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

NCT05559255 | Completed

• 1 other identifier: WilliamCareyU-COM-PT
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

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.

Conditions

Pain; Spasticity, Muscle; Quality of Life

Keywords

pain; spasticity; quality of life; spinal cord injury; counterstrain manual manipulative treatment

Outcome Measures

Primary Outcomes (4)

• 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.

  Sessions/days 1,2,3,4,5,6,7,8,9,10,11,12

• Muscle Spasticity

  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

  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.

  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)

Interventions

Counterstrain manual manipulative treatment OTHER

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.

Eligibility Criteria

• Age: 21 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• William Carey University: lead
• American Osteopathic Association: collaborator

Study Sites (1)

William Carey University

Hattiesburg, Mississippi, 39401, United States

Location

MeSH Terms

Conditions

Pain; Muscle Spasticity; Spinal Cord Injuries

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Muscular Diseases; Musculoskeletal Diseases; Muscle Hypertonia; Neuromuscular Manifestations; Nervous System Diseases; Spinal Cord Diseases; Central Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries

Study Officials

• Italo Subbarao, DO

  William Carey University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: David R. Dolbow, Primary Investigator

Model Details: 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.

Study Record Dates

• First Submitted: August 10, 2022
• First Posted: September 29, 2022
• Study Start: September 9, 2022
• Primary Completion: March 31, 2024
• Study Completion: March 31, 2024
• Last Updated: August 6, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)