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Treatment of Hamstring Muscle in Patients With Low-back Pain

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ClinicalTrials.gov Identifier: NCT04090502
Recruitment Status : Recruiting
First Posted : September 16, 2019
Last Update Posted : October 1, 2019
Sponsor:
Information provided by (Responsible Party):
Prof. Dr. Daniel Pecos Martín, University of Alcala

Brief Summary:
This study evaluates the treatment of hamstrings in the management of patients with mechanical low back pain of non-specific origin. Half of the participants will received the application of a dry needle technique in the most hyperalgesic areas of the muscle, while the other half will received the same technique in areas not hyperalgesic.

Condition or disease Intervention/treatment Phase
Low Back Pain Other: Dry needling in hamstring muscle trigger points Other: Dry needling in hamstring muscle not trigger points Not Applicable

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


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effectiveness of Hamstring Muscle Dry Needling in Patients With Chronic Mechanical Low Back Pain of Non-specific Origin
Estimated Study Start Date : October 1, 2019
Estimated Primary Completion Date : November 30, 2019
Estimated Study Completion Date : April 30, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Back Pain

Arm Intervention/treatment
Experimental: Grupo A. Dry needling in Trigger point
Participants will be treated in the most hyperalgesic foci within the hamstring musculature.
Other: Dry needling in hamstring muscle trigger points
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 Name: intramuscular stimulation of muscle

Placebo Comparator: Grupo B. Dry needling in non-hyperalgesic areas
Participants will be treated in non-hyperalgesic areas within the hamstring muscles.
Other: Dry needling in hamstring muscle not trigger points
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.




Primary Outcome Measures :
  1. Low back pain [ Time Frame: Change from Baseline Pressure Pain Threshold at 3 months ]
    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.


Secondary Outcome Measures :
  1. Disability with Oswestry Disability Index [ Time Frame: Change from Baseline disability at 3 months ]
    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

  2. The extensibility of the hamstring muscle [ Time Frame: Change from Baseline disability at 3 months ]

    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.


  3. Pressure Pain Threshold [ Time Frame: Change from Baseline Pressure Pain Threshold at 3 months ]
    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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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04090502


Contacts
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Contact: Daniel Pecos-Martin, PhD +34 918855142 daniel.pecos@uah.es

Locations
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Spain
Centro Investigación Fisioterapia y Dolor Recruiting
Alcalá De Henares, Madrid, Spain, 28805
Contact: Patricia Martinez-Merinero, PhD    683378391    info@institutofisioterapiaydolor.es   
Contact: Oliva Azucena       info@institutofisioterapiaydolor.es   
Instituto Fisioterapia y Dolor Recruiting
Alcalá De Henares, Madrid, Spain, 28807
Contact: Azucena Oliva, Mrs       azu.oliva@uah.es   
Sponsors and Collaborators
University of Alcala
Investigators
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Study Chair: Tomas Gallego-Izquierdo, PhD Alcala University

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Responsible Party: Prof. Dr. Daniel Pecos Martín, Clinical professor, University of Alcala
ClinicalTrials.gov Identifier: NCT04090502     History of Changes
Other Study ID Numbers: CEIM/HU2019/18
First Posted: September 16, 2019    Key Record Dates
Last Update Posted: October 1, 2019
Last Verified: September 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Prof. Dr. Daniel Pecos Martín, University of Alcala:
pain
Back
Hamstrings
Additional relevant MeSH terms:
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Back Pain
Low Back Pain
Pain
Neurologic Manifestations
Signs and Symptoms