Back to resultsTreatment of Hamstring Muscle in Patients With Low-back Pain
Primary Purpose
Low Back Pain
Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Dry needling in hamstring muscle trigger points
Dry needling in hamstring muscle not trigger points
Sponsored by
About this trial
This is an interventional treatment trial for Low Back Pain focused on measuring pain, Back, Hamstrings
Eligibility 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
Sites / Locations
- Centro Investigación Fisioterapia y Dolor
- Instituto Fisioterapia y Dolor
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Grupo A. Dry needling in Trigger point
Grupo B. Dry needling in non-hyperalgesic areas
Arm Description
Participants will be treated in the most hyperalgesic foci within the hamstring musculature.
Participants will be treated in non-hyperalgesic areas within the hamstring muscles.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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
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.
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.
Full Information
NCT ID
NCT04090502
First Posted
September 12, 2019
Last Updated
October 24, 2023
Sponsor
University of Alcala
1. Study Identification
Unique Protocol Identification Number
NCT04090502
Brief Title
Treatment of Hamstring Muscle in Patients With Low-back Pain
Official Title
Effectiveness of Hamstring Muscle Dry Needling in Patients With Chronic Mechanical Low Back Pain of Non-specific Origin
Study Type
Interventional
2. Study Status
Record Verification Date
October 2023
Overall Recruitment Status
Completed
Study Start Date
October 1, 2019 (Actual)
Primary Completion Date
October 24, 2023 (Actual)
Study Completion Date
October 24, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Alcala
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Low Back Pain
Keywords
pain, Back, Hamstrings
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
50 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Grupo A. Dry needling in Trigger point
Arm Type
Experimental
Arm Description
Participants will be treated in the most hyperalgesic foci within the hamstring musculature.
Arm Title
Grupo B. Dry needling in non-hyperalgesic areas
Arm Type
Placebo Comparator
Arm Description
Participants will be treated in non-hyperalgesic areas within the hamstring muscles.
Intervention Type
Other
Intervention Name(s)
Dry needling in hamstring muscle trigger points
Other Intervention Name(s)
intramuscular stimulation of muscle
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Dry needling in hamstring muscle not trigger points
Intervention Description
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 Measure Information:
Title
Low back pain
Description
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.
Time Frame
Change from Baseline Pressure Pain Threshold at 3 months
Secondary Outcome Measure Information:
Title
Disability with Oswestry Disability Index
Description
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
Time Frame
Change from Baseline disability at 3 months
Title
The extensibility of the hamstring muscle
Description
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.
Time Frame
Change from Baseline disability at 3 months
Title
Pressure Pain Threshold
Description
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.
Time Frame
Change from Baseline Pressure Pain Threshold at 3 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tomas Gallego-Izquierdo, PhD
Organizational Affiliation
Alcala University
Official's Role
Study Chair
Facility Information:
Facility Name
Centro Investigación Fisioterapia y Dolor
City
Alcalá De Henares
State/Province
Madrid
ZIP/Postal Code
28805
Country
Spain
Facility Name
Instituto Fisioterapia y Dolor
City
Alcalá De Henares
State/Province
Madrid
ZIP/Postal Code
28807
Country
Spain
12. IPD Sharing Statement
Learn more about this trial
Treatment of Hamstring Muscle in Patients With Low-back Pain
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