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

August 4, 2024 updated by: David Dolbow, William Carey University

Changes in Pain, Spasticity, and Quality of Life After Use of Counterstrain Osteopathic Manipulative Treatment in Individuals With Spinal Cord Injury

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

8

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Mississippi
      • Hattiesburg, Mississippi, United States, 39401
        • William Carey University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Neurogenic Pain after each session
Time Frame: Sessions/days 1,2,3,4,5,6,7,8,9,10,11,12
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.
Sessions/days 1,2,3,4,5,6,7,8,9,10,11,12
Muscle Spasticity
Time Frame: Sessions/days 1,2,3,4,5,6,7,8,9,10,11,12
Spasticity as described by the participants' Modified Ashworth Test scores 0-4 where 0 is no tone and 4 is rigid tone.
Sessions/days 1,2,3,4,5,6,7,8,9,10,11,12
Self-perceived quality of life via WHO Brief QoL questionnaire
Time Frame: four weeks (sessions 1 and 12)
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.
four weeks (sessions 1 and 12)
Change in neuropathic pain after the 4 weeks of the program.
Time Frame: four weeks (sessions 1 and 12)
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"
four weeks (sessions 1 and 12)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

William Carey University

Collaborators

American Osteopathic Association

Investigators

  • Study Director: Italo Subbarao, DO, William Carey University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 9, 2022

Primary Completion (Actual)

March 31, 2024

Study Completion (Actual)

March 31, 2024

Study Registration Dates

First Submitted

August 10, 2022

First Submitted That Met QC Criteria

September 27, 2022

First Posted (Actual)

September 29, 2022

Study Record Updates

Last Update Posted (Actual)

August 6, 2024

Last Update Submitted That Met QC Criteria

August 4, 2024

Last Verified

August 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • WilliamCareyU-COM-PT

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

There is no plan to make individual data available.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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