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Changes in Pain, Spasticity, and Quality of Life After Use of Counterstrain Treatment in Individuals With SCI

W

William Carey University

Status

Completed

Conditions

Spasticity, Muscle
Quality of Life
Pain

Treatments

Other: Counterstrain manual manipulative treatment

Study type

Interventional

Funder types

Other

Identifiers

NCT05559255
WilliamCareyU-COM-PT

Details and patient eligibility

About

Individuals with spinal cord injury (SCI) often suffer from pain and spasticity. Traditional treatments for both of these conditions have been medications. However, it has been suggested that the counterstrain osteopathic manual manipulation treatment can decrease pain and possibly spasticity. The aim of this study is to investigate the effects of counterstrain osteopathic manual manipulation treatment on pain and spasticity in individuals with SCI.

Full description

Individuals with SCI often suffer from pain and spasticity. Traditional treatments for both of these conditions have been medications. However, it has been suggested that the counterstrain osteopathic manual manipulation treatment can decrease pain and possibly spasticity. The aim of this study is to investigate the effects of counterstrain osteopathic manual manipulation treatment on pain and spasticity in individuals with SCI.

The hypothesis for our research aim is that the use of the counterstrain osteopathic manipulation treatment will decrease pain, decrease muscle spasticity, and improve the participants' perception of their quality of life. After reviewing and signing an informed consent form that has been approved by the institutional review board at William Carey University, each participant will then provide a signed clearance form from their primary care physician stating that they have been screened and are approved to participate in the study. Participants will be asked to attend the William Carey Research Laboratory for the initial pre-testing. Height, weight, age, level of injury, and time since the injury will be recorded during the first visit to the William Carey University Research Laboratory. Vital signs including heart rate, blood pressure, and oxygen saturation will be assessed before and after the counterstrain technique is performed to ensure hemodynamic stability. The participants will be monitored by a licensed osteopathic medical physician. Any indication of discomfort by the participant will be evaluated which includes tests pertaining to pain, spasticity, and quality of life. Tests including the Universal Pain Assessment Tool (UPAT), Douleur Neuropathique 4 (DN4) Neuropathic Pain Diagnostic Questionnaire, and Spinal Cord Injury Spasticity Evaluation Tool will be performed while the participants are seated in their wheelchairs before and after each session. The Modified Ashworth Test will be performed both while the patient is seated and again while supine on the treatment table prior to and after each session. The World Health Organization Brief Quality of Life Questionnaire will be performed while the participants are seated in their wheelchairs at the start of the four-week program and then again after the four-week program has ended.

Enrollment

8 patients

Sex

All

Ages

21 to 70 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Men and women with C4-L5 spinal cord injury
  • American Spinal Injury Association Impairment Scale A, B, and C as per International Standards for Neurological Classification of spinal cord injury.
  • Participants will be one or more years post-injury
  • Age 21-70 years

Exclusion criteria

  • Pressure wounds on buttocks or feet
  • Unhealed bone fractures or history of fragility fractures
  • Uncontrolled cardiovascular or metabolic disease
  • Diagnosed with severe osteoporosis (T score ≤ 4)
  • Uncontrolled autonomic dysreflexia.

Trial design

Primary purpose

Treatment

Allocation

Non-Randomized

Interventional model

Single Group Assignment

Masking

None (Open label)

Trial contacts and locations

1

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Central trial contact

Ajay Sharma, DO; David R Dolbow, DPT, Ph.D

Data sourced from clinicaltrials.gov

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