NCT05440253

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Apr 2022

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2022

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 29, 2022

Completed
25 days until next milestone

First Submitted

Initial submission to the registry

June 23, 2022

Completed
1 day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 24, 2022

Completed
6 days until next milestone

First Posted

Study publicly available on registry

June 30, 2022

Completed
Last Updated

August 15, 2022

Status Verified

August 1, 2022

Enrollment Period

2 months

First QC Date

June 23, 2022

Last Update Submit

August 11, 2022

Conditions

Keywords

dry needlinglow back painphysiotherapy specialtypain

Outcome Measures

Primary Outcomes (1)

  • Pain

    Visual Scale Analogue (0 minimum, 10 maximum).

    1 week

Secondary Outcomes (2)

  • movement

    1 week

  • quality of life

    1 week

Study Arms (2)

dry needling group

EXPERIMENTAL
Device: dry needling

ischaemic compression group

ACTIVE COMPARATOR
Procedure: ischemic compression

Interventions

Dry needling of the trigger point of the gluteus medius in patients diagnosed with non-specific low back pain.

dry needling group

Ischaemic trigger point compression of the gluteus medius in patients diagnosed with non-specific low back pain.

ischaemic compression group

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.
  • Systemic or local infection in the lumbar region.
  • Pregnancy.
  • Presence of fear of needles (belonephobia).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Universidad Católica de Ávila

Ávila, 05005, Spain

Location

Related Publications (8)

  • 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.

    PMID: 11472684BACKGROUND
  • Kim 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.

    PMID: 8873236BACKGROUND
  • Perez-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.

  • Aguilera 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.

  • Roland 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.

  • Martin-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.

  • Martin-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.

  • Ziaeifar 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.

MeSH Terms

Conditions

Low Back PainPain

Interventions

Dry NeedlingAcupressure

Condition Hierarchy (Ancestors)

Back PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Complementary TherapiesTherapeuticsPhysical Therapy ModalitiesTherapy, Soft TissueMusculoskeletal ManipulationsRehabilitation

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

June 23, 2022

First Posted

June 30, 2022

Study Start

April 1, 2022

Primary Completion

May 29, 2022

Study Completion

June 24, 2022

Last Updated

August 15, 2022

Record last verified: 2022-08

Locations