior, baseline, immediately after DDN, 90 minutes after DDN, 24 hours after DDN, and 72 hours after DDN |
| Ability to Move the Limb as Measured by Range of Motion (ROM) | ROM is measured in degrees using a standard goniometer. ROM will be measured both passively (moved by the assessor) and actively (participant moves the leg themselves) and the value reported is the maximum degree of dorsiflexion in each condition. Positive values indicate degrees of dorsiflexion beyond neutral, negative values indicate degrees of plantarflexion. Greater values indicate greater degrees of dorsiflexion. | Timepoints are defined as baseline, 0-minutes post, 90 minutes post and 72 hours post DDN during intervention week and the corresponding 4 timepoints the week prior (non-intervention) but without DDN. |
| Measure | Description | Time Frame |
|---|---|---|
| Ability to Move the Leg as Measured by the Fugl-Meyer Assessment (FMA) Lower Extremity | An increase in the FMA-LE score indicates better movement of the leg. Score ranges from 0 - 34. | Timepoints are defined as baseline, 0-minutes post, 90 minutes post and 72 hours post DDN during intervention week and the corresponding 4 timepoints the week prior (non-intervention) but without DDN. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Gretchen Seif, DPT | Medical University of South Carolina | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Medical University of South Carolina | Charleston | South Carolina | 29425 | United States |
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Participants were enrolled in a cross-sectional study. Eleven participants were enrolled in the non-intervention week, of which 9 participants completed all visits. Those 9 participants went on to the Dry Needling Reflex Measurements, of which 8 participants completed all visits. So 11 participants were enrolled, and 8 completed the study procedures.
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| ID | Title | Description |
|---|---|---|
| FG000 | Non-Intervention Week Reflex Measurements | Baseline reflex measurements will be collected during the first week of the study (Visits 1-4). No dry needling will occur during this week. The aim of this arm is to track any natural variability in nervous system excitability at the same time points as reflex measurements during the intervention week. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Non-intervention Week |
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| Dry Needling Reflex Measurment Week |
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| ID | Title | Description |
|---|---|---|
| BG000 | Single Arm | Baseline reflex measurements will be collected during the first week of the study (Visits 1-4). No dry needling will occur during this week. The aim of this arm is to track any natural variability in nervous system excitability at the same time points as reflex measurements during the intervention week. All participants who participated in baseline reflex measurements during week 1 will continue to the second week of the study (Visits 5-7). Participants will receive dry needling to relieve spasticity in the target calf muscle (middle gastrocnemius) during Visit 5. The study team will examine the effects of this treatment on the nervous system by performing assessments just prior to DDN, immediately after DDN, 90 minutes after DDN, 24 hours after DDN, and 72 hours after DDN. These assessments will examine how you move your leg and how your nervous system responds to non-invasive nerve stimulation. Dry Needling: Dry needling is a procedure in which a thin, stainless steel needle is inserted into the skin to produce a muscle twitch response. It is intended to release a knot in a muscle and relieve pain. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Changes in the H-reflex Amplitude in Response to Nerve Stimulation | H-reflex amplitude (mV) reflects the excitability of its reflex pathway. Changes in the H-reflex amplitude indicate that DDN influences the spinal excitability. This will be measured in the tibialis anterior and the triceps surae. | Due to equipment malfunction, we could not obtain data with adequate quality for this analysis. | Posted | 7 days prior (2 time points), 6 days prior, 4 days prior, baseline, immediately after DDN, 90 minutes after DDN, 24 hours after DDN, and 72 hours after DDN |
|
7 days prior, 6 days prior, 4 days prior, baseline, immediately after DDN, 90 minutes after DDN, 24 hours after DDN, and 72 hours after DDN
Each day of participation, study personnel communicated with the participant regarding their general health and any side-effect of the intervention.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Non-Intervention Week Reflex Measurements | Baseline reflex measurements will be collected during the first week of the study (Visits 1-4). No dry needling will occur during this week. The aim of this arm is to track any natural variability in nervous system excitability at the same time points as reflex measurements during the intervention week. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Gretchen Seif, PT, DPT, MHS, OCS, FAAOMPT | Medical University of South Carolina | (843) 792-9345 | seif@musc.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Nov 4, 2021 | Jun 3, 2024 | Prot_SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | Apr 20, 2023 | Nov 20, 2023 | ICF_000.pdf |
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| ID | Term |
|---|---|
| D020521 | Stroke |
| D009128 | Muscle Spasticity |
| D009461 | Neurologic Manifestations |
| ID | Term |
|---|---|
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| D000079245 | Dry Needling |
| ID | Term |
|---|---|
| D000529 | Complementary Therapies |
| D013812 | Therapeutics |
| D026741 | Physical Therapy Modalities |
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| Change in Spasticity as Measured by the Modified Ashworth Scale (mAS) | The mAS score ranges from 0: normal muscle tone to 4: rigid in flexion or extension. A decrease in mAS indicates decreased spasticity. A score of 1.5 reported below is equal to 1+ on the mAS | baseline, immediately after DDN, 90 minutes after DDN, 24 hours after, and 72 hours after DDN |
| Change in Pain Level as Measured by the Visual Analog Scale (VAS) for Pain | Pain is rated by the participant on a scale from 0 (no pain) to 10 (worst pain imaginable). Decreased score on the VAS for pain indicates decreased pain. | 7 days prior (2 time points), 6 days prior, 4 days prior, baseline, immediately after DDN, 90 minutes after DDN, 24 hours after DDN, and 72 hours after DDN |
| Change in Time Needed to Walk 10 Meter (10 m Walk Test) | Decreased time indicates improved ability to walk | Timepoints are defined as baseline, 0-minutes post, 24 hours post and 72 hours post DDN during intervention week and the corresponding 4 timepoints the week prior (non-intervention) but without DDN. |
| Timepoint 3/Post 90 Minutes DDN |
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| Timepoint 4/Post 24 Hours DDN |
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| Timepoint 4/Post 24 Hours DDN |
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| Timepoint 5/Post 72 Hours DDN |
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| COMPLETED |
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| NOT COMPLETED |
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| Participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Count of Participants | Participants |
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| Primary | Changes in Cutaneous Reflexes Elicited by Non-noxious Stimulation of Cutaneous or Mix Nerves | Changes in the cutaneous reflex amplitudes would indicate that DDN can influence the spinal processing of cutaneous information. | Due to equipment malfunction, we could not obtain data with adequate quality for this analysis. | Posted | 7 days prior (2 time points), 6 days prior, 4 days prior, baseline, immediately after DDN, 90 minutes after DDN, 24 hours after DDN, and 72 hours after DDN |
|
|
| Primary | Changes in Perception of Cutaneous Stimuli as Measured by Perception and Radiating Threshold of Cutaneous Nerve Stimulation | Changes in the cutaneous reflex amplitudes would indicate that DDN can influence the spinal processing of cutaneous information. | Due to equipment malfunction, we could not obtain data with adequate quality for this analysis. | Posted | 7 days prior (2 time points), 6 days prior, 4 days prior, baseline, immediately after DDN, 90 minutes after DDN, 24 hours after DDN, and 72 hours after DDN |
|
|
| Primary | Ability to Move the Limb as Measured by Range of Motion (ROM) | ROM is measured in degrees using a standard goniometer. ROM will be measured both passively (moved by the assessor) and actively (participant moves the leg themselves) and the value reported is the maximum degree of dorsiflexion in each condition. Positive values indicate degrees of dorsiflexion beyond neutral, negative values indicate degrees of plantarflexion. Greater values indicate greater degrees of dorsiflexion. | Posted | Median | Standard Deviation | maximum degrees of dorsiflexion | Timepoints are defined as baseline, 0-minutes post, 90 minutes post and 72 hours post DDN during intervention week and the corresponding 4 timepoints the week prior (non-intervention) but without DDN. |
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| Secondary | Ability to Move the Leg as Measured by the Fugl-Meyer Assessment (FMA) Lower Extremity | An increase in the FMA-LE score indicates better movement of the leg. Score ranges from 0 - 34. | Posted | Median | Standard Deviation | score on a scale | Timepoints are defined as baseline, 0-minutes post, 90 minutes post and 72 hours post DDN during intervention week and the corresponding 4 timepoints the week prior (non-intervention) but without DDN. |
|
|
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| Secondary | Change in Spasticity as Measured by the Modified Ashworth Scale (mAS) | The mAS score ranges from 0: normal muscle tone to 4: rigid in flexion or extension. A decrease in mAS indicates decreased spasticity. A score of 1.5 reported below is equal to 1+ on the mAS | Posted | Number | score on a scale | baseline, immediately after DDN, 90 minutes after DDN, 24 hours after, and 72 hours after DDN |
|
|
|
| Secondary | Change in Pain Level as Measured by the Visual Analog Scale (VAS) for Pain | Pain is rated by the participant on a scale from 0 (no pain) to 10 (worst pain imaginable). Decreased score on the VAS for pain indicates decreased pain. | No pain was reported by any participant throughout the study. All participants reported "0" pain at all time points. | Posted | Mean | Standard Deviation | score on a scale | 7 days prior (2 time points), 6 days prior, 4 days prior, baseline, immediately after DDN, 90 minutes after DDN, 24 hours after DDN, and 72 hours after DDN |
|
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| Secondary | Change in Time Needed to Walk 10 Meter (10 m Walk Test) | Decreased time indicates improved ability to walk | Posted | Median | Standard Deviation | seconds | Timepoints are defined as baseline, 0-minutes post, 24 hours post and 72 hours post DDN during intervention week and the corresponding 4 timepoints the week prior (non-intervention) but without DDN. |
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|
| 0 |
| 11 |
| 0 |
| 11 |
| 0 |
| 11 |
| EG001 | Dry Needling Reflex Measurements | All participants who participated in baseline reflex measurements during week 1 will continue to the second week of the study (Visits 5-7). Participants will receive dry needling to relieve spasticity in the target calf muscle (middle gastrocnemius) during Visit 5. The study team will examine the effects of this treatment on the nervous system by performing assessments just prior to DDN, immediately after DDN, 90 minutes after DDN, 24 hours after DDN, and 72 hours after DDN. These assessments will examine how you move your leg and how your nervous system responds to non-invasive nerve stimulation. Dry Needling: Dry needling is a procedure in which a thin, stainless steel needle is inserted into the skin to produce a muscle twitch response. It is intended to release a knot in a muscle and relieve pain. | 0 | 11 | 0 | 11 | 0 | 11 |
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| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D009135 | Muscular Diseases |
| D009140 | Musculoskeletal Diseases |
| D009122 | Muscle Hypertonia |
| D020879 | Neuromuscular Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| passive DF ROM (with knee extended) 90-min post |
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| passive DF ROM (with knee extended) 72 hour post |
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| active DF ROM (with knee extended) baseline |
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| active DF ROM (with knee extended) 0-min post |
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| active DF ROM (with knee extended) 90-min post |
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| active DF ROM (with knee extended) 72-hr post |
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| passive DF ROM (with knee flexed) baseline |
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| passive DF ROM (with knee flexed) post-0 min DDN |
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| passive DF ROM (with knee flexed) post-90 min DDN |
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| passive DF ROM post-72 hr DDN |
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| active DF ROM (with knee flexed) baseline |
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| active DF ROM (with knee flexed) post-0 min DDN |
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| active DF ROM (with knee flexed) post-90 min DDN |
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| active DF ROM (with knee flexed) post-72 hr DDN |
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| Median FMA-LE score 90 min post |
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| Median FMA-LE score 72 hr post |
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| Participant 2 |
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| Participant 4 |
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| Participant 5 |
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| Participant 6 |
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| Participant 8 |
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| Participant 14 |
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| Median 10MWT time in seconds 24 hours post |
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| Median 10MWT time in seconds 72 hours post |
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