Effectiveness of Manual Therapy in Non-specific Low Back Pain

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.

Study Overview

• Status: Completed
• Conditions: Low Back Pain; Physiotherapy Specialty
• Intervention / Treatment: Device: dry needling; Procedure: ischemic compression

• Study Type: Interventional
• Enrollment (Actual): 80
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Ávila, Spain, 05005
    • Universidad Católica de Ávila

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: dry needling group	Device: dry needling; Dry needling of the trigger point of the gluteus medius in patients diagnosed with non-specific low back pain.
Active Comparator: ischaemic compression group	Procedure: ischemic compression; Ischaemic trigger point compression of the gluteus medius in patients diagnosed with non-specific low back pain.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain	Visual Scale Analogue (0 minimum, 10 maximum).	1 week

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
movement	Schober test (0 minimum, 45 maximun).	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).	1 week

Collaborators and Investigators

• Sponsor: Universidad Católica de Ávila

Publications and helpful links

General 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.
• 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.
• 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.
• 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. Erratum In: Spine 2001 Apr 1;26(7):847.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2022
• Primary Completion (Actual): May 29, 2022
• Study Completion (Actual): June 24, 2022

Study Registration Dates

• First Submitted: June 23, 2022
• First Submitted That Met QC Criteria: June 28, 2022
• First Posted (Actual): June 30, 2022

Study Record Updates

• Last Update Posted (Actual): August 15, 2022
• Last Update Submitted That Met QC Criteria: August 11, 2022
• Last Verified: August 1, 2022

More Information

Terms related to this study

• Keywords: pain; low back pain; dry needling; physiotherapy specialty
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Back Pain; Low Back Pain
• Other Study ID Numbers: 230622

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No