search
Back to results

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

Primary Purpose

Pain, Spasticity, Muscle, Quality of Life

Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Counterstrain manual manipulative treatment
Sponsored by
William Carey University
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pain focused on measuring pain, spasticity, quality of life, spinal cord injury, counterstrain manual manipulative treatment

Eligibility Criteria

21 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • William Carey University

Outcomes

Primary Outcome Measures

Change in Neurogenic Pain after each session
Pain as described by the participant ( Universal Pain Assessment Tool (UPAT), score range from 0-10 where 0 is no pain and 10 is the worst pain possible.
Muscle Spasticity
Spasticity as described by the participants' Modified Ashworth Test scores 0-4 where 0 is no tone and 4 is rigid tone.
Self-perceived quality of life via WHO Brief QoL questionnaire
Quality of life as described by the participants (World Health Organization Quality of Life questionnaire) Twenty six questions each with a Likert scale range 1-5 where 1 equals not at all and 5 equals extremely. Five is typically the better score.
Change in neuropathic pain after the 4 weeks of the program.
The Neuropathic Pain Diagnostic Questionnaire). Ten yes or no questions without a numerical score. Then six questions concerning the impact of pain on life activities with a 0-10 scale where 0 is "does not interfere" and 10 is "completely interferes"

Secondary Outcome Measures

Full Information

First Posted
August 10, 2022
Last Updated
October 1, 2023
Sponsor
William Carey University
Collaborators
American Osteopathic Association
search

1. Study Identification

Unique Protocol Identification Number
NCT05559255
Brief Title
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

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
September 9, 2022 (Actual)
Primary Completion Date
March 2024 (Anticipated)
Study Completion Date
March 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
William Carey University
Collaborators
American Osteopathic Association

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain, Spasticity, Muscle, Quality of Life
Keywords
pain, spasticity, quality of life, spinal cord injury, counterstrain manual manipulative treatment

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
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.
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
8 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Other
Intervention Name(s)
Counterstrain manual manipulative treatment
Intervention Description
The steps required to perform counterstrain in any region of the body are as follows: Find the tender point. Assess the tenderness using a pain scale. 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%. Maintain the position for 90 seconds while continuing to monitor the patient's tender point. Passively return the patient to a neutral position. Re-test for tenderness at the tender point.
Primary Outcome Measure Information:
Title
Change in Neurogenic Pain after each session
Description
Pain as described by the participant ( Universal Pain Assessment Tool (UPAT), score range from 0-10 where 0 is no pain and 10 is the worst pain possible.
Time Frame
Sessions/days 1,2,3,4,5,6,7,8,9,10,11,12
Title
Muscle Spasticity
Description
Spasticity as described by the participants' Modified Ashworth Test scores 0-4 where 0 is no tone and 4 is rigid tone.
Time Frame
Sessions/days 1,2,3,4,5,6,7,8,9,10,11,12
Title
Self-perceived quality of life via WHO Brief QoL questionnaire
Description
Quality of life as described by the participants (World Health Organization Quality of Life questionnaire) Twenty six questions each with a Likert scale range 1-5 where 1 equals not at all and 5 equals extremely. Five is typically the better score.
Time Frame
four weeks (sessions 1 and 12)
Title
Change in neuropathic pain after the 4 weeks of the program.
Description
The Neuropathic Pain Diagnostic Questionnaire). Ten yes or no questions without a numerical score. Then six questions concerning the impact of pain on life activities with a 0-10 scale where 0 is "does not interfere" and 10 is "completely interferes"
Time Frame
four weeks (sessions 1 and 12)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Italo Subbarao, DO
Organizational Affiliation
William Carey University
Official's Role
Study Director
Facility Information:
Facility Name
William Carey University
City
Hattiesburg
State/Province
Mississippi
ZIP/Postal Code
39401
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
There is no plan to make individual data available.

Learn more about this trial

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

We'll reach out to this number within 24 hrs