The Influence of Dry Needling for Hypertonia and Spasticity Treatment on Neuropathic Pain in Lower Extremity of Spinal Cord Injury: A Case Series Study

NCT06954688 | Terminated DMC

• 1 other identifier: 6585
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

Brief Summary

Spinal cord injury is a life-changing event that places a burden on the healthcare system, including caregivers and affected individuals. Studies do not provide a conclusive incidence rate due to methodological differences. However, a trend observed in recent years is an increasing incidence among the elderly population due to falls or non-traumatic spinal cord injury. The clinical consequences of spinal cord injury include pain and spasticity, in addition to loss of function and activity. On average, 69% of spinal cord injury patients report pain, with one-third experiencing severe pain. A similar prevalence is seen for spasticity, which is often underreported among spinal cord injury patients. Unlike pain, spasticity is considered a common symptom in chronic spinal cord injury, with at least 35% of the SCI population suffering from this sensorimotor control disorder. These two symptoms suggest a correlation, yet clear evidence is lacking. The secondary aim of this study is to explain the mechanisms of action of Dry Needling at various levels to better determine which subgroup of spinal cord injury patients would benefit most. A targeted study could optimize the effects of such a treatment: a better understanding of the underlying mechanisms could help with patient stratification and promote a more individualized approach, taking into account the pathogenesis of spasticity and the different mechanisms that can effectively modulate it. Additionally, this study examines the effect of the dry needling technique on hypertonia and spasticity in the spastic calf muscles of spinal cord injury patients. Research has already shown that this technique has acute effects on hypertonia and spasticity in stroke, multiple sclerosis, and Parkinson's disease. However, reliable research on spinal cord injury is lacking-currently, only a case report has investigated these effects. Therefore, this study is well-suited to build upon that case report and provide more evidence. Furthermore, this study serves as a prospective study to observe the correlation between neuropathic pain and spasticity over time. As a pilot study, it has established a collaboration with the REVARTE rehabilitation hospital, which has a large spinal cord injury population. The research will be conducted under the supervision of Prof. Dr. Steven Truijen (Universiteitsplein 1, 2610 Wilrijk, Belgium, steven.truijen@uantwerpen.be) and Prof. Dr. Wim Saeys (Universiteitsplein 1, 2610 Wilrijk, Belgium, wim.saeys@uantwerpen.be), organized from the University of Antwerp. During this study, no research costs will be charged to the patient, health insurance, or research environment. Thank you in advance for your attention to our research.

Conditions

Neuropathic Pain; Spasticity; Dry Needling Technique; Spinal Cord Injury

Keywords

spinal cord injury; pain; spasticity; dry needling

Outcome Measures

Primary Outcomes (3)

• DN4 Questionnaire:

  This questionnaire consists of ten items (four questions) on a total score of ten points. It has a cut-off of four points to identify the reported pain as neuropathic. The DN4 Questionnaire has been identified as a reliable and sensitive assessment for neuropathic pain

  At week 1(beginning of the study, pre-intervention period) , week 4 (mid-study) and week 8 (end of the study, post-intervention period)

• PainDetect Questionnaire(PD-Q)

  This questionnaire has been included to monitor pain severity and/or its time-dependent course17. It is a more extensive questionnaire In comparison to the DN4 Questionnaire despite having a lower sensitivity than the latter in SCI populationn16. Still, the PD-Q was chosen over the Leeds Assessment of Neuropathic Symptoms and Signs (LANSS) because of the difference between sensitivity (PD-Q 68% versus LANSS 36%).

  At week 1(beginning of the study, pre-intervention period) , week 4 (mid-study) and week 8 (end of the study, post-intervention period)

• The International Spinal Cord Injury Pain (ISCIP) Classification:

  This classification fits as a valid assessment that is comprehensive and feasible in use for experienced as well as non-experiences clinicians and includes all types of pain related to Spinal Cord Injury.

  Twice: Pre-intervention period (week 1) and post-intervention period (week 8)

Secondary Outcomes (5)

• Modified Tardieu Scale

  Every week (week1 to week 8)

• ASIA scale

  Twice: Pre-intervention period (week 1) and post-intervention period (week 8)

• Spinal Cord Independence Measure (SCIM)

  At week 1(beginning of the study, pre-intervention period) , week 4 (mid-study) and week 8 (end of the study, post-intervention period)

• Two minute walk test

  At week 1(beginning of the study, pre-intervention period) , week 4 (mid-study) and week 8 (end of the study, post-intervention period)

• Quality of Life Questionaire(Sci-QoL)

  At week 1(beginning of the study, pre-intervention period) , week 4 (mid-study) and week 8 (end of the study, post-intervention period)

Study Arms (1)

dry needling

EXPERIMENTAL

dry needling

Other: dry needling

Interventions

dry needling OTHER

Dry Needling: The puncture is intramuscular and is performed with a non-beveled, filiform, solid needle, similar to those used in acupuncture, which has been shown to produce less damage at the muscle level. It does not infiltrate any substance. As many entries as necessary are made until the local twitch response (LTR) is exhausted.

dry needling

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Spinal Cord Injury with ASIA impairment scale of B, C or D
• Age between 18 and 85 years
• Minimal spasticity (TDS \>1) in the ankle flexors.

You may not qualify if:

• ASIA impairment scale A or E
• severe co-existent other systemic injuries
• concomitant head injury
• Glasgow coma scale score \<15
• non-cooperative patient
• No informed consent given

Sponsors & Collaborators

• Universiteit Antwerpen: lead
• Revalidatieziekenhuis RevArte: collaborator

Study Sites (1)

Department of Rehabilitation sciences and physiotherapy (MOVANT)

Antwerp, Antwerpen, 2020 Antwerpen, Belgium

Location

MeSH Terms

Conditions

Neuralgia; Muscle Spasticity; Spinal Cord Injuries; Pain

Interventions

Dry Needling

Condition Hierarchy (Ancestors)

Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Muscular Diseases; Musculoskeletal Diseases; Muscle Hypertonia; Neuromuscular Manifestations; Spinal Cord Diseases; Central Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Complementary Therapies; Therapeutics; Physical Therapy Modalities

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, PhD

Model Details: monocentric interventional cohort study

Study Record Dates

• First Submitted: March 31, 2025
• First Posted: May 1, 2025
• Study Start: September 6, 2024
• Primary Completion: February 4, 2025
• Study Completion: February 4, 2025
• Last Updated: May 1, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will share

Locations

BE (1)