- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04090502
Treatment of Hamstring Muscle in Patients With Low-back Pain
Effectiveness of Hamstring Muscle Dry Needling in Patients With Chronic Mechanical Low Back Pain of Non-specific Origin
Study Overview
Status
Conditions
Detailed Description
Shortening of the hamstrings could be related to low back pain.Therefore, the treatment of these muscles may improve pain.
The dry needling technique seems to improve the extensibility of the muscles. This technique seems to be more effective when is applied in the most hyperalgesic areas related to the participant's pain.
In order to demonstrate this hypothesis, the investigators will check if the dry needling technique produces the same effects when is applied in other areas of those same muscles
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Daniel Pecos-Martin, PhD
- Phone Number: +34 918855142
- Email: daniel.pecos@uah.es
Study Locations
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Madrid
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Alcalá De Henares, Madrid, Spain, 28807
- Instituto Fisioterapia y Dolor
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Alcalá De Henares, Madrid, Spain, 28805
- Centro Investigación Fisioterapia y Dolor
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Nonspecific chronic low back pain lasting ≥ 3 months.
- Age between 18 and 65 years.
- History of non-specific lumbar pain not irradiated to lower extremities of at least 1 year of evolution.
- Those subjects who have not received a physiotherapy session in the last 6 months.
Exclusion Criteria:
Specific low back pain (infection, tumor, inflammation, canal stenosis, spondylolisthesis, hernia or disc prolapse, structural deformity, rheumatic disease, radicular pain, cauda equina, previous history of spinal surgery).
- Fibromyalgia.
- Treatment with corticosteroids or oral medications in the last 6 months.
- History of spinal surgery.
- Contraindications typical of deep dry puncture (needle phobia, coagulation or psychological disorders, varicose regions, cysts, wounds, metal or latex allergy, lymphedema, hypothyroidism, diabetes).
- Those subjects with a value of 0º in the Active Knee Extension (EAR) test.
- Pregnancy
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Grupo A. Dry needling in Trigger point
Participants will be treated in the most hyperalgesic foci within the hamstring musculature.
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Participants with nonspecific mechanical low back pain will be assessed for the hamstring muscle.
Subsequently, the most sensitive areas associated with the shortening of the muscle will be located and the technique will be applied to this area.
Other Names:
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Placebo Comparator: Grupo B. Dry needling in non-hyperalgesic areas
Participants will be treated in non-hyperalgesic areas within the hamstring muscles.
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Participants with nonspecific mechanical low back pain will be assessed for the hamstring muscle.
Subsequently, the most sensitive areas associated with the shortening of the muscle will be located and the technique will be applied out of this area.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Low back pain
Time Frame: Change from Baseline Pressure Pain Threshold at 3 months
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The investigators use a Visual Analog Scale (VAS) to determine the intensity of the patient with blowback pain.The VAS is a 100-mm line, oriented horizontally, with one end representing "no pain" and the other end representing "worst pain."
Subjects will be asked to rate their current pain with a mark on the scale.
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Change from Baseline Pressure Pain Threshold at 3 months
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Disability with Oswestry Disability Index
Time Frame: Change from Baseline disability at 3 months
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The Oswestry Disability Index (ODI) is a questionnaire used by clinicians and researchers to quantify disability for low back pain.The self-completed questionnaire contains ten topics concerning intensity of pain, lifting, ability to care for oneself, ability to walk, ability to sit, sexual function, ability to stand, social life, sleep quality, and ability to travel.Each topic category is followed by 6 statements describing different potential scenarios in the patient's life relating to the topic.
The patient then checks the statement which most closely resembles their situation.
Each question is scored on a scale of 0-5 with the first statement being zero and indicating the least amount of disability and the last statement is scored 5 indicating most severe disability.
The scores for all questions answered are summed, then multiplied by two to obtain the index (range 0 to 100).
Zero is equated with no disability and 100 is the maximum disability possible
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Change from Baseline disability at 3 months
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The extensibility of the hamstring muscle
Time Frame: Change from Baseline disability at 3 months
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The extensibility of the hamstring muscle will be measured by the popliteal or active knee extension (AKE) test, with the patient supine on the stretcher, with the contralateral limb in extension, will placed with the hip at 90 degrees of flexion. While maintaining this position, the clinician tries to extend the knee. Limitation of knee extension is measured with a goniometer in degrees. |
Change from Baseline disability at 3 months
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Pressure Pain Threshold
Time Frame: Change from Baseline Pressure Pain Threshold at 3 months
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The PPT serves to determine the sensitivity of hiperalgesic focus.
The investigators will done it with one algometer.
A lower threshold is a worse result.
A higher threshold is a better result.
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Change from Baseline Pressure Pain Threshold at 3 months
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Collaborators and Investigators
Sponsor
Investigators
- Study Chair: Tomas Gallego-Izquierdo, PhD, Alcala University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- CEIM/HU2019/18
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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