PainNCT05559255
Changes in Pain, Spasticity, and Quality of Life After Use of Counterstrain Treatment in Individuals With SCI
A study testing Counterstrain manual manipulative treatment in people with Pain and Spasticity, Muscle, run by William Carey University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 to 70 years
- Conditions the study is for
- Pain, Spasticity, Muscle, Quality of Life
- What is being tested?
- Counterstrain manual manipulative treatment
- How many people
- 8 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Sep 2022to 31 Mar 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
William Carey University
Hattiesburg, Mississippi, 39401
About this study
Official title: 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.
Read the 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
- Being tested
- Counterstrain manual manipulative treatment
- Keywords
- pain, spasticity, quality of life, spinal cord injury, counterstrain manual manipulative treatment
- Medical subject headings
- Pain, Muscle Spasticity, Spinal Cord Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Counterstrain manual manipulative treatmentOther
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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"
Measured: four weeks (sessions 1 and 12)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Sep 2022
- Study start9 Sep 2022
- Primary completion31 Mar 2024
- Study completion31 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- 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)
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- William Carey University
- Sponsor type
- University, hospital or other
- Collaborators
- American Osteopathic Association
- Responsible party
- Principal investigator, David Dolbow, William Carey University
- Investigators
- Italo Subbarao, DO, Study director, William Carey University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05559255
- Sponsor's protocol ID
- WilliamCareyU-COM-PT
- Status last verified
- Aug 2024
- First submitted
- 10 Aug 2022
- Last updated
- 6 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There is no plan to make individual data available.
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Changes in Pain, Spasticity, and Quality of Life After Use of Counterstrain Osteopathic Manipulative Treatment in Individuals With Spinal Cord Injury
- ClinicalTrials.gov ID
- NCT05559255
- Acronym / sponsor ID
- WilliamCareyU-COM-PT
- Conditions
- Pain, Spasticity, Muscle, Quality of Life
- Keywords
- pain, spasticity, quality of life, spinal cord injury, counterstrain manual manipulative treatment
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- William Carey UniversityUniversity, hospital or other
- Collaborators
- American Osteopathic Association
- Study start
- 9 Sep 2022 (actual)
- Primary completion
- 31 Mar 2024 (actual)
- Study completion
- 31 Mar 2024 (actual)
- First posted
- 29 Sep 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- 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.
Who may qualify
- Ages
- 21 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Counterstrain manual manipulative treatmentThe 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. | Other | – |
Primary outcome
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.
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.
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.
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"
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Aug 2024.
- Individual participant dataSharing planned: No. There is no plan to make individual data available.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Italo Subbarao, DO study director
William Carey University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Counterstrain manual manipulative treatment in people with Pain and Spasticity, Muscle, run by William Carey University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Neurogenic Pain after each session (time frame: Sessions/days 1,2,3,4,5,6,7,8,9,10,11,12). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Aug 2024.