Low Back PainNCT04090502
Treatment of Hamstring Muscle in Patients With Low-back Pain
A study testing Dry needling in hamstring muscle trigger points and Dry needling in hamstring muscle not trigger points in people with Low Back Pain, run by University of Alcala at 2 sites in Spain.
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… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Low Back Pain
- What is being tested?
- Dry needling in hamstring muscle trigger points and Dry needling in hamstring muscle not trigger points
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 2 sitesSpain
- Study dates
- 1 Oct 2019to 24 Oct 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
Spain2 sites
Centro Investigación Fisioterapia y Dolor
Alcalá de Henares, Madrid, 28805
Instituto Fisioterapia y Dolor
Alcalá de Henares, Madrid, 28807
About this study
Official title: Effectiveness of Hamstring Muscle Dry Needling in Patients With Chronic Mechanical Low Back Pain of Non-specific Origin
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.
Read the 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
- Conditions
- Low Back Pain
- Being tested
- Dry needling in hamstring muscle trigger points, Dry needling in hamstring muscle not trigger points
- Keywords
- pain, Back, Hamstrings
- Medical subject headings
- Low Back Pain, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dry needling in hamstring muscle trigger pointsOther
Also called intramuscular stimulation of muscle
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 pointsOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Grupo A. Dry needling in Trigger point | Experimental | Participants will be treated in the most hyperalgesic foci within the hamstring musculature. Receives: Other: Dry needling in hamstring muscle trigger points |
| Grupo B. Dry needling in non-hyperalgesic areas | Placebo comparator | Participants will be treated in non-hyperalgesic areas within the hamstring muscles. Receives: Other: Dry needling in hamstring muscle not trigger points |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Change from Baseline Pressure Pain Threshold at 3 months
Secondary outcomes (3)
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
Measured: Change from Baseline disability at 3 months
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.
Measured: Change from Baseline disability at 3 months
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.
Measured: Change from Baseline Pressure Pain Threshold at 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2019
- Study start1 Oct 2019
- Primary completion24 Oct 2023
- Study completion24 Oct 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Low Back PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Alcala
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Prof. Dr. Daniel Pecos Martín, University of Alcala
- Investigators
- Tomas Gallego-Izquierdo, PhD, Study chair, Alcala University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04090502
- Sponsor's protocol ID
- CEIM/HU2019/18
- Status last verified
- Oct 2023
- First submitted
- 12 Sep 2019
- Last updated
- 25 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Hamstring Muscle Dry Needling in Patients With Chronic Mechanical Low Back Pain of Non-specific Origin
- ClinicalTrials.gov ID
- NCT04090502
- Acronym / sponsor ID
- CEIM/HU2019/18
- Conditions
- Low Back Pain
- Keywords
- pain, Back, Hamstrings
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- University of AlcalaUniversity, hospital or other
- Study start
- 1 Oct 2019 (actual)
- Primary completion
- 24 Oct 2023 (actual)
- Study completion
- 24 Oct 2023 (actual)
- First posted
- 16 Sep 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Grupo A. Dry needling in Trigger point | Experimental | Other: Dry needling in hamstring muscle trigger pointsParticipants will be treated in the most hyperalgesic foci within the hamstring musculature. |
| Grupo B. Dry needling in non-hyperalgesic areas | Placebo comparator | Other: Dry needling in hamstring muscle not trigger pointsParticipants will be treated in non-hyperalgesic areas within the hamstring muscles. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (7 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dry needling in hamstring muscle trigger pointsAlso: intramuscular stimulation of muscleParticipants 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 | Grupo A. Dry needling in Trigger point |
| Dry needling in hamstring muscle not trigger pointsParticipants 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. | Other | Grupo B. Dry needling in non-hyperalgesic areas |
Primary outcome
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.
3 secondary outcomes
Disability with Oswestry Disability Index
Time frame: Change from Baseline disability at 3 months
The extensibility of the hamstring muscle
Time frame: Change from Baseline disability at 3 months
Pressure Pain Threshold
Time frame: Change from Baseline Pressure Pain Threshold at 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Oct 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tomas Gallego-Izquierdo, PhD study chair
Alcala University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dry needling in hamstring muscle trigger points and Dry needling in hamstring muscle not trigger points in people with Low Back Pain, run by University of Alcala at 2 sites in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Low back pain (time frame: Change from Baseline Pressure Pain Threshold at 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Oct 2023.