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

NCT ID: NCT05559255

Last Updated: 2024-08-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 8 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-09-09
• Study Completion Date: 2024-03-31

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.

Conditions

Pain; Spasticity, Muscle; Quality of Life

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Interventions

Counterstrain manual manipulative treatment

The steps required to perform counterstrain in any region of the body are as follows:

1. Find the tender point.

2. Assess the tenderness using a pain scale.

3. Passively and gently place the patient in a position-of-comfort that results in the greatest reduction of tenderness at the tender point. Approximate the position first, then fine-tune through small arcs of movement. Aim to achieve at least 70% tenderness reduction, with the goal of 100%.

4. Maintain the position for 90 seconds while continuing to monitor the patient's tender point.

5. Passively return the patient to a neutral position.

6. Re-test for tenderness at the tender point.

Intervention Type: OTHER

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.

• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

American Osteopathic Association

OTHER

Sponsor Role: collaborator

William Carey University

OTHER

Sponsor Role: lead

Responsible Party

David Dolbow

David R. Dolbow, Primary Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Italo Subbarao, DO

Role: STUDY_DIRECTOR

William Carey University

Locations

William Carey University

Hattiesburg, Mississippi, United States

Countries

United States

Other Identifiers

WilliamCareyU-COM-PT

Identifier Type: -

Identifier Source: org_study_id