Physiotherapy SpecialtyNCT05440253
Effectiveness of Manual Therapy in Non-specific Low Back Pain
A study testing dry needling and ischemic compression in people with Physiotherapy Specialty and Low Back Pain, run by Universidad Católica de Ávila at 1 site in Spain.
Trial summary
Low back pain affects many people and involves high medical costs. For this reason, we wish to test the efficacy of dry needling VS ischaemic compression in patients with non-specific low back pain. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Physiotherapy Specialty, Low Back Pain
- What is being tested?
- dry needling and ischemic compression
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteSpain
- Study dates
- 1 Apr 2022to 24 Jun 2022
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Signed informed consent form.
- Presence of non-specific low back pain for more than six weeks.
- Presence of a palpable tight band nodule in the gluteus medius muscle.
- Presence of a hypersensitive or hyperirritable point in the tight band.
- Patients reporting local or referred pain in the area of the latent MGP after mechanical stimulation mechanical stimulation.
Who cannot join
- Surgeries in the lumbopelvic region.
- Diagnosis of herniated discs in the lumbar region.
- Positive cognitive screening according to the Pfeiffer questionnaire.
- Heterometrics.
- Age outside the range of 18 to 75 years.
- Ingested or injected anticoagulant or antiplatelet drugs.
Show all 9Show fewer
- Systemic or local infection in the lumbar region.
- Pregnancy.
- Presence of fear of needles (belonephobia).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effectiveness of Dry Needling VS Ischaemic Compression on Latent Myofascial Myofascial Trigger Points in the Gluteus Medius in Patients With Patients With Non-specific Low Back Pain: a Randomised Clinical Trial
Low back pain affects many people and involves high medical costs. For this reason, we wish to test the efficacy of dry needling VS ischaemic compression in patients with non-specific low back pain. To this end, an investigation was carried out on 40 patients diagnosed with this ailment, divided into two groups by randomisation to assess the intensity of pain, range of movement, pain threshold to pressure and quality of life, measuring these variables prior to the intervention, immediately, at 48 hours and one week after the intervention.
- Conditions
- Physiotherapy Specialty, Low Back Pain
- Being tested
- dry needling, ischemic compression
- Keywords
- dry needling, low back pain, physiotherapy specialty, pain
- 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 needlingDevice
Dry needling of the trigger point of the gluteus medius in patients diagnosed with non-specific low back pain.
ischemic compressionProcedure or surgery
Ischaemic trigger point compression of the gluteus medius in patients diagnosed with non-specific low back pain.
| Study group | Role | What they receive |
|---|---|---|
| dry needling group | Experimental | Not described Receives: Device: dry needling |
| ischaemic compression group | Active comparator | Not described Receives: Procedure: ischemic compression |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain
Visual Scale Analogue (0 minimum, 10 maximum).
Measured: 1 week
Secondary outcomes (2)
movement
Schober test (0 minimum, 45 maximun).
Measured: 1 week
quality of life
Oswestry low back pain disability scale (0 minimum, 100% maximum; Between 0-20% minimal limitation or disability, 21-40% moderate limitation or disability, 41- 60% severe limitation or disability, 61-80% disabled and above 81% limitation or disability.
60% severe limitation or disability, 61-80% disabled and above 81% maximum functional limitation or disability, 61-80% disabled and above 81% maximum functional limitation or disability.
maximum functional limitation).
Measured: 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jun 2022
- Study start1 Apr 2022
- Primary completion29 May 2022
- Study completion24 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Physiotherapy SpecialtyStudies 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidad Católica de Ávila
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, JORGE VELAZQUEZ SAORNIL, Universidad Católica de Ávila
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05440253
- Sponsor's protocol ID
- 230622
- Status last verified
- Aug 2022
- First submitted
- 23 Jun 2022
- Last updated
- 15 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Martinez de la Iglesia J, Duenas Herrero R, Onis Vilches MC, Aguado Taberne C, Albert Colomer C, Luque Luque R. [Spanish language adaptation and validation of the Pfeiffer's questionnaire (SPMSQ) to detect cognitive deterioration in people over 65 years of age]. Med Clin (Barc). 2001 Jun 30;117(4):129-34. doi: 10.1016/s0025-7753(01)72040-4. Spanish.
PubMed 11472684Kim HS, Lee JH, Kim IK. Intracellular glutathione level modulates the induction of apoptosis by delta 12-prostaglandin J2. Prostaglandins. 1996 Jun;51(6):413-25. doi: 10.1016/0090-6980(96)00047-0.
PubMed 8873236Perez-Palomares S, Jimenez-Sanchez C, Serrano-Herrero I, Herrero P, Calvo S. Is Instrumental Compression Equally Effective and Comfortable for Physiotherapists and Physiotherapy Students than Manual Compression? A Comparative Cross-Sectional Study. Int J Environ Res Public Health. 2021 Nov 18;18(22):12121. doi: 10.3390/ijerph182212121.
PubMed 34831877Aguilera FJ, Martin DP, Masanet RA, Botella AC, Soler LB, Morell FB. Immediate effect of ultrasound and ischemic compression techniques for the treatment of trapezius latent myofascial trigger points in healthy subjects: a randomized controlled study. J Manipulative Physiol Ther. 2009 Sep;32(7):515-20. doi: 10.1016/j.jmpt.2009.08.001.
PubMed 19748402Roland M, Fairbank J. The Roland-Morris Disability Questionnaire and the Oswestry Disability Questionnaire. Spine (Phila Pa 1976). 2000 Dec 15;25(24):3115-24. doi: 10.1097/00007632-200012150-00006. No abstract available.
PubMed 11124727Martin-Pintado-Zugasti A, Mayoral Del Moral O, Gerwin RD, Fernandez-Carnero J. Post-needling soreness after myofascial trigger point dry needling: Current status and future research. J Bodyw Mov Ther. 2018 Oct;22(4):941-946. doi: 10.1016/j.jbmt.2018.01.003. Epub 2018 Jan 17.
PubMed 30368339Martin-Pintado-Zugasti A, Rodriguez-Fernandez AL, Fernandez-Carnero J. Postneedling soreness after deep dry needling of a latent myofascial trigger point in the upper trapezius muscle: Characteristics, sex differences and associated factors. J Back Musculoskelet Rehabil. 2016 Apr 27;29(2):301-308. doi: 10.3233/BMR-150630.
PubMed 26406209Ziaeifar M, Arab AM, Karimi N, Nourbakhsh MR. The effect of dry needling on pain, pressure pain threshold and disability in patients with a myofascial trigger point in the upper trapezius muscle. J Bodyw Mov Ther. 2014 Apr;18(2):298-305. doi: 10.1016/j.jbmt.2013.11.004. Epub 2013 Nov 9.
PubMed 24725800
Study at a glance
From the registry record, last updated by the sponsor on 15 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Dry Needling VS Ischaemic Compression on Latent Myofascial Myofascial Trigger Points in the Gluteus Medius in Patients With Patients With Non-specific Low Back Pain: a Randomised Clinical Trial
- ClinicalTrials.gov ID
- NCT05440253
- Acronym / sponsor ID
- 230622
- Conditions
- Physiotherapy Specialty, Low Back Pain
- Keywords
- dry needling, low back pain, physiotherapy specialty, pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Universidad Católica de ÁvilaUniversity, hospital or other
- Study start
- 1 Apr 2022 (actual)
- Primary completion
- 29 May 2022 (actual)
- Study completion
- 24 Jun 2022 (actual)
- First posted
- 30 Jun 2022 (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.
Low back pain affects many people and involves high medical costs. For this reason, we wish to test the efficacy of dry needling VS ischaemic compression in patients with non-specific low back pain. To this end, an investigation was carried out on 40 patients diagnosed with this ailment, divided into two groups by randomisation to assess the intensity of pain, range of movement, pain threshold to pressure and quality of life, measuring these variables prior to the intervention, immediately, at 48 hours and one week after the intervention.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| dry needling group | Experimental | Device: dry needling |
| ischaemic compression group | Active comparator | Procedure: ischemic compression |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Signed informed consent form.
- Presence of non-specific low back pain for more than six weeks.
- Presence of a palpable tight band nodule in the gluteus medius muscle.
- Presence of a hypersensitive or hyperirritable point in the tight band.
- Patients reporting local or referred pain in the area of the latent MGP after mechanical stimulation mechanical stimulation.
Key exclusion criteria (9 listed)
- Surgeries in the lumbopelvic region.
- Diagnosis of herniated discs in the lumbar region.
- Positive cognitive screening according to the Pfeiffer questionnaire.
- Heterometrics.
- Age outside the range of 18 to 75 years.
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 needlingDry needling of the trigger point of the gluteus medius in patients diagnosed with non-specific low back pain. | Device | dry needling group |
| ischemic compressionIschaemic trigger point compression of the gluteus medius in patients diagnosed with non-specific low back pain. | Procedure or surgery | ischaemic compression group |
Primary outcome
Pain
Time frame: 1 week
Visual Scale Analogue (0 minimum, 10 maximum).
2 secondary outcomes
movement
Time frame: 1 week
quality of life
Time frame: 1 week
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 15 Aug 2022.
- Background: PubMed 11472684Martinez de la Iglesia J, Duenas Herrero R, Onis Vilches MC, Aguado Taberne C, Albert Colomer C, Luque Luque R. [Spanish language adaptation and validation of the Pfeiffer's questionnaire (SPMSQ) to detect cognitive deterioration in people over 65 years of age]. Med Clin (Barc). 2001 Jun 30;117(4):129-34. doi: 10.1016/s0025-7753(01)72040-4. Spanish.
- Background: PubMed 8873236Kim HS, Lee JH, Kim IK. Intracellular glutathione level modulates the induction of apoptosis by delta 12-prostaglandin J2. Prostaglandins. 1996 Jun;51(6):413-25. doi: 10.1016/0090-6980(96)00047-0.
- Results publication: PubMed 34831877Perez-Palomares S, Jimenez-Sanchez C, Serrano-Herrero I, Herrero P, Calvo S. Is Instrumental Compression Equally Effective and Comfortable for Physiotherapists and Physiotherapy Students than Manual Compression? A Comparative Cross-Sectional Study. Int J Environ Res Public Health. 2021 Nov 18;18(22):12121. doi: 10.3390/ijerph182212121.
- Results publication: PubMed 19748402Aguilera FJ, Martin DP, Masanet RA, Botella AC, Soler LB, Morell FB. Immediate effect of ultrasound and ischemic compression techniques for the treatment of trapezius latent myofascial trigger points in healthy subjects: a randomized controlled study. J Manipulative Physiol Ther. 2009 Sep;32(7):515-20. doi: 10.1016/j.jmpt.2009.08.001.
- Results publication: PubMed 11124727Roland M, Fairbank J. The Roland-Morris Disability Questionnaire and the Oswestry Disability Questionnaire. Spine (Phila Pa 1976). 2000 Dec 15;25(24):3115-24. doi: 10.1097/00007632-200012150-00006. No abstract available.
- Results publication: PubMed 30368339Martin-Pintado-Zugasti A, Mayoral Del Moral O, Gerwin RD, Fernandez-Carnero J. Post-needling soreness after myofascial trigger point dry needling: Current status and future research. J Bodyw Mov Ther. 2018 Oct;22(4):941-946. doi: 10.1016/j.jbmt.2018.01.003. Epub 2018 Jan 17.
- Results publication: PubMed 26406209Martin-Pintado-Zugasti A, Rodriguez-Fernandez AL, Fernandez-Carnero J. Postneedling soreness after deep dry needling of a latent myofascial trigger point in the upper trapezius muscle: Characteristics, sex differences and associated factors. J Back Musculoskelet Rehabil. 2016 Apr 27;29(2):301-308. doi: 10.3233/BMR-150630.
- Results publication: PubMed 24725800Ziaeifar M, Arab AM, Karimi N, Nourbakhsh MR. The effect of dry needling on pain, pressure pain threshold and disability in patients with a myofascial trigger point in the upper trapezius muscle. J Bodyw Mov Ther. 2014 Apr;18(2):298-305. doi: 10.1016/j.jbmt.2013.11.004. Epub 2013 Nov 9.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing dry needling and ischemic compression in people with Physiotherapy Specialty and Low Back Pain, run by Universidad Católica de Ávila at 1 site 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 5 inclusion and 9 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 15 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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. 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?
Pain (time frame: 1 week). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05440253, which also lists 8 linked publications.
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 15 Aug 2022.