An interventional study of Dry Needling in Stroke, Spasticity, Muscle and CVA, sponsored by Medical University of South Carolina. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-11-20.
Sponsored by Medical University of South Carolina · Not applicable, Interventional, and Treatment
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.
7,441 studies on the registry are indexed under Stroke; 2,012 are open to participants now.
This study's enrollment of 11 is below the median of 50 across 5,482 interventional studies indexed under Stroke.
Browse Stroke studies →Medical University of South Carolina is the lead sponsor of 871 studies on the registry; 163 are open to participants now.
Of its 131 completed or terminated interventional studies of FDA-regulated products, 104 (79%) have results posted.
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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.
Behavioral: 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.
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
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.
Time frame: 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.
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
Time frame: 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.
Time frame: 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
Time frame: 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.
| Milestone | Non-Intervention Week Reflex Measurements |
|---|---|
| Started | 11 |
| Timepoint 1/pre-ddn | 9 |
| Timepoint 2/post immediate ddn) | 9 |
| Timepoint 3/post 90 minutes ddn | 9 |
| Timepoint 4/post 24 hours ddn | 9 |
| Timepoint 5/post 72 hours ddn | 9 |
| Completed | 9 |
| Not completed | 2 |
| Withdrew: Lost to follow-up | 2 |
| Milestone | Non-Intervention Week Reflex Measurements |
|---|---|
| Started | 9 |
| Timepoint 1/pre-ddn | 9 |
| Timepoint 2/post immediate ddn) | 9 |
| Timepoint 3/post 90 minutes ddn | 9 |
| Timepoint 4/post 24 hours ddn | 9 |
| Timepoint 4/post 24 hours ddn | 9 |
| Timepoint 5/post 72 hours ddn | 8 |
| Completed | 8 |
| Not completed | 1 |
| Withdrew: Protocol violation | 1 |
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.
No measurements were reported for this outcome.
Changes in the cutaneous reflex amplitudes would indicate that DDN can influence the spinal processing of cutaneous information.
No measurements were reported for this outcome.
Changes in the cutaneous reflex amplitudes would indicate that DDN can influence the spinal processing of cutaneous information.
No measurements were reported for this outcome.
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.
| maximum degrees of dorsiflexion | Non-Intervention Week Reflex Measurements | Dry Needling Reflex Measurements |
|---|---|---|
| passive DF ROM (with knee extended) baseline | 0.5 ± 4.09 | 0 ± 3.89 |
| passive DF ROM (with knee extended) 0-min post | 0 ± 4.62 | 0.5 ± 3.83 |
| passive DF ROM (with knee extended) 90-min post | 0 ± 5.26 | 3 ± 3.93 |
| passive DF ROM (with knee extended) 72 hour post | 0 ± 6.20 | 0 ± 11.51 |
| active DF ROM (with knee extended) baseline | -28.5 ± 10.92 | -24.5 ± 8.94 |
| active DF ROM (with knee extended) 0-min post | -26 ± 11.36 | -22.5 ± 7.14 |
| active DF ROM (with knee extended) 90-min post | -26.5 ± 9.34 | -22 ± 9.24 |
| active DF ROM (with knee extended) 72-hr post | -22 ± 11.51 | -21 ± 12.06 |
| passive DF ROM (with knee flexed) baseline | 2.5 ± 6.00 | 5.5 ± 5.66 |
| passive DF ROM (with knee flexed) post-0 min DDN | 4 ± 8.30 | 8 ± 3.70 |
| passive DF ROM (with knee flexed) post-90 min DDN | 2.5 ± 6.57 | 8 ± 4.93 |
| passive DF ROM post-72 hr DDN | 4.5 ± 4.64 | 5.5 ± 5.28 |
| active DF ROM (with knee flexed) baseline | -24.5 ± 13.80 | -14 ± 12.71 |
| active DF ROM (with knee flexed) post-0 min DDN | -20 ± 8.29 | -16 ± 10.23 |
| active DF ROM (with knee flexed) post-90 min DDN | -19 ± 6.85 | -15.5 ± 9.52 |
| active DF ROM (with knee flexed) post-72 hr DDN | -17 ± 10.92 | -15.5 ± 13.15 |
An increase in the FMA-LE score indicates better movement of the leg. Score ranges from 0 - 34.
| score on a scale | Non-Intervention Week\Measurements | Intervention Week Measurements |
|---|---|---|
| Median FMA-LE score baseline | 22 ± 5.00 | 20 ± 5.23 |
| Median FMA-LE score 0-min post | 24 ± 5.01 | 19.5 ± 5.19 |
| Median FMA-LE score 90 min post | 22.5 ± 5.68 | 21 ± 4.78 |
| Median FMA-LE score 72 hr post | 22.5 ± 5.44 | 21 ± 4.97 |
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
| score on a scale | Baseline | Post-immediate | Post-90 Min | Post-24 Hrs | Post-72 Hrs |
|---|---|---|---|---|---|
| Participant 1 | 3 | 3 | 3 | 3 | 3 |
| Participant 2 | 3 | 2 | 2 | 2 | 3 |
| Participant 4 | 2 | 1.5 | 1.5 | 2 | 2 |
| Participant 5 | 2 | 2 | 2 | 2 | 3 |
| Participant 6 | 3 | 3 | 3 | 3 | 3 |
| Participant 8 | 3 | 3 | 3 | 3 | 3 |
| Participant 14 | 1.5 | 1.5 | 1.5 | 1 | 1 |
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.
| score on a scale | Single Arm |
|---|---|
| Change in Pain Level as Measured by the Visual Analog Scale (VAS) for Pain | 0 ± 0 |
Decreased time indicates improved ability to walk
| seconds | Non-Intervention Week 10MWT Measurement | Intervention Week 10MWT Measurement |
|---|---|---|
| Median 10MWT time in seconds at baseline | 9.525 ± 2.61 | 7.91 ± 2.25 |
| Median 10MWT time in seconds 90 min post | 9.515 ± 2.52 | 8.1 ± 2.00 |
| Median 10MWT time in seconds 24 hours post | 8.175 ± 1.99 | 7.57 ± 2.44 |
| Median 10MWT time in seconds 72 hours post | 7.945 ± 1.90 | 7.555 ± 2.13 |
Collected over 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. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Non-Intervention Week Reflex Measurements | 0/11 (0%) | 0/11 (0%) | 0/11 (0%) |
| Dry Needling Reflex Measurements | 0/11 (0%) | 0/11 (0%) | 0/11 (0%) |
| Age, Categorical(Participants) | Single Arm |
|---|---|
| <=18 years | 0 |
| Between 18 and 65 years | 11 |
| >=65 years | 0 |
| Sex: Female, Male(Participants) | Single Arm |
|---|---|
| Female | 5 |
| Male | 6 |
| Ethnicity (NIH/OMB)(Participants) | Single Arm |
|---|---|
| Hispanic or Latino | 0 |
| Not Hispanic or Latino | 11 |
| Unknown or Not Reported | 0 |
| Race (NIH/OMB)(Participants) | Single Arm |
|---|---|
| American Indian or Alaska Native | 0 |
| Asian | 1 |
| Native Hawaiian or Other Pacific Islander | 1 |
| Black or African American | 4 |
| White | 5 |
| More than one race | 0 |
| Unknown or Not Reported | 0 |
| Region of Enrollment(Participants) | Single Arm |
|---|---|
| United States | 11 |
Documents are hosted by the registry — open the source record to download them.
Plan to share: No
Ran from Mar 2022 to primary completion in Jun 2023, 15 months.
Results were first posted in Nov 2024, 1 year 5 months after primary completion.
Of 2,859 non-industry interventional studies with no phase under Stroke, half reached primary completion within 23 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 45. This study's 15 months is below that.
Counting every sponsor, half of 2,988 studies reached it within 23 months; a quarter within 10 and three quarters within 45.
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This study is completed, as verified in Oct 2024. You cannot join it, but the record below documents what was studied.
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