Clinical trial NCT05411627: A Pilot Study of Shockwave Therapy in HSP
Official title: A Pilot Study of Shockwave Therapy for Lower Extremity Spasticity in Persons With Genetically-Confirmed HSP
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Hereditary Spastic Paraplegia
Lead sponsor: Spaulding Rehabilitation Hospital
Sponsor class: OTHER
Collaborators: name: Massachusetts General Hospital
First posted: 2022-06-09
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This is a pilot study of the efficacy, safety, and tolerability of shockwave therapy for the treatment of spasticity in Hereditary Spastic Paraplegia.

Detailed description: This is a pilot study investigating the efficacy, safety, and tolerability of Extracorporeal Shockwave Therapy (ESWT) for the treatment of lower-extremity spasticity in the setting of Hereditary Spastic Paraplegia (HSP). 8 participants will be treated with shockwave therapy targeting sites of maximal spasticity in the lower extremities for 3 sessions at a rate of once per week. Participants will fill out baseline questionnaires assessing their overall wellbeing and function prior to treatment session 1, and will complete follow-up questionnaires at visit 2, visit 3, a phone call within 7 days of visit 3, and 8 weeks after initial visit. Total time enrolled in the study will be 8 weeks

Eligibility criteria: Inclusion Criteria:

1. Over the age of 18
2. Diagnosis of genetically-confirmed HSP
3. Score of 2, 3 or 4 on the PLSFRS walking question
4. 30 days stable dosages of oral spasticity medications prior to screening and throughout study participation
5. Able to come to site for treatment sessions
6. Able to understand all study procedures

Exclusion Criteria:

1. Diagnosis of any other neurological disorder that may impact gait
2. Lower motor neuron (LMN) disease or combined UMN and LMN
3. Non-ambulatory or requiring two-person assistance for any functional ambulation on most days
4. Less than 3 months of symptoms
5. Have received SWT within the past 3 months
6. Prior botulinum toxin injection within 3 months or planning to receive botulinum toxin injections during the study participation for spasticity management
7. Presence of an intra-thecal baclofen pump
8. Women who are pregnant. This is due to the fact that pregnancy will reduce participants activity after the treatment and the safety concerns related to shockwave treatment.
9. Patients with neuropathy affecting sensation to pain
10. Patients with a known underlying cardiac disease that could be affected by shockwave therapy
11. Concomitant intake of another clinical trial or other off-label experimental treatments that might influence study outcomes
12. Presence of unstable psychiatric disease, cognitive impairments, or dementia impairing study participation
13. Presence of other chronic neurological diseases such as Alzheimer's Parkinson's, stroke, or multiple sclerosis
14. Personal history of narcotic overuse for chronic pain or substance abuse or dependence
15. Contraindications for ESWT, including local skin breakdown, infection, malignancy or other soft tissue pathology at sites of planned treatment.

Primary outcomes:
measure: Numerical Rating Scale for Pain
timeFrame: 0-8 weeks; assessed at baseline visit, 1, 2, 3, and 8 weeks
measure: Primary Lateral Sclerosis Functional Rating Scale (PLSFRS)
timeFrame: 0-8 weeks; assessed at baseline visit, 1, 3, and 8 weeks
measure: Neurological Quality of Life (Neuro-QoL) Questionnaire: Fatigue Short Form
timeFrame: 0-8 weeks; assessed at baseline visit, 1, 3, and 8 weeks
measure: Foot and Ankle Ability Measure (FAAM) Questionnaire: Activities of Daily Living Subscale
timeFrame: 0-8 weeks; assessed at baseline visit, 1, 3, and 8 weeks
measure: Global Rate of Change (GROC) Questionnaire
timeFrame: 0-8 weeks; assessed at baseline visit, 1, 3, and 8 weeks
measure: Neurological Quality of Life (Neuro-QoL) Questionnaire: Lower Extremity Function - Mobility Short Form
timeFrame: 0-8 weeks; assessed at baseline visit, 1, 3, and 8 weeks
measure: Neurological Quality of Life (Neuro-QoL) Questionnaire: Positive Affect and Wellbeing Short Form
timeFrame: 0-8 weeks; assessed at baseline visit, 1, 3, and 8 weeks
measure: Neurological Quality of Life (Neuro-QoL) Questionnaire: Satisfaction with Social Roles and Activities Short Form
timeFrame: 0-8 weeks; assessed at baseline visit, 1, 3, and 8 weeks
measure: Foot and Ankle Ability Measure (FAAM) Questionnaire: Sports Subscale
timeFrame: 0-8 weeks; assessed at baseline visit, 1, 3, and 8 weeks
measure: Ten-Meter Walk Test
timeFrame: 0-3 weeks; assessed at baseline visit, 1, 2, and 3 weeks
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
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