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NCT Number: NCT04090502

Treatment of Hamstring Muscle in Patients With Low-back Pain

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.

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Key information

Conditions

Low Back Pain Back Pain Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Centro Investigación Fisioterapia y Dolor, Alcalá de Henares, Madrid, Spain

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About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Dry needling in hamstring muscle trigger points

Other

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: intramuscular stimulation of muscle

Dry needling in hamstring muscle not trigger points

Other

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 outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

University of Alcala

Other

Registry information

Official study title

Effectiveness of Hamstring Muscle Dry Needling in Patients With Chronic Mechanical Low Back Pain of Non-specific Origin

Important dates

Study start
2019
Primary completion
2023
Study completion
2023
First posted
Sep 16, 2019
Registry last updated
Oct 25, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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