Spinal Cord InjuriesNCT03709797
Effectiveness of Dry Needling as a Treatment of Shoulder Myofascial Pain Syndrome in Spinal Cord Injury Patients
A study testing Dry needling in infraspinatus muscle in people with Spinal Cord Injuries and Myofascial Pain Syndrome, run by Universidad de León at 1 site in Spain.
Trial summary
Shoulder pain in people with spinal cord injury is one of the most prevalent in acute and chronic patients because of weakness in shoulder periarticular muscles, and also because of overuse of these part of the body in assistive devices. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Spinal Cord Injuries, Myofascial Pain Syndrome, Shoulder Pain
- What is being tested?
- Dry needling in infraspinatus muscle
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteSpain
- Study dates
- 9 Nov 2018to Oct 2020
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- At least one year after Spinal Cord Injury (chronic patients).
- Spinal Cord Injury under C5-C6 spinal level with American Spinal Injury Association (ASIA) classification.
- Patients with shoulder pain and at least one active trigger point in infraspinatus muscle.
Who cannot join
- Be apprehensive to the needles (belonephobia).
- Immunosuppression.
- Drug instability.
- Other medical causes that, under medical prescription, dry needling in the shoulder are discouraged.
Trial locations and contacts
1 site in 1 country.
Spain1 site, 1 recruiting
- Recruiting
Sandra Palacios Alfonso
Burgos, 09007
Sandra Palacios Alfonso, PhD student, 650667306, sandra.palac@gmail.com
About this study
Official title: Effectiveness of Dry Needling as a Treatment of Shoulder Myofascial Pain Syndrome in Spinal Cord Injury Patients: a Randomized Controlled Clinical Trial
Shoulder pain in people with spinal cord injury is one of the most prevalent in acute and chronic patients because of weakness in shoulder periarticular muscles, and also because of overuse of these part of the body in assistive devices.
This study aims to evidence if dry needling (a physiotherapy technique) is also useful in patients with spinal cord injury, and how long it could hold out without or less pain.
- Being tested
- Dry needling in infraspinatus muscle
- Keywords
- Spinal Cord Injury, Shoulder Pain, Myofascial Pain Syndrome, Dry Needling
- Medical subject headings
- Spinal Cord Injuries, Myofascial Pain Syndromes, Shoulder Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dry needling in infraspinatus muscleProcedure or surgery
Dry needling technique with multiple rapid needle insertion.
| Study group | Role | What they receive |
|---|---|---|
| Experimental group | Experimental | Experimental group will receive dry needling treatment. Receives: Procedure: Dry needling in infraspinatus muscle |
| Control group | Sham comparator | Control group will receive sham dry needling treatment. Receives: Procedure: Dry needling in infraspinatus muscle |
What is being measured
The primary outcome is the main question the study is designed to answer.
Disabilities of the Arm, Shoulder and Hand Spanish version (DASHe).
In upper limb pathology this test evaluates functional activities in relation to the difficulty involved in performing them with a score between 1 and 5.
The DASHe questionnaire consists of a main part of 30 items, and two specific modules for people who work with musical instruments / sports or for the workplace. In this study, only the main part has been used. The 30 items have a score of 1 to 5, with 5 being the maximum of the valued symptom, and at least 27 questions of 3 must be answered.
The disability / symptom score will therefore be between 0 (best possible score) and 100 (worst possible score).
Measured: Change from baseline and one week later.
Secondary outcomes (5)
Pressure Pain Thershold (algometry).
Baseline®dolorimeter - 22lb / 10kg, STOCK CODE: 12-1442 It will be measured with an algometer that is an instrument that provides quantitative / objective information on pain at a specific point, depending on the pressure on which it is applied. A circle is drawn around the trigger point on which the indelible marker test will be performed to confirm in the last measurement which is the exact point on which it is worked. 3 consecutive measurements are made at the same point, waiting between one and another measurement for a period between 30-60 seconds, and the average of the 3 measurements will be used as a statistical value.
Measured: Change from baseline, immediately after intervention and one week later.
McGill Pain Questionnaire (Spanish version).
This scale consists of a set of 78 adjectives included in 20 groups (including 2 to 6 in each group) and that express a characteristic of pain. Within these 20 groups we find the Pain Rating Index (PRI) divided into: sensory (groups 1-10), affective (groups 11-15), evaluative (group 16) and miscellaneous (group 17-20) ), of which the patient can only choose one word from each of the 20 groups, choosing only those adjectives that best suit his pain sensation. It also includes a category on the changes that experimental pain, and another with a rate of pain intensity (Present Pain Index = PPI).
Measured: Change from baseline and one week later.
Visual Analog Scale (VAS)
This scale is a line of 10 centimeters without marks between the parameters without pain and unbearable pain, where the patient has to mark between those parameters where his pain is.
Measured: Change from baseline and one week later.
Shoulder Pain And Disability Index Spanish version (SPADIe).
It consists of a 10-item scale that assesses shoulder pain and the difficulties in activities of daily life that it generates, divided into two main sections: the first 4 items refer to the intensity of pain and the last 6 refer to the difficulty of carrying out specific activities. All the items have a minimum score of 0 and a maximum of 10, therefore the total score is between 0 and 100, with 0 being the best possible value in relation to pain and difficulty, and 100 being the highest value and so much more painful and disabling.
Measured: Change from baseline and one week later.
Range Of Movement (ROM)
Objective will be to measure different ranges of movement of the affected upper limb (internal rotation and horizontal adduction) in question due to myofascial pain syndrome. In this case the movements that passively will be measured with a bubble inclinometer.
Measured: Change from baseline, immediately after intervention and one week later.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Oct 2018
- Study start9 Nov 2018
- Primary completionJan 2020 (estimated)
- Study completionOct 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spinal Cord InjuriesStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universidad de León
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sandra Palacios Alfonso, Universidad de León
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03709797
- Sponsor's protocol ID
- ULeon-020-2018
- Status last verified
- Feb 2019
- First submitted
- 8 Oct 2018
- Last updated
- 5 Feb 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Dry Needling as a Treatment of Shoulder Myofascial Pain Syndrome in Spinal Cord Injury Patients: a Randomized Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT03709797
- Acronym / sponsor ID
- ULeon-020-2018
- Keywords
- Spinal Cord Injury, Shoulder Pain, Myofascial Pain Syndrome, Dry Needling
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Universidad de LeónUniversity, hospital or other
- Study start
- 9 Nov 2018 (actual)
- Primary completion
- Jan 2020 (estimated)
- Study completion
- Oct 2020 (estimated)
- First posted
- 17 Oct 2018 (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.
Shoulder pain in people with spinal cord injury is one of the most prevalent in acute and chronic patients because of weakness in shoulder periarticular muscles, and also because of overuse of these part of the body in assistive devices.
This study aims to evidence if dry needling (a physiotherapy technique) is also useful in patients with spinal cord injury, and how long it could hold out without or less pain.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental group | Experimental | Procedure: Dry needling in infraspinatus muscleExperimental group will receive dry needling treatment. |
| Control group | Sham comparator | Procedure: Dry needling in infraspinatus muscleControl group will receive sham dry needling treatment. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- At least one year after Spinal Cord Injury (chronic patients).
- Spinal Cord Injury under C5-C6 spinal level with American Spinal Injury Association (ASIA) classification.
- Patients with shoulder pain and at least one active trigger point in infraspinatus muscle.
Key exclusion criteria (4 listed)
- Be apprehensive to the needles (belonephobia).
- Immunosuppression.
- Drug instability.
- Other medical causes that, under medical prescription, dry needling in the shoulder are discouraged.
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 |
|---|---|---|
| Dry needling in infraspinatus muscleDry needling technique with multiple rapid needle insertion. | Procedure or surgery | Control group, Experimental group |
Primary outcome
Disabilities of the Arm, Shoulder and Hand Spanish version (DASHe).
Time frame: Change from baseline and one week later.
In upper limb pathology this test evaluates functional activities in relation to the difficulty involved in performing them with a score between 1 and 5. The DASHe questionnaire consists of a main part of 30 items, and two specific modules for people who work with musical instruments / sports or for the workplace. In this study, only the main part has been used. The 30 items have a score of 1 to 5, with 5 being the maximum of the valued symptom, and at least 27 questions of 3 must be answered. The disability / symptom score will therefore be between 0 (best possible score) and 100 (worst possible score).
5 secondary outcomes
Pressure Pain Thershold (algometry).
Time frame: Change from baseline, immediately after intervention and one week later.
McGill Pain Questionnaire (Spanish version).
Time frame: Change from baseline and one week later.
Visual Analog Scale (VAS)
Time frame: Change from baseline and one week later.
Shoulder Pain And Disability Index Spanish version (SPADIe).
Time frame: Change from baseline and one week later.
Range Of Movement (ROM)
Time frame: Change from baseline, immediately after intervention and one week later.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Feb 2019.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dry needling in infraspinatus muscle in people with Spinal Cord Injuries and Myofascial Pain Syndrome, run by Universidad de León at 1 site in Spain.
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 3 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 5 Feb 2019. 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 Spain. 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. Some participants in this study may receive a placebo. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sandra Ms Palacios Alfonso (+34650667306, sandra.palac@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Disabilities of the Arm, Shoulder and Hand Spanish version (DASHe). (time frame: Change from baseline and one week later.). 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 5 Feb 2019.