Treatment of Hamstring Muscle in Patients With Low-back Pain

Low Back Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04090502
• Other study ID #: CEIM/HU2019/18
• Status: Completed
• Phase: N/A
• Start date: October 1, 2019
• Est. completion date: October 24, 2023

Study information

• Verified date: October 2023
• Source: University of Alcala
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: October 24, 2023
• Est. primary completion date: October 24, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Back Pain
• Low Back Pain

Intervention

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.
• 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.

Locations

Country	Name	City	State
Spain	Centro Investigación Fisioterapia y Dolor	Alcalá De Henares	Madrid
Spain	Instituto Fisioterapia y Dolor	Alcalá De Henares	Madrid

Sponsors (1)

Lead Sponsor	Collaborator
University of Alcala

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Low back pain	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.	Change from Baseline Pressure Pain Threshold at 3 months
Secondary	Disability with Oswestry Disability Index	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	Change from Baseline disability at 3 months
Secondary	The extensibility of the hamstring muscle	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
Secondary	Pressure Pain Threshold	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.	Change from Baseline Pressure Pain Threshold at 3 months