Clinical trial NCT05559255: Changes in Pain, Spasticity, and Quality of Life After Use of Counterstrain Treatment in Individuals With SCI
Official title: Changes in Pain, Spasticity, and Quality of Life After Use of Counterstrain Osteopathic Manipulative Treatment in Individuals With Spinal Cord Injury
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pain
Spasticity, Muscle
Quality of Life
Keywords: pain
spasticity
quality of life
spinal cord injury
counterstrain manual manipulative treatment
Lead sponsor: William Carey University
Sponsor class: OTHER
Collaborators: name: American Osteopathic Association
First posted: 2022-09-29
Enrollment: 8
Sex: ALL
Minimum age (years): 21
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Intervention model description: Thirty individuals with pain and spasticity after SCI will undergo the counterstrain manual manipulative treatment three times per week for four weeks. Pre and post program measures for pain, spasticity, and quality of life will be performed.
Primary purpose: TREATMENT

Brief summary: 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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Change in Neurogenic Pain after each session
timeFrame: Sessions/days 1,2,3,4,5,6,7,8,9,10,11,12
measure: Muscle Spasticity
timeFrame: Sessions/days 1,2,3,4,5,6,7,8,9,10,11,12
measure: Self-perceived quality of life via WHO Brief QoL questionnaire
timeFrame: four weeks (sessions 1 and 12)
measure: Change in neuropathic pain after the 4 weeks of the program.
timeFrame: four weeks (sessions 1 and 12)
Secondary outcomes:
Other outcomes:
Locations:
city: Hattiesburg
country: United States
facility: William Carey University
state: Mississippi
Study officials:
affiliation: William Carey University
name: Italo Subbarao, DO
role: STUDY_DIRECTOR
References: